Each effervescent tablet contains 200 mg ibuprofen. Excipients: Each effervescent tablet contains: • 2.2 mmol (85 mg) potassium, as potassium carbonate. • 8.8 mmol (204 mg) sodium, as sodium hydrogen carbonate, mono sodium citrate, sodium carbonate and saccharin sodium. • up to 0.2 mg sucrose, present in saccharose palmitate.

Effervescent tablet. Round, white tablet, flat-faced on both sides.

This medicinal product is suitable for adults and adolescents over 12 years of age and over 30 kg in weight for the relief of mild to moderate pain such as headache, backache, rheumatic or muscular pain, dysmenorrhoea, dental pain, feverishness and for the relief of symptoms of colds and influenza.

For oral use.

For short-term use only.

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the medicinal product is required for more than 5 days for pain or 3 days for fever or if the symptoms worsen, the patient should consult a doctor.

The effervescent tablets should be dissolved in a glass of water and the solution drunk immediately after dissolution. Do not swallow effervescent tablets whole.

Suitable for adults, the elderly and adolescents over 12 years of age and over 30 kg in weight:

The single dose is 200-400 mg (one or two effervescent tablets).

Adults, the elderly and adolescents over 12 years of age and over 30 kg in weight: 200 to 400 mg (one or two tablets) to be repeated, if necessary, every 4-6 hours. Do not take more than 1200 mg ibuprofen (6 effervescent tablets) in any 24 hour period.

The product is not recommended for use in children below 12 years old.

The elderly and patients with renal and hepatic impairment should always be treated with the lowest effective dose.

Hypersensitivity to ibuprofen or any of the excipients.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis or urticaria) in response to acetylsalicylic acid/aspirin or other NSAIDs.

Active or previous peptic ulcer.

Active or history of upper gastrointestinal bleeding or perforation (two or more different episodes of ulceration or bleeding), including that associated with previous NSAID therapy.

Patients with severe hepatic failure, severe renal failure or severe heart failure.

Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors.

Use in third trimester of pregnancy

The use of Anadin LiquiFast 200mg Effervescent Tablets with concomitant NSAIDs including cyclo-oxygenase-2 selective inhibitors should be avoided.

Caution is required in patients with certain conditions:

- systemic lupus erythematosus as well as those with mixed connective tissue disease, due to increased risk of aseptic meningitis.

- gastrointestinal disorders and chronic inflammatory intestinal disease as these conditions may be exacerbated (ulcerative colitis, Crohn's disease.

- oedema, hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur.

- renal impairment as renal function may deteriorate.

- hepatic dysfunction.

- bronchial asthma.

Bronchospasm, urticaria or angioedema may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.

Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration (see gastro-intestinal (GI) and cardiovascular risks below).

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation that may be fatal.

There is some evidence that medicinal products which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.

Gastrointestinal effects

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose acetylsalicylic acid/aspirin, or other drugs likely to increase gastrointestinal risk.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid/aspirin.

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Cardiovascular and cerebrovascular effects

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. 1200 mg daily) is associated with an increased risk of myocardial infarction.

Dermatological effects

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk for 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. Anadin LiquiFast 200mg Effervescent Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

This medicine contains 2.2 mmol (85 mg) potassium per effervescent tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

This medicine also contains 8.8 mmol (204 mg) sodium per effervescent tablet. To be taken into consideration by patients on a controlled sodium diet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Ibuprofen should not be used in combination with:

- Acetylsalicylic acid/aspirin: (above 75 mg daily): as this may increase the risk of adverse reactions.

- Other NSAIDs: as these may increase the risk of adverse reactions.

Ibuprofen should be used with caution in combination with:

- Acetylsalicylic acid/aspirin when used as an anti-aggregrant, because this may increase the risk of gastrointestinal bleeding and decrease the benefit of taking acetylsalicylic acid/aspirin.

- SSRIs (selective serotonin-reuptake inhibitors): may increase the risk of gastrointestinal bleeding.

- Corticosteroids: may increase the risk of adverse reactions, especially of the gastrointestinal tract.

- Antihypertensives and diuretics: Diuretics and ACE-inhibitors can increase the nephrotoxicity of NSAIDs. NSAIDs may diminish the effects of these medicinal products, including ACE-inhibitors and beta-blockers. In particular, concomitant use of potassium-sparing diuretics or ACE-inhibitors can result in hyperkalaemia.

- Anticoagulants: NSAIDS may enhance the effects of anticoagulants, such as warfarin and ticlopidine.

- Lithium, digoxin, phenytoin: there is evidence for potential increase in plasma levels of these medicinal products when co-administered with ibuprofen.

- Methotrexate: there is the potential for increased plasma levels of methotrexate.

- Cyclosporin: inhibition of renal prostaglandin activity by NSAIDs may increase the plasma concentration of cyclosporin and the risk of cyclosporin-induced nephrotoxicity.

- Zidovudine: there is evidence of an increased risk of haemarthroses and haematoma in HIV positive haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

Experimental data suggest that ibuprofen may inhibit the effect of low dose acetylsalicylic acid/aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

Undesirable effects are mostly dose-dependent. In particular the risk of occurrence of gastrointestinal bleeding which is dependant on the dosage range and duration of treatment.

The undesirable effects are less frequent when the maximum daily dose is 1200mg.

Hypersensitivity reactions have been reported and these may consist of:

a) Anaphylaxis and non-specific allergic reactions.

b) Respiratory tract reactivity comprising bronchospasm, asthma, aggravated asthma or dyspnoea.

c) Various skin reactions, e.g. rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme), angioedema, pruritus and urticaria.

The following list of adverse reactions relates to those experienced with ibuprofen at OTC doses (maximum 1200 mg per day), from short-term use. In chronic conditions, under long-term treatment, additional adverse reactions may occur.

Adverse reactions have been ranked under headings of frequency using the following convention: very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1,000 to <1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses, 2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

Wyeth Consumer Healthcare

GSL – General Sales List

01 October 2010