Consumer medicine information

Blooms the Chemist Anti-inflammatory Pain Relief Tablets

Diclofenac sodium

BRAND INFORMATION

Brand name

Blooms the Chemist Anti-inflammatory Pain Relief Tablets

Active ingredient

Diclofenac sodium

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Blooms the Chemist Anti-inflammatory Pain Relief Tablets.

SUMMARY CMI

BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.

1. Why am I taking this medicine?

BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets contain the active ingredient diclofenac sodium. BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets is used for short-term treatment of the following conditions:

  • painful conditions where swelling is a problem such as back pain, rheumatism, muscle strains, sprains and tendonitis (e.g. tennis elbow)
  • menstrual cramps (period pain)

For more information, see Section 1. Why am I taking this medicine? in the full CMI.

2. What should I know before I take this medicine?

Do not take BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets if you have ever had an allergic reaction to diclofenac or any of the ingredients listed at the end of this leaflet. Do not take if you have had a stomach or intestinal ulcer, bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools), kidney or liver problems, severe heart failure, heart bypass surgery.

Do not take this medicine during the first 6 months of pregnancy, except on doctor's advice. Do not take this medicine during the last 3 months of pregnancy. Use of this medicine during the last 3 months of pregnancy may affect your baby and may delay labour and birth. Use of non-aspirin NSAIDs can increase the risk of miscarriage, particularly when taken close to the time of conception. Tell your doctor if you are breastfeeding or wish to breastfeed. Like most NSAID medicines, this medicine is not recommended for use during breastfeeding because it passes into breast milk and may affect your baby.

For more information, see Section 2. What should I know before I take this medicine? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take this medicine?

  • Follow all directions given to you by your doctor and pharmacist carefully.
  • Swallow the tablet whole with a full glass of water or other liquid. Do not chew the tablet.

More instructions can be found in Section 4. How do I take this medicine? in the full CMI.

5. What should I know while taking this medicine?

Things you should do
  • If you become pregnant while taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets, tell your doctor immediately. Your doctor can discuss with you the risk of taking it while you are pregnant.
  • Ensure to keep all your doctor's appointments so that your progress can be checked.
  • If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets.
  • If you get an infection while taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets, tell your doctor.
  • If you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately.
  • If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets.
Things you should not do
  • Do not take any of the following medicines while taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets without first telling your doctor: aspirin (also called ASA or acetylsalicylic acid), other salicylates, other medicines containing diclofenac, ibuprofen and any other NSAID medicines. If you take these medicines together with BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets, they may cause unwanted effects.
  • If you need to take medicine for headache or fever, it is usually okay to take paracetamol. If you are not sure, your doctor or pharmacist can advise you.
  • Do not take to treat any other conditions unless your doctor tells you to.
  • Do not give your medicine to anyone else, even if they have the same condition as you.
Driving or using machines
  • Be careful driving, operating machinery or doing jobs that require you to be alert until you know how BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets affects you. BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets may cause dizziness, drowsiness, spinning sensation (vertigo) or blurred vision in some people. If you have any of these symptoms, do not drive or do anything else that could be dangerous.
Looking after your medicine
  • Keep your tablets in a cool dry place where the temperature stays below 25°C.

For more information, see Section 5. What should I know while taking this medicine? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets. It is important to be aware of them so that you can identify any symptoms if they occur. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets

Active ingredient: diclofenac sodium

Consumer Medicine Information (CMI)

This leaflet provides important information about taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets.

Where to find information in this leaflet:

1. Why am I taking this medicine?
2. What should I know before I take this medicine?
3. What if I am taking other medicines?
4. How do I take this medicine?
5. What should I know while taking this medicine?
6. Are there any side effects?
7. Product details

1. Why am I taking this medicine?

BLOOMS THE CHEMIST Anti-Inflammatory Pain Relief tablets contain the active ingredient diclofenac sodium. It belongs to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines can relieve the symptoms of pain and inflammation, but they will not cure your condition.

This medicine is taken to treat pain and reduce inflammation (swelling and redness) that may occur in the following:

  • painful conditions where swelling is a problem such as back pain, rheumatism, muscle strains, sprains and tendonitis (e.g. tennis elbow)
  • menstrual cramps (period pain).

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why it has been prescribed for you. Your doctor may have prescribed it for another purpose.

This medicine is only available with a doctor's prescription.

This medicine is not addictive.

2. What should I know before I take this medicine?

Warnings

Do not take this medicine if:

  • you are allergic (hypersensitive) to:
    - diclofenac, or any of the ingredients listed at the end of this leaflet
    - other medicines containing diclofenac
    - aspirin
    - ibuprofen
    - any other NSAID medicines.

If you are not sure if you are taking any of the above medicines, ask your doctor or pharmacist.

Some of the symptoms of an allergic reaction may include:

  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema)
  • Rash, itching or hives on the skin.

Many medicines used to treat headache, period pain and other aches and pains contain aspirin or NSAID medicines. If you are allergic to aspirin or NSAID medicines and take this medicine, these symptoms may be severe.

