Consumer medicine information

Inflamax Liquid Caps 25

Diclofenac potassium

BRAND INFORMATION

Brand name

Inflamax Liquid Caps 25

Active ingredient

Diclofenac potassium

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Inflamax Liquid Caps 25.

SUMMARY CMI

Inflamax Liquid Caps 25

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?

Inflamax Liquid Caps 25 contain the active ingredient diclofenac potassium. Inflamax Liquid Caps 25 is used for short-term treatment of the following conditions:

  • muscular and rheumatic pain, backache, period pain, headache and dental pain.
  • painful symptoms of cold and flu (including aches and pains, sore throat pain).
  • reduces fever. 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 Inflamax Liquid Caps 25 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 Inflamax Liquid Caps 25 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 capsule whole with a full glass of water or other liquid. Do not chew the capsule.

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 Inflamax Liquid Caps 25, 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 Inflamax Liquid Caps 25.
  • If you get an infection while taking Inflamax Liquid Caps 25, 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 Inflamax Liquid Caps 25.
Things you should not do
  • Do not take any of the following medicines while taking Inflamax Liquid Caps 25 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 Inflamax Liquid Caps 25, 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 Inflamax Liquid Caps 25 affects you. Inflamax Liquid Caps 25 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 capsules 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 Inflamax Liquid Caps 25. 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

Inflamax Liquid Caps 25

Active ingredient: diclofenac potassium

Consumer Medicine Information (CMI)

This leaflet provides important information about taking Inflamax Liquid Caps 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 taking Inflamax Liquid Caps 25.

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?

Inflamax Liquid Caps 25 contains the active ingredient diclofenac potassium. 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:

  • muscular and rheumatic pain, backache, period pain, headache and dental pain
  • painful symptoms of cold and flu (including aches and pains, sore throat pain)
  • reduces fever.

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 capsules to take.

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

Do not exceed the recommended dose.

For adults and children above 14 years:

Take an initial dose of 25 mg (one capsule) at the first sign of pain. A further dose of 25 mg (one capsule) can be taken every 4 - 6 hours as required.

Do not take more than 75 mg (3 capsules) in 24 hours.

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 capsules whole with a full glass of water. Do not chew them.

How long to take this medicine

Do not take this medicine for more than a few days at a time (up to one week), or for longer than your doctor says.

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

Store your capsules 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 potassium
Other ingredients
(inactive ingredients)
  • propylene glycol
  • macrogol 400
  • povidone
  • gelatin
  • brilliant blue FCF
  • lecithin
  • medium chain triglycerides
  • sorbitol special-glycerin blend (PI 1048)
  • ink-white opacode NSP-78-18022 (PI ARTG 3883)
Potential allergensMay contain traces of sulfites.

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

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

What this medicine looks like

Oval clear blue soft capsule. Printed “D25” on one side with white ink.

AUST R 326046

Blister pack containing 10, 12, 20 and 30* soft capsules.

*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

Inflamax Liquid Caps 25

Active ingredient

Diclofenac potassium

Schedule

S3

 

1 Name of Medicine

Diclofenac potassium.

2 Qualitative and Quantitative Composition

Each Inflamax Liquid Caps 25 capsule contains 25 mg of diclofenac potassium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Inflamax Liquid Caps 25 - oval clear blue soft capsules. Printed "D25" on one side with white ink.

4 Clinical Particulars

4.1 Therapeutic Indications

Inflamax Liquid Caps 25 provides rapid temporary relief of:
Muscular and rheumatic pain, backache, period pain, headache and dental pain.
Painful symptoms associated with cold and flu (including aches and pains, sore throat pain).
Reduces fever.
Inflamax Liquid Caps 25 should only be prescribed when benefits are considered to outweigh the potential risk (see Section 4.4 Special Warnings and Precautions for Use).

4.2 Dose and Method of Administration

The capsule should be swallowed with a drink or water, and must not be divided or chewed.

