Consumer medicine information

APOHealth Anti-inflammatory Pain Relief Rapid 25

Diclofenac potassium

BRAND INFORMATION

Brand name

APOHealth Anti-inflammatory Pain Relief Rapid 25

Active ingredient

Diclofenac potassium

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APOHealth Anti-inflammatory Pain Relief Rapid 25.

FULL CMI

APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25

Active ingredient: diclofenac potassium

Consumer Medicine Information (CMI)

This leaflet provides important information about using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25.

Where to find information in this leaflet:

1. Why am I using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?
2. What should I know before I use APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?
3. What if I am taking other medicines?
4. How do I use APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?
5. What should I know while using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?
6. Are there any side effects?
7. Product details

1. Why am I using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?

APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 contains the active ingredient diclofenac potassium. APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAID). It relieves pain and reduces inflammation (swelling and redness).

It is used for short-term treatment of the following conditions:

  • migraine headaches and it may also relieve the accompanying symptoms, such as nausea and vomiting, which you sometimes experience when you have a migraine
  • relief of menstrual cramps (period pain)
  • short-term treatment (up to 1week) of other painful conditions where swelling is a problem such as back or joint pain, dental pain, muscle strains or sprains and tendonitis (e.g. tennis elbow).

APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 can relieve the symptoms of pain and inflammation but it will not cure your condition.

2. What should I know before I use APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?

Warnings

Do not use APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 if:

  • you have a stomach or intestinal ulcer
  • you have bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools)
  • you have kidney or liver problems
  • you have severe heart failure
  • you have heart bypass surgery
  • you are under 14 years of age
  • you are allergic to diclofenac (the active ingredient of APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25), other medicines containing diclofenac, aspirin, ibuprofen, any other NSAID or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine. 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 or other parts of the body
  • 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 you take APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, these symptoms may be severe.

Check with your doctor or pharmacist if you have any other medical conditions including:

  • 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 APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 is generally not recommended.
  • 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, and your doctor decides to prescribe APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, you must not increase the dose above 100 mg per day if you are treated for more than 4 weeks.
  • 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
  • If you take APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 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.
  • take any medicines for any other condition
  • Your doctor may want to take special precautions if you have any of the above conditions. It is generally important to take the lowest dose of APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 that relieves your pain and/or swelling and for the shortest time possible in order to keep your risk for cardiovascular side effects as small as possible.
  • You are allergic to any other medicines, foods, dyes or preservatives. Your doctor will want to know of you are prone to allergies, especially if you get skin reactions with redness, itching or rash.

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

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.

Do not take APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 during the first 6 months of pregnancy, except on doctor's advice. Do not use 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.

APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 may also reduce fertility and affect your chances of becoming pregnant. Your doctor can discuss with you the risks and benefits involved.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Breast-feeding is not recommended while you are using this medicine. The active ingredient in APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 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.

Some medicines may interfere with APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 and affect how it works. Some medicines that are important to mention include:

  • other anti-inflammatory medicines, e.g. aspirin, salicylates or ibuprofen
  • warfarin or other "blood thinners" (medicines used to prevent blood clotting)
  • digoxin (a medicine for your 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 betablockers (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)
  • cyclosporin, tacrolimus (a medicine used in patients who have received organ transplants)
  • trimethoprim (a medicine used to prevent or treat urinary tract infections)
  • some medicines used to treat infection (quinolone antibacterials)
  • glucocorticoid medicines, 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).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25.

4. How do I use APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?

How much to take

Follow all directions given to you by your pharmacist or doctor carefully. These instructions may differ from the information contained in this leaflet.

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

  • Do not exceed the recommended dosage.

Take the lowest dose that relieves your pain and/or swelling. Stop taking as soon as symptoms are relieved.

For most painful conditions:

Adults (According to pain): Take 1-2 tablets initially, followed by 1-2 tablets at 8 hourly intervals.

Children over 14 years:

Take 1-2 tablets initially, followed by 1 tablet at 8 hourly intervals.

For menstrual pain (period pain): Take 2 tablets at the first sign of symptoms, then 2 tablets up to three times daily for the next 3 days if required.

For migraine: Take 2 tablets at the first sign of a migraine attack. If the pain is not relieved within 2 hours, a further 1 to 2 tablets may be taken. After that dose, you must wait at least 4 hours before taking any more APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25. For migraine attack do not take more than 8 tablets per day even if you have more than one migraine attack within that 24 hour period.

