Hidrasec granules for oral suspension 10 mg in a sachet 16 pcs.

• active ingredient: racecadotril;
• 1 sachet contains 10 mg of racecadotril;
• excipients: sucrose, colloidal anhydrous silicon dioxide, polyacrylate dispersion, apricot flavoring.

Hypersensitivity to the active substance or to any of the excipients.

Patients who have developed angioedema while taking angiotensin-converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril) should not use racecadotril.

Due to the presence of sucrose, Hidrasec is contraindicated in patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Hidrasec is administered orally together with oral agents to restore water balance.

Hidrasec, 10 mg granules, is used in children weighing up to 13 kg.

Hidrasec, 30 mg granules, is used in children weighing 13 kg or more.

The recommended dose is calculated by body weight: 1.5 mg/kg body weight per dose. This is 1–2 sachets of the appropriate dosage, taken 3 times a day at equal intervals.

Children weighing up to 9 kg – 1 sachet (10 mg) 3 times a day.

Children weighing 9 kg to 13 kg – 2 sachets (10 mg) 3 times a day.

Children weighing 13 kg to 27 kg – 1 sachet (30 mg) 3 times a day.

Children weighing 27 kg or more – 2 sachets (30 mg) 3 times a day.

In clinical studies involving children, the duration of treatment was 5 days.

Treatment should be continued until 2 cases of normal bowel movements are recorded.

The duration of treatment should not exceed 7 days.

Long-term treatment with racecadotril is not recommended.

Clinical studies have not been conducted in children under 3 months of age.

Hidrasec granules can be added to food, dissolved in a glass of water or in a feeding bottle, mixed well. The product should then be administered immediately.

The use of the drug Hidrasec does not change the usual regimen for restoring water balance.

Diabetics should note that each sachet contains:

Hidrasec, 10 mg granules – 0.966 g sucrose;

Hidrasec, 30 mg granules – 2.899 g of sucrose.

If the amount of sucrose (source of glucose and fructose) in the daily dose of Hidrasec exceeds 5 g per day, this should be taken into account in the daily sugar intake.

The drug should not be used in infants under 3 months of age, as clinical studies have not been conducted in this population.

Use during pregnancy or breastfeeding

There are no adequate data from the use of racecadotril in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. However, in the absence of specific clinical studies, racecadotril should not be used during pregnancy.

Due to insufficient information on the excretion of Hidrasec into breast milk, it should not be used during breastfeeding.

Children

Hidrasec, 10 mg granules, is used in infants and children aged 3 months to 2 years.

Hidrasec, 30 mg granules, is used for children from 2 years of age.

Ability to influence reaction speed when driving vehicles or other mechanisms

Racecadotril has no or negligible influence on the ability to drive and use machines.

Isolated cases of overdose without adverse reactions have been reported in infants and children. The doses taken were 7 times the required dose.

In adults, single doses of more than 2 g, i.e. 20 times the therapeutic dose, did not cause harmful effects.

Angiotensin-converting enzyme inhibitors (such as captopril, enalapril, lisinopril, fosinopril, perindopril, ramipril) may cause angioedema. This risk may be increased in the presence of racecadotril.

Concomitant use of racecadotril with loperamide or nifuroxazide in humans does not alter the kinetics of racecadotril.

Infections and infestations – uncommon: tonsillitis.

Skin and subcutaneous tissue disorders – uncommon: rash, erythema. Frequency unknown: erythema multiforme, tongue oedema, face oedema, lip oedema, eyelid oedema, angioedema, urticaria, erythema nodosum, papular rash, pruritus.

Severe skin reactions (including angioedema) have been reported in patients treated with racecadotril. The frequency of these reactions is unknown, but if they occur, racecadotril should be discontinued and appropriate alternative therapy instituted. In such cases, patients should be advised to avoid repeated administration of racecadotril.

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life 3 years.