Consumer medicine information

Viclofen Tablets

Diclofenac sodium

BRAND INFORMATION

Brand name

Viclofen

Active ingredient

Diclofenac sodium

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Viclofen Tablets.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Viclofen Tablets.

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. You can also download the most up to date leaflet from www.sandoz.com.au.

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 or pharmacist has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

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

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

WHAT VICLOFEN TABLETS ARE USED FOR

Viclofen Tablets belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to relieve pain and reduces inflammation (swelling and redness).

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

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

It contains the active ingredient diclofenac sodium.

Viclofen Tablets can relieve the symptoms of pain and inflammation but it will not cure your condition.

Ask your doctor or pharmacist if you have any questions about this medicine.

This medicine is not addictive.

BEFORE YOU TAKE VICLOFEN TABLETS

When you must not take it

Do not take this medicine if you have an allergy to:

  • diclofenac sodium, the active ingredient or any of the inactive ingredients listed at the end of this leaflet under Product Description
  • other medicines containing diclofenac
  • aspirin
  • any other NSAID.

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 use diclofenac, these symptoms may be severe.

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

  • an ulcer (stomach or intestinal)
  • bleeding from the stomach or bowel (symptoms of which may include blood in your stools or black stools)
  • severe liver problems
  • kidney problems
  • heart failure.

Do not take this medicine during the first 6 months of pregnancy, except on doctor's advice. Do not use during the last three months of pregnancy. Use of this medicine during the last three 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 breastfeed if you are taking this medicine. The active ingredient in Viclofen Tablets passes into breast milk and there is a possibility that your baby may be affected.

Viclofen Tablets should not be taken by children.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes. Your doctor will want to know if you are prone to allergies, especially if you get skin reactions with redness, itching or rash.

Tell your doctor or pharmacist if you have or have had any of the following medical conditions:

  • liver or kidney function problems
  • currently suffering from any infection
  • 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
  • severe attacks of indigestion, or any other stomach or bowel disorder in the past (e.g. Crohn's disease, ulcerative colitis)
  • a rare liver condition called porphyria
  • asthma or any other lung disease that causes difficulty in breathing
  • seasonal allergies (e.g. hay fever)
  • repeated chest infection
  • polyps in the nose
  • diabetes
  • recent major surgery
  • a tendency to bleed or other blood problems such as anaemia
  • history of haemorrhoids (piles) or irritation of the rectum (back passage)
  • any other problems with your heart or blood vessels, including disease of the heart with shortness of breath, and swelling of the feet or lips due to fluid build-up; high blood pressure or significant risk of high level of fat in your blood, diabetes or if you smoke, as treatment with Viclofen Tablets is not recommended, and if your doctor decides to prescribe Viclofen Tablets you must not increase the dose above 100 mg per day if you are treated for more than 4 weeks
  • dehydration (e.g. due to sickness, diarrhoea, before or after recent major surgery)
  • swollen feet.

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 or pharmacist if you are pregnant or plan on becoming pregnant or are breastfeeding. Do not use Viclofen Tablets during the first 6 months of pregnancy, except on doctor's advice 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 or pharmacist can discuss with you the risks and benefits involved.

Tell your doctor or pharmacist if you are lactose intolerant. Viclofen Tablets contain lactose monohydrate.

If you have not told your doctor or pharmacist about any of the above, tell him/her before you start taking Viclofen Tablets.

Taking other medicines

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

Some medicines and Viclofen Tablets may interfere with each other. These include:

  • aspirin, salicylates or other anti-inflammatory (NSAID) medicines
  • lithium or selective serotonin-reuptake inhibitors (SSRIs), a medicine used to treat some types of depression
  • digoxin, a medicine for your heart
  • diuretics, also called fluid or water tablets
  • warfarin or other "blood thinners" (medicines used to prevent blood clotting)
  • antidiabetic agents for diabetes
  • methotrexate, a medicine used for treatment of rheumatoid arthritis, as well as some types of cancers
  • cyclosporin, tacrolimus (a medicine used to suppress the immune system)
  • certain antibiotics called quinolones
  • glucocorticoid medicines, used to treat arthritis
  • ACE inhibitors or beta-blockers, medicines used to treat high blood pressure, heart conditions, glaucoma and migraine
  • corticosteroids, medicines such as prednisone and cortisone, which reduce the activity of your immune system
  • antacids used for indigestion. You can still take these medicines while you are taking Viclofen Tablets. However, you must take Viclofen Tablets at least 1 hour before or 2 hours after taking any antacid to make sure there is no problem with absorption.
  • sulfinpyrazone (a medicine used to treat gout)
  • rifampicin, a medicine used to treat variety of infections
  • voriconazole, a medicine used to treat fungal infections
  • phenytoin (a medicine used to treat seizures)
  • trimethoprim (a medicine used to treat urinary tract infections).