Do not take this medicine if you have had any of the following medical conditions:

  • A stomach or intestinal ulcer
  • Bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools)
  • Kidney or liver problems
  • Severe heart failure
  • Heart bypass surgery.

Do not take this medicine during the first 6 months of pregnancy, except on doctor's advice. Do not take during the last 3 months of pregnancy. Use of this medicine during the last 3 months of pregnancy may affect your baby and may delay labour and birth.

Use of non-aspirin NSAIDs can increase the risk of miscarriage, particularly when taken close to the time of conception.

Do not take this medicine if the expiry date printed on the carton has passed. Do not take this medicine if the packaging is torn or shows signs of tampering.

Do not give this medicine to a child under 14 years of age. This medicine is not recommended for use in children, there is not enough information on its use in this age group.

Tell your doctor if you have any medical conditions, especially the following:

  • Established disease of the heart or blood vessels (also called cardiovascular disease, including uncontrolled high blood pressure, congestive heart failure, established ischemic heart disease, peripheral arterial disease or atherosclerotic cardiovascular disease), as treatment with this medicine is generally not recommended. You must not take this medicine if you have heart failure.
  • Established cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in your blood, diabetes, or if you smoke.
  • A past history of ulcers (stomach or intestinal)
  • Gastrointestinal problems such as stomach ulcer, bleeding or black stools, or have experienced stomach discomfort or heartburn after taking anti-inflammatory medicines in the past
  • Diseases of the bowel or inflammation of the intestinal tract (Crohn's disease) or colon (ulcerative or ischemic colitis)
  • Liver or kidney problems
  • A rare liver condition called porphyria
  • Bleeding disorders or other blood disorders (e.g. anaemia)
  • Asthma or any other chronic lung disease that causes difficulty in breathing
  • Hay fever (seasonal allergic rhinitis)
  • Repeated chest infections
  • Polyps in the nose
  • Diabetes
  • Dehydration (e.g. by sickness, diarrhoea, before or after recent major surgery)
  • Swollen feet.

Your doctor may want to take special care if you have any of these conditions.

It is generally important to take the lowest dose that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk for heart problems or high blood pressure as small as possible.

Tell your doctor if you currently have an infection.

If you take this medicine while you have an infection, some of the signs of the infection such as pain, fever, swelling and redness may be hidden. You may think, mistakenly, that you are better or that the infection is not serious.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies, especially if you get skin reaction with redness, itching or rash.

If you have not told your doctor about any of the above, tell your doctor before taking this medicine.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

There is not enough information to recommend this medicine during the first 6 months of pregnancy and it must not be used during the last 3 months. This medicine may also reduce fertility and affect your chances of becoming pregnant. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breastfeeding or wish to breastfeed. Like most NSAID medicines, this medicine is not recommended for use during breastfeeding because this medicine passes into breast milk and may affect your baby.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

You may need to take different amounts of your medicine or to take different medicines while you are taking this medicine. Your doctor and pharmacist have more information.

Some medicines may interfere with this medicine and affect how it works:

  • Other anti-inflammatory medicines, e.g. aspirin, salicylates or ibuprofen
  • Warfarin or other "blood thinners" (medicines used to prevent blood clotting)
  • Digoxin (medicine for heart problems)
  • Lithium or selective serotonin - reuptake inhibitors (SSRIs), medicines used to treat some types of depression
  • Diuretics (medicines used to increase the amount of urine)
  • ACE inhibitors or beta-blockers (medicines used to treat high blood pressure, heart conditions, glaucoma and migraine)
  • Prednisone, cortisone, or other corticosteroids (medicines used to provide relief for inflamed areas of the body)
  • Medicines (such as metformin) used to treat diabetes, except insulin
  • Methotrexate (a medicine used to treat arthritis and some cancers)
  • Ciclosporin and tacrolimus (medicines used in patients who have received organ transplants)
  • Trimethoprim (a medicine used to treat urinary tract infections)
  • Some medicines used to treat infection (quinolone antibacterials)
  • Glucocorticoid (a medicine used to treat arthritis)
  • Sulfinpyrazone (a medicine used to treat gout)
  • Voriconazole (a medicine used to treat fungal infections)
  • Phenytoin (a medicine used to treat seizures)
  • Rifampicin (an antibiotic medicine used to treat bacterial infections).

4. How do I take this medicine?

How much to take

Follow all directions given to you by your doctor and pharmacist carefully.

These instructions may differ from the information contained in this leaflet.

If you do not understand the instructions on the carton, ask your doctor or pharmacist for help.

There are different ways to take this medicine depending upon your condition. Your doctor will tell you exactly how many tablets to take.

Elderly patients should take the minimum number of tablets that provides relief of symptoms. Elderly patients may be more sensitive to the effects of this medicine than other adults.

Adults: The usual dosage is one or two tablets two or three times a day when necessary. Do not take more than eight tablets in 24 hours.

Not recommended for use in children.

Do not exceed the recommended dose.

When to take this medicine

It is recommended to take this medicine before meals or on an empty stomach. If they upset your stomach, you can take them with food or immediately after food.

