MOTILIUM Film-coated tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Motilium 10 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains domperidone maleate 12.72 mg equivalent to domperidone 10 mg. Excipients with known effect: Each film-coated tablet contains 53.88mg of lactose monohydrate. For the full ...
Pharmaceutical form
Film-coated tablets white to faintly cream coloured, circular, biconvex tablets.
Therapeutic indications
Motilium is indicated for the relief of the symptoms of nausea and vomiting.
Posology and method of administration
Motilium should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. It is recommended to take oral Motilium before meals. If taken after meals, absorption ...
Contraindications
Motilium is contraindicated in the following situations: Known hypersensitivity to domperidone or any of the excipients. Prolactin-releasing pituitary tumour (prolactinoma). When stimulation of the gastric ...
Special warnings and precautions for use
Cardiovascular effects Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation ...
Interaction with other medicinal products and other forms of interaction
The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. ...
Pregnancy and lactation
Pregnancy There are limited post-marketing data on the use of domperidone in pregnant women. Studies in animals have shown reproductive toxicity at maternally toxic doses (see section 5.3). Motilium should ...
Effects on ability to drive and use machines
Motilium has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Tabulated list of adverse reactions The safety of Motilium was evaluated in clinical trials and in postmarketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal ...
Overdose
Symptoms Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions,disorientation, somnolence and extrapyramidal reactions. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Propulsives ATC code: A03FA03 Mechanism of action Domperidone is a dopamine antagonist with anti-emetic properties, Domperidone does not readily cross the blood-brain barrier. ...
Pharmacokinetic properties
Absorption Domperidone is rapidly absorbed after oral administration, with peak plasma concentrations occurring at approximately 1hr after dosing. The C<sub>max</sub> and AUC values of domperidone increased ...
Preclinical safety data
Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QT interval in humans. In in vitro experiments on isolated cells transfected with hERG ...
List of excipients
Lactose monohydrate Maize starch Microcrystalline cellulose Pregelatinised starch Povidone K90 Magnesium stearate Silica colloidal hydrated Polysorbate 20 Hypromellose Propylene glycol
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Blister packs consisting of aluminium foil and PVC genotherm clear glass. Pack sizes of 4, 10, 28, 30 and 100 tablets. HDPE (Duma) containers Pack size 500 tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 17780/0300
Date of first authorization / renewal of the authorization
01 July 2007
Date of revision of the text
31<sup>st</sup> July 2018
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