These medicines may be affected by Viclofen Tablets, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE VICLOFEN TABLETS

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

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

How much to take

Adults
The usual dosage is one or two tablets two to three times a day when necessary. Not recommended for use in children.

Do not take more than eight tablets in 24 hours.

How to take it

The tablets should be swallowed whole with a full glass of water. Do not chew them. The tablets have a special coating to stop them from dissolving until they have gone through the stomach into the bowel. If you chew them, the coating is destroyed.

When to take Viclofen Tablets

Take your medicine with or immediately after a meal. If you take it on an empty stomach, it may cause stomach upset.

How long to take Viclofen Tablets

Viclofen Tablets are for short term use only.

If pain persists for more than 3 days, please see your doctor.

If you forget to take it

Viclofen Tablets should only be taken when necessary. It should not be taken on a regular basis.

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

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much Viclofen Tablets. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include: nausea, vomiting, gastrointestinal haemorrhage, diarrhoea, abdominal pain, drowsiness, tinnitus (ringing in the ears) or convulsions, headache, dizziness and blurred vision.

WHILE YOU ARE TAKING VICLOFEN TABLETS

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Viclofen Tablets.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If at any time while taking Viclofen Tablets, 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.

Tell your doctor or pharmacist if you become pregnant or plan on becoming pregnant or breastfeeding while taking Viclofen Tablets.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. NSAID medicines can slow down blood clotting and affect kidney function.

If you get an infection while taking Viclofen Tablets, tell your doctor or pharmacist. 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.

Things you must not do

Do not take Viclofen Tablets to treat any other complaints unless your doctor or pharmacist tells you to.

Do not give your medicine to anyone else, even if their symptoms seem similar to yours.

Do not take any of the following medicines while you are using Viclofen Tablets without first telling your doctor:

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

If you take these medicines together with Viclofen Tablets, 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.

Things to be careful of

Be careful driving or operating machinery until you know how Viclofen Tablets affects you. This medicine may cause dizziness, drowsiness, light-headedness, spinning sensation (vertigo) or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

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

SIDE EFFECTS

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

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

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

If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your doctor or pharmacist. As people grow older, they are more likely to get side effects from medicines.

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

  • stomach or abdominal pain, abdominal cramps, wind, indigestion, loss of appetite
  • 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)
  • nausea (feeling sick), vomiting
  • constipation, diarrhoea
  • sore mouth or tongue
  • altered taste sensation
  • anorexia
  • rashes
  • dizziness, spinning sensation (vertigo)
  • 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
  • blurred or double vision
  • buzzing or ringing in the ears, difficulty hearing
  • hypertension (high blood pressure)
  • hair loss or thinning
  • visual disturbances like impairment, blurred vision
  • headache.

*If symptoms of vision disorders occur during treatment with Viclofen Tablets, contact your doctor as an eye examination may be considered to exclude other causes.

If any of the following happen, stop taking Viclofen Tablets, and tell your doctor or pharmacist immediately, or go to accident and emergency at your nearest hospital:

  • signs of possible blood vessel inflammation such as red or purple skin
  • signs of possible stomach problems such as 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
  • signs of allergy such as: 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), shortness of breath, wheezing, troubled breathing, or feelings of tightness in the chest
  • peptic ulceration and gastrointestinal bleeding may occur in some patients. If you feel unusually weak and tired, or notice blood in your faeces, together with severe stomach pain, stop taking the tablets and see your doctor immediately.
  • signs of liver problem such as persistent nausea, loss of appetite, unusual tiredness, vomiting, pain in the upper abdomen, yellowing of skin and/or eyes, dark urine or pale bowel motions
  • signs of a possible blood problem such as constant "flu-like" symptoms (chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy), bleeding or bruising more easily than normal
  • signs of serious skin reaction such as painful red areas, large blisters, peeling of layers of skin, bleeding in the lips, eyes, mouth, nose or genitals. These signs may be accompanied by fever and chills, aching muscles and feeling generally unwell.
  • signs of a possible effect on brain, such as sudden and severe headache, stiff neck, severe nausea, dizziness, numbness, difficulty in speaking, paralysis, convulsions (fits)
  • signs of possible kidney disorders such as a change in the colour or amount of urine passed, frequent need to urinate, burning feeling when passing urine, blood in the urine or excess protein in the urine
  • fainting or seizures (fits)
  • signs of cardiac failure such as breathlessness, difficulty breathing when lying down, swelling of the feet or legs
  • chest pain, which may be a sign of a heart attack.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

