Consumer medicine information

Voltaren Rapid

Diclofenac potassium

BRAND INFORMATION

Brand name

Voltaren Rapid 50

Active ingredient

Diclofenac potassium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Voltaren Rapid.

What is in this leaflet

This leaflet answers some common questions about Voltaren Rapid.

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.novartis.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 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 Voltaren Rapid is used for

Voltaren Rapid belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAID). It relieves pain and reduces inflammation (swelling and redness).

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

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

Voltaren Rapid 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.

Voltaren Rapid is only available with a doctor's prescription. It is not addictive.

There is not enough information to recommend this medicine for children and adolescents under 14 years of age.

Before you take Voltaren Rapid

When you must not take it

Do not take Voltaren Rapid if you are allergic (hypersensitive) to:

  • diclofenac (the active ingredient in Voltaren Rapid) or any of the other ingredients listed at the end of this leaflet
  • other medicines containing diclofenac (e.g. Voltaren tablets or suppositories, Voltaren Emulgel, Voltfast 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, throat, and/or extremities (signs of angioedema)
  • rash, itching or hives on the skin.

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

Do not take Voltaren Rapid if you have had any of the following medical conditions:

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

Do not take Voltaren Rapid 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 3 months of pregnancy may affect your baby and may delay labour and birth.

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

Do not take Voltaren Rapid 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 Voltaren is generally not recommended
  • established cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally high levels of fat (cholesterol, triglycerides) in your blood, diabetes, or if you smoke, and your doctor decides to prescribe Voltaren, you must not increase the dose above 100 mg per day if you are treated for more than 4 weeks.
  • history of ulcers (stomach or intestinal)
  • gastrointestinal problems such as stomach ulcer, bleeding or black stools, or have experienced stomach discomfort or heartburn after taking anti-inflammatory medicines in the past
  • diseases of the bowel or inflammation of the intestinal tract (Crohn's disease) or colon (ulcerative or ischemic colitis)
  • liver or kidney problems
  • a rare liver condition called porphyria
  • bleeding disorders or other blood disorders (e.g. anaemia)
  • asthma or any other chronic lung disease that causes difficulty in breathing
  • hay fever (seasonal allergic rhinitis)
  • repeated chest infections
  • polyps in the nose
  • diabetes
  • dehydration (e.g. by sickness, diarrhoea, before or after recent major surgery
  • swollen feet

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 Voltaren 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 Voltaren Rapid during the first 6 months of pregnancy and it must not be used during the last 3 months.

Voltaren Rapid 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 Voltaren Rapid 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 Voltaren Rapid passes into breast milk and may affect your baby.

Tell your doctor if you are fructose intolerant. This medicine contains sucrose, which is converted by the liver to fructose.

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 a 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 Voltaren Rapid. 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 Voltaren Rapid

Swallow the Voltaren Rapid tablets whole with a full glass of water. Do not break them or chew them.

When to take it

Take the tablets 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 Voltaren Rapid 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 Voltaren Rapid depending on your condition. Your doctor will tell you exactly how many tablets to take.

Do not exceed the recommended dose.

To treat migraine

The usual dose is 50 mg (one tablet) at the first sign of an attack. If the pain is not relieved within 2 hours, another tablet can be taken. After that, you must wait at least 4 hours before taking any more Voltaren Rapid.

Do not take more than 200 mg (4 tablets) in 24 hours even if you have more than one migraine attack within that 24 hour period.

To treat menstrual cramps (period pain)

The usual dose is 50 mg to 100 mg (1 to 2 tablets) beginning as soon as cramps begin. This is usually followed by 1 tablet three times each day until the pain goes away, but for no longer than 3 days.

To treat other painful conditions

The usual dose is 100 mg to 150 mg (2 to 3 tablets) each day. In milder cases, as well as in children over 14 years old, 75 mg to 100 mg each day is usually enough.

How long to take it

Do not take Voltaren Rapid for longer than your doctor says. It is usually taken for a short time only (up to one week) but it may be prescribed on repeated occasions, depending on your condition.

If you forget to take it

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

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

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

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

If you 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 Voltaren Rapid. 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 Voltaren Rapid, you may experience:

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

While you are taking Voltaren Rapid

Things you must do

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

If you are going to have surgery, make sure the surgeon and anaesthetist know that you are taking Voltaren Rapid. NSAID medicines can slow down blood clotting and affect kidney function.

