WebSite Samoa: Hedex Ibuprofen Tablets

1. Name Of The Medicinal Product

Hedex Ibuprofen Tablets

2. Qualitative And Quantitative Composition

Ibuprofen EP 200.0mg

3. Pharmaceutical Form

White, film-coated tablet

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of headaches including tension headaches and migraine, rheumatic and muscular pains, period pains, backache, neuralgia, toothache, feverishness and symptoms of colds and flu.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

200mg – 400mg, up to three times a day, as required, preferably with or after food.

Leave at least four hours between doses and do not take more than 1200mg in any 24 hour period.

Children:

Not recommended for children under twelve.

Elderly:

Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with particular caution in elderly patients who are more prone to adverse events.

Method of Administration

For oral administration and short-term use only.

4.3 Contraindications

Solpaflex tablets/ Cuprofen PLUS / Solpadeine Migraine Ibuprofen & Codeine Tablets are contraindicated in individuals with hypersensitivity to the active ingredients.

Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.

Active or previous peptic ulcer.

History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (See section 4.5 Interactions).

Severe hepatic failure, renal failure or heart failure (See section 4.4, Special warnings and precautions for use)

Last trimester of pregnancy (See section 4.6 Pregnancy and lactation).

Severe heart failure.

4.4 Special Warnings And Precautions For Use

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.

Bronchospasm 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 lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

Patients should be advised to consult their doctor if their headaches become persistent.

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

Cardiovascular and cerebrovascular effects

Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg 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.

Caution is required in patients with renal, cardiac or hepatic impairments since renal function may deteriorate.

The label will state:

Do not use if you have ever had a stomach ulcer or are allergic to ibuprofen or aspirin. If you are allergic to or are taking any other painkiller, pregnant, or suffer from asthma, speak to your doctor before taking ibuprofen. Do not exceed the stated dose. Keep safely away from children. If symptoms persist, consult your doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

NSAIDS may enhance the effect of anti-coagulants and diminish the effect of anti-hypertensives or thiazide diuretics. Concurrent aspirin or other NSAIDS may result in an increased incidence of adverse reactions.

4.6 Pregnancy And Lactation

Whilst no teratogenic effects have been demonstrated in animal experiments the use of ibuprofen tablets during pregnancy should, if possible, be avoided. The onset of labour may be delayed and its duration increased. In the limited data available, ibuprofen appears in the breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

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

Adverse effects reported include:

Gastro-intestinal: abdominal pain, nausea and dyspepsia. Occasionally peptic ulcer and gastro-intestinal haemorrhage.

Skin: rarely exfoliate dermatitis and epidermal necrolysis.

Haematological: thrombocytopenia.

Renal: papillary necrosis which can lead to renal failure.

Others: rarely hepatic dysfunction, headache, dizziness, hearing disturbance.

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).

Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg 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).

4.9 Overdose

The symptoms of overdose include headache, vomiting, drowsiness and hypertension. Gastric lavage and correction of severe electrolyte abnormalities should be considered. There is no specific antidote to ibuprofen overdosage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ibuprofen is a non-steroidal anti-inflammatory analgesic.

5.2 Pharmacokinetic Properties

Ibuprofen is absorbed from the gastrointestinal tract and peak concentrations in the circulation occur about 1.5 hours after ingestion. Ibuprofen is extensively bound to plasma proteins and has a half life of about 2 hours. It is rapidly excreted in the urine; about 60% of a dose is recovered in the urine as metabolites and their conjugates. It is believed that some ibuprofen may be excreted in the faeces possibly after excretion in the bile.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize starch, microcrystalline cellulose, magnesium stearate, spray dried lactose, colloidal silicon dioxide, croscarmellose sodium, hypromellose (HPMC, 6CPS), triacetin.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

PVC/aluminium foil blisters in cardboard cartons: 36 months.

HDPE bottles: 24 months.

6.4 Special Precautions For Storage

The product should be stored below 25°C.

6.5 Nature And Contents Of Container

PVC 250µm/Aluminium foil 20µm blisters in cardboard cartons containing 12, 18 or 24 tablets, or 250µm/Aluminium foil 20µm blisters in a round, wallet style pack containing 12 tablets.

HDPE bottles with clik-lok cap containing 25, 50 or 100 tablets

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

SmithKline Beecham (SWG) Limited

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as

GlaxoSmithKline Consumer Healthcare