Do not take more than 8 tablets in 24 hours, for relief of any of the above conditions. Do not take for longer than 3 days at a time unless on the advice of a healthcare professional.

If symptoms persist or worsen, see your doctor to ensure that they are not due to a serious illness. The use of APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 could mask potentially serious infections.

How to take APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25

Swallow the tablets with a full glass of liquid.

Take the tablets on an empty stomach (at least half an hour before food or two hours after food). They will work more quickly if you take them on an empty stomach. If they upset your stomach, take the tablets with food.

Do not lie down for about 15 to 30 minutes after taking the tablets. This helps them reach your stomach quickly and prevents throat irritation, which could lead to problems with swallowing.

If you forget to take APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25

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

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25

If you think that you have used too much APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26 in Australia; 0800 POISON OR 0800 764 766 in New Zealand for advice), 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 APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, you may experience:

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

5. What should I know while using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25?

Things you should do

If you become pregnant while taking APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, tell your doctor immediately.

Your doctor can discuss with you the risks of taking it while you are pregnant.

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

Your doctor will periodically re-evaluate whether you should continue treatment with APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, 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 APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 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 are going to have surgery, make sure the surgeon and anaesthetist know that you are taking APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25.

NSAID medicines can slow down blood clotting and affect kidney function.

If you get an infection while taking APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, 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 APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25.

Elderly patients should take the minimum number of tablets that provides relief of symptoms.

Elderly patients, especially those with a low body weight, may be more sensitive to the effects of APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 than other adults.

Remind any doctor, dentist or pharmacist you visit that you are using APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25.

Things you should not do

Do not take any of the following medicines while you are taking APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 without first telling your doctor:

  • aspirin (also called ASA or acetylsalicylic acid), or other salicylates
  • other medicines containing diclofenac
  • ibuprofen
  • any other NSAID medicine

If you take these medicines together with APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, they may cause unwanted side effects.

If you need to take something 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 give this medicine to anyone else, even if their condition seems similar to yours.

Do not use it to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 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, use machines, or carry out other activities that need careful attention.

Looking after your medicine

Keep your medicine in the original container until it is time to take it.

Store it in a cool dry place.

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

Store it in a cool dry place 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.

A locked cupboard at least one and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

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

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your doctor.

As people grow older, they are more likely to get side effects from medicines.

Do not be alarmed by these lists of possible side effects. You may not experience any of them.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

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 heart-beat
  • 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)
  • 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 using this medicine after gastrointestinal surgery.

If symptoms of vision disorders occur during treatment with APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25, contact your doctor as an eye examination may be considered to exclude other causes.

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 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 problem)
  • 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)
  • a change in the colour or amount of urine passed, frequent need to urinate, burning feeling when passing urine, blood or excess of protein in the urine (possible kidney disorders)
  • sudden and oppressive chest pain (which may be a sign of myocardial infarction or a 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 APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 contains

Active ingredient
(main ingredient)		Diclofenac potassium
Other ingredients
(inactive ingredients)		Magnesium stearate, hypromellose, macrogol 6000, sodium lauryl sulfate, mannitol, crospovidone, potassium bicarbonate, macrogol 400

APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 does not contain lactose, gluten, sugar, preservative, color, sulfite, tartrazine or any other azo dyes.

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

What APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25 looks like

APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25mg tablets are white to off-white, circular, biconvex film-coated tablets. Blister packs of 4, 5, 6, 10, 20 and 30 tablets (Aust R 407498).

Who distributes APOHEALTH ANTI-INFLAMMATORY PAIN RELIEF RAPID 25

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrowpharma.com.au

This leaflet was prepared in April 2023.

Published by MIMS May 2024

BRAND INFORMATION

Brand name

APOHealth Anti-inflammatory Pain Relief Rapid 25

Active ingredient

Diclofenac potassium

Schedule

S3

 

1 Name of Medicine

Diclofenac potassium.

2 Qualitative and Quantitative Composition

APOHealth Anti-inflammatory Pain Relief Rapid 25 contains potassium-[2-{(2,6-dichlorophenyl)-amino}-phenyl]-acetate (= diclofenac potassium). Diclofenac potassium is a white or slightly yellowish, crystalline powder, slightly hygroscopic, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, slightly soluble in acetone.
APOHealth Anti-inflammatory Pain Relief Rapid 25 tablets contain 25 mg of diclofenac potassium.