If you get an infection while taking Voltaren Rapid, 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 Voltaren Rapid.

Tell any other doctor, dentist or pharmacist who treats you that you are taking Voltaren Rapid.

Things you must not do

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

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

If you take these medicines together with Voltaren Rapid, 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 Voltaren Rapid 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 tablets that provides relief of symptoms. Elderly patients, especially those with a low body weight, may be more sensitive to the effects of Voltaren Rapid than other adults.

Side effects

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

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

NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal anastomotic leak. Close medical surveillance and caution are recommended when using this medicine after gastrointestinal surgery.

*If symptoms of vision disorders occur during treatment with Voltaren Rapid, 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)
  • Coincidental occurrence of chest pain and allergic reactions (signs of Kounis syndrome)

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 Voltaren Rapid

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 Voltaren Rapid 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 metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking Voltaren Rapid 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

Voltaren Rapid 50 mg tablets are reddish-brown sugar-coated tablets; blister packs of 20 tablets.

Ingredients

Voltaren Rapid tablets contain 50 mg diclofenac potassium as the active ingredient. They also contain:

  • silica colloidal anhydrous
  • calcium phosphate (E341)
  • magnesium stearate (E572)
  • maize starch
  • povidone (E1201)
  • sodium starch glycolate
  • microcrystalline cellulose (E460)
  • iron oxide red CI77491 (E172)
  • macrogol 8000
  • sucrose
  • purified talc (E553b)
  • titanium dioxide (E171)

Voltaren Rapid does not contain lactose, gluten, tartrazine or any other azo dyes.

Sponsor

Voltaren Rapid is supplied in Australia by:

Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1800 671 203

® = Registered Trademark

This leaflet was prepared in June 2019.

Australian registration number:
50 mg tablet AUST R 42943

(vlr030123c) based on PI (vlr030123i)

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Voltaren Rapid 50

Active ingredient

Diclofenac potassium

Schedule

S4

 

1 Name of Medicine

Active ingredient: diclofenac potassium.

2 Qualitative and Quantitative Composition

Voltaren Rapid tablets contain 50 mg of diclofenac potassium.
Diclofenac potassium is a white or slightly yellowish, crystalline powder, slightly hygroscopic, sparingly soluble in water, freely soluble in methanol, soluble in alcohol, slightly soluble in acetone.

Excipients.

Each diclofenac potassium 50 mg tablet contains 5.8 mg of potassium.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tablets (reddish-brown, round, biconvex sugar-coated tablets).

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Pregnancy.

See Section 4.3 Contraindications; Section 4.6 Fertility, Pregnancy and Lactation.
After assessing the risk/ benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see Section 4.4 Special Warnings and Precautions for Use). Patients on long-term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment.
The tablets should be swallowed whole with liquid, preferably before meals, and must not be divided or chewed.

Dose.

Adults.

Acute pain states with an inflammatory component.

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

Acute migraine.

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

Symptomatic treatment of primary dysmenorrhoea.

In primary dysmenorrhoea, initially a dose of 50 or 100 mg should be given followed by 50 mg three times daily for 3 days. Treatment should be started upon appearance of the first symptoms and, depending on their duration and severity, continued for up to three days. If the pain has not resolved satisfactorily after 3 days' treatment, the patient should be instructed to return for review by the doctor.
Children. Voltaren Rapid is not recommended for use in children.

Method of administration.

Voltaren Rapid tablets should be taken with liquid, preferably before meals.

4.3 Contraindications

Gastric or duodenal ulcer, gastrointestinal bleeding or perforation.
Patients who are hypersensitive to the active ingredient, diclofenac, or any of the excipients contained in the tablets.
Third trimester of pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation).
Patients with severe hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use).
Renal failure (see Section 4.4 Special Warnings and Precautions for Use).
Severe cardiac failure (see Section 4.4 Special Warnings and Precautions for Use).
Treatment of perioperative pain in setting of coronary artery bypass surgery (CABG).
Patients in whom diclofenac, aspirin or other NSAIDs induce asthma, 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 Voltaren Rapid 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 Voltaren Rapid only after careful consideration and only at doses ≤ 100 mg daily when treatment continues for more than 4 weeks.
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used for the shortest duration possible. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment continues for more than 4 weeks.
Physicians and patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be informed about signs and/or symptoms of serious cardiovascular toxicity and be instructed to see a physician immediately in case of such an event.
There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.

