Sanofi Buscofenact 400mg Ibuprofen Pain Reliever 12 Softgels

Product details
Therapeutic indications
Bucofenact is used for the treatment of:

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 weighing 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 acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
Hematological disorders of unknown origin;
History of recurrent or ongoing 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 liver failure, severe renal failure or severe heart failure
Third trimester of pregnancy
Adolescents with body weight below 40 kg and children.
In patients with severe dehydration (due to vomiting, diarrhea or insufficient fluid intake).
Special warnings
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to achieve symptom control.

Pregnancy and breastfeeding

Pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies raise concerns about an increased risk of spontaneous abortion, cardiac malformations and gastroschisis following the 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 resulted in increased pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of malformations, including cardiovascular malformations, has been reported in animals treated with a prostaglandin synthesis inhibitor during the period of organogenesis.

During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester 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 can expose the fetus to:

cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
renal dysfunction, which can progress to renal failure with oligohydroamnios;
The mother and the newborn, at the end of pregnancy, may be exposed to:

possible prolongation of bleeding time, and antiplatelet 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.

Feeding time
Ibuprofen and its metabolites can pass in low concentrations into breast milk. To date, no deleterious effects on infants are known. Therefore, for short-term treatment of pain and fever at the recommended dose, it should generally not be necessary to stop breastfeeding.

Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store in the original package in order to protect from moisture.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition
Buscofenact contains:
Active ingredient: 400 mg of ibuprofen.

Buscofenact 400 gr in packs of 12 tablets