AFTER TAKING VICLOFEN TABLETS

Storage

Keep your medicine in the original container.

If you take it out of its original container it may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store Viclofen Tablets or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in a car. Heat and dampness can destroy some medicines.

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

Disposal

Return any unused or out of date medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Viclofen Tablets 25mg - round, brown-yellow enteric coated tablets.

Available in blisters of 20 and 30 tablets.

Ingredients

Active ingredients:

Viclofen Tablets 25mg - 25mg diclofenac sodium.

Inactive ingredients:

  • lactose monohydrate
  • calcium hydrogen phosphate dihydrate
  • microcrystalline cellulose
  • maize starch
  • sodium starch glycollate
  • magnesium stearate
  • colloidal silicon dioxide
  • methacrylic acid copolymer
  • triethyl citrate
  • talc
  • titanium dioxide (E171)
  • yellow ferric oxide (E172, CI 77492).

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

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia

Tel: 1800 634 500

This leaflet was revised in May 2017.

Australian Register Number

25mg tablets: AUST R 75245 (blisters)

Published by MIMS October 2017

BRAND INFORMATION

Brand name

Viclofen

Active ingredient

Diclofenac sodium

Schedule

S3

 

1 Name of Medicine

Diclofenac sodium.

2 Qualitative and Quantitative Composition

Each Viclofen enteric coated tablet contains 25 mg diclofenac sodium.
The active ingredient diclofenac sodium, a phenylacetic acid derivative, structurally similar to both the phenylalkanoic acid and the anthranilic acid series of compounds. Diclofenac sodium is an odourless, yellowish-white, crystalline powder sparingly soluble in water.

List of excipients with known effect.

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

3 Pharmaceutical Form

Viclofen tablets 25 mg enteric coated tablet: brown yellow film coated tablets, biconvex with an intact surface and uniform colour.

4 Clinical Particulars

4.1 Therapeutic Indications

For the temporary relief of pain states in which there is an inflammatory component.
Symptomatic treatment of primary dysmenorrhoea.

4.2 Dose and Method of Administration

Dosage.

Adults.

After assessing the risk/ benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.
Viclofen tablets should not be used for more than a few days at a time unless on medical advice, in which case the patient should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.
The usual dosage is 25 to 50 mg two to three times a day when necessary.
In primary dysmenorrhoea the daily dosage, which should be individually adapted, is generally 50 to 150 mg. Initially, a dose of 50 to 100 mg should be given and, if necessary, raised in the course of several menstrual cycles up to a maximum of 200 mg/day. Treatment should be started upon appearance of the first symptoms and, depending on the symptomatology, continued for a few days.

Paediatric use.

Diclofenac is not recommended for use in children.

Pregnancy.

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

Method of administration.

The tablets should be swallowed whole, after food with liquid and must not be divided or chewed.

4.3 Contraindications

Gastric or duodenal ulcer, gastrointestinal bleeding or perforation.
Known hypersensitivity to the active ingredient, diclofenac, or any of the excipients.
Third 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).
Patients undergoing treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Patients in whom diclofenac, aspirin or other NSAIDs induce asthma, angioedema, urticaria, or other allergic type reactions, because severe, rarely fatal, anaphylactic type reactions to diclofenac have been reported in such patients.

4.4 Special Warnings and Precautions for Use

Cardiovascular thrombotic events.

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

Hypertension.

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

Heart failure.

Fluid retention and oedema have been observed in some patients taking NSAIDs, including diclofenac, therefore caution is advised in patients with fluid retention. Use of diclofenac in patients with heart failure is not recommended (see Section 4.3 Contraindications).

Gastrointestinal effects.

