Package leaflet: Information for the user

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 brand names of the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse (see section 4).

Table of contents of the leaflet

What Hidrasec 30 mg is and what it is used for
Important information before taking Hidrasec 30 mg
How to take Hidrasec 30 mg
Possible side effects
How to store Hidrasec 30 mg
Contents of the pack and other information

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

Hidrasec 30 mg is a medicine used in the treatment of diarrhoea.
Hidrasec 30 mg is used to treat symptoms of acute diarrhoea in children over 3 months of age.
The medicine should be taken together with plenty of fluids and a supportive diet, when these alone are not sufficient to control diarrhoea and when the diarrhoea cannot be treated causally.
Racecadotril may be used as an adjunctive treatment when causal therapy is possible.

2. Important information before using Hidrasec 30 mg

When not to use 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 certain sugars, consult a doctor before giving the child Hidrasec 30 mg
if the patient has previously experienced severe skin rash, skin peeling, blisters, and (or) oral mucosal ulceration after taking racecadotril.

Warnings and precautions
Consult a doctor or pharmacist before starting treatment with Hidrasec 30 mg if:

the child is under 3 months of age
there is blood or pus in the stool and the child has fever. This may be due to a bacterial infection requiring medical treatment
the child has chronic diarrhoea or diarrhoea caused by antibiotic use
the child has impaired kidney or liver function
the child has persistent or uncontrolled vomiting
the child has diabetes (see "Hidrasec 30 mg contains sucrose"). Skin reactions have been reported during treatment with this medicine. In most cases, these were mild reactions. If severe skin reactions occur, treatment must be stopped immediately.

Special caution is required when using racecadotril
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril treatment. If the patient experiences any of the symptoms related to serious skin reactions described in section 4, treatment with racecadotril must be discontinued immediately and medical advice must be sought without delay.

Hidrasec 30 mg and other medicines
Inform the doctor about all medicines currently taken or recently taken by the child, as well as any medicines planned to be given.
In particular, inform the doctor about medicines taken by the child:

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

Pregnancy and breastfeeding
Hidrasec 30 mg is not recommended during pregnancy or breastfeeding. Consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Hidrasec 30 mg has no or negligible influence on the ability to drive and operate machinery.

Hidrasec 30 mg contains sucrose
Hidrasec 30 mg contains approximately 3 g of sucrose per sachet.
If the child has been diagnosed with intolerance to certain sugars, consult a doctor before administering Hidrasec 30 mg.
In children with diabetes, the amount of sucrose contained in Hidrasec 30 mg should be taken into account when calculating the child's daily sugar intake.

3. How to use Hidrasec 30 mg

Hidrasec 30 mg should always be given to a child according to the doctor's or pharmacist's instructions.
If in doubt, consult a doctor or pharmacist.
Hidrasec 30 mg is available as granules for oral administration.
The granules should be added to food or mixed with water in a glass or feeding bottle, stirred well, 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 daily at regular intervals.
In children weighing from 13 kg to 27 kg: one sachet per dose.
In children with an approximate body weight above 27 kg: two sachets per dose.
The duration of treatment with Hidrasec 30 mg will be determined by the doctor. Treatment should be continued until two normal stools have been passed and should not last longer than 7 days.
To replace fluids lost due to diarrhoea, this medicine should be used together with an adequate amount of fluids and salts (electrolytes). The best way to replenish fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult a doctor or pharmacist).
Taking more Hidrasec 30 mg than recommended
If a child has taken more Hidrasec 30 mg than recommended, seek immediate advice from a doctor or pharmacist.
Missing a dose of Hidrasec 30 mg
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
You must stop giving the child Hidrasec 30 mg and contact a doctor immediately if symptoms of angioedema occur, such as:

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

You must stop using racecadotril and seek immediate medical help if any of the following symptoms occur:

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

The following adverse reactions have been reported:
Not common (occur in fewer than 1 in 100 patients):
tonsillitis, rash and erythema (redness of the skin).
Frequency unknown (cannot be estimated from available data):
erythema multiforme (pink skin lesions on limbs and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin eruptions with small, firm, nodular changes), prurigo (itchy skin lesions), pruritus (generalized itching).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hidrasec 30 mg

Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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, polyacrylate dispersion 30%, peach flavour.

What Hidrasec 30 mg looks like and contents of the pack
Hidrasec 30 mg is a granulate for oral suspension, packed in sachets.
Each pack contains: 10, 16, 20, 30, 50 or 100 sachets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, 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
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in France, country of export: 34009 352 114 2 2
352 114-2

Parallel Import Licence Number: 366/24

This medicinal product is authorised for sale in the European Economic Area countries 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