FARCOTILIUM 5 mg/5 ml, 120 ml

Trade Name:

FARCOTILIUM

Domperidone 5 mg/5 ml

Oral Suspension

120 ml

Composition:

Each 5 ml oral suspension contain:

Domperidone 5 mg

Inactive ingredients:

Methylparaben, propylparaben, propylene glycol, saccharin sodium, Avicel CL611, polysorbate 20, sorbitol, carmellose sodium, peach flavor, citric acid anhydrous, sodium citrate anhydrous, purified water

Properties:

Domperidone is a dopamine antagonist with antiemetic properties. Domperidone poorly penetrates through the GEB. The use of domperidone is rarely accompanied by extrapyramidal side effects, especially in adults, but domperidone stimulates prolactin release from the pituitary gland. Its antiemetic action may be due to a combination of peripheral (gastrokinetic) action and antagonism to dopamine receptors in the chemoreceptor trigger zone, which is outside the GEB.

When administered orally, domperidone increases the duration of antral and duodenal contractions, accelerates gastric emptying and increases lower esophageal sphincter pressure. Domperidone has no effect on gastric secretion.

Indications:

-for relief of symptoms of nausea and vomiting.

-Medicine should not normally be used for longer than one week.

-Farcotilium should be used at lowest effective dose of the shortest duration necessary to control nausea and vomiting.

-It is recommended to take farcotilium before meals . If taken after meals, absorption of the drug is somewhat delayed. 

-Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed.

-Shake the bottle of suspension well before use.

-Dosage for adults and adolescents weighting 35 kg or more:2 teaspoonful ( 10 mg domperidone ) up to three times daily by mouth.

-Dosage for adults and adolescents weighting less than 35 kg:0.25 mg/kg body weight by mouth up to three times daily . use measuring device for accurate dosing.

Side effects:

Mental disorders: infrequently – increased excitability, nervousness.

Nervous system: often – dizziness; rarely – convulsions; frequency unknown – extrapyramidal disorders.

Cardiac disorders: ventricular arrhythmia*, ventricular tachycardia of “pirouette” type, sudden coronary death*.

Gastrointestinal tract: frequency unknown – dry mouth.

Skin and subcutaneous tissue: frequency unknown – angioedema.

Kidney and urinary tract: infrequently – urinary retention.

Laboratory and instrumental data: infrequently – abnormalities of laboratory indicators of liver function; rarely – hyperprolactinemia.

Contraindications:

-hypersensitivity to domperidone or any other component of the drug;

-prolactinoma;

-simultaneous use of oral forms of ketoconazole, erythromycin or other potent inhibitors of CYP3A4 isoenzyme that cause prolongation of the QT interval, except for apomorphine;

-expressed electrolyte disturbances or cardiac disease such as chronic heart failure;

-Gastrointestinal bleeding, mechanical intestinal obstruction, gastric or intestinal perforation;

-hepatic insufficiency of moderate to severe severity;

-body weight less than 35 kg;

-children under 12 years of age with body weight less than 35 kg;

-pregnancy;

-period of breastfeeding.

With caution: pediatric age, renal dysfunction.

Warnings and precautions:

• Domperidone is not recommended for the prevention of nausea and vomiting after anesthesia.
• During prolonged therapy with the drug, patients should be under regular medical supervision.
• Domperidone may cause prolongation of the QT interval on ECG. During postmarketing studies in patients taking domperidone, in rare cases QT interval prolongation and occurrence of ventricular tachycardia of “pirouette” type were observed in patients taking domperidone. These adverse reactions were noted mainly in patients with risk factors, with marked electrolyte disturbances or concomitantly taking drugs increasing QT interval.
• Keep out of reach of children.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds a glass bottle 120 ml and an insert leaflet