SOSHYDRA^®

COMPOSITION

Each sachet contains:

Racecadotril................................................................. 30 mg

Excipients: Mannitol, Copovidone, Sucralose, Xylitol, Strawberry flavor, Purified water q.s. one sachet.

INDICATIONS

Racecadotril is indicated for treatment of acute diarrhea.

DOSAGE AND ADMINISTRATION

The usual daily dose is determined according to bodyweight: 1.5 mg/kg three times daily. Drug can be used for children over 3 months.

Children 30 months – 9 years old: 1 sachet x 4 times/ day for the first day. Maintenance dose: 1 sachet x 3 times/ day for ≤ 7 days.

Children over 9 years of age: 2 sachets x 4 times/ day for the first day. Maintenance dose: 2 sachets x 3 times/ day for ≤ 7 days.

Stir well in some water, administer immediately after preparation.

Drug can be taken with or without food.

Drug should be given in conjunction with the replenishment of necessary water and electrolytes.

CONTRAINDICATIONS

Hypersensitive with any of its ingredients.

PRECAUTIONS

In the case of infectious diarrhea with clinical manifestations suggesting an invasive phenomenon, use antibacterial with good systemic diffusion.

Racecadotril should not be used as treatment of first intent for acute dysentery with blood in the stools or high fever and it should not be used in the case of diarrhea occurring during treatment with a broad-spectrum antibiotic.

Do not use over the recommended period of treatment.

Use Racecadotril with caution on patients who have renal insufficiency.

PREGNANCY OR LACTATION

Adequate human data on use during pregnancy are not available. However, animal studies have not identified any risk to pregnancy or embryo-fetal development. Drug should not be used in pregnancy unless the potential benefits outweigh the risks.

PRESENTATION

Sachet of 1 g. Box of 10 sachets.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A PJSC

Nhon Trach 3 I.P, Hiep Phuoc, Nhon Trach, Dong Nai.

Tel: 02513 566 202    -     Fax: 02513 566 203