COMPOSITION

Each tablet contains domperidone 10 mg.

THERAPEUTIC INDICATIONS

I. Dyspeptic symptoms complex, which often associated with bradyperistalsis, gastro esophageal reflux, esophagitis:
- The sense of overfilling in epigastria, abdominal distension, pain in upper part of a stomach.
- Eructation.
- Nausea, vomiting.
- Pyrosis.
II. Nausea and vomiting of functional, organic an infectious etiology caused by radiotherapy, drug therapy or deviation from diet. Nausea and vomiting caused by agonists of dopamine (L-dopa and bromocriptin) in case of their application for treatment of Parkinsonism are specific indications.
III. Pediatric practice: regurgitation syndrome, cyclic vomiting, gastroesophageal reflux and other disturbances of stomach motility.

CONTRAINDICATIONS

Doprokin is contraindicated for patients with known hypersensitivity to domperidone. Doprokin should not be administered when stimulation of gastric motor activity can be dangerous (i.e. in case of gastrointestinal bleeding, mechanical ileus or perforation).
Doprokin is contraindicated for patients with prolactin-secreting pituitary tumor (prolactinoma).

ADVERSE EFFECTS

Adverse effects are seldom observed.
Effects from GIT: extraordinary cases – temporary intestinal colic (completely reversible and spontaneously disappear after treatment cessation).
Effects from CNS: extrapyramidal events in children and in single cases in adults. As hypophysis is out of blood brain barrier Doprokin can induce increasing of prolactin plasma level. In rare cases this hyperprolactinemia can stimulate the appearance of neuroendocrinal events.
Allergic reactions: seldom – rash and urticaria.

DOSAGE AND ADMINISTRATION

1. Chronic dyspepsia
Adults: 10 mg (1 tablet) 3 times a day 15-30 minutes before meal and if necessary before sleep.
Children: 2.5 mg/10 kg of body weight 3 times a day 15-30 minutes before meal and if necessary before sleep.
If necessary the indicated dose can be doubled (except for children younger one year).
2. Acute and subacute states (primarily nausea and vomiting).
Adults: 20 mg (2 tablets) 3-4 times a day before meal and sleep.
Children: 5 mg/10 kg of body weight 3-4 times a day before meal and sleep.
Notes:
- Peroral administration of Doprokin before meal is recommended. Absorption is slow down following administration after meal.
- Doprokin tablets are indicated only for adults and for children older 5 years.
- Reducing of frequency of Doprokin administration is recommended in case of renal insufficiency.

DRUG INTERACTIONS

Anticholinergic drugs can neutralize antidyspeptic action of Doprokin. Antacid and antisecretory agents should not be co-administered with Doprokin as they reduce bioavailability of domperidone following oral administration.

PREGNANCY AND LACTATION

Doprokin should be prescribed during the first trimester of pregnancy only if its application is justified by the expected therapeutic benefit. If nursering mother takes Doprokin breast-feeding is not recommended except for cases when expected benefit justifies potential risk.

MANUFACTURED FORM

Tablets for oral use 10 mg.
10 tablets are in PVC and aluminum foil blisters. 2 blisters with a leaflet are in a carton box.