Adults.

Take an initial dose of 25 mg when symptoms appear. A further dose of 25 mg can be taken every 4-6 hours, as required. The maximum daily dose is 75 mg.

Children.

Children above 14 years of age: up to 75 mg daily in divided dose. The maximum daily dose is 75 mg.
Inflamax Liquid Caps 25 is not recommended for use in children 14 years or below.

Pregnancy.

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

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 in the capsules.
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).
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 Inflamax Liquid Caps 25 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 Inflamax Liquid Caps 25 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 NSAIDs 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 for patients with fluid retention or heart failure.

Gastrointestinal events.

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. 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 Inflamax Liquid Caps 25, 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; Section 4.4 Special Warnings and Precautions for Use).
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 Inflamax Liquid Caps 25 after gastro-intestinal surgery.

Serious skin reaction.

Serious skin reactions, where some of them can be 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 NSAIDs use, including diclofenac 25 mg (see Section 4.8 Adverse Effects (Undesirable Effects)). These serious adverse events are idiosyncratic and are independent of the dose or duration of use. Patients appear to be at higher risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of patients within the first month of treatment. Patients should be advised of 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 Inflamax Liquid Caps 25 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.

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.

Infections.

NSAIDs including Inflamax Liquid Caps 25 may mask the usual signs and symptoms during an infection due to its pharmacodynamic properties.

Haematological effects.

Inflamax Liquid Caps 25 is only recommended for short-term treatment. However, if prolonged treatment is required, monitoring of blood count is recommended.
NSAIDs including Inflamax Liquid Caps 25 may inhibit platelet aggregation temporarily. Patients with haemostatic disorders should be carefully monitored.

Hypersensitivity.

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

Peri-operative bleeding.

Pre-operative administration of Inflamax Liquid Caps 25 may increase the risk of post-operative bleeding.
Since Inflamax Liquid Caps 25 may temporarily inhibit platelet aggregation, children undergoing minor procedures such as tonsillectomy, myringotomy, circumcision, orchidopexy and strabismus surgery should be carefully monitored.

Use in hepatic impairment.

Close medical surveillance is required when prescribing Inflamax Liquid Caps 25 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 be seen during Inflamax Liquid Caps 25 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 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, Inflamax Liquid Caps 25 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), Inflamax Liquid Caps 25 therapy should be discontinued.
Physicians should inform the patients of the warning signs and symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abnormal tenderness in the right upper quadrant and "flu-like" symptoms) and the appropriate action to take should these signs and symptoms appear.
In patients with hepatic porphyria caution should be exercised when prescribing Inflamax Liquid Caps 25 as its use may trigger an attack.

Use in renal impairment.

As a class, NSAIDs have been associated with renal papillary necrosis and other renal pathology during long-term administration in animals.
Diclofenac administration has been associated with oedema and fluid retention. Owing to 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 on renal function, and in those with extracellular volume depletion from any cause e.g. in pre and post-operative phase of major surgical operations (see Section 4.3 Contraindications). Monitoring of renal function is recommended as a precaution during therapy with Inflamax Liquid Caps 25. Recovery to pre-treatment state is seen after the discontinuation of therapy.

Use in the elderly.

Cautions should be exercised with all patients of advanced age on basic medical grounds. In particular, it is recommended to use the lowest effective dosage in frail elderly patients or those with low body weight.
Treatment with Inflamax Liquid Caps 25 in elderly patients is usually necessary for a few days only.

Paediatric use.

Inflamax Liquid Caps 25 is not recommended for use in children as safety and efficacy in this age group has 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 reported with Inflamax Liquid Caps 25 and 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 Inflamax Liquid Caps 25.

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 events). 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. Inflamax Liquid Caps 25 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 events).

Antidiabetic agents.

Inflamax Liquid Caps 25 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 if NSAIDs, including diclofenac, are administered less than 24 hours before or after the treatment with methotrexate, since blood concentrations of methotrexate may rise and toxicity of this substance be increased.

Cyclosporine and tacrolimus.

Nephrotoxicity of ciclosporin 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 ciclosporin or tacrolimus.

Drugs known to cause hyperkalaemia.

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, Use in renal impairment).

Glucocorticoids.

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

Quinolone antibacterials.

Isolated incidences have been reported of convulsions which may be attributed 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.

Inflamax Liquid Caps 25 use may impair fertility in women attempting to conceive and is not recommended. In women who have difficulty in conceiving or who are undergoing investigation of infertility, withdrawal of Inflamax Liquid Caps 25 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, Inflamax Liquid Caps 25 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.
Data from epidemiological studies suggest an increased risk of miscarriage after the use of a prostaglandin synthesis inhibitor in early pregnancy.
Use of Inflamax Liquid Caps 25 during the third trimester of pregnancy is contraindicated owing to the possibility of uterine inertia, foetal renal impairment with subsequent oligohydramnios and/or premature closure of the ductus arteriosus (see Section 4.3 Contraindications).
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.

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). Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.
 Diclofenac passes into milk after oral doses of 50 mg administered every 8 hours. As with other drugs that are excreted in milk Inflamax Liquid Caps 25 is not recommended to be given to nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

Patients experiencing any dizziness or other CNS disturbances, including visual disturbances, vertigo, somnolence should not drive a vehicle or operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Not all adverse events listed below are specific to Inflamax Liquid Caps 25 use, similarities between NSAIDs as a group require them to be considered possible.

Blood and lymphatic system disorders.

Very rare: thrombocytopenia, leucopoenia, anaemia (haemolytic and aplastic), 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.

Eye disorders.

Very rare: visual disturbance, blurred vision, diplopia.

Ear and labyrinth disorders.

Common: vertigo.
Very rare: tinnitus, hearing impaired.

Cardiac disorders.

Uncommon: myocardial infarction (based on higher dose 150 mg/day), cardiac failure, palpitations, chest pain.

Vascular disorders.

Very rare: hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders.

Rare: asthma (including dyspnoea).
Very rare: pneumonitis.

Gastrointestinal (GIT) disorders.

Common: nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia.
Rare: gastritis, GIT haemorrhagic, haematemesis, diarrhoea haemorrhagic, melaena, GIT ulcer (with or without bleeding), 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.

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 eruption, 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 renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions.

Rare: oedema.
Very rare: impotence (association with Inflamax Liquid Caps 25 intake is doubtful). Toxic shock syndrome has been reported in patients administered NSAIDs post-operatively.

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.

4.9 Overdose

Management of acute poisoning with NSAIDs consists essentially of supportive and symptomatic measures. No typical clinical picture resulting from diclofenac overdose has been reported.
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.
Following measures should be taken in case of overdose.
Supportive and symptomatic treatment is indicated for complications as such as hypotension, renal failure, convulsions, GI irritation, and respiratory depression.
Haematological and biological parameters, and the presence or absence of blood in the stools, should be monitored.
Specific therapies such as forced diuresis, dialysis or haemoperfusion are unlikely to be helpful in eliminating NSAIDs because of their protein-binding rate and extensive metabolism.
Activated charcoal may reduce the absorption of diclofenac if given within 1 to 2 hours of ingestion. If patients who are fully conscious or have impaired gag reflex, consideration should be given to administration of activated charcoal via nasogastric tube, once airway is protected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Inflamax Liquid Caps 25 is non-steroidal anti-inflammatory (NSAID) drug with analgesic and antipyretic properties and contains potassium salt of diclofenac.
The anti-inflammatory effects of diclofenac are believed to be due to inhibition of leukocyte migration and the enzyme cyclo-oxygenase (COX-1 and COX-2), leading to the peripheral inhibition of prostaglandin synthesis. As prostaglandins sensitize pain receptors, inhibition of their synthesis is responsible for the analgesic effects of diclofenac. Antipyretic effects may be due to action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat dissipation.
Low concentration of diclofenac inhibits 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 completely absorbed from the gastrointestinal tract. Food has no effect on the extent of absorption of diclofenac. Amount absorbed is in linear proportion to the dose.
Since half of the diclofenac is metabolized during its first pass through liver, the area under the concentration curve (AUC) is about half as large following oral or rectal administration as it is following a parenteral dose of equal size.
Pharmacokinetic behaviour does not change after the repeated administration. No accumulation occurs provided recommended dose intervals are adhered to.

Distribution.

99.7% of diclofenac binds to serum proteins, mainly to albumin (99.4%). Apparent volume of distribution calculated is 0.12-0.17 L/kg.
Diclofenac enters the synovial fluid, where maximum concentration is measured 2-4 hours after the peak plasma values have been reached. The apparent half-life for elimination from synovial fluid is 3-6 hrs. Two hours after reaching the peak plasma levels, concentration of active in synovial fluid are higher than plasma and remain high for up-to 12 hours.

Metabolism.

Diclofenac biotransformation takes place partly by glucuronidation of the intact molecule, but mainly be single and multiple hydroxylation and methoxylation resulting in several phenolic metabolites (3'-hydroxy, 4'-hydroxy, 5-hydroxy,4',5-dihydoxy, and 3'-hydroxy-4'-methoxy-diclofenac), most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, but to lesser extent then diclofenac.

Excretion.

Diclofenac total plasma clearance is 263±56 mL/min (mean value ± SD). Terminal half-life in plasma is 1 to 2 hours. Four of the metabolites including the active ones, also have short half-life 1 to 3 hours.
About 60% of administered dose is excreted in urine as glucuronide conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronide conjugates. Less than 1% is excreted as unchanged substance and rest of the dose is excreted as metabolites through the bile in the faeces.

Characteristics in patients.

No relevant age related differences in absorption, metabolism, or excretion have been observed.
In patients suffering from renal impairment, no accumulation of unchanged active can be inferred from single-dose kinetics when administering usual dose schedule. The theoretical steady-state plasma concentrations of metabolites are about the four times higher than in normal subjects at a creatinine clearance of < 10 mL/min.
In patients with impaired hepatic function such as chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are same as 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 carcinogenic effects in the studies conducted.

6 Pharmaceutical Particulars

6.1 List of Excipients

Inflamax Liquid Caps 25 contain the following excipients: propylene glycol, macrogol 400, povidone, gelatin, brilliant blue FCF, lecithin, medium chain triglycerides, purified water, opacode WB water based monogramming ink NSP-78-18022 white (PI 3883), sorbitol special-glycerin blend (PI 1048).
See Section 2 Qualitative and Quantitative Composition.

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

Inflamax Liquid Caps 25 should be stored below 25°C and protected from moisture.

6.5 Nature and Contents of Container

Blister packs (PVC/PE/PVDC/Al) of 10, 12, 20 and 30 soft capsules containing 25 mg of diclofenac potassium.

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.

Inflamax Liquid Caps 25 contains Potassium-[2-{(2,6-dichlorophenyl)-amino}-phenyl]-acetate (=diclofenac potassium).
The active ingredient, diclofenac potassium, is a well characterized small molecule with molecular formula C14H10Cl2KNO2 and molecular weight 334.24. Diclofenac potassium is white or slightly yellowish, crystalline powder, slightly soluble in water under acidic pH; solubility increases as the pH increases to 7.5.
Molecular Formula: C14H10Cl2KNO2.
Molecular Weight: 334.24.

CAS number.

CAS Number: 15307-81-0.

7 Medicine Schedule (Poisons Standard)

Inflamax Liquid Caps 25 is a Schedule 3 Medicine.

Summary Table of Changes