Brufen analgesico 400 mg - analgesic medicament 12 tablets

Product Description

Medicine for the treatment of mild to moderate pain

Indications

Brufen analgesic is indicated for the symptomatic treatment of mild to moderate pain, such as headache, acute migraine with or without aura, dental pain, menstrual pain and fever and pain in the common cold.

Composition

Active substances

Each tablet contains 200 mg of ibuprofen (as lysine salt) Each tablet contains 400 mg of ibuprofen (as lysine salt) For the full list of excipients, see section 6.1 of the package leaflet

Excipients

Tablet core Cellulose, microcrystalline (E460) Colloidal anhydrous silica (E551) Crospovidone (E1202) Povidone (E1201) Magnesium stearate (E572) Talc (E553b). Tablet coating Hydrolysed polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol (E1521) Talc (E553b). Printing ink Shellac (E904) Black iron oxide (E172) Ammonium hydroxide (E527).

How to use and Dosage

• Adults and adolescents ≥ 40 kg body weight (12 years of age and over):
  (200 mg only) Initial dose: 200 mg or 400 mg. If necessary, an additional dose of 1 or 2 tablets (200 mg to 400 mg) can be taken. The corresponding interval between doses should be chosen based on symptoms and the maximum recommended daily dose. It should be no less than 6 hours for a 400 mg dose and no less than 4 hours for a 200 mg dose. Do not exceed 1200 mg in any 24-hour period. (400 mg only)
  Starting dose: 400 mg. If necessary, an additional dose of 400 mg may be taken. The corresponding interval between doses should be chosen based on symptoms and the maximum recommended daily dose. It should be no less than 6 hours for a 400 mg dose. Do not exceed 1200 mg in any 24-hour period. For the treatment of migraine, the dose should be one 400 mg tablet as a single dose, if necessary 400 mg at 4- to 6-hour intervals. Do not exceed the dose of 1200 mg in any 24-hour period.

• Paediatric population(200 mg only)Children over 6 years (20 kg - 40 kg body weight): Ibuprofen should only be used in children with a body weight of at least 20 kg. The maximum daily dose of ibuprofen is 20 - 30 mg ibuprofen per kg body weight, divided into 3 or 4 individual doses with an interval between doses of 6 to 8 hours. The maximum recommended daily dose should not be exceeded. A maximum dosage of 30 mg/kg ibuprofen in any 24-hour period should not be exceeded.
  The following dosage information applies:

  Body weight	Single dose	Maximum daily dose
  20 kg - 29 kg	1 tablet (200 mg ibuprofen)	3 tablets (equivalent to 600 mg ibuprofen)
  30 kg - 39 kg	1 tablet (200 mg ibuprofen)	4 tablets (equivalent to 800 mg ibuprofen) ibuprofen)

  If this medicine is required for more than 3 days in children over 6 years of age and in adolescents or if symptoms worsen, you should contact your doctor. Children under 6 years of age Brufen Analgesic is contraindicated in children under 6 years of age. (Only 400 mg)Brufen Analgesic is contraindicated in adolescents under 40 kg of body weight or in children under 12 years of age. If this medicine is required for more than 3 days in children over 12 years of age and in adolescents or if symptoms worsen, you should contact your doctor. Undesirable effects can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If the medicine is required for more than 3 days in the case of migraine or fever or for more than 4 days for the treatment of pain, or if symptoms worsen, the patient should be advised to consult a doctor. Elderly patientsNo dose adjustment is necessary. Elderly patients should be monitored particularly carefully due to the possible side effect profile (see section 4.4).

• Patients with gastric sensitivityPatients with sensitive stomachs should take Brufen Analgesic during a meal. Taking ibuprofen after a meal may delay the onset of its action. If this occurs, no additional ibuprofen should be taken beyond that specified in section 4.2 (Posology) or until the corresponding dosing interval has elapsed.
• Patients with renal impairmentNo dose reduction is required in patients with mild to moderate renal impairment. For patients with severe renal impairment, see section 4.3.
• Patients with hepatic impairmentNo dose reduction is required in patients with mild to moderate hepatic impairment.
• For patients with severe hepatic impairment, see section 4.3. Method of administration For oral administration and short-term use only. Ibuprofen tablets should be swallowed whole with plenty of water. Do not chew the tablets.

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 and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with 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 the period of organogenesis. During the first and second trimesters of pregnancy, ibuprofen should not be administered 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. To date, no harmful effects on the infant are known. Therefore, ibuprofen can be used during breastfeeding for the treatment of pain and fever in the short term and at the recommended doses. Safety for prolonged use has not been established.

Fertility There is evidence showing that drugs that inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility as a result of an effect on ovulation. This event, however, is reversible upon discontinuation of treatment.

Format

12 tablets