They will work more quickly if you take them on an empty stomach, but they will still work if you have to take them with food to prevent stomach upset.

How to take this medicine

Swallow the tablets whole with a full glass of water. Do not chew them. The tablets have a special coating to keep them from dissolving until they have passed through the stomach into the bowel. Chewing the tablets would destroy the coating.

How long to take this medicine

This medicine should only be taken when necessary. It should not be taken on a regular basis.

This medicine is for short term use only. If pain persists for more than 3 days, please see your doctor.

If you forget to take this medicine

If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed. This may increase the chance of you getting unwanted side effects.

Ask your doctor or pharmacist if you are not sure what to do.

If you take too much of this medicine

If you think that you have taken too much of this medicine, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much of this medicine, you may experience:

  • vomiting
  • bleeding from the stomach or bowel
  • diarrhoea
  • dizziness
  • ringing in the ears
  • convulsions (fits).

5. What should I know while taking this medicine?

Things you should do

If you take this medicine for more than a few weeks, you should make sure you visit your doctor for regular check-ups to ensure that you are not suffering from unnoticed undesirable side effects.

If you become pregnant while taking this medicine, tell your doctor immediately. Your doctor can discuss with you the risk of taking it while you are pregnant.

Be sure to keep all your doctor's appointments so that your progress can be checked.

Your doctor will periodically re-evaluate whether you should continue treatment, if you have established heart disease or significant risks for heart disease, especially in case you are treated for more than 4 weeks.

Your doctor may want to check your kidneys, liver and blood from time to time to help prevent unwanted side effects.

If, at any time while taking this medicine you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness, or slurring of speech, contact your doctor immediately. These may be signs of cardiovascular toxicity.

If you plan to have surgery, including dental surgery, tell your doctor or dentist that you are taking this medicine. NSAID medicines can slow down blood clotting and affect kidney function.

If you get an infection while taking this medicine, tell your doctor. This medicine may hide some of the signs of an infection (pain, fever, swelling, redness). You may think, mistakenly, that you are better or that the infection is not serious.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine. Tell any other doctors, dentists and pharmacists who are treating you that you are taking this medicine.

Things you should not do

Do not take any of the following medicines while you are taking this medicine without first telling your doctor:

  • Aspirin (also called ASA or acetylsalicylic acid)
  • Other salicylates
  • Other medicines containing diclofenac
  • Ibuprofen
  • Any other NSAID medicines.

If you take these medicines together with this medicine, they may cause unwanted effects.

If you need to take medicine for headache or fever, it is usually okay to take paracetamol. If you are not sure, your doctor or pharmacist can advise you.

Do not take this medicine to treat any other conditions unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful driving, operating machinery or doing jobs that require you to be alert until you know how this medicine affects you. This medicine may cause dizziness, drowsiness, spinning sensation (vertigo) or blurred vision in some people. If you have any of these symptoms, do not drive or do anything else that could be dangerous.

Looking after your medicine

Follow the instructions on the carton on how to take care of your medicine properly.

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Store your tablets in a cool dry place where the temperature stays below 25°C. Store away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to take this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not take this medicine after the expiry date.

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.

Like all other medicines, this medicine may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age, you may have an increased chance of getting side effects. Report any side effects to your doctor. As people grow older, they are more likely to get side effects from medicines.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Less serious side effects

Less serious side effectsWhat to do
  • Stomach upset including nausea (feeling sick), vomiting, indigestion, cramps, loss of appetite, wind
  • Heartburn or pain behind or below the breastbone (possible symptoms of an ulcer in the tube that carries food from the throat to the stomach)
  • Stomach or abdominal pain
  • Constipation, diarrhoea
  • Sore mouth or tongue
  • Altered taste sensation
  • Headache
  • Dizziness, spinning sensation
  • Drowsiness, disorientation, forgetfulness
  • Feeling depressed, anxious or irritable
  • Strange or disturbing thoughts or moods
  • Shakiness, sleeplessness, nightmares
  • Tingling or numbness of the hands or feet
  • Feeling of fast or irregular heartbeat
  • Unusual weight gain or swelling of arms, hands, feet, ankles or legs due to fluid build-up
  • Symptoms of sunburn (such as redness, itching, swelling, blistering of the lips, eyes, mouth, and/or skin) that happen more quickly than normal
  • Skin inflammation with flaking or peeling
  • Vision disorders (e.g. blurred or double vision). If symptoms of vision disorders occur during treatment with this medicine, contact your doctor as an eye examination may be considered to exclude other causes
  • Buzzing or ringing in the ears, difficulty hearing
  • Hypertension (high blood pressure)
  • Hair loss or thinning.
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.
  • NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal anastomotic leak.
Close medical surveillance and caution are recommended when taking this medicine after gastrointestinal surgery.

