Motil Fast 10 mg 10 sachets

Motil Fast 10 mg 10 sachets

Composition:

Each sachet contains:
Domperidone — 0.01 g (10 mg).
Excipients: sodium bicarbonate, citric acid, saccharin sodium, povidone, lemon flavor, ethyl alcohol 96%.

Product Description:

• Motil Fast is a dopamine receptor antagonist with antiemetic and prokinetic properties.
• Poorly crosses the blood-brain barrier (BBB); its antiemetic effect is due to a combination of peripheral (gastrokinetic) action and antagonism toward dopamine receptors in the chemoreceptor trigger zone.
• Increases the duration of antral and duodenal contractions, accelerates gastric emptying, and increases lower esophageal sphincter pressure. 
• Does not affect gastric secretion.

Indications for Use:

Relief of nausea and vomiting symptoms.

Method of Administration and Dosage:

• Method of Administration: oral.
• Dissolve the contents of the sachet in water and take 15–30 minutes before meals (absorption of domperidone may be delayed if taken after meals).
• Adults and adolescents over 12 years of age (body weight ≥ 35 kg): 1 sachet (10 mg) 3 times daily. Maximum daily dose is 3 sachets (30 mg).
• Children: not for use in children under 12 years of age and/or weighing less than 35 kg.

Contraindications:

• Hypersensitivity to domperidone or any of the excipients of the drug.
• Prolactin-secreting pituitary tumor (prolactinoma).
• Concomitant use of oral forms of ketoconazole, erythromycin, or other potent CYP3A4 inhibitors that cause QT interval prolongation (except apomorphine).
• Severe electrolyte disturbances or heart conditions (including chronic heart failure).
• Gastrointestinal hemorrhage, mechanical intestinal obstruction, or gastric/intestinal perforation.
• Moderate to severe hepatic impairment.
• Body weight under 35 kg and/or age under 12 years.
• Pregnancy and lactation.

Precautions:

• Cardiac Risks: domperidone may cause QT interval prolongation on ECG and Torsades de Pointes ventricular tachycardia. Risk is higher in patients with risk factors, electrolyte disturbances, or concomitant use of QT-prolonging drugs.
• Renal Impairment: caution and possible adjustment of dosing frequency are required in renal failure.
• Prophylactic Use: not recommended for the prevention of postoperative nausea and vomiting.
• Long-term Therapy: regular medical supervision is required during prolonged treatment.

Adverse Reactions / Side Effects:

• Psychiatric Disorders: uncommon — agitation, nervousness.
• Nervous System Disorders: common — dizziness; rare — convulsions; frequency unknown — extrapyramidal disorders.
• Cardiovascular Disorders: frequency unknown — ventricular arrhythmia, Torsades de Pointes, sudden cardiac death.
• Gastrointestinal Disorders: frequency unknown — dry mouth.
• Skin and Subcutaneous Tissue Disorders: frequency unknown — angioedema.
• Renal and Urinary Disorders: uncommon — urinary retention.
• Investigations / Laboratory Data: uncommon — abnormal liver function tests; rare — hyperprolactinemia.

Pregnancy and Lactation:

Pregnancy: use of the drug is contraindicated.
Lactation: use during breastfeeding is contraindicated (domperidone is excreted in human milk).

Storage Conditions:

Store in a dry place at a temperature not exceeding 25 °C.
Keep out of reach of children.

Packaging:

The cardboard box contains 10 sachets of 5 g each and a medical instruction insert.