Excipient with known effect.

Contains 7.21 mg potassium per tablet.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off-white, circular, biconvex film-coated tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

As short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component.
Treatment of acute migraine attacks (with or without aura).
Symptomatic treatment of primary dysmenorrhoea.

4.2 Dose and Method of Administration

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 minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4 Special Warnings and Precautions for Use). Patients on long term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.
The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.

Adults.

Acute pain states with an inflammatory component.

As a rule, the initial daily dosage for adults is 100 to 150 mg. In milder cases, as well as for children over 14 years of age, 75 to 100 mg daily is usually sufficient. The total daily dosage should generally be prescribed in 2 or 3 fractional doses. Treatment is to continue for a maximum of 7 days. If the pain has not resolved satisfactorily after 7 days' treatment, the patient should be instructed to return for review by the doctor.

Acute migraine.

In migraine, an initial dose of 50 mg should be taken at the first signs of an impending attack. If the pain is not relieved within 2 hours of this initial dose, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6 hours. The total dose to treat an acute migraine should not exceed 200 mg. The total daily dose should not exceed 200 mg. Diclofenac potassium should not be used for migraine prophylaxis.

Symptomatic treatment of primary dysmenorrhoea.

In primary dysmenorrhoea, initially a dose of 50 or 100 mg should be given followed by 50 mg three times daily for 3 days. Treatment should be started upon appearance of the first symptoms and, depending on their duration and severity, continued for up to three days. If the pain has not resolved satisfactorily after 3 days' treatment, the patient should be instructed to return for review by the doctor.
Diclofenac tablets should be taken with liquid, preferably before meals.

Children.

Diclofenac tablets is not recommended for use in children.

4.3 Contraindications

Gastric or duodenal ulcer, gastrointestinal 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).
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, 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 tablets 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 tablets 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 gastrointestinal 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 potassium tablets. 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 tablets, 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)).

Serious skin reactions.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac tablets (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 tablets should be discontinued.

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, pruritis or urticaria.

Liver.

Close medical surveillance is required when prescribing diclofenac tablets 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 tablets 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 tablets 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 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.
Severe hepatotoxicity may develop without prodromal symptoms. If, contrary to its recommended use for short term treatment, diclofenac tablets is administered for a more prolonged period, monitoring of hepatic function is indicated as a precautionary measure. 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 tablets should be discontinued.
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 tablets in patients with hepatic porphyria, since diclofenac tablets may trigger an attack.

Kidney.

As a class, NSAIDs have been associated with renal papillary necrosis and other renal pathology during long-term administration in animals.
Fluid retention and oedema have been reported in association with diclofenac tablets therapy. 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 tablets in such cases. Discontinuation of therapy is typically followed by recovery to the pretreatment state.

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 tablets may mask the usual signs and symptoms of infection due to its pharmacodynamic properties.

Haematological effects.

Use of diclofenac tablet is recommended only for short-term treatment. If, however, diclofenac tablet is used for a prolonged period, monitoring of the blood count is recommended.
Like other NSAIDs, diclofenac tablets may temporarily inhibit platelet aggregation. Patients with haemostatic disorders should be carefully monitored.

Use in the elderly.

In patients of advanced age, caution is indicated on basic medical grounds. In particular it is recommended that the lowest effective dosage be used in frail elderly patients or those with low body weight.
Treatment with diclofenac tablets in the elderly usually proves necessary only for a few days.

Hypersensitivity.

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

Mutagenicity, carcinogenicity, and reproduction toxicity studies.

Diclofenac showed no mutagenic, carcinogenic, or teratogenic effects in the studies conducted, despite the induction of maternal and foetal toxicity.

Use in children.

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

Paediatric use.

No data available.

Effects of laboratory tests.

No data available.

Sucrose.

Diclofenac tablets contain sucrose and therefore are not recommended for patients with rare hereditary problems of fructose intolerance, or glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions include those observed with diclofenac tablets 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 tablets.

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, Kidney).

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, ciclosporin, 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, Kidney).

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.

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 tablets 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 tablets 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 tablets 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 tablets 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.
Dysmorphogenic effects (rib defects in 1 rat foetus at 4 mg/kg and in 1 mouse foetus at 1 and 4 mg/kg doses) were observed at 1 of 3 laboratories in which embryogenesis studies were conducted.
 Following oral doses of 50 mg administered every 8 hours, the active substance; diclofenac passes into human milk. As with other drugs that are excreted in milk, diclofenac tablets 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 tablets should refrain from driving a vehicle or operating machines.

