Hidrasec 30 mg

Package Leaflet: Information for the Patient

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Hidrasec 30 mg (TIORFAN 30 mg FOR CHILDREN )

30 mg, granules for oral suspension

Racecadotril
Hidrasec 30 mg and TIORFAN 30 mg FOR CHILDREN are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be re-read in case of need.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the child experiences any adverse reactions, including any possible adverse reactions not listed in the leaflet, the doctor, pharmacist, or nurse should be informed (see section 4).

Table of Contents of the Leaflet

• 1. What is Hidrasec 30 mg and what is it used for
• 2. Important information before taking Hidrasec 30 mg
• 3. How to take Hidrasec 30 mg
• 4. Possible side effects
• 5. How to store Hidrasec 30 mg
• 6. Contents of the package and other information

1. What is Hidrasec 30 mg and what is it used for

Hidrasec 30 mg is a medicine used to treat diarrhea.
Hidrasec 30 mg is a medicine used to treat the symptoms of acute diarrhea in children over 3 months of age. The medicine should be taken with a large amount of fluids and a supporting diet when these are not sufficient to control diarrhea and when diarrhea cannot be treated causally.
Racecadotril may be used as a supportive treatment when causal treatment is possible.

2. Important information before taking Hidrasec 30 mg

When not to take Hidrasec 30 mg

• if the child is allergic to racecadotril or any of the other ingredients of Hidrasec 30 mg
• if the child has intolerance to some sugars, the doctor should be consulted before giving the child Hidrasec 30 mg
• if the patient has ever experienced a severe skin rash or skin peeling after taking racecadotril.

Warnings and precautions

Before starting to take Hidrasec 30 mg, the doctor or pharmacist should be consulted if:

• the child is less than 3 months old
• there is blood or pus in the stool and the child has a fever. The cause may be a bacterial infection that should be treated by a doctor
• the child has chronic diarrhea or diarrhea caused by taking antibiotics
• the child has kidney or liver function disorders
• the child has prolonged or uncontrolled vomiting
• the child has diabetes (see "Hidrasec 30 mg contains sucrose"). Skin reactions have been reported during treatment with the medicine. In most cases, they were mild. If severe skin reactions occur, treatment should be stopped immediately.

Particular caution should be exercised when taking racecadotril.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with racecadotril. If the patient notices any of the symptoms associated with severe skin reactions described in section 4, they should stop taking racecadotril and seek medical attention immediately.

Hidrasec 30 mg and other medicines

The doctor should be informed about all medicines the child is currently taking or has recently taken, as well as any medicines planned to be given to the child.
In particular, the doctor should be informed about medicines the child is taking:

• angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or facilitate heart function.

Pregnancy and breastfeeding

Hidrasec 30 mg should not be used during pregnancy or breastfeeding. The doctor or pharmacist should be consulted before taking this medicine.

Driving and using machines

Hidrasec 30 mg has a minor or no effect on the ability to drive and use machines.

Hidrasec 30 mg contains sucrose

Hidrasec 30 mg contains approximately 3 g of sucrose in one sachet.
If the doctor has informed about the child's intolerance to some sugars, the doctor should be consulted before giving the child Hidrasec 30 mg.
In children with diabetes, the amount of sucrose taken with Hidrasec 30 mg should be included in the child's daily sugar intake.

3. How to take Hidrasec 30 mg

Hidrasec 30 mg should always be given to the child according to the doctor's or pharmacist's recommendations.
In case of doubts, the doctor or pharmacist should be consulted.
Hidrasec 30 mg is available in the form of granules for oral suspension.
The granules should be added to food or mixed with water in a glass or feeding bottle, well mixed, and given to the child immediately.
The recommended dose depends on the child's body weight: 1.5 mg/kg per dose (corresponding to 1-2 sachets), 3 times a day at regular intervals.
For children with a body weight from 13 kg to 27 kg: one sachet per dose.
For children with a body weight of approximately over 27 kg: two sachets per dose.
The doctor will decide on the duration of treatment with Hidrasec 30 mg. Treatment should be continued until two normal stools are passed and should not last longer than 7 days.
To replace lost fluids due to diarrhea, this medicine should be used simultaneously with an adequate amount of fluids and salts (electrolytes). The best way to replace fluids and electrolytes is to drink so-called oral rehydration solutions (in case of doubts, consult a doctor or pharmacist).

Using a higher dose of Hidrasec 30 mg than recommended

In case the child takes a higher dose of Hidrasec 30 mg than recommended, the doctor or pharmacist should be consulted immediately.

Missing a dose of Hidrasec 30 mg

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment with Hidrasec 30 mg should be stopped, and the doctor should be contacted immediately if symptoms of angioedema occur, such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing.

Treatment with racecadotril should be stopped, and medical help should be sought immediately if any of the following symptoms occur:

• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome);
• difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and feeling of losing consciousness, which are symptoms of a severe allergic reaction.

The following side effects have been reported:
Uncommon (occurring in less than 1 in 100 patients):
tonsillitis, rash, and erythema (redness of the skin).
Frequency not known (cannot be estimated from the available data):
erythema multiforme (pink patches on the skin and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (subcutaneous inflammatory conditions in the form of nodules), papular rash (rash with small, hard, and nodular lesions), pruritus (itching skin lesions), pruritus (generalized itching).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Hidrasec 30 mg

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the package and other information

What Hidrasec 30 mg contains

• The active substance of the medicine is racecadotril. Each sachet contains 30 mg of racecadotril.
• The other ingredients are: sucrose, colloidal anhydrous silica, polyacrylate dispersion 30%, apricot flavor.

What Hidrasec 30 mg looks like and what the package contains

Hidrasec 30 mg is available in the form of granules for oral suspension packaged in sachets.
Each package contains: 10, 16, 20, 30, 50, or 100 sachets.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in France, the country of export

BIOPROJET PHARMA
9 rue Rameau
75002 Paris
France

Manufacturer:

Laboratories Sophartex
21 rue du Pressoir
28500 Vernouillet
France
Ferrer International, S.A.
Cl Joan Buscalla, 1-9
08190 Sant Cugat Del Valles (Barcelona)
Spain

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in France, the country of export: 34009 352 114 2 2
352 114-2

Parallel import authorization number: 366/24

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Tiorfan
Austria: Hidrasec
Belgium: TIORFIX
Czech Republic: Hidrasec
Denmark: Hidrasec
Estonia: Hidrasec
Finland: Hidrasec
Germany: Tiorfan
Greece: Hidrasec
Hungary: Hidrasec
Ireland: Hidrasec
Italy: Tiorfix
Latvia: Hidrasec
Lithuania: Hidrasec
Luxembourg: TIORFIX
Netherlands: HIDRASEC
Norway: Hidrasec
Poland: Hidrasec 30 mg
Portugal: Tiorfan
Slovakia: Hidrasec
Slovenia: Hidrasec
Sweden: Hidrasec

Date of leaflet approval: 18.10.2024

[Information about the trademark]