Serious side effects

Serious side effectsWhat to do
  • Red or purple skin (possible signs of blood vessel inflammation)
  • Severe pain or tenderness in the stomach, vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea (possible stomach problems)
  • Rash, skin rash with blisters, itching or hives on the skin; swelling of the face, lips, mouth, tongue, throat, or other part of the body which may cause difficulty to swallow, low blood pressure (hypotension), fainting, shortness of breath (possible allergic reaction)
  • Wheezing, troubled breathing, or feelings of tightness in the chest (signs of asthma)
  • Yellowing of the skin and/or eyes (signs of hepatitis/ liver failure)
  • Persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the upper right abdomen, dark urine or pale bowel motions (possible liver problems)
  • Constant "flu-like" symptoms including chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy, bleeding or bruising more easily than normal (possible blood problems)
  • Painful red areas, large blisters, peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals, which may be accompanied by fever and chills, aching muscles and feeling generally unwell (possible serious skin reaction)
  • Signs of a possible effect on the brain, such as sudden and severe headache, stiff neck (signs of viral meningitis), severe nausea, dizziness, numbness, difficulty in speaking, paralysis (signs of cerebral attack), convulsions (fits)
  • Change in the colour or amount of urine passed, frequent need to urinate, burning feeling when passing urine, blood or excess protein in the urine (possible kidney disorders)
  • Sudden and oppressive chest pain may be a sign of myocardial infarction or heart attack
  • Breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure)
  • Coincidental occurrence of chest pain and allergic reactions (signs of Kounis syndrome).
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What this medicine contains

Active ingredient
(main ingredient)
  • diclofenac sodium
Other ingredients
(inactive ingredients)
  • colloidal anhydrous silica
  • cellulose microcrystalline
  • lactose monohydrate
  • magnesium stearate
  • maize starch
  • povidone
  • hypromellose
  • iron oxide yellow
  • titanium dioxide
  • sodium starch glycollate A
  • purified talc
  • PEG-40 hydrogenated castor oil
  • EUDRAGIT L30D-55 (PI 3700)
  • triethyl citrate
Potential allergensContains sugars as lactose. May contain traces of sulfites.

Do not take this medicine if you are allergic to any of these ingredients.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

What this medicine looks like

Round, pale yellow, enteric coated tablets plain on both sides.

AUST R 287705

Blister pack containing 10, 20 and 30* tablets.

*Not all pack sizes are available.

Who distributes this medicine

Arrotex Pharmaceuticals Pty Ltd
15 - 17 Chapel Street,
Cremorne, VIC 3121
arrotex.com.au

This leaflet was prepared in February 2025.

Published by MIMS April 2025

BRAND INFORMATION

Brand name

Blooms the Chemist Anti-inflammatory Pain Relief Tablets

Active ingredient

Diclofenac sodium

Schedule

S3

 

1 Name of Medicine

Diclofenac sodium.

2 Qualitative and Quantitative Composition

Each tablet contains diclofenac sodium 25 mg as the active ingredient.

Excipients with known effect.

Lactose monohydrate.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

25 mg.

Tablets.
Pale yellow, round, enteric coated tablets plain on both sides.

4 Clinical Particulars

4.1 Therapeutic Indications

Relief of acute pain states in which there is an inflammatory component.
Symptomatic treatment of primary dysmenorrhoea.

4.2 Dose and Method of Administration

Diclofenac enteric coated tablets are intended for oral administration.

Dosage.

After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. Adverse effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4 Special Warnings and Precautions for Use).

Adults.

The usual dosage is 25 to 50 mg two to three times a day when necessary. The tablets should be swallowed whole, with or immediately after food with liquid and must not be divided or chewed.
In primary dysmenorrhoea the daily dosage, which should be individually adapted, is generally 50 to 150 mg. Initially a dose of 50 to 100 mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started upon appearance of the first symptoms and, depending on the symptomatology, continued for a few days.

Paediatric use.

Diclofenac is not recommended for use in children.

Pregnancy.

See Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation.

4.3 Contraindications

Gastric or duodenal ulcer, gastro-intestinal bleeding or perforation.
Patients who are hypersensitive to the active ingredient, diclofenac, or any of the excipients contained in the tablets.
Last trimester of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Patients with severe hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use).
Renal failure (see Section 4.4 Special Warnings and Precautions for Use).
Severe cardiac failure (see Section 4.4 Special Warnings and Precautions for Use).
Treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria or other allergic-type reactions, because severe, rarely fatal, anaphylactic type reactions to diclofenac have been reported in such patients.

4.4 Special Warnings and Precautions for Use

Cardiovascular thrombotic events.

Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events including myocardial infarction and stroke, which may increase with dose or duration of use. Patients with cardiovascular disease, history of atherosclerotic cardiovascular disease or cardiovascular risk factors may also be at greater risk (see Section 4.2 Dose and Method of Administration).
Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) should be treated with diclofenac only after careful consideration and only at doses ≤ 100 mg daily when treatment continues for more than 4 weeks.
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used for the shortest duration possible. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment continues for more than 4 weeks.
Physicians and patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be informed about signs and/or symptoms of serious cardiovascular toxicity and be instructed to see a physician immediately in case of such an event.
There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.

Hypertension.

NSAIDs may lead to the onset of new hypertension or worsening of pre-existing hypertension and patients taking anti-hypertensives with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.

Heart failure.

Fluid retention and oedema have been observed in some patients taking NSAIDs, including diclofenac, therefore caution is advised in patients with fluid retention or heart failure.