Close medical surveillance during treatment with Viclofen tablets 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. 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 perforations in general have more serious consequences in the elderly. They can occur at any time during treatment with or without warning symptoms or a previous history. In instances, where gastrointestinal bleeding or ulcerations occur in patients receiving diclofenac, the drug should be withdrawn immediately. Physicians should warn patients about the signs and symptoms of serious gastrointestinal toxicity and what steps to take if they occur.
Combination therapy with protective agents (e.g. proton pump inhibitors or misoprostol) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid (ASA)/aspirin or other medicinal products likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis, or with Crohn's disease, as well as in patients suffering from pre-existing dyshaemopoiesis or disorders of blood coagulation, as their condition may be exacerbated (see Section 4.8 Adverse Effects (Undesirable Effects)).

Serious skin reactions.

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

Infection.

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

Hypersensitivity.

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

Lactose intolerance.

Viclofen tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Peri-operative bleeding.

Pre-operative administration of diclofenac may increase the risk of post-operative bleeding.

Use in hepatic impairment.

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

Use in renal impairment.

As a class, NSAIDs have been associated with renal papillary necrosis and other pathology during long-term administration in animals.
Fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac. Owing to the importance of prostaglandins for maintaining renal blood flow, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, in the elderly, in patients being treated with diuretics or medicinal products that can significantly impact renal function and in those with extracellular volume depletion from any cause, e.g. in the peri- or post-operative phase of major surgical operations (see Section 4.3 Contraindications). Monitoring of renal function as a precautionary measure is therefore recommended when using diclofenac in such cases. Discontinuation of therapy is typically followed by recovery to the pre-treatment state. Use of Viclofen tablets in patients with kidney impairment is not recommended (see Section 4.3 Contraindications).

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 and should not be used at all in those with pre-existing renal impairment.

Use in the elderly.

In elderly patients who are generally more prone to side effects, particular caution should be exercised. It is recommended that the lowest effective dosage be used in elderly patients or those with a low bodyweight.
Treatment with Viclofen tablets in the elderly usually proves necessary only for a few days.

Paediatric use.

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

Effects on laboratory tests.

Haematological effects.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

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

Lithium/ digoxin.

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

Diuretics and antihypertensive agents.

Like other NSAIDs, concomitant use of diclofenac with diuretics or anti-hypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their anti-hypertensive 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. Concomitant treatment with potassium sparing diuretics may be associated with increased serum potassium levels, thus making it necessary to monitor the latter (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 (e.g. warfarin).

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

Selective serotonin reuptake inhibitors (SSRIs).

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

Antidiabetic agents.

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

Methotrexate.

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

Ciclosporin 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.

Antacids.

Concurrent administration may affect the absorption of diclofenac by increasing the time to peak concentration. Therefore diclofenac should be given at least one hour before or two hours after each dose of antacid.

Quinolone antibacterials.

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

CYP2C9 inhibitors.

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

CYP2C9 inducers.

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

Phenytoin.

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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

Oligohydramnios and neonatal renal impairment.

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

4.7 Effects on Ability to Drive and Use Machines

Patients experiencing visual disturbances, dizziness, vertigo, somnolence or other CNS disturbances should refrain from driving a vehicle or operating machines.

4.8 Adverse Effects (Undesirable Effects)

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

Blood and lymphatic system disorders.

Very rare: thrombocytopenia, leucopoenia, anaemia (including haemolytic anaemia, aplastic anaemia), agranulocytosis, positive Coombs' test.

Immune system disorders.

Rare: hypersensitivity, anaphylactic/ 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 (drowsiness).
Very rare: disturbances of sensation, including paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, cerebrovascular accident, myoclonic encephalopathy (described in two patients).

Eye disorders.

Very rare: visual disturbance, blurred vision, diplopia.

Ear and labyrinth disorders.

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

Cardiac disorders.

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

Vascular disorders.

Very rare: hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders.

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

Gastrointestinal disorders.

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

Hepatobiliary disorders.

Common: transaminases increased.
Rare: liver disorders, hepatitis, jaundice.
Very rare: fulminant hepatitis, hepatic necrosis, hepatic failure.

Skin and subcutaneous tissue disorders.

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

Renal and urinary disorders.

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

General disorders and administration site conditions.

Rare: oedema.
Very rare: impotence (association with diclofenac intake is doubtful), toxic shock syndrome has been reported in patients administered NSAIDs post-operatively.

Pregnancy, puerperium and perinatal conditions.

Unknown: oligohydramnios, neonatal renal impairment.
* The frequency reflects data from long-term treatment with a high dose (150 mg/day).

Description of selected adverse drug reactions.

Arteriothrombotic events.

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

Visual effects.

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

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

Symptoms.

There is no typical clinical picture resulting from an overdosage of diclofenac. Overdosage can cause symptoms such as nausea, vomiting, gastrointestinal haemorrhage, diarrhoea, abdominal pain, drowsiness, tinnitus or convulsions, headache, dizziness and blurred vision. In the event of significant poisoning, acute renal failure and liver damage are possible.

Treatment.

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

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Diclofenac sodium, a non-steroidal compound, exhibits pronounced antirheumatic, anti-inflammatory, analgesic and anti-pyretic properties.
As with other NSAIDs, its mode of action is not known; however, its ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.

Clinical trials.

In rheumatic diseases, the anti-inflammatory and analgesic properties of Viclofen tablets elicit a clinical response characterised by relief from signs and symptoms such as pain at rest, pain on movement, morning stiffness, and swelling of the joints, as well as by an improvement in function.
In addition, clinical studies have revealed that in primary dysmenorrhoea diclofenac preparations are capable of relieving the pain and reducing the extent of bleeding. Low concentrations of diclofenac sodium inhibit the aggregation of platelets induced in vitro by collagen and by adenosine diphosphate. Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in canine cartilage at concentrations equivalent to the concentrations reached in humans. It is unknown whether or not diclofenac sodium affects the integrity of human osteoarthritic cartilage.

5.2 Pharmacokinetic Properties

Absorption.

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

Distribution.

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

Metabolism.

Following oral administration, about half the active substance is metabolised during its first passage through the liver ("first-pass" effect).

Excretion.

The total systemic clearance of diclofenac in plasma is 263 ± 56 mL/minute (mean value ± SD). The terminal half-life in plasma is 1 to 2 hours.
After administration of diclofenac for 15 days in an oral dose of 25 mg three times daily, there was no evidence of the drug's accumulation in plasma.
In a study in 16 patients with rheumatoid arthritis and knee joint effusions it was found that diclofenac enters the synovial fluid where maximum concentrations were measured 2 to 4 hours after oral administration. The apparent half-life for elimination from the synovial fluid was 3 to 6 hours. Only 4 to 6 hours after administration, therefore, concentrations of the active substance were already higher in the synovial fluid than they were in the plasma and remained higher for up to 12 hours. These results could possibly explain that the duration of clinical effect is longer than might be inferred from the short plasma half-life of diclofenac.
The biotransformation of diclofenac partly involves glucuronidation of the intact molecule, but mainly single and multiple hydroxylation followed by glucuronidation.
About 60% of the administered dose is excreted in the urine in the form of metabolites from one of these two processes; less than 1% is excreted as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

Special patient populations.

No relevant age dependent differences in the drug's absorption, metabolism or excretion have been observed.
In patients suffering from renal impairment, no accumulation of the unchanged active substance could be inferred from the single dose kinetics when applying the usual dosage schedule. At a creatinine clearance of less than 10 mL/minute, the theoretical steady-state plasma levels of metabolites are about four times higher than in normal subjects. However, the metabolites appear to be satisfactorily cleared through the bile.
In the presence of impaired hepatic function (chronic hepatitis, non-decompensated cirrhosis), the kinetics and metabolism of diclofenac were the same as in patients without hepatic disease.

5.3 Preclinical Safety Data

Genotoxicity.

Diclofenac showed no mutagenic or carcinogenic 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.

6 Pharmaceutical Particulars

6.1 List of Excipients

In addition to diclofenac sodium, Viclofen tablets contain lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica, methacrylic acid copolymer, triethyl citrate, purified talc, titanium dioxide and iron oxide yellow CI 77492.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Viclofen 25 mg enteric-coated tablets are available in PVC/PVDC/Al blister packs of 10, 20 or 30 tablets.
Not all presentations may be marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

The chemical name of diclofenac sodium is sodium 2-[(2,6- dichlorophenyl)amino]phenylacetate. Its Molar weight is 318.13 and its structure is:

CAS number.

15307-79-6.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes