Migaura Paracetamol micronized 500 mg / Metoclopramide HCl 5 mg Tablets 1. NAME OF THE MEDICINAL PRODUCT Migaura 500 mg/5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active ingredient: 5 mg Metoclopramide HCl Paracetamol micronized 500 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White flat round tablet scored (non functional) from one side. 4. CLINICAL DATA 4.1 Application areas Treatment of headaches with dizziness, nausea and vomiting associated with migraine attacks. 4.2 Posology and method of administration Dose Adolescents from 14 years and adults: At the first signs of migraine, 2 Migaura tablets once. If necessary, this dose can be taken again at 4-hourly intervals, but shouldn’t take more than 6 tablets per day without a doctor's prescription. Depending on the paracetamol content of the fixed combination, the total daily dose should not exceed 60 mg/kg body weight and depending on metoclopramide content the maximum dose in 24 hours is 0.5 mg per kg body weight; in adults, the usual dose of conventional formulations (all routes) is 10 mg up to 3 times daily. Special patient groups Hepatic insufficiency and mild renal insufficiency In patients with hepatic or renal dysfunction and Gilbert's syndrome, the dose should be reduced or the dose interval extended. (The following information applies to adults): Creatinine clearance up to 10 ml/min: 2 Migaura tablets once daily (equivalent to 1000 mg paracetamol and 10 mg metoclopramide) Creatinine clearance from 11 to 60 mL/min: 2 Migaura tablets once daily (equivalent to 1000 mg paracetamol and 10 mg metoclopramide) and 1 Migaura tablet once daily (equivalent to 500 mg paracetamol and 5 mg metoclopramide). Severe renal insufficiency In case of severe renal insufficiency (creatinine clearance < 10 ml/min), a dosing interval of at least 8 hours should be observed. In patients with severe hepatic dysfunction (hepatic insufficiency) with abdominal dropsy (ascites), the dose should be halved due to delayed excretion. If there is a congenital increase in the content of bilirubin in the blood (Gilbert's syndrome or Meulengracht's disease), Migaura should be taken at longer intervals or in reduced amounts. Elderly patients No special dose adjustment is required. Children and adolescents with low body weight -Migaura is not recommended for use in children below 14 years of age or with a body weight of less than 43 kg, as the dose is not appropriate for this group of patients (see section 4.3). Mode of administration The tablets can be taken whole with enough liquid at the first sign of pain or a migraine attack. Migaura is designed for immediate pain management and should not be used for long-term therapy. Consult a doctor before using the product for more than 3-4 days. 4.3 Contraindications Migaura should not be used in: Hypersensitivity to the active substances or to any of the other conditions listed in section 6.1. components Known genetically determined glucose-6-phosphate dehydrogenase deficiency (risk of hemolytic anemia) Pheochromocytoma (adrenal medulla tumor) Mechanical ileus Intestinal perforation and bleeding in the gastrointestinal area Prolactin-dependent carcinomas Epileptics and patients with extrapyramidal motor disorders Severe liver failure with ascites and/or impaired renal function Severe hepatocellular insufficiency (Child-Pugh > 9) Pregnancy (see section 4.6) Lactation (see section 4.6) Children under 14 years of age.