Gastrointestinal effects.

Close medical surveillance is imperative and particular caution should be exercised when prescribing NSAIDs, including diclofenac, in patients with symptoms indicative of gastrointestinal disorders (GI) or with a history suggestive of gastro-intestinal ulceration, bleeding or perforation (see Section 4.8 Adverse Effects (Undesirable Effects)).
Upper GI ulcers, gross bleeding or perforation caused by NSAIDs, including diclofenac, occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. The risk of GI bleeding is higher with increasing NSAID doses, with increasing duration of use and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.
Gastric or duodenal ulceration, perforation or gastrointestinal bleeding, which can be fatal, have been reported in patients receiving diclofenac. Studies to date have not identified any subset of patients who are not at risk of developing these problems.
Caution is advised in patients with risk factors for gastrointestinal events who may be at greater risk of developing serious gastrointestinal events, e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism.
The concurrent use of aspirin and NSAIDs, including diclofenac, also increases the risk of serious gastrointestinal adverse events.
To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose. Gastrointestinal bleeding, ulceration and perforation in general have more serious consequences in the elderly. They can occur at any time during treatment with or without warning symptoms or a previous history. In instances where gastrointestinal bleeding or ulcerations occur in patients receiving diclofenac, the drug should be withdrawn immediately. Physicians should warn patients about the signs and symptoms of serious gastrointestinal toxicity and what steps to take if they occur.
Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid (ASA)/aspirin or other medicinal products likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis, or with Crohn's disease, as well as in patients suffering from pre-existing dyshaemopoiesis or disorders of blood coagulation, as their condition may be exacerbated (see Section 4.8 Adverse Effects (Undesirable Effects)).
NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery.

Serious skin reactions.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS) (see Drug reaction with eosinophilia with systemic symptoms (DRESS)) have been reported very rarely in association with the use of NSAIDs, including diclofenac (see Section 4.8 Adverse Effects (Undesirable Effects)). These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of skin rash, mucosal legion or any other sign of hypersensitivity, and diclofenac should be discontinued.

Drug reaction with eosinophilia with systemic symptoms (DRESS).

DRESS has been reported in patients taking NSAIDs. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue the NSAID and evaluate the patient immediately.

Pre-existing asthma.

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to NSAIDs such as asthma exacerbations (so-called intolerance to analgesics/ analgesics-asthma), Quincke's oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients. This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.

Use in hepatic impairment.

Close medical surveillance is required when prescribing diclofenac to patients with impaired hepatic function, as their condition may be exacerbated (see Section 4.3 Contraindications).
As with other NSAIDs, including diclofenac, elevations of one or more liver enzymes may occur during diclofenac therapy. These laboratory abnormalities may progress, remain unchanged, or revert to normal despite continued therapy. Borderline elevations (i.e. 1.2 to 3 times the upper limit of normal (ULN)), or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients. In clinical trials, meaningful elevations (i.e. more than 3 times the ULN) of AST and/or ALT occurred in about 4% of patients treated for several months, including marked elevations (i.e. more than 8 times the ULN) in about 1% of patients. Transaminase elevations were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis (see Section 4.8 Adverse Effects (Undesirable Effects)).
Transaminase elevations were reversible on cessation of therapy, and even among patients with marked elevations, signs and symptoms of liver disease occurred only in isolated cases. Most patients with borderline elevations did not have therapy interrupted, and transaminase elevations in most of these cases disappeared or did not progress. There were no identifying features to distinguish those patients who developed marked elevations from those who did not.
In addition to the enzyme elevations seen in clinical trials, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, have been reported.
Severe hepatotoxicity may develop without prodromal symptoms, so transaminases should be measured periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the measurements are not known. In most patients who have developed marked transaminase elevations, abnormal tests occurred during the first 2 months of therapy with diclofenac. Based on this experience the first transaminase measurement should be made no later than 8 weeks after the start of diclofenac treatment. As with other NSAIDs, including diclofenac, if abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc.), diclofenac should be discontinued.
To minimise the possibility of hepatic injury becoming severe between transaminase measurements, physicians should inform patients of the warning signs and symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms) and the appropriate action to take should these signs and symptoms appear.
Caution should be exercised when using diclofenac in patients with hepatic porphyria, since diclofenac may trigger an attack.

Use in renal impairment.

As a class, NSAIDs have been associated with renal papillary necrosis and other pathology during long-term administration in animals.
Fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac. Owing to the importance of prostaglandins for maintaining renal blood flow, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, in the elderly, in patients being treated with diuretics or medicinal products that can significantly impact renal function, and in those with extracellular volume depletion from any cause, e.g. in the peri or post-operative phase of major surgical operations (see Section 4.3 Contraindications). Monitoring of renal function as a precautionary measure is therefore recommended when using diclofenac in such cases. Discontinuation of therapy is typically followed by recovery to the pre-treatment state.

Lactose intolerance.

This medicine contains lactose monohydrate and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Combination use of ACE inhibitors or angiotensin receptor antagonist, anti-inflammatory drugs and thiazide diuretics.

