Buscofenact 400 mg - painkiller 12 soft capsules

Product Description

Bucofenact is used to treat:

• mild to moderate pain such as headache, toothache and menstrual pain,
• fever and pain associated with the common cold.

Ibuprofen Boehringer Ingelheim is indicated in adults and adolescents with a body weight of more than 40 kg (aged 12 years and over).

Contraindications

• Hypersensitivity to ibuprofen or to any of the excipients,
• 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 hepatic insufficiency, severe renal insufficiency or severe cardiac insufficiency
• Third trimester of pregnancy
• Adolescents with body weight below 40 kg and children.
• In patients with severe dehydration (due to vomiting, diarrhoea or insufficient fluid intake).

Special warnings

Undesirable effects may be minimised by using the lowest effective dose for the highest effective dose. shortest possible duration of treatment, necessary to achieve symptom control.

Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Results of epidemiological studies raise concerns about an increased risk of spontaneous abortion, cardiac malformations, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. 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. Furthermore, an increased incidence of malformations, including cardiovascular, has been reported in animals treated with a prostaglandin synthesis inhibitor during the period of organogenesis.

During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters of pregnancy, the dose should be kept as low and the duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension),
• renal dysfunction, which may lead to:
  • progress to renal failure with oligohydramnios,

  The mother and the newborn, at the end of pregnancy, may be exposed to:

  • possible prolongation of bleeding time, and antiaggregant effect which may occur even at very low doses,
  • inhibition of uterine contractions resulting in delayed or prolonged labor.

  Consequently, diclofenac 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 breastfeeding.

  Expiry and storage

  Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in its intact packaging, stored correctly. Store in the original packaging to protect the medicine from moisture.

  Caution: Do not use the medicine after the expiry date indicated on the package.

  Composition

  Buscofenact contains:
  Active ingredient: 400 mg of ibuprofen.
  Excipients: Macrogol 600, Potassium hydroxide, Purified water.

  Format

  Pack with 12 soft capsules.

   
  Product Code:FRCM047011