Retch (Tablets) Instructions for Use

Marketing Authorization Holder

Xantis Pharma, Limited (Cyprus)

Manufactured By

Saneca Pharmaceuticals, a.s. (Slovakia)

ATC Code

A03FA (Gastrointestinal motility stimulants)

Active Substance

Itopride (Rec.INN registered by WHO)

Dosage Form

Retch

Tablets 50 mg: 10, 20, 30, 40, 50, 60, 70, 90 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with a score on one side.

Excipients : lactose monohydrate – 65.56 mg, pregelatinized starch – 1.2 mg, croscarmellose sodium – 1.2 mg, colloidal anhydrous silicon dioxide – 0.84 mg, magnesium stearate – 1.2 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (7) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.

Clinical-Pharmacological Group

A drug that increases the tone and motility of the gastrointestinal tract. Acetylcholine release stimulant

Pharmacotherapeutic Group

GI motility stimulator – acetylcholine release stimulator

Pharmacological Action

A drug that stimulates gastrointestinal motility. Itopride enhances propulsive gastrointestinal motility due to antagonism of dopamine D₂ receptors and dose-dependent inhibition of acetylcholinesterase activity. Itopride activates the release of acetylcholine and suppresses its degradation.

Itopride has a specific effect on the upper gastrointestinal tract, accelerates gastric transit and improves gastric emptying.

It also has an antiemetic effect due to interaction with D₂ receptors located in the trigger zone. Itopride caused a dose-dependent suppression of apomorphine-induced vomiting.

It does not affect the serum gastrin level.

Indications

Relief of symptoms of functional non-ulcer dyspepsia (chronic gastritis), including: abdominal bloating; feeling of rapid satiety; pain or discomfort in the upper abdomen; anorexia; heartburn; nausea; vomiting.

ICD codes

Dosage Regimen

Administer orally with water.

The standard adult dosage is one 50 mg tablet taken three times daily.

Take tablets before meals.

The total recommended daily dose is 150 mg.

For geriatric patients or those with renal impairment, adjust the dose based on patient tolerance and clinical response.

Do not exceed the maximum daily dose of 150 mg.

The tablet is scored and can be split for dose titration if necessary.

Treatment duration is determined by the prescribing physician based on symptom relief.

Discontinue use if symptoms worsen or do not improve after a prescribed course of therapy.

This medication is not approved for use in children under 16 years of age.

Adverse Reactions

From the hematopoietic system: leukopenia, thrombocytopenia.

From the endocrine system: increased prolactin level, gynecomastia.

From the CNS dizziness, headache, tremor.

From the digestive system: diarrhea, constipation, abdominal pain, increased salivation, nausea, jaundice.

Allergic reactions skin hyperemia, skin itching, rash, anaphylaxis.

Changes in laboratory parameters increased activity of AST and ALT, GGT, ALP and bilirubin level.

Contraindications

Gastrointestinal bleeding, mechanical obstruction or perforation of the gastrointestinal tract; pregnancy; lactation (breastfeeding); children under 16 years of age; hypersensitivity to itopride.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Special Precautions

Itopride should be used with caution in patients for whom the occurrence of cholinergic adverse reactions (associated with the enhancement of acetylcholine action under the influence of itopride) may worsen the course of the underlying disease.

Drug Interactions

Itopride enhances gastric motility, so it may affect the absorption of other concomitantly administered oral drugs.

Use with particular caution concomitantly with drugs with a low therapeutic index, as well as in sustained-release formulations or enteric-coated drugs.

Anticholinergic agents may weaken the effect of itopride.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.