Hidrasec 30 mg

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Hidrasec 30 mg(TIORFAN 30 mg ENFANTS)

30 mg, granules for oral suspension

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as the child's.
• If the child experiences any side effects, including any possible side effects not listed in the leaflet, you should tell the doctor, pharmacist, or nurse (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 packaging 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 symptoms of acute diarrhea in children over three months old. The medicine should be taken with a large amount of fluids and a supportive diet when these are not enough 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, consult a doctor before giving Hidrasec 30 mg to the child
• 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, you should consult a doctor or pharmacist if:

• the child is less than three 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").

Racecadotril, the active substance of Hidrasec 30 mg, may cause an allergic reaction called angioedema, which can cause swelling of the face, lips, throat, or tongue. If the child experiences such side effects, you should stop the treatment and consult a doctor immediately. Angioedema may occur at any time during treatment with this medicine.
Taking this medicine and some other medicines at the same time may increase the risk of angioedema (see "Hidrasec 30 mg and other medicines").
Skin reactions have been reported in connection with the use of this medicine. In most cases, they are mild and do not require treatment. In some cases, severe skin reactions may occur.
In such cases, you should stop the treatment and not give the child racecadotril again.
Severe skin reactions, including drug rash with eosinophilia and systemic symptoms (DRESS), have been reported in connection with the use of racecadotril. If the patient notices any symptoms associated with severe skin reactions described in section 4, they should stop taking racecadotril and consult a doctor immediately.

Hidrasec 30 mg and other medicines

You should tell the doctor about all medicines the child is taking or has recently taken, as well as any medicines that are planned to be given to the child.
In particular, you should tell the doctor about medicines the child is taking, as they may increase the risk of certain side effects (see "Warnings and precautions"):

• angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, or ramipril) used to lower blood pressure or treat heart failure
• angiotensin II receptor antagonists (e.g., candesartan or irbesartan) used to treat high blood pressure and heart failure
• sacubitril used to treat heart failure
• certain immunosuppressive medicines (e.g., sirolimus or everolimus)
• certain medicines used to treat diabetes (e.g., sitagliptin or wildagliptin)
• estramustine used to treat cancer
• aleptase used to treat blood clots.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Hidrasec 30 mg is not recommended during pregnancy and breastfeeding.

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, you should consult a doctor before giving Hidrasec 30 mg to the child.
In children with diabetes, the amount of sucrose taken with Hidrasec 30 mg should be taken into account 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 recommendations. In case of doubts, you should consult a doctor or pharmacist.
Hidrasec 30 mg comes in the form of granules.
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 (which corresponds 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 taken 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).

Taking a higher dose of Hidrasec 30 mg than recommended

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

Missing a dose of Hidrasec 30 mg

You should not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop giving Hidrasec 30 mg to the child and consult a doctor immediately if the child experiences symptoms of angioedema, such as:

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

You should stop taking racecadotril and immediately seek medical help if the child experiences any of the following symptoms:

• widespread rash, high body temperature, 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, inside the mouth, and sometimes on the genitals), tongue, face, mouth, and eyelid swelling, urticaria, erythema nodosum (lumps under the skin), papular rash (small bumps on the skin), pruritus (itching), and pruritus generalized (generalized itching).

Reporting side effects

If the child experiences any side effects, including any side effects not listed in the leaflet, you should tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. 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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hidrasec 30 mg contains

• The active substance of Hidrasec 30 mg is racecadotril. Each sachet contains 30 mg of racecadotril.
• The other ingredients are: sucrose, colloidal anhydrous silica, polycarbophil, and apricot flavor.

What Hidrasec 30 mg looks like and contents of the pack

Hidrasec 30 mg comes in the form of granules for oral suspension, packaged in sachets.
Each pack contains: 10, 16, 20, 30, 50, or 100 sachets.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Bioprojet Pharma
9 rue Rameau
75002 Paris
France

Manufacturer:

Ferrer Internacional, S.A.
CL Joan Buscallà, 1-9
08190 Sant Cugat del Vallès (Barcelona), Spain
Laboratoires Sophartex
21 rue du Pressoir
28500 Vernouillet, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:3400935211422
Parallel import authorization number:358/24

This medicine 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
United Kingdom: Hidrasec

Date of leaflet approval: 21.03.2025

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