Advil Liqui-gel, 200mg Capsules

Each capsule contains 200 mg Ibuprofen.

For excipients, see section 6.1

Soft capsule.

Green translucent, oval soft gelatin capsule printed 'Advil' on one side in white ink.

For the relief of mild to moderate pain including rheumatic and muscular pain, backache, headache, dental pain, dysmenorrhoea, feverishness and for the relief of symptoms of cold and influenza.

For all indications:

Adults, the elderly and children over 12 years of age:

1 or 2 capsules every 4 to 6 hours as required.

The capsules should be taken with water.

Do not exceed 6 capsules (1200 mg) in 24 hours.

Not to be used for children under 12 years of age.

Use in patients hypersensitive to any of the ingredients. Use in patients hypersensitive to aspirin or with bronchospasm, asthma, rhinitis or urticaria associated with non-steroidal anti-inflammatory drugs. Ibuprofen should not be given to patients with current or previous peptic ulceration, inflammatory gastrointestinal disorders, gastrointestinal bleeding, cerebrovascular bleeding or other active bleeding; haematological disease; severe hepatic failure, severe renal failure or severe uncontrolled heart failure. Sever heart failure.

Caution (discussion with a 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.

Should not be used with other pain relievers such as NSAIDs.

Bronchospasms may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease and it should not be used where other NSAIDs have produced reactions.

Caution is required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate. The dose should be as low as possible and renal function should be monitored.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. (See GI and cardiovascular risks below) .

The elderly are at increased risk of the serious consequence of adverse reactions.

Should not be given to patients who are pregnant or breastfeeding.

Caution should be taken when Ibuprofen is given to patients with SLE and autoimmune diseases.

The pharmacological activity of Ibuprofen may reduce fever and inflammation, thus diminishing their utility as diagnostic signs in detecting underlying conditions.

Cardiovascular and cerebrovascular effects: Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2,400 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. 1200mg daily) is associated with an increased risk of myocardial infarction.

Not recommended combinations:

Animal studies show that acetylsalicylic acid reduces the plasma concentrations of Ibuprofen. Ibuprofen should not be used with other pain relievers such as NSAIDs.

Combinations requiring precautions:

Concurrent aspirin, NSAIDs, or corticosteroids may result in an increased incidence of adverse reactions.

NSAIDs may enhance the effects of anticoagulants and diminish the effects of antihypertensive or thiazide diuretics.

Increases in serum lithium concentrations, following administration of Ibuprofen may be clinically significant.

Ibuprofen may increase serum digitalis concentrations. Serum digitalis concentrations should therefore be monitored in patients with decreased renal function or congestive heart failure.

Ibuprofen may increase the pharmacologically active free phenytoin. Patients taking Ibuprofen for long-term use should be monitored.

Concomitant administration of Ibuprofen with moderate and high doses of methotrexate may lead to serious and fatal methotrexate toxicity. Patients with reduced renal function may be at additional risk of toxicity from the combination even when low doses of methotrexate (20 mg/week) are used.

Certain antacids may increase the gastrointestinal absorption of Ibuprofen. This is considered to be of clinical relevance particularly during long-term use of Ibuprofen.

When taking anticoagulants it should be taken into account that long-term use of Ibuprofen may increase the risk of bleeding.

When taking corticosteroids and Ibuprofen concomitantly there is an increased risk of GI bleeding.

No teratogenic effect has been demonstrated in animal experiments, however, use of Ibuprofen during pregnancy, especially during the first 3 months, should, if possible, be avoided. The onset of labour may be delayed and duration of labour increased.

Due to the effect of NSAIDs on prostaglandin synthesis there may be foetal problems (pulmonary hypertension, respiratory insufficiency due to the closure of the ductus arteriosus Botalli or due to increased intrauterine pressure).

NSAIDs should therefore not be used in the last 3 months of pregnancy.

Ibuprofen does appear in breast milk in very low concentrations. Based upon the low level detected (0.0008% of maternal dose), it is unlikely to affect the breast fed infant adversely.

None known

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 (2,400 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). (See section 4.4).

Gastro-intestinal and skin disorders are most frequently reported. Adverse effects include the following:

CNS: headache, dizziness.

Gastro-intestinal: Abdominal pain, nausea and dyspepsia, constipation, diarrhoea and occasionally peptic ulcer and gastro-intestinal haemorrhage, lack of appetite.

Haematological: Thrombocytopenia, occasionally agranulocytosis and aplastic anaemia.

Renal: Haematuria, interstitial nephritis, renal papillary necrosis and renal failure have occasionally been reported.

Hypersensitivity reactions have been reported following treatment with Ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactivity comprising of asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritis, urticaria, purpura, angiodema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).

Other: Rarely hepatic dysfunction, hearing disturbances.

In case of overdosage, headache, vomiting, drowsiness and hypotension have been reported. Hyperkalaemia may develop. Treatment is supportive with gastric lavage and correction of severe electrolyte imbalance if required.

ATC code: M01A E01

Ibuprofen is a phenylpropionic acid derivative, which has analgesic, anti-inflammatory and anti-pyretic actions.

After oral administration, solubilised Ibuprofen (Liquigel Capsules) is quickly absorbed when administered under fasting conditions. C_max is achieved within 0.6 hours compared to conventional tablets (3/4 – 1 ½ hours). When taken with food, peak levels are observed after 1-2 hours.

Ibuprofen protein binding is approximately 99%. After an oral dose, Ibuprofen is 75 – 85% excreted via kidneys during the first 24 hours (mainly in the form of two metabolites), the remainder being eliminated in the faeces following excretion in bile. Excretion is complete within 24 hours.

The half-life of Ibuprofen is about 2 hours.

In limited studies, Ibuprofen appears in the breast milk in very low concentrations.

Preclinical data reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. No teratogenic effect has been demonstrated in animal experiments, however, use of Ibuprofen during pregnancy should, if possible, be avoided.

Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Macrogol 600

Potassium hydroxide

Sorbitol

Sorbitan

Mannitol

Gelatin

Purified water

Quinoline yellow (E104)

Patent blue (E131)

Opacode White Ink:

In case of ribbon printing technique opacode white ink composition is: titanium dioxide (E171), propylene glycol, polyvinyl acetate phthalate and macrogol 400.

In case of Markem printing technique opacode white ink composition is: titanium dioxide (E171), shellac, soya lecithin and simethicone.

Not applicable.

3 years

Do not store above 25°C.

The Liquigel Capsules are packed into blister strips in a cardboard box.

A pack range will consist of packs of 6, 10, 12, 20, 24, 30, 36, 40, 48, 50, 60, 70, 72, 80, 90, 96 and 100 Liquigel capsules.

Not all pack sizes may be marketed.

No special requirements.

Pfizer Consumer Healthcare Ltd

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

PA 0172/029/002

Date of first authorisation: 8 March 2002

Date of last renewal: 8 November 2004

May 2011