Methylergometrine tablets

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Name of this product METHYLERGOMETRINE 0.125 mg tablets. Cardiac disorders Uncommon Chest pain. Description and composition Rare Bradycardia, tachycardia, palpitations. Pharmaceutical form Very rare Myocardial infarction, arteriospasm coronary. Coated tablets for oral administration. Active substance Vascular disorders METHYLERGOMETRINE Common Hypertension. Uncommon Hypotension. Indications Rare Vasoconstriction, vasospasm, arterial spasm. Prevention or treatment of uterine haemorrhage. Very rare Thrombophlebitis. Respiratory, thoracic and mediastinal disorders Dosage and administration Very rare Nasal congestion. Dosage Gastrointestinal disorders General target population Uncommon Vomiting, nausea. Treatment of subinvolution, lochiometra, puerperal bleeding Very rare Diarrhoea. The recommended dosage of Methylergometrine is: 1 or 2 tablets (0.125 to 0.25 Skin and subcutaneous tissue disorders mg) orally, up to 3 times daily and usually for up to 5 days. Common Skin eruptions. Uncommon Hyperhidrosis. Special populations Renal impairment / Hepatic impairment Musculoskeletal and connective tissue disorders Caution should be exercised in the presence of impaired hepatic or renal function Very rare Muscle spasms. (see section 6 Warnings and precautions). Pregnancy, puerperium and perinatal conditions Contraindications Common Abdominal pain (caused by uterine contractions). • Pregnancy; Interactions • First stage of labor; second stage of labor before delivery of the anterior Ergot alkaloids are substrates of CYP3A4. shoulder (Methylergometrine must not be used for induction or enhancement of Interactions resulting in concomitant use not being recommended labor);

• Severe hypertension; CYP3A4 inhibitors • Pre-eclampsia and eclampsia; The concomitant use of Methylergometrine with potent CYP3A4 inhibitors such • Occlusive vascular disease (including ischemic heart disease); as macrolide antibiotics (e.g. troleandomycin, erythromycin, clarithromycin), HIV • Sepsis; protease or reverse transcriptase inhibitors (e.g. ritonavir, indinavir, nelfinavir, • Known hypersensitivity to methylergometrine, to other ergot alkaloids or to any delavirdine), or azole antifungals (e.g. ketoconazole, itraconazole, voriconazole) excipients of Methylergometrine. should be avoided, since this can result in an elevated exposure to methylergometrine and ergot toxicity (vasospasm and ischemia of the Warnings and precautions extremities and other tissues).

General recommendation on administration Prostaglandins In breech presentation and other abnormal presentations Methylergometrine Prostaglandins (e.g. sulprostone, dinoprostone, misoprostol) facilitate contraction should not be given before delivery of the child is completed, and in multiple of the myometrium hence, Methylergometrine can potentiate the uterine action birth not before the last child has been delivered. of prostaglandins and vice versa.

Active management of the third stage of labor requires obstetric supervision. Drugs (e.g. nevirapine, rifampicin) that are strong inducers of CYP3A4 are likely to Methylergometrine tablets contain lactose. Patients with rare hereditary decrease the pharmacological action of Methylergometrine. problems of galactose intolerance, severe lactase deficiency or glucose-galactose Glyceryl trinitrate and other antianginal drugs malabsorption should not take Methylergometrine tablets. Women of child-bearing potential, pregnancy, breast-feeding Breastfeeding and fertility Due to the possible side effects for the child and the reduction of the milk yield, Women of child-bearing potential Methylergometrine is not recommended for use during breast-feeding. Women Not applicable for Methylergometrine due to the targeted indications. should not breast-feed during treatment with Methylergometrine and at least 12 hours after administration of the last dose. Milk secreted during this period Pregnancy should be discarded The use of Methylergometrine in pregnancy is contraindicated because of its potent uterotonic activity. Driving and using machines Methylergometrine may cause dizziness and convulsions. Therefore, caution Breast-feeding should be exercised when driving or operating machines. In view of the possible side effects for the child and the reduction of the milk yield Methylergometrine is not recommended for use during breast-feeding. Women Adverse drug reactions should not breast-feed during treatment with Methylergometrine and at least 12 Immune system disorders hours after administration of the last dose. Milk secreted during this period Very rare Anaphylactic reactions. should be discarded.

Nervous system disorders Fertility Common Headache. Not applicable for Methylergometrine due to the targeted indications. Uncommon Dizziness, convulsions. Very rare Hallucinations.

Ear and labyrinth disorders Very rare Tinnitus.

Lagaay International BV Van Helmontstraat 99 3029 AA Rotterdam, The Netherlands Tel: +31 - 10 4123871

Overdosage Symptoms Nausea; vomiting; hypertension or hypotension; numbness, tingling and pain in theextremities; respiratory depression; convulsions; coma.

Treatment Elimination of orally ingested drug by administration of high doses of activated charcoal. Symptomatic treatment under close monitoring of the cardiovascular and the respiratory system. If sedation is required, benzodiazepines may be used.

Pharmaceutical information Incompatibilities None known.

Special precautions for storage Store in the refrigerator at 2-8° degrees.

Lagaay International BV Van Helmontstraat 99 3029 AA Rotterdam, The Netherlands Tel: +31 - 10 4123871