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 Infantil)

30 mg, granules for oral suspension

Racecadotril
Hidrasec 30 mg and Tiorfan Infantil 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.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 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 supportive 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, consult a doctor 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, you should consult a doctor or pharmacist 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 using 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

You should tell the doctor about all medicines the child is currently taking or has recently taken, as well as any medicines that are planned to be given to the child.
Particularly, you should tell the doctor 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 and breastfeeding. Before taking this medicine, you should consult a doctor or pharmacist.

Driving and using machines

Hidrasec 30 mg has a minor or no influence 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 you that the child has intolerance to some sugars, you should consult a doctor before giving the child Hidrasec 30 mg.
In children with diabetes, the amount of sucrose taken with Hidrasec 30 mg should be taken into account in the daily amount of sugar taken by the child.

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, you should consult a doctor or pharmacist.
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 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 replenish lost fluids due to diarrhea, this medicine should be used simultaneously with an adequate amount of fluids and salts (electrolytes). The best way to replenish 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 the child Hidrasec 30 mg and immediately contact a doctor if the following symptoms of angioedema occur:

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

You should stop taking racecadotril and immediately seek medical attention 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, nodular rash (lumps under the skin), papular rash (small bumps on the skin), pruritus (itching), and generalized pruritus.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell the doctor or pharmacist. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you 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 stated.
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 is racecadotril. Each sachet contains 30 mg of racecadotril.
• The other ingredients are: sucrose, colloidal anhydrous silica, polycarbophil, and peach flavor.

What Hidrasec 30 mg looks like and contents of the pack

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

Marketing authorization holder in Portugal, the country of export:

Ferrer Internacional, S.A.
Gran Via Carlos III, 94
08028 Barcelona
Spain

Manufacturer:

Ferrer Internacional, S.A.
C/ Joan Buscallà 1-9
08173 Sant Cugat del Vallès
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
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Marketing authorization number in Portugal, the country of export: 5109186, 5109285, 5109384
Parallel import authorization number: 339/19

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
United Kingdom: Hidrasec

Date of revision of the leaflet: 19.08.2024

[Information about the trademark]