Biogaran Ibuprofen Set 400 mg 12 film-coated tablets

Description Biogaran Ibuprofen Set 400 mg 12 film-coated tablets

Short-term symptomatic treatment of:

- mild to moderate pain such as headache, toothache and painful periods ;

- fever and pain associated with the common cold.

Indicated for adults, adolescents and children from 20 kg of body weight (6 years and older).

Directions for use Biogaran Ibuprofen Set 400 mg 12 film-coated tablets

The product is dosed as shown in the table below. The dosage of IBUPROFENE SET 400 mg film-coated tablets in children and adolescents is based on body weight and age and generally ranges from a single dose of 7 to 10 mg/kg body weight to a maximum daily dose of 30 mg/kg body weight. The interval between doses varies depending on the symptoms and the maximum daily dose. Allow at least 6 hours between doses.

Do not exceed recommended dose.

- Body Weight (Age): 20 - 29 kg (Children 6 - 9 years) Single dose: 200 mg ibuprofen Maximum daily dose: 600 mg ibuprofen

- Body Weight (Age): 30 - 39 kg (Child 10-11 years) Single Dose: 200 mg ibuprofen Maximum Daily Dose: 800 mg ibuprofen

- Body Weight (Age): >= 40 kg (Adolescent from 12 years of age and adult) Single dose: 200 or 400 mg ibuprofen Maximum daily dose: 1200 mg ibuprofen Use for a short time only.

If this medication is needed for more than 3 days for fever, or more than 4 days for pain, or if symptoms worsen, the patient should consult a physician.

Special Patient Populations

- Elderly Subjects: No specific dosage modification is necessary. Elderly patients should be closely monitored for potential adverse effects (see Warnings and Precautions).

- Renal impairment: No dose reduction is necessary in patients with mild to moderate renal impairment (for patients with severe renal impairment, see Contraindications).

- Hepatic impairment (see Pharmacokinetics): No dose reduction is necessary in patients with mild to moderate hepatic impairment (for patients with severe hepatic impairment, see Contraindications).

- Children and adolescents: IBUPROFENE SET 400 mg, film-coated tablet is contraindicated in children weighing less than 20 kg or under 6 years of age (see Contraindications). If it is necessary to take this medicine for more than 3 days for children (over 6 years) and/or adolescents (over 12 years) or if symptoms worsen, consult a doctor.

Method of administration Oral. Swallow the tablet whole without chewing, with sufficient water, during or after a meal. Patients with a sensitive stomach should take IBUPROFENE SET 400 mg, film-coated tablet with food.

The occurrence of adverse reactions can be minimized by using the lowest possible effective dose for the shortest duration of treatment necessary to relieve symptoms (see Warnings and Precautions for Use).

Precautions for use

Contraindications:

- Hypersensitivity to the active substance or to any of the excipients mentioned in the Composition section.

- History of bronchospasm, asthma, rhinitis, angioedema or urticaria triggered by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

- Unexplained hematopoietic disorders.

- Active peptic ulcer disease, history of recurrent peptic ulcer disease, gastrointestinal bleeding, or history of recurrent gastrointestinal bleeding (2 or more separate episodes of bleeding or ulceration documented).

- History of gastrointestinal bleeding or perforation during previous NSAID therapy.

- Cerebrovascular hemorrhage or other bleeding in progress.

- Severe hepatic insufficiency or severe renal insufficiency. - Severe heart failure (NYHA class IV).

- Severe dehydration (due to vomiting, diarrhea or inadequate fluid intake).

- Last trimester of pregnancy (see Fertility, Pregnancy and Lactation).

- IBUPROFENE SET 400 mg, film-coated tablet is contraindicated in children weighing less than 20 kg or under 6 years of age as this dosage is not appropriate due to the high content of active substance.

Composition Biogaran Ibuprofen Set 400 mg 12 film-coated tablets

film-coated tablet (white, oval, biconvex, scored, 20.2 mm long, 9.2 mm wide and 6.2 to 6.8 mm high): Ibuprofen-DL-lysine 684 mg.

Excipients: Microcrystalline cellulose, Magnesium stearate (Ph. Eur.) (of vegetable origin), Colloidal anhydrous silica, Polyvinyl alcohol, Titanium dioxide (E 171), Talc, Macrogol 3000, qsp 1 film coated tablet.