GASTROMOTIL
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Description


Composition

Gastromotil F.C. Tablets:
Each film coated tablet contains: Domperidone (as maleate) .................................. 10 mg
Gastromotil Suspension:
Each 100 ml contains: Domperidone .......................................................................... 100 mg
Gastromotil Suppositories:
Each suppository contains: Domperidone ................................................................... 30 mg
Inactive ingredients:
Gastromotil F.C. Tablets: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal silicone dioxide, povidone K 30, sodium lauryl sulphate, magnesium stearate.
Gastromotil Suspension: Microcrystalline cellulose, carboxymethyl cellulose sodium, sorbitol 70 % solution, methylparaben, propylparaben, polysorbate 80, sodium hydroxide, purified water.
Gastromotil Suppositories: Hard fat, butylated hydroxyanisole, aerosil 200, polysorbate 80.

Therapeutic Indications

Adults and Children: The relief of the symptoms of nausea and vomiting.

Dosage and Administration

It is recommended to take Gastromotil before meals. If taken after meals, absorption of the drug is somewhat delayed.
Gastromotil should not normally be used for longer than one week.
Adults and Adolescents (weighing 35 kg or more):
The dose is 10 mg up to three times daily by mouth. These patients may also be given the medicine as suppositories of 30 mg twice daily.
Children and Adolescents (weighing less than 35 kg):
The dose is 0.25 mg/kg body weight by mouth up to three times daily.
Tablets are unsuitable for use in Children weighing less than 35 kg.

Contraindications

Gastromotil is contraindicated in the following situations:
Known hypersensitivity to domperidone or any of the excipients.
Prolactin-releasing pituitary tumour (prolactinoma).
Gastromotil should not be used when stimulation of gastric motility could be harmful: e.g. gastrointestinal haemorrhage, mechanical obstruction or perforation.
Concomitant administration with ketaconazole, erythromycin or other potent CYP3A4 inhibitors which prolong QTc interval such as fluconazole, voriconazole, clarithromycin and amiodarone.
Gastromotil must not be given to patients with moderate or severe impairment of liver function, or in those who have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased risk of such effects.
Gastromotil should not be used with other medicines that have similar effects on the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side effects).