The use of an ACE inhibiting drug (ACE-inhibitors or angiotensin receptor antagonist), an anti-inflammatory drug (NSAID or COX-2 inhibitor) and a thiazide diuretic at the same time increases the risk of renal impairment. This includes use in fixed combination products containing more than one class of drug. Combined use of these medications should be accompanied by increased monitoring of serum creatinine, particularly at the institution of the combination. The combination of drugs from these three classes should be used with caution particularly in elderly patients or those with pre-existing renal impairment.

Infection.

Like other NSAIDs, diclofenac may mask the usual signs and symptoms of infection due to its pharmacodynamic properties.

Haematological effects.

Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with haemostatic disorders should be carefully monitored.
During prolonged treatment with diclofenac a slight reduction in haemoglobin has been noted in some patients. On rare occasions, blood dyscrasias have been reported. Periodic blood counts are therefore recommended.

Peri-operative bleeding.

Pre-operative administration of diclofenac may increase the risk of post-operative bleeding.
Since diclofenac may temporarily inhibit platelet aggregation, children undergoing minor procedures such as tonsillectomy, myringotomy, circumcision, orchidopexy and strabismus surgery should be carefully monitored.

Hypersensitivity.

As with NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, have been reported with diclofenac. These reactions can occur without earlier exposure to the drug.

Use in the elderly.

In elderly patients, who are generally more prone to side effects, particular caution should be exercised. It is recommended that the lowest effective dosage be used in elderly patients or those with a low body weight.

Paediatric use.

Diclofenac is not recommended for use in children as safety and efficacy in this age group have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions include those observed with diclofenac and/or other pharmaceutical forms of diclofenac.

Lithium/digoxin.

When given together with preparations containing lithium or digoxin, diclofenac may raise their plasma concentrations and these concentrations should be monitored during treatment with diclofenac.

Diuretics and antihypertensive agents.

Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. When NSAIDs, including diclofenac are combined with diuretics, ACE inhibitors or angiotensin II receptor antagonists, the risk of worsening of renal function, including possible acute renal failure (which is usually reversible) may be increased in some patients, especially when renal function is compromised (e.g. dehydrated or elderly patients). Patients should be adequately hydrated and monitoring of renal function is recommended after initiation of concomitant therapy and periodically thereafter (see Section 4.4 Special Warnings and Precautions for Use, Use in renal impairment).

Other NSAIDs and corticosteroids.

The concomitant use of diclofenac with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects. Concomitant administration of diclofenac and other systemic NSAIDs or corticosteroids may increase the frequency of gastrointestinal undesirable effects. Concurrent treatment with aspirin lowers the plasma concentration, peak plasma levels and AUC values of diclofenac. The use of both drugs concurrently is not recommended.

Anticoagulants and anti-platelet agents.

Caution is recommended since concomitant administration could increase the risk of bleeding (see Section 4.4 Special Warnings and Precautions for Use, Gastrointestinal effects). The concurrent use of NSAIDs and warfarin has been associated with severe, sometimes fatal, haemorrhage. The exact mechanism of the interaction between NSAIDs and warfarin is unknown, but may involve enhanced bleeding from NSAID-induced gastrointestinal ulceration or an additive effect of anticoagulation by warfarin and inhibition of platelet function by NSAIDs. Diclofenac should be used with caution in combination with warfarin and such patients should be closely monitored.

Selective serotonin reuptake inhibitors (SSRIs).

Concomitant administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see Section 4.4 Special Warnings and Precautions for Use, Gastrointestinal effects).

Antidiabetic agents.

Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there are isolated reports of both hypoglycaemic and hyperglycaemic effects in the presence of diclofenac which necessitated changes in the dosage of the antidiabetic agents. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.
There have also been isolated reports of metabolic acidosis when diclofenac was co-administered with metformin, especially in patients with pre-existing renal impairment.

Methotrexate.

Caution should be exercised when NSAIDs, including diclofenac, are administered less than 24 hours before or after treatment with methotrexate, since the blood concentration of methotrexate may rise and the toxicity of this substance be increased.

Cyclosporin and tacrolimus.

Nephrotoxicity of cyclosporin may be enhanced through effects of NSAIDs, including diclofenac, on renal prostaglandins. Therefore, diclofenac should be given at doses lower than those that would be used in patients not receiving cyclosporin or tacrolimus.

Drugs known to cause hyperkalemia.

Concomitant treatment with potassium-sparing drugs (e.g. diuretics, cyclosporin, tacrolimus or trimethoprim) may be associated with increased serum potassium levels, which should therefore be monitored frequently (see Section 4.4 Special Warnings and Precautions for Use, Use in renal impairment).

Glucocorticoids.

The addition of glucocorticoids to NSAIDs, though sometimes necessary for therapeutic reasons, may aggravate gastrointestinal side effects.

Quinolone antibacterials.

There have been isolated reports of convulsions which may have been due to concomitant use of quinolones and NSAIDs.

Potent CYP2C9 inhibitors.

Caution is recommended when co-prescribing diclofenac with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentrations and exposure to diclofenac due to inhibition of diclofenac metabolism. Concomitant administration of voriconazole with diclofenac may increase plasma diclofenac levels.

