Motilium 10 mg 40 tablets

Motilium Domperidone maleate 10 mg 40 tablets

Composition:

Each tablet contains:

Domperidone maleate 10 mg

Description:

Domperidone is a dopamine antagonist with antiemetic properties. It poorly crosses the blood-brain barrier, reducing the likelihood of extrapyramidal side effects, especially in adults. Domperidone stimulates prolactin release from the pituitary gland. Its antiemetic effect is believed to be a result of both peripheral (gastrokinetic) action and dopamine receptor antagonism in the chemoreceptor trigger zone, which lies outside the BBB. Animal studies and low CNS concentrations support its predominantly peripheral effect.

Indications for Use:

For the relief of symptoms of nausea and vomiting.

Dosage and Administration:

Administer orally 15–30 minutes before meals. Absorption may be delayed if taken after meals.

Adults and children over 12 years of age weighing ≥35 kg: 1 tablet (10 mg) 3 times daily. Maximum daily dose is 3 tablets (30 mg).

Contraindications:

-Hypersensitivity to domperidone or any excipient

-Lactose intolerance, lactase deficiency, glucose-galactose malabsorption

-Prolactinoma

-Concomitant use with oral ketoconazole, erythromycin, or other potent CYP3A4 inhibitors that prolong the QT interval (e.g., clarithromycin, itraconazole, fluconazole, posaconazole, ritonavir, saquinavir, amiodarone, telithromycin, telaprevir, voriconazole)

-Significant electrolyte imbalances or cardiac disease, such as chronic heart failure

-GI bleeding, mechanical obstruction, or perforation

-Moderate or severe hepatic impairment

-Body weight under 35 kg

-Children under 12 years of age weighing less than 35 kg

-Pregnancy

-Breastfeeding period

Precautions:

-Not recommended for the prevention of postoperative nausea and vomiting

-Long-term use requires regular medical supervision

Side Effects:

-Immune system: anaphylactic reactions, including anaphylactic shock (frequency unknown)

-Psychiatric disorders: excitability, nervousness (uncommon)

-Nervous system: dizziness (common), seizures (rare), extrapyramidal effects (unknown frequency)

-Cardiovascular system: ventricular arrhythmia, torsades de pointes, sudden cardiac death (frequency unknown)

-Gastrointestinal: dry mouth (frequency unknown)

-Skin and subcutaneous tissue: angioedema (frequency unknown)

-Renal and urinary system: urinary retention (uncommon)

-Laboratory findings: liver function abnormalities (uncommon), hyperprolactinemia (rare)

Storage Conditions:

Store at a temperature not exceeding 30°C.

Packaging:

The carton box contains 4 blisters of 10 tablets and a paper insert.