Buscofenact - pain relief medicament 20 capsules 400 mg

Product Description

Medicine to counteract pain and fever

Indications

Buscofenact is indicated for the short-term symptomatic treatment of:

• mild to moderate pain such as headache, toothache and menstrual pain;
• fever and pain associated with the common cold. BuscofenAct is indicated in adults and adolescents with a body weight greater than 40 kg (aged 12 years and over).

Composition

Active substances

One soft capsule contains 400 mg of ibuprofen. Excipients with known effect: Sorbitol 95.94 mg/capsule. For the full list of excipients, see section 6.1. of the package leaflet

Excipients

Capsule contents: Macrogol 600 Potassium hydroxide Purified water Capsule shell : Gelatin Liquid sorbitol Purified water Printing ink Ingredients of Opacode WB black NS-78-17821: Black iron oxide (E172) Propylene glycol (E1520) Hypromellose 6cP

Directions for use and Dosage

Adults and adolescents with a body weight > 40 kg (12 years of age and older): Initial dose of 400 mg ibuprofen. If necessary, an additional 400 mg dose of ibuprofen can be taken. The interval between doses should be based on the symptoms observed and the maximum recommended daily dose, and should not be less than 6 hours. Do not take more than 1200 mg ibuprofen in 24 hours. For short-term treatment only. Undesirable effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If BuscofenAct soft capsules must be taken in adults for more than 3 days in case of fever or for more than 4 days for the treatment of pain, or if symptoms worsen, the patient is advised to consult a doctor. Taking BuscofenAct soft capsules on a full stomach is recommended for people with gastric disorders. If taken shortly after eating, the onset of the effect of BuscofenAct may be delayed. If this happens, do not take BuscofenAct more than recommended in section 4.2 (dosage) or until the correct dose interval has elapsed.

Special patient populations Elderly No special dosage adjustments are required. Due to possible adverse effects (see section 4.4), elderly patients should be carefully monitored. Renal impairment No special dose modifications are required in patients with mild or moderate renal impairment (for patients with severe renal impairment, see section 4.3). Hepatic impairment (see section 5.2) No special dose modifications are required in patients with mild or moderate liver impairment (for patients with severe liver dysfunction, see section 4.3). Paediatric population BuscofenAct is contraindicated in adolescents with a body weight below 40 kg and in children under 12 years of age due to the high content of the active substance (see section 4.3). If the use of the medicinal product is necessary for more than one year, the use of the medicinal product should be discontinued. 3 days in adolescents, or in case of worsening of symptoms, a doctor should be consulted.

Method of administration For oral use. The soft capsules should not be chewed.

Warnings

Read the package leaflet carefully before starting treatment.

Contraindications and side effects

BuscofenAct soft capsules are contraindicated in case of: - hypersensitivity to ibuprofen or to any of the excipients listed in paragraph 6.1; - history of hypersensitivity (e.g. bronchospasm, asthma, rhinitis, angioedema or urticaria) associated with the intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); - haematological disorders of unknown origin; - history of recurrent or active peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding); - history of gastrointestinal bleeding or perforation, related to previous NSAID therapy; - cerebrovascular haemorrhage or other bleeding episodes; - severe heart failure (NYHA class IV) (see also section 4.4); - severe hepatic insufficiency or severe renal insufficiency (see also section 4.4); - patients in the third trimester of pregnancy (see section 4.6); - adolescents with a body weight below 40 kg and children under 12 years of age; - patients with severe dehydration (due to vomiting, diarrhoea or insufficient fluid intake).

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Results of epidemiological studies suggest an increased risk of spontaneous abortion, cardiac malformations, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with increasing dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has resulted in increased pre- and post-implantation loss and embryo-fetal mortality. Additionally, an increased incidence of malformations, including cardiovascular ones, has been reported in animals treated with a prostaglandin synthesis inhibitor during organogenesis. During the first and second trimesters of pregnancy, ibuprofen should be administered only when clearly needed. If ibuprofen is used in women attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to the risk of: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may worsen to renal failure with oligohydramnios. At the end of pregnancy, the mother and newborn are at risk of: - possible prolongation of bleeding time, an antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions, which may result in a delay or prolongation of labor at the time of delivery. Consequently, ibuprofen administration is contraindicated during the third trimester of pregnancy.

Breastfeeding Ibuprofen and its metabolites may pass into breast milk in low concentrations. To date, no harmful effects on breast-fed infants are known. Therefore, for short-term treatment of pain and fever at the recommended dose, it should not generally be necessary to interrupt breast-feeding.

Fertility There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may impair female fertility by affecting ovulation. Once treatment with ibuprofen has ended, the effect is reversible.

Storage

This medicine does not require any special storage temperatures.

Format

20 capsules