Farcotilium 10 mg 24 capsules

Farcotilium 10 mg 24 capsules

Composition:
Each soft gelatin capsule contains:
Active ingredient:
Domperidone 10 mg.
Description:
Farcotilium is a prokinetic and antiemetic medicine containing domperidone, a dopamine receptor antagonist that acts primarily at the peripheral level.
It enhances gastrointestinal motility and accelerates gastric emptying, reducing symptoms of nausea and vomiting without affecting gastric secretion.
Domperidone has a limited ability to cross the blood-brain barrier, thus extrapyramidal side effects are rare in adults.
Indications for Use:
Farcotilium is indicated for the relief of nausea and vomiting of various origins, including functional, drug-induced, and postprandial causes.
Dosage and Method of Administration:
Farcotilium should be used at the lowest effective dose for the shortest duration necessary to control symptoms. It is recommended to take capsules before meals; if taken after meals, absorption may be delayed.
Treatment duration usually should not exceed one week.
Adults and adolescents (≥12 years and ≥35 kg): 1 capsule (10 mg) up to three times daily, maximum 30 mg per day.
Children under 12 years and adolescents <35 kg: Not recommended.
Elderly patients (>60 years): Consult a healthcare professional before use.
Hepatic impairment: Contraindicated in moderate or severe hepatic impairment.
No dose adjustment is required for mild hepatic impairment.
Renal impairment: In severe renal impairment, reduce dosing frequency to once or twice daily depending on the severity.
Regular medical review is required.
Contraindications:
- Hypersensitivity to domperidone or any excipient.
- Prolactin-releasing pituitary tumor (prolactinoma).
- Gastrointestinal hemorrhage, mechanical obstruction, or perforation.
- Moderate or severe hepatic impairment.
- Prolonged QT interval, significant electrolyte disturbances, or underlying cardiac disease such as congestive heart failure.
- Concomitant use with QT-prolonging drugs (except apomorphine) or potent CYP3A4 inhibitors such as ketoconazole, erythromycin, fluconazole, clarithromycin, and amiodarone.
Precautions:
- Cardiac effects: Domperidone may prolong the QT interval. Serious ventricular arrhythmias and sudden cardiac death have been reported, particularly in patients over 60 years or those taking doses above 30 mg/day, QT-prolonging drugs, or CYP3A4 inhibitors. Use the lowest effective dose.
- Renal impairment: Reduce dosing frequency in severe impairment.
- Neurological effects: Young children are more susceptible to neurological adverse effects; use is not recommended below 12 years.
- Hepatic impairment: Contraindicated in moderate to severe cases.
- Symptoms suggestive of cardiac arrhythmia (such as palpitations, fainting) require immediate discontinuation and medical evaluation.
- Contains less than 1 mmol sodium (23 mg) per dose - essentially sodium-free.
Side Effects:
Adverse reactions are generally mild and reversible.
Reported effects include:
- Immune system disorders: Anaphylactic reaction, including anaphylactic shock (rare).
- Nervous system disorders: Drowsiness, dizziness, headache, anxiety, restlessness, loss of libido, extrapyramidal symptoms (very rare).
- Cardiac disorders: QT prolongation, ventricular arrhythmia, torsades de pointes, sudden cardiac death (very rare).
- Gastrointestinal disorders: Dry mouth, diarrhea.
- Skin and subcutaneous tissue disorders: Rash, urticaria, angioedema.
- Reproductive system and breast disorders: Galactorrhea, gynecomastia, amenorrhea, breast tenderness or pain.
- General disorders: Asthenia, elevated prolactin levels, abnormal liver function tests.
Pregnancy and Lactation:
Pregnancy:
Limited data are available.
Farcotilium should only be used during pregnancy when the potential therapeutic benefit outweighs possible risk.
Breastfeeding:
Domperidone is excreted in breast milk in small amounts (<0.1% of maternal dose).
Cardiac effects in infants cannot be excluded.
A decision should be made to discontinue either breastfeeding or the drug, taking into account the benefit to the child and mother.
Storage Conditions:
Store at temperature not exceeding 30°C, in a dry place.
Packaging:
Carton box containing 2 blisters, each with 12 soft gelatin capsules, and an insert leaflet.