Metoclopramid-BP (tab)

Metoclopramidum

Each tablet contains metoclopramide hydrochloride anhydrous 10 mg (as metoclopramide hydrochloride monohydrate 10.54 mg). Excipients with known effect: lactose monohydrate. Square, white or almost white tablets with flat surfaces and rounded edges, marked 'B' and 'P' on either side of the score line.

Indication: In adults, indicated for the prevention of delayed nausea and vomiting induced by chemotherapy or radiotherapy, and for the symptomatic treatment of nausea and vomiting, including that induced by acute migraine. In adolescents (15-18 years), indicated as a second-line antiemetic for the prevention of delayed chemotherapy-induced nausea and vomiting.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to anhydrous metoclopramide hydrochloride or to any of the excipients listed in section 6.1. − Gastrointestinal haemorrhage, mechanical obstruction or perforation of the gastrointestinal tract, for which stimulation of gastrointestinal motility constitutes a risk. − Confirmed or suspected phaeochromocytoma, because of the risk of severe hypertensive episodes. − History of tardive dyskinesia induced by neuroleptics or metoclopramide. − Epilepsy (increases the frequency and intensity of seizures). − Parkinson's disease. − Combination with levodopa or dopaminergic agonists (see section 4.5). − Known history of methaemoglobinaemia associated with metoclopramide, or NADH cytochrome b5 deficiency. − Use in children under 1 year of age, because of the increased risk of extrapyramidal disorders (see section 4.4). Metoclopramide must not be used in the first three to four days after surgery such as pyloroplasty or intestinal anastomosis, as strong muscle contractions may impair healing.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Precautions If vomiting persists, the patient should be reassessed to exclude a pre-existing condition, e.g. cerebral irritation. Neurological disorders Extrapyramidal disorders may occur, particularly in children and young adults and/or when high doses are used. These reactions usually occur at the start of treatment and may occur even after a single administration. If extrapyramidal symptoms occur, metoclopramide administration should be stopped immediately. These reactions are generally fully reversible after treatment is discontinued, but may require symptomatic treatment (benzodiazepines in children and/or anticholinergic antiparkinsonian medicinal products in adults). The interval of at least 6 hours specified in section 4.2 must be observed between administrations of […]