IBUPROFEN 400mg Film-coated tablet Ref.[7559] Active ingredients: Ibuprofen

Posology

The treatment should start with the lowest dose anticipated to be effective, which can subsequently be adjusted, depending on the therapeutic response and any undesirable effects. In long-term treatment a low maintenance dose should be the aim.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Rheumatic diseases

Initial treatment: 2x400 mg tablets, three times daily, i.e. 2400 mg per day

Maintenance treatment: 1x400 mg tablets, three to four times daily, i.e. 1200 to 1600 mg per day.

An interval of at least 4-6 hours should be allowed between doses. The total daily dose must not exceed 2400mg in divided doses. Some patients can be maintained on 600–1200mg daily.

Juvenile Rheumatoid Arthritis

For Juvenile Rheumatoid Arthritis, the recommended dose is 20mg-30mg/kg body weight daily in 3 to 4 divided doses up to a maximum of 40mg/kg body weight daily in severe cases. In children weighing less than 40 kg, use of a different strength or a liquid formulation of ibuprofen should be considered to aid accurate dosing.

Short term symptomatic treatment of fever and pain of mild to moderate intensity

Adults and adolescents over 12 years (>40 kg)

One 400 mg tablet one to four times daily, as needed. An interval of at least 4-6 hours should be allowed between doses. Single doses exceeding 400 mg have not been shown to have any additional analgesic effect. The 400 mg tablet should only be used for more intense pain or fever that are not relieved by a 200 mg ibuprofen tablet.

Dysmenorrhoea

One 400 mg tablet one to three times daily, as needed. An interval of at least 4-6 hours should be allowed between doses. Treatment is started at the first sign of menstruation problems.

Elderly

The elderly are at increased risk of serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. If renal or hepatic function is impaired, dosage should be assessed individually.

Renal impairment

Caution should be taken with ibuprofen dosage in patients with renal impairment. The dosage should be assessed individually. The dose should be kept as low as possible and renal function should be monitored (see sections 4.3, 4.4 and 5.2).

Hepatic impairment

Caution should be taken with dosage in patients with hepatic impairment. The dosage should be assessed individually and the dose should be kept as low as possible (see sections 4.3, 4.4 and 5.2).

Method of administration

For oral use.

It is recommended that patients with sensitive stomachs take ibuprofen tablet with food. If taken shortly after eating, the onset of action of ibuprofen tablet may be delayed. To be taken preferably with or after food, with plenty of fluid. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.

Toxicity

Risk of symptoms at doses >80–100 mg/kg. At doses >200 mg/kg there is a risk of severe symptoms, though with considerable variations between individuals. A dose of 560 mg/kg in a child aged 15 months gave severe intoxication, 3.2 g in a 6-year-old mild to moderate intoxication, 2.8–4 g in a 1½-year-old and 6 g in a 6-year-old severe intoxication even after gastric lavage, 8 g in an adult moderate intoxication and >20 g in an adult very severe intoxication. 8 g administered to a 16-year-old affected the kidney and 12 g in combination with alcohol administered to a teenager resulted in acute tubular necrosis.

Symptoms

Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours.

The predominant symptoms of overdose are ones from the gastrointestinal tract, e.g. nausea, abdominal pain and vomiting (possibly blood-streaked). Central nervous system effects include headache, tinnitus, confusion and nystagmus. At high doses loss of consciousness and convulsions (mainly in children) may occur. Cardiovascular toxicity, including bradycardia, tachycardia and hypotension have been reported. Hypernatraemia, kidney effects and haematuria may occur. In serious poisoning metabolic acidosis may occur. In significant overdose, renal failure and liver damage are possible. Hypothermia and ARDS have occasionally been reported.

Treatment

Management should be symptomatic and supportive as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

In the event of gastrointestinal problems, administer antacids. In the event of hypotension, intravenous fluid and, if required, inotropic support. Ensure adequate diuresis. Correct acid-base and electrolyte disorders.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

5 years.

This medicinal product does not require any special storage conditions.

PVC – Aluminium blisters or PVC/PVdC – Aluminium Blisters

Pack sizes: 10, 12, 14, 20, 21, 24, 28, 30, 40, 42, 48, 50, 60, 84, 100 or 500 film-coated tablets in carton.

Not all pack sizes may be marketed.

No special requirements.