CYP2C9 inducers.

Caution is recommended when co-prescribing diclofenac with CYP2C9 inducers (such as rifampicin), which could result in a significant decrease in plasma concentration and exposure to diclofenac.

Phenytoin.

When using phenytoin concomitantly with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered.
(Category C)
NSAIDs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the foetal ductus arteriosus, foetal renal impairment, inhibition of platelet aggregation, and delay labour and birth.
The use of diclofenac in pregnant women has not been studied and safety in pregnancy has not been established. Therefore, diclofenac should not be used in pregnant women during the first two trimesters or in women who are likely to become pregnant unless the potential benefit to the mother outweighs the risk to the foetus. Use of diclofenac during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia, fetal renal impairment with subsequent oligohydramnios and/or premature closure of the ductus arteriosus (see Section 4.3 Contraindications).
Data from epidemiological studies suggest an increased risk of miscarriage after the use of a prostaglandin synthesis inhibitor in early pregnancy.

Oligohydramnios and neonatal renal impairment.

Use of NSAIDs from about 20 weeks gestation may cause foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some post-marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. If, after careful consideration of alternative treatment options for pain management, NSAID treatment is necessary from about 20 weeks to the end of the second trimester, limit use to the lowest effective dose and shortest duration possible. Use of diclofenac during the third trimester of pregnancy is contraindicated (see Use in pregnancy (Category C)). Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.
 Following oral doses of 50 mg administered every 8 hours, the active substance, diclofenac, passes into the breast milk. As with other drugs that are excreted in milk, this medicine is not recommended for use in nursing women.

4.7 Effects on Ability to Drive and Use Machines

Patients experiencing visual disturbances, dizziness, vertigo, somnolence or other central nervous disturbances while taking diclofenac should refrain from driving a vehicle or operating machines.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports.
The following undesirable effects include those reported with diclofenac tablets and/or other pharmaceutical forms of diclofenac, with either short-term or long-term use.

Blood and lymphatic system disorders.

Very rare: Thrombocytopenia, leucopenia, anaemia (including haemolytic and aplastic anaemia), agranulocytosis, positive Coombs' test.

Immune system disorders.

Rare: Hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare: Angioneurotic oedema (including face oedema).

Psychiatric disorders.

Very rare: Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders.

Common: Headache, dizziness.
Rare: Somnolence.
Very rare: Paraesthesia, memory impairment, convulsion, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident, myoclonic encephalopathy (described in two patients).

Eye disorders.

Very rare: Visual disturbance, vision blurred, diplopia.

Ear and labyrinth disorders.

Common: Vertigo.
Very rare: Tinnitus, hearing impaired.

Cardiac disorders.

Uncommon*: Myocardial infarction, cardiac failure, palpitations, chest pain.
Frequency unknown: Kounis syndrome.

Vascular disorders.

Very rare: Hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders.

Rare: Asthma (including dyspnoea).
Very rare: Pneumonitis.

Gastrointestinal disorders.

Common: Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Rare: Gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhoea, melaena, gastrointestinal ulcer (with or without bleeding or perforation), gastrointestinal stenosis, or perforation, which may lead to peritonitis.
Very rare: Colitis (including haemorrhagic colitis, ischemic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis, glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Hepatobiliary disorders.

Common: Transaminases increased.
Rare: Hepatitis, jaundice, liver disorder.
Very rare: Fulminant hepatitis, hepatic necrosis, hepatic failure.

Pregnancy, puerperium and perinatal conditions.

Unknown: Oligohydramnios, neonatal renal impairment.

Skin and subcutaneous tissue disorders.

Common: Rashes or skin eruptions.
Rare: Urticaria.
Very rare: Bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.
Unknown: Drug Reaction with Eosinophilia with Systemic Symptoms (DRESS).

Renal and urinary disorders.

Very rare: Acute kidney injury (acute renal failure), haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions.

Common: Application site irritation.
Rare: Oedema.
Very rare: Impotence (association with diclofenac intake is doubtful). Toxic shock syndrome has been reported in patients administered NSAIDs post-operatively.
* The frequency reflects data from long-term treatment with a high dose (150 mg/day).

Description of selected adverse drug reactions.

Arteriothrombotic events.

Meta-analysis and pharmacoepidemiological data point towards an increased risk of arteriothrombotic events (for example myocardial infarction) associated with the use of diclofenac, particularly at a high dose (150 mg daily) and during long-term treatment (see Section 4.4 Special Warnings and Precautions for Use). A recent meta-analysis (CNT) estimates that, in comparison with placebo, allocation to diclofenac caused around 3 additional major vascular events per 1000 participants per year. This estimate reflects data from long term treatment with high dose diclofenac (150 mg/day).

Visual effects.

