MAXOLON Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Maxolon 10mg Tablets.
Qualitative and quantitative composition
Each tablet contains Metoclopramide Hydrochloride BP 10mg equivalent to 10mg of the anhydrous substance. Excipients with known effect: Lactose: contains 125.00 mg of lactose per tablet. For the full list ...
Pharmaceutical form
White to ivory-white circular double convex tablet with a single break bar on one side.
Therapeutic indications
Adult population <u>Maxolon is indicated in adults for:</u> Prevention of delayed chemotherapy induced nausea and vomiting (CINV). Prevention of radiotherapy induced nausea and vomiting (RINV). Symptomatic ...
Posology and method of administration
Posology Adult patients The recommended single dose is 10 mg, repeated up to three times daily. The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight. The maximum recommended treatment duration ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation ...
Special warnings and precautions for use
Precautions If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation. Neurological Disorders Extrapyramidal disorders may occur, ...
Interaction with other medicinal products and other forms of interaction
Contraindicated combination Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3). Combination to be avoided Alcohol potentiates the sedative effect of metoclopramide. ...
Pregnancy and lactation
Pregnancy A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. ...
Effects on ability to drive and use machines
Maxolon has moderate influence on the ability to drive and use machines. Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ...
Undesirable effects
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to<1/100), rare (≥1/10000 to<1/1000), ...
Overdose
Symptoms Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur. Management In case of extrapyramidal symptoms related ...
Pharmacodynamic properties
ATC Code: A03FA01 (Drugs For Functional Gastrointestinal Disorders Propulsives) Mechanism of action The action of metoclopramide is closely associated with parasympathetic nervous control of the upper ...
Pharmacokinetic properties
Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney. Renal impairment The clearance of metoclopramide is reduced ...
Preclinical safety data
No additional data available.
List of excipients
Maize starch (dried) Colloidal silicon dioxide Magnesium stearate Pregelatinised maize starch Lactose
Incompatibilities
Not applicable.
Shelf life
Sixty months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Standard aluminium containers of 3, 6, 9, 12, 100 or 500 tablets. Plastic reclosable containers packed into carton of 42, 84, 100 or 500 tablets. Amber glass bottles of 100 or 500 tablets. PVC blister ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 20072/0048
Date of first authorization / renewal of the authorization
16 June 1995
Date of revision of the text
December 2018
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