Ibuprofen - pain relief medicament 12 tablets 200 mg

Product Description

Painkiller

Indications

Ibuprofen Pharmentis is indicated for the short-term symptomatic treatment of mild to moderate pain.

Composition

Active substances

Each film-coated tablet contains 200 mg of ibuprofen. For the full list of excipients, see section 6.1.

Excipients

Tablet core: modified maize starch, croscarmellose sodium, hypromellose, stearic acid, colloidal anhydrous silica.Coating: hypromellose, macrogol 8000, titanium dioxide.

Directions for use and dosage

PosologyThe lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The dose of ibuprofen is based on the patient's body weight and age. The intervals between doses depend on the symptoms and the maximum total daily dose. A minimum interval of at least 6 hours should be applied. The recommended dose should not be exceeded. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).IBUPROFENE PHARMENTIS 200 mg film-coated tablets

For short-term use: If use of the medicine is necessary for more than 3 days in adolescents, or if symptoms worsen, a doctor should be consulted. If use of the medicine is necessary for more than 4 days in adults, or if symptoms worsen, a doctor should be consulted.

Special patient groups Elderly: No specific dose adjustment is required. Due to the possible adverse effect profile (see section 4.4), elderly patients should be monitored with particular care. Renal impairment: No dose reduction is recommended for patients with mild to moderate renal impairment (for patients with severe renal impairment, see section 4.3). Hepatic impairment (see section 5.2): No dose reduction is recommended for patients with mild to moderate hepatic impairment (for patients with severe hepatic dysfunction, see section 4.3). Children and adolescents: For use in children and adolescents, see also section 4.3. Method of administration: For oral use. The film-coated tablets should be swallowed whole with water. In patients with gastric sensitivity, it is recommended to take ibuprofen during meals.

Pregnancy and breastfeeding

Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development. Data from epidemiological studies show an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with the dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has induced an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during organogenesis. Ibuprofen should not be administered during the first and second trimesters of pregnancy unless clearly necessary. If ibuprofen is used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose and duration of treatment should be kept as low 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 progress to renal failure with oligohydramnios; – the mother and newborn, at the end of pregnancy, 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, the use of ibuprofen is contraindicated during the third trimester of pregnancy. Breastfeeding Only small amounts of ibuprofen and its metabolic products are excreted in breast milk. Since no adverse effects are known in breast-fed infants, it is generally not necessary to interrupt breastfeeding during short-term use at the doses recommended for the treatment of mild to moderate pain. However, if the drug is prescribed for prolonged treatment or at high doses, early weaning should be considered.FertilityThere is evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility due to an effect on ovulation. This event, however, is reversible upon discontinuation of treatment.

Format

12 tablets