Visual disturbances such as visual impairment, blurred vision or diplopia appear to be NSAID class effects and are usually reversible on discontinuation. A likely mechanism for the visual disturbances is the inhibition of prostaglandin synthesis and other related compounds that alter the regulation of retinal blood flow resulting in potential changes in vision. If such symptoms occur during diclofenac treatment, an ophthalmological examination may be considered to exclude other causes.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems and contact Arrotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.9 Overdose

Management of acute poisoning with NSAIDs, including diclofenac, consists essentially of supportive measures and symptomatic treatment. There is no typical clinical picture resulting from an overdosage of diclofenac. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube, once the airway is protected.
Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Haematological and biochemical parameters, and the presence or absence of blood in the stools, should be monitored.
Specific therapies such as forced diuresis, dialysis, or haemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, because of their high protein-binding rate and extensive metabolism.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Diclofenac sodium, a non-steroidal compound, exhibits pronounced antirheumatic, anti-inflammatory, analgesic, and antipyretic properties.
As with other NSAIDs, its mode of action is not known; however, its ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.
In rheumatic diseases, the anti-inflammatory and analgesic properties of diclofenac elicit a clinical response characterised by relief from signs and symptoms such as pain at rest, pain on movement, morning stiffness, and swelling of the joints, as well as by an improvement in function.
In addition, clinical studies have revealed that in primary dysmenorrhoea diclofenac is capable of relieving the pain and reducing the extent of bleeding. Low concentrations of diclofenac sodium inhibit the aggregation of platelets induced in vitro by collagen and by adenosine diphosphate. Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in canine cartilage at concentrations equivalent to the concentrations reached in humans. It is unknown whether or not diclofenac sodium affects the integrity of human osteoarthritic cartilage.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Diclofenac is completely absorbed from the enteric coated tablets after their passage through the stomach. Following ingestion of one tablet with or after a meal, its passage through the stomach is slower than when it is taken before a meal, but the amount of active substance absorbed remains the same. In fasting subjects, the mean peak plasma concentration of 1.5 microgram/mL (5 micromol/litre) is attained on average 2 hours after ingestion of one tablet of 50 mg. The plasma concentrations, as measured by the area under the time-concentration curve, are in linear relation to the size of the dose.

Distribution.

Diclofenac becomes bound to serum proteins to the extent of 99.7%, chiefly to albumin (99.4%).

Metabolism.

Following oral or rectal administration, about half the active substance is metabolised during its first passage through the liver ("first pass" effect). The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

Excretion.

The total systemic clearance of diclofenac in plasma is 263 + 56 mL/min (mean value + SD). The terminal half-life in plasma is 1 to 2 hours.
After administration of diclofenac for 15 days in an oral dose of 25 mg three times daily, there was no evidence of drug accumulation in plasma.
In a study in 16 patients with rheumatoid arthritis and knee joint effusions it was found that diclofenac enters the synovial fluid, where maximum concentrations were measured 2 to 4 hours after oral administration. The apparent half-life for elimination from the synovial fluid was 3 to 6 hours. Only 4 to 6 hours after administration, therefore, concentrations of the active substance were already higher in the synovial fluid than they were in the plasma and remained higher for up to 12 hours. These results could possibly explain that the duration of clinical effect is longer than might be inferred from the short plasma half-life of diclofenac.
About 60% of the administered dose is excreted in the urine in the form of metabolites from one of these two processes. Less than 1% is excreted as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.
No relevant age-dependent differences in the drug's absorption, metabolism or excretion have been observed.
In patients suffering from renal impairment, no accumulation of the unchanged active substance could be inferred from the single-dose kinetics when applying the usual dosage schedule. At a creatinine clearance of < 10 mL/min, the theoretical steady-state plasma levels of metabolites are about four times higher than in normal subjects. However, the metabolites appear to be satisfactorily cleared through the bile.
In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis), the kinetics and metabolism of diclofenac were the same as in patients without liver disease.

5.3 Preclinical Safety Data

Genotoxicity.

Diclofenac showed no mutagenic effects in the studies conducted.

Carcinogenicity.

Dietary administration of diclofenac to mice and rats at doses up to 0.5 mg/kg/day revealed no carcinogenic activity. However, the plasma concentration of diclofenac at this dose level was 20 to 100 times lower than that in humans. Administration of higher doses to rats and mice resulted in increased mortality due to gastrointestinal ulceration. Diclofenac showed no mutagenic or carcinogenic effects in the studies conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

Colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, povidone, hypromellose, iron oxide yellow, titanium dioxide, sodium starch glycollate type A, purified talc, PEG-40 hydrogenated castor oil, Eudragit L30D-55 (PI 3700), triethyl citrate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Blooms the Chemist Anti-Inflammatory Pain Relief enteric coated tablets.
25 mg: Tablets.
Blister pack (Alu/PVC or Alu/PVC/PVdC) of 10, 20 and 30 tablets.
AUST R 287705.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The active ingredient of this medicine is diclofenac sodium, a phenylacetic acid derivative, structurally similar to both the phenylalkanoic acid and the anthranilic acid series of compounds. Diclofenac sodium is an odourless, yellowish-white, crystalline powder sparingly soluble in water.

Chemical structure.


Chemical name: sodium-2-[(2,6-dichlorophenyl)-amino] phenyl]-acetate.
Molecular weight: 318.1.
Molecular formula: C14H10Cl2NNaO2.

CAS number.

15307-79-5.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes