SERACTIL Film-coated tablet Ref.[2735] Active ingredients: Dexibuprofen

The dosage should be adjusted to the severity of the disorder and the complaints of the patient. During chronic administration, the dosage should be adjusted to the lowest maintenance dose that provides adequate control of symptoms.

For individual dosage film-coated tablets with 200, 300 and 400 mg dexibuprofen are available.

The recommended dosage is 600 to 900 mg dexibuprofen daily, divided in up to three single doses.

For the treatment of mild to moderate pain, initially single doses of 200 mg dexibuprofen and daily doses of 600 mg dexibuprofen are recommended.

The maximum single dose is 400 mg dexibuprofen.

The dose may be temporarily increased up to 1200 mg dexibuprofen per day in patients with acute conditions or exacerbations. The maximum daily dose is 1200 mg.

For dysmenorrhoea a daily dose of 600 to 900 mg dexibuprofen, divided in up to three single doses, is recommended. The maximum single dose is 300 mg, the maximum daily dose is 900 mg.

Dexibuprofen has not been studied in children and adolescents (<18 years): Safety and efficacy have not been established and therefore it is not recommended in these age groups.

In elderly patients it is recommended to start the therapy at the lower end of the dosage range. The dosage may be increased to that recommended for general population only after good general tolerance has been ascertained.

Hepatic dysfunction: Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses and be closely monitored. Dexibuprofen should not be used in patients with severe hepatic dysfunction (see 4.3. Contraindications).

Renal dysfunction: The initial dosage should be reduced in patients with mild to moderate impaired renal function. Dexibuprofen should not be used in patients with severe renal dysfunction (see 4.3. Contraindications).

The film coated tablets can be taken with or without a meal (see 5.2). In general NSAIDs (non-steroidal anti-inflammatory drugs) are preferably taken with food to reduce gastrointestinal irritation, particularly during chronic use. However, a later onset of action in some patientsmay be anticipated when the tablets are taken with or directly after a meal.

The score in the 200 and 400 mg tablets makes it possible to divide the tablets before administration so as to assist with swallowing.

Dividing the tablets will not provide an exact “half” dose.

Dexibuprofen has a low acute toxicity and patients have survived after single doses as high as 54 g of racemic ibuprofen. Most overdoses have been asymptomatic. There is a risk of symptoms at doses >80-100 mg/kg racemic ibuprofen.

The onset of symptoms usually occurs within 4 hours. Mild symptoms are most common, including abdominal pain, nausea, vomiting, lethargy, drowsiness, headache, nystagmus, tinnitus and ataxia. Rarely, moderate or severe symptoms include gastrointestinal bleeding, hypotension, hypothermia, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress syndrome and transient episodes of apnea (in very young children following large ingestions).

Treatment is symptomatic, and there is no specific antidote. Amounts not likely to produce symptoms (less than 50 mg/kg dexibuprofen) may be diluted with water to minimize gastrointestinal upset. In case of ingestion of a significant amount, activated charcoal should be administered.

Emptying of the stomach by emesis may only be considered if the procedure can be undertaken within 60 minutes of ingestion. Gastric lavage should not be considered unless a patient has ingested a potentially life-threatening amount of the drug and the procedure can be undertaken within 60 minutes of ingestion. Forced diuresis, hemodialysis or hemoperfusion are unlikely to be of assistance because dexibuprofen is strongly bound to plasma proteins.

3 years (PVC/PVDC/aluminium blisters).

18 months (PE jars).

Do not store above 25°C.

10, 20, 30, 50, 60, 90, 100, 100x1 and 500x1 film-coated tablets in PVC/PVDC/aluminium blisters.

150 film-coated tablets in PE jars with dosing hole and hinged closure.

Not all pack sizes may be marketed.

No special requirements.