Hypertension.

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

Heart failure.

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

Gastrointestinal effects.

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

Serious skin reactions.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia with systemic symptoms (DRESS) (see Drug reaction with eosinophilia with systemic symptoms (DRESS)) have been reported very rarely in association with the use of NSAIDs, including Voltaren Rapid (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 lesion or any other sign of hypersensitivity, and Voltaren Rapid should be discontinued.

Drug reaction with eosinophilia with systemic symptoms (DRESS).

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

Pre-existing asthma.

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

Infection.

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

Hypersensitivity.

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

Sucrose.

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

Use in hepatic impairment.

Close medical surveillance is required when prescribing Voltaren Rapid to patients with impaired hepatic function, as their condition may be exacerbated (see Section 4.3 Contraindications).
As with other NSAIDs, including diclofenac, elevations of one or more liver enzymes may occur during Voltaren Rapid 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 Voltaren 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, Voltaren Rapid is administered for a more prolonged period, monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, etc.), Voltaren Rapid should be discontinued.
Physicians should inform patients of the warning signs and symptoms of hepatotoxicity (e.g. nausea, fatigue, lethargy, pruritus, jaundice, abdominal tenderness in the right upper quadrant and "flu-like" symptoms) and the appropriate action to take should these signs and symptoms appear.
Caution should be exercised when using Voltaren Rapid in patients with hepatic porphyria, since Voltaren Rapid may trigger an attack.

Use in renal impairment.

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

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

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

Use in the elderly.

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

Paediatric use.

Voltaren Rapid 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.

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

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following interactions include those observed with Voltaren Rapid 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 Voltaren Rapid.

Diuretics and antihypertensive agents.

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

Other NSAIDs and corticosteroids.

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

Anticoagulants and anti-platelet agents.

Caution is recommended since concomitant administration could increase the risk of bleeding (see Section 4.4 Special Warnings and Precautions for Use). 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 the antidiabetic agents. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.
There have also been isolated reports of metabolic acidosis when diclofenac was co-administered with metformin, especially in patients with pre-existing renal impairment.

Methotrexate.

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

Cyclosporin and tacrolimus.

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

Drugs known to cause hyperkalaemia.

Concomitant treatment with potassium sparing drugs (e.g. diuretics, cyclosporine, 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).

Glucocorticoids.

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

Quinolone antibacterials.

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

CYP2C9 inhibitors.

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

CYP2C9 inducers.

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

Phenytoin.

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

The use of Voltaren Rapid 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 Voltaren Rapid 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, Voltaren Rapid 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.
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.
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.
Use of Voltaren Rapid during the 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 Voltaren Rapid during the third trimester of pregnancy is contraindicated (see Use in pregnancy (Category C)). Consider ultrasound monitoring of amniotic fluid if treatment extends beyond 48 hours. Discontinue treatment with NSAIDs if oligohydramnios occurs.
Following oral doses of 50 mg administered every 8 hours, the active substance; diclofenac passes into human milk. As with other drugs that are excreted in milk, Voltaren Rapid is not recommended for use in nursing women.

4.7 Effects on Ability to Drive and Use Machines

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

4.8 Adverse Effects (Undesirable Effects)

Whilst not all the reactions listed have been reported specifically with Voltaren Rapid, similarities between the NSAIDs as a group require them to be considered possible.
Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), including isolated reports.
The following undesirable effects include those reported with Voltaren Rapid and/or other pharmaceutical forms of diclofenac, with either short-term or long-term use.

Blood and lymphatic system disorders.

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

Immune system disorders.

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

Psychiatric disorders.

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

Nervous system disorders.

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

Eye disorders.

Very rare: visual disturbance, blurred vision, diplopia.

Ear and labyrinth disorders.

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

Cardiac disorders.

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

Vascular disorders.

Very rare: hypertension, vasculitis.

Respiratory, thoracic and mediastinal disorders.

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

Gastrointestinal disorders.

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

Hepatobiliary disorders.

Common: elevation of serum aminotransferase (AST, ALT).
Rare: hepatitis, jaundice, liver disorder.
Very rare: fulminant hepatitis, hepatic necrosis, hepatic failure.

Pregnancy, puerperium and perinatal conditions.

Unknown: oligohydramnios, neonatal renal impairment.

Skin and subcutaneous tissue disorders.

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

Renal and urinary disorders.

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

General disorders and administration site conditions.

Rare: oedema.
Very rare: impotence (association with Voltaren Rapid intake is doubtful).
*The frequency reflects data from long-term treatment with a high dose (150 mg/day).

Description of selected adverse drug reactions.

Arteriothrombotic events.

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

Visual effects.

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

Reporting suspected adverse effects.

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

4.9 Overdose

Management of acute poisoning with NSAIDs, including diclofenac, consists essentially of supportive and symptomatic measures. There is no typical clinical picture resulting from an overdosage of diclofenac. Overdosage can cause symptoms such as vomiting, gastrointestinal haemorrhage, diarrhoea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible. The therapeutic measures to be taken in cases of overdosage are as follows.
Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube, once the airway is protected.
Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Haematological and biochemical parameters, and the presence or absence of blood in the stools, should be monitored.
Specific therapies such as forced diuresis, dialysis, or haemoperfusion are probably of no help in eliminating NSAIDs, including diclofenac, because of their high protein-binding and extensive metabolism.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Voltaren Rapid is a non-steroidal anti-inflammatory drug (NSAID) and contains the potassium salt of diclofenac. In Voltaren Rapid, the sodium ion of diclofenac sodium (Voltaren) has been replaced by a potassium ion. The active principle is thus the same as in Voltaren. The preparation possesses analgesic, anti-inflammatory, and antipyretic properties.
Voltaren Rapid tablets have a rapid onset of action which makes them particularly suitable for the treatment of acute painful and inflammatory conditions.
As with other NSAIDs, its mode of action is not known; however, their ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.

Clinical trials.

In clinical trials Voltaren Rapid has also been found to exert an analgesic effect in moderately and severely painful states in the presence of inflammation, e.g. due to trauma or after surgical operations. It rapidly relieves both spontaneous pain and pain on movement and diminishes inflammatory swelling and wound oedema. In addition, the active substance is capable of relieving pain in primary dysmenorrhoea and may reduce the extent of bleeding.
In migraine attacks, Voltaren Rapid has been shown to be effective in relieving the headache. It may improve the accompanying symptoms of nausea and vomiting.
Low concentrations of diclofenac inhibit the aggregation of platelets induced in vitro by collagen and by adenosine diphosphate.

5.2 Pharmacokinetic Properties

Absorption.

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

Distribution.

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

Metabolism.

The biotransformation of diclofenac involves partly glucuronidation of the intact molecule but mainly single and multiple hydroxylation followed by glucuronidation.

Excretion.

The total systemic clearance of diclofenac from plasma is 263 ± 56 mL/min (mean value ± SD). The terminal half-life in plasma is 1 to 2 hours. Approximately 60% of the dose administered is excreted in the urine in the form of metabolites from one of these two processes. Less than 1% is excreted as unchanged substance. The remainder of the dose is eliminated as metabolites through the bile in the faeces.

Special patient populations.

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

5.3 Preclinical Safety Data

Genotoxicity.

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

Carcinogenicity.

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

6 Pharmaceutical Particulars

6.1 List of Excipients

Silica colloidal anhydrous, calcium phosphate, magnesium stearate, starch maize, povidone, sodium starch glycollate, cellulose microcrystalline, iron oxide red (CI No. 77491), macrogol 8000, sucrose, talc purified and titanium dioxide.

6.2 Incompatibilities

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

6.3 Shelf Life

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

6.4 Special Precautions for Storage

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

6.5 Nature and Contents of Container

Voltaren Rapid tablets: PVC/Aluminium foil blister packs containing 20 coated tablets of 50 mg diclofenac potassium.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

Diclofenac potassium.
Chemical name: potassium-[2-((2,6-dichlorophenyl) -amino)-phenyl]-acetate.

CAS number.

15307-81-0.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes