Consumer medicine information

Chemists’ Own Diclofenac 25 Liquid Capsules

Diclofenac potassium

BRAND INFORMATION

Brand name

Chemists' Own Diclofenac 25 Liquid Capsules

Active ingredient

Diclofenac potassium

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists’ Own Diclofenac 25 Liquid Capsules.

What is in this leaflet

This leaflet answers some common questions about Chemists’ Own Diclofenac 25 Liquid Capsules.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available.

You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. Those updates may contain important information about the medicine and its use of which you should be aware.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will provide.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Chemists’ Own Diclofenac 25 Liquid Capsules is used for

Chemists’ Own Diclofenac 25 Liquid Capsules belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAID).

It 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 (inlcuding aches and pains, sore throat pain).
  • reduces fever.

Chemists’ Own Diclofenac 25 Liquid Capsules can relieve the symptoms of pain and inflammation but it will not cure your condition.

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

Chemists’ Own Diclofenac 25 Liquid Capsules is available as a pharmacist only medicine. It is not addictive.

Do not give this medicine to a child under 14 years of age.

Before you take Chemists’ Own Diclofenac 25 Liquid Capsules

When you must not take it

Do not take Chemists’ Own Diclofenac 25 Liquid Capsules if you are allergic (hypersensitive) to:

  • diclofenac (the active ingredient in Chemists’ Own Diclofenac 25 Liquid Capsules) or any of the other ingredients listed at the end of this leaflet
  • other medicines containing diclofenac (e.g. Diclofenac tablets or suppositories, Diclofenac Emulgel or powder)
  • aspirin
  • ibuprofen
  • any other NSAID

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 Chemists’ Own Diclofenac 25 Liquid Capsules, these symptoms may be severe.

Do not take Chemists’ Own Diclofenac 25 Liquid Capsules 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
  • heart failure
  • heart bypass surgery

Do not take Chemists’ Own Diclofenac 25 Liquid Capsules during the last three months of pregnancy. Use of this medicine during the last 3 months of pregnancy may affect your baby and may delay labour and birth.

Do not take Chemists’ Own Diclofenac 25 Liquid Capsules after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist.

Before you start to take it

Tell your doctor if you have any of the following health problems / medical conditions:

  • 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 Chemists’ Own Diclofenac 25 Liquid Capsules is generally not recommended. You must not take Chemists’ Own Diclofenac 25 Liquid Capsules 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.
  • 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 precautions if you have any of the above conditions.

It is generally important to take the lowest dose of Chemists’ Own Diclofenac 25 Liquid Capsules 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.

Tell your doctor if you are pregnant or trying to become pregnant. There is not enough information to recommend the use of Chemists’ Own Diclofenac 25 Liquid Capsules during the first 6 months of pregnancy and it must not be used during the last 3 months.

Chemists’ Own Diclofenac 25 Liquid Capsules 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 currently have an infection. If you take Chemists’ Own Diclofenac 25 Liquid Capsules 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 breast- feeding. Breast-feeding is not recommended while you are using this medicine. The active ingredient in Chemists’ Own Diclofenac 25 Liquid Capsules passes into breast milk and may affect your baby.

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 reactions with redness, itching or rash.

Taking other medicines

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

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 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)
  • 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).

You may need to take different amounts of your medicines or to take different medicines while you are taking Chemists’ Own Diclofenac 25 Liquid Capsules. Your doctor and pharmacist have more information.

If you have not told your doctor about any of these things, tell him/ her before you start taking this medicine.

How to take Chemists’ Own Diclofenac 25 Liquid Capsules

Swallow the Chemists’ Own Diclofenac 25 Liquid Capsules softgel capsule whole with a full glass of water. Do not chew capsules.

When to take it

Take the softgel capsule preferably before meals. 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 much Chemists’ Own Diclofenac 25 Liquid Capsules 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 label, ask your doctor or pharmacist for help.

There are different ways to take Chemists’ Own Diclofenac 25 Liquid Capsules depending on your condition. Your doctor will tell you exactly how many capsules to take.

Do not exceed the recommended dose.

For adults and children above 14 years:
Take an initial dose of 25 mg (one softgel 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 softgel capsules) in 24 hours.

How long to take it

Do not take Chemists’ Own Diclofenac 25 Liquid Capsules for more than a few days at a time (up to one week), or for longer than your doctor says.

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital if you think that you or anyone else may have taken too much Chemists’ Own Diclofenac 25 Liquid Capsules. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy.

If you take too much Chemists’ Own Diclofenac 25 Liquid Capsules, you may experience:

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

While you are taking Chemists’ Own Diclofenac 25 Liquid Capsules

Things you must do

If you become pregnant while taking Chemists’ Own Diclofenac 25 Liquid Capsules, 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 Chemists’ Own Diclofenac 25 Liquid Capsules, 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 Chemists’ Own Diclofenac 25 Liquid Capsules 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 anesthetist know that you are taking Chemists’ Own Diclofenac 25 Liquid Capsules. NSAID medicines can slow down blood clotting and affect kidney function.

If you get an infection while taking Chemists’ Own Diclofenac 25 Liquid Capsules, 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 Chemists’ Own Diclofenac 25 Liquid Capsules.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Chemists’ Own Diclofenac 25 Liquid Capsules.

Things you must not do

Do not take any of the following medicines while you are taking Chemists’ Own Diclofenac 25 Liquid Capsules without first telling your doctor:

  • aspirin (also called ASA or acetylsalicylic acid), or other salicylates
  • other medicines containing diclofenac (e.g. Diclofenac tablets or suppositories, Diclofenac Emulgel or powder)
  • ibuprofen
  • any other NSAID medicine

If you take these medicines together with Chemists’ Own Diclofenac 25 Liquid Capsules, 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.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Chemists’ Own Diclofenac 25 Liquid Capsules 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.

Elderly patients should take the minimum number of softgel capsules that provides relief of symptoms. Elderly patients, especially those with low body weight, may be more sensitive to the effects of Chemists’ Own Diclofenac 25 Liquid Capsules than other adults.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Chemists’ Own Diclofenac 25 Liquid Capsules.

All medicines can have side effects. 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 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.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • 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

*If symptoms of vision disorders occur during treatment with Chemists’ Own Diclofenac 25 Liquid Capsules, contact your doctor as an eye examination may be considered to exclude other causes.

If any of the following signs appear, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • 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 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)
  • 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)

Tell your doctor if you notice anything else that is making you feel unwell. Some people may have other side effects not yet known or mentioned in this leaflet.

After using Chemists’ Own Diclofenac 25 Liquid Capsules

Storage

  • Keep your medicine in the original container until it is time to take it.
  • Store it in a cool dry place.
  • Do not store Chemists’ Own Diclofenac 25 Liquid Capsules or any other medicine in the bathroom or near a sink.
  • Do not leave it in the car or on window sills.

Keep the medicine where children cannot reach it. A locked cupboard at least one-and- a-half meters above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Chemists’ Own Diclofenac 25 Liquid Capsules or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.

Product description

What it looks like

Chemists’ Own Diclofenac 25 Liquid Capsules softgel capsule is an oval clear blue softgel capsule printed “D25” on one side with white ink.; blister packs of 10, 12, 20 and 30 softgel capsules.

Ingredients

Chemists’ Own Diclofenac 25 Liquid Capsules softgel capsule contains 25 mg diclofenac potassium as the active ingredient. They also contain:

  • propylene glycol
  • macrogol 400
  • povidone
  • gelatin
  • brilliant blue FCF CI 42090
  • sorbitol
  • glycerin
  • ink-white opacode NSP-78-18022/ARTG 3883

Chemists’ Own Diclofenac 25 Liquid Capsules does not contain lactose, gluten, tartrazine or any other azo dyes.

Sponsor

Chemists’ Own Diclofenac 25 Liquid Capsules is supplied in Australia by:

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared in July 2017

Australian registration number:

AUST R 291598

Published by MIMS September 2018

BRAND INFORMATION

Brand name

Chemists' Own Diclofenac 25 Liquid Capsules

Active ingredient

Diclofenac potassium

Schedule

S3

 

Name of the medicine

Diclofenac potassium.

Excipients.

Polyethylene glycol, macrogol 400, povidone, gelatin, brilliant blue (CI42090), ink white opacode (NSP-78-18022/ARTG), sorbitol, glycerin.

Description

CAS Number: 15307-81-0. Molecular Formula: C14H10Cl2KNO2. Molecular Weight: 334.24. Chemists' Own Diclofenac 25 Liquid Capsules 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.
Chemists' Own Diclofenac 25 Liquid Capsules softgel capsule contain 25 mg of diclofenac potassium with the excipients: Polyethylene glycol, macrogol 400, povidone, gelatin, brilliant blue (CI42090), ink white opacode (NSP-78-18022/ARTG), sorbitol, glycerin.
Each Chemists' Own Diclofenac 25 Liquid Capsules capsule contains 2.5 mg of potassium.

Pharmacology

Pharmacodynamics.

Chemists' Own Diclofenac 25 Liquid Capsules 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 cylo-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.

Pharmacokinetics.

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 behavior 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 0.12-0.017 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.

Elimination.

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.

Clinical Trials

Not Applicable.

Indications

Chemists' Own Diclofenac 25 Liquid Capsules softgel capsules 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.
Chemists' Own Diclofenac 25 Liquid Capsules should only be prescribed when benefits are considered to outweigh the potential risk (Warning and precautions).

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 'Precautions-Use in pregnancy').
Patients with severe hepatic impairment (see 'Precautions').
Renal failure (see 'Precautions').
Cardiac failure (see 'Precautions').
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.

Precautions

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 'Dosage and Administration').
Treatment with Chemists' Own Diclofenac 25 Liquid Capsules 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 Chemists' Own Diclofenac 25 Liquid Capsules 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 'Adverse 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 Chemists' Own Diclofenac 25 Liquid Capsules, 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 'Interactions with Other Medicines').
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 'Adverse Effects').

Serious skin reaction.

Serious skin reactions, where some of them can be fatal, including exfoliative dermatitis, Steven-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with NSAIDs use, including diclofenac 25 mg (see 'Adverse 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 Chemists' Own Diclofenac 25 Liquid Capsules 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, pruritus or urticaria.

Liver.

Close medical surveillance is required when prescribing Chemists' Own Diclofenac 25 Liquid Capsules to patients with impaired hepatic function, as their condition may be exacerbated (see 'Contraindications').
As with other NSAIDs including diclofenac, elevations of one or more liver enzymes may be seen during Chemists' Own Diclofenac 25 Liquid Capsules 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, Chemists' Own Diclofenac 25 Liquid Capsules 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 or/and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc), Chemists' Own Diclofenac 25 Liquid Capsules 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 Chemists' Own Diclofenac 25 Liquid Capsules as its use 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.
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 'Contraindications'). Monitoring of renal function is recommended as a precaution during therapy with Chemists' Own Diclofenac 25 Liquid Capsules. Recovery to pretreatment state is seen after the discontinuation of therapy.

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 Chemists' Own Diclofenac 25 Liquid Capsules may mask the usual signs and symptoms during an infection due to its pharmacodynamic properties.

Haematological effects.

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

Use in 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 Chemists' Own Diclofenac 25 Liquid Capsules in elderly patients is usually necessary for a few days only.

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.

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 pregnancy.

(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 Chemists' Own Diclofenac 25 Liquid Capsules 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 Chemists' Own Diclofenac 25 Liquid Capsules 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 '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.

Use in lactation.

Diclofenac passes into milk after oral doses of 50 mg administered every 8 hours. As with other drugs that are excreted in milk Chemists' Own Diclofenac 25 Liquid Capsules is not recommended to be given to nursing mothers.

Effects on fertility.

Chemists' Own Diclofenac 25 Liquid Capsules 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 Chemists' Own Diclofenac 25 Liquid Capsules should be considered.

Use in children.

Chemists' Own Diclofenac 25 Liquid Capsules is not recommended for use in children as safety and efficacy in this age group has not been established.

Effect on ability to drive or use machinery.

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

Interactions

The following interactions include those reported with Chemists' Own Diclofenac 25 Liquid Capsules and other pharmaceutical forms of diclofenac. See Table 1.

Adverse Effects

Not all adverse event listed below are specific to Chemists' Own Diclofenac 25 Liquid Capsules 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 Coomb's 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 disturbances, 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/d), 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).
Very rare: Colitis (including haemorrhagic 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 eruption, eczema, erythema, erythema multiforme, Steven-Johnson syndrome, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Renal and urinary disorders.

Very rare: Actual renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and administration site conditions.

Rare: Oedema.
Very rare: Impotence (association with Chemists' Own Diclofenac 25 Liquid Capsules intake is doubtful).

Dosage and 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.
Chemists' Own Diclofenac 25 Liquid Capsules is not recommended for use in children 14 years or below.

Overdosage

Management of acute poisoning with NSAIDs consists essentially of supportive and symptomatic measures. No typical clinical picture resulting from diclofenac overdose has been reported.
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.

Presentation

Blister packs of 10, 12, 20 and 30 softgel capsules containing 25 mg of diclofenac potassium.

Storage

Chemists' Own Diclofenac 25 Liquid Capsules softgel capsules should be stored below 25°C and protected from moisture.

Poison Schedule

S3.