4.8 Adverse Effects (Undesirable Effects)

Whilst not all the reactions listed have been reported specifically with diclofenac tablets, similarities between the NSAIDs as a group require them to be considered possible.
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, leucopoenia, 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, blurred vision, diplopia.

Ear and labyrinth disorders.

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

Cardiac disorders.

Uncommon*: Myocardial infarction, cardiac failure, palpitations, chest pain.
* The frequency reflects data from long-term treatment with a high dose (150 mg/day).

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: Elevation of serum aminotransferase (AST, ALT).
Rare: Hepatitis, jaundice, liver disorder.
Very rare: Fulminant hepatitis, hepatic necrosis, hepatic failure.

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.

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.

Rare: Oedema.
Very rare: Impotence (association with diclofenac tablet intake is doubtful).

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Management of acute poisoning with NSAIDs, including diclofenac, consists essentially of supportive and symptomatic measures. 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. The therapeutic measures to be taken in cases of overdosage are as follows:
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 and extensive metabolism.
Contact the Poisons Information Centre on 13 11 26 for advice on management.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Diclofenac tablet is a non-steroidal anti-inflammatory drug (NSAID) and contains the potassium salt of diclofenac. The preparation possesses analgesic, anti-inflammatory, and antipyretic properties.
Diclofenac tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and inflammatory conditions.
As with other NSAIDs, its mode of action is not known; however, their ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.
In clinical trials diclofenac tablets has also been found to exert an analgesic effect in moderately and severely painful states in the presence of inflammation, e.g. due to trauma or after surgical operations. It rapidly relieves both spontaneous pain and pain on movement and diminishes inflammatory swelling and wound oedema. In addition, the active substance is capable of relieving pain in primary dysmenorrhoea and may reduce the extent of bleeding.
In migraine attacks, diclofenac tablets has been shown to be effective in relieving the headache. It may improve the accompanying symptoms of nausea and vomiting.
Low concentrations of diclofenac inhibit the aggregation of platelets induced in vitro by collagen and by adenosine diphosphate.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Diclofenac is rapidly and completely absorbed from diclofenac potassium tablets. The quantity of active substance absorbed is not diminished when the tablets are taken together with food. After ingestion of 50 mg, plasma concentrations of diclofenac attain a mean peak value of 3.9 micromol/L after 20 to 60 minutes. The plasma concentrations show a linear relationship to the size of the dose.
Roughly half of the active substance is metabolised during its first passage through the liver ("first-pass" effect); consequently, the areas under the concentration curves (AUCs) after an oral dose are only about one-half as large as after parenteral administration of a dose of the same size.
Repeated oral administration of diclofenac for 8 days in daily doses of 50 mg t.i.d. does not lead to accumulation of diclofenac in plasma.

Distribution.

Diclofenac is bound to serum proteins at 99.7%, mainly to albumin (99.4%).

Metabolism.

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 from plasma is 263 ± 56 mL/min (mean value ± SD). The terminal half-life in plasma is 1 to 2 hours. Approximately 60% of the dose administered 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.

Characteristics in patients.

No relevant age-dependent differences in the absorption, metabolism, or excretion of diclofenac have been observed.
In patients suffering from renal impairment, no accumulation of the unchanged active substance can 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 concentrations of metabolites are about four times higher than in normal subjects. However, the metabolites are ultimately cleared through the bile.
In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis), the kinetics and metabolism of diclofenac are the same as in patients without liver disease.

5.3 Preclinical Safety Data

Genotoxicity.

Diclofenac showed no mutagenic, carcinogenic, or teratogenic effects in the studies conducted, despite the induction of maternal and foetal toxicity.

Carcinogenicity.

Diclofenac showed no mutagenic, carcinogenic, or teratogenic effects in the studies conducted, despite the induction of maternal and foetal toxicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Magnesium stearate, hypromellose, macrogol 6000, sodium lauryl sulfate, mannitol, crospovidone, potassium bicarbonate and macrogol 400.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Diclofenac tablets should be protected from heat and moisture and stored below 30°C.

6.5 Nature and Contents of Container

Available in a blister packs containing 4, 5, 6, 10, 20 and 30 tablets.

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

Chemical structure.


CAS number.

15307-81-0.

7 Medicine Schedule (Poisons Standard)

Pharmacist only medicine (S3).

Summary Table of Changes