Package leaflet: Information for the patient

Caution! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Hidrasec 10 mg (Hidrasec)
10 mg, granules for oral suspension
Racecadotril
Hidrasec 10 mg and Hidrasec are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for a certain child. Do not give it to anyone else. This medicine may harm others, even if their symptoms are the same as the child's.
If the child experiences any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse (see section 4).

Table of contents of the leaflet

What Hidrasec 10 mg is and what it is used for
What you need to know before using Hidrasec 10 mg
How to use Hidrasec 10 mg
Possible side effects
How to store Hidrasec 10 mg
Contents of the pack and other information

1. What Hidrasec 10 mg is and what it is used for

Hidrasec 10 mg is a medicine used in the treatment of diarrhoea.
Hidrasec 10 mg is indicated for the symptomatic treatment of acute diarrhoea in children over 3 months of age.
The medicine should be taken together with adequate fluid intake and supportive diet, when these measures alone are not sufficient to control diarrhoea and when aetiological treatment is not possible.
Racecadotril may be used as an adjunctive treatment when aetiological therapy is feasible.

2. Important information before using Hidrasec 10 mg

When not to use Hidrasec 10 mg

if the child is allergic to racecadotril or to any of the other ingredients of Hidrasec 10 mg (listed in section 6),
if the child has intolerance to certain sugars, consult a doctor before administering Hidrasec 10 mg to the child,
if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulceration after taking racecadotril.

Warnings and precautions
Before starting treatment with Hidrasec 10 mg, 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. 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 prolonged or uncontrolled vomiting,
the child has diabetes (see "Hidrasec 10 mg contains sucrose").

Racecadotril, the active substance in Hidrasec, may cause an allergic reaction known as angioedema, which may lead to swelling of the face, lips, throat or tongue. If such adverse effects occur in the child, treatment must be stopped immediately and medical advice sought. Angioedema may occur at any time during treatment with this medicine.
Concomitant use of this medicine with certain other medicines may increase the risk of angioedema (see "Hidrasec 10 mg and other medicines").
Skin reactions have been reported with the use of this medicine. In most cases, they are mild and do not require treatment. However, severe skin reactions may occur in some cases. In such cases, treatment must be stopped immediately and racecadotril must not be given again to the child.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred during treatment with racecadotril. If the patient notices any of the symptoms associated with serious skin reactions described in section 4, treatment with racecadotril must be stopped and immediate medical advice sought.

Hidrasec 10 mg and other medicines
Inform the doctor about all medicines currently or recently taken by the child, as well as any medicines planned to be administered.
In particular, inform the doctor about medicines taken by the child, as they may increase the risk of certain adverse effects (see "Warnings and precautions"):

angiotensin-converting enzyme (ACE) 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 in the treatment of high blood pressure and heart failure,
sacubitril used in the treatment of heart failure,
certain immunosuppressive medicines (e.g. sirolimus or everolimus),
certain medicines used in the treatment of diabetes (e.g. sitagliptin or vildagliptin),
estramustine used in the treatment of cancer,
alemtuzumab used to treat blood clots.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The use of Hidrasec 10 mg is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
Hidrasec 10 mg has no or negligible influence on the ability to drive and operate machinery.

Hidrasec 10 mg contains sucrose
Hidrasec 10 mg contains approximately 1 g of sucrose per sachet.
If the doctor has informed that the child has an intolerance to certain sugars, consult a doctor before administering Hidrasec 10 mg to the child.
If a doctor has prescribed more than 5 sachets of Hidrasec 10 mg per day for infants with diabetes (corresponding to more than 5 g of sucrose), this should be taken into account when calculating the child's daily sugar intake.

3. How to use Hidrasec 10 mg

Hidrasec 10 mg should always be given to a child according to the doctor's instructions. If in
doubt, consult a doctor or pharmacist.
Hidrasec 10 mg is available as a granulate.
The granulate should be added to food or mixed with water in a glass or feeding bottle, stirred
well, and administered immediately to the child.
The recommended dose depends on the child's body weight: 1.5 mg/kg per dose (corresponding to 1–2 sachets), given 3 times daily at regular intervals.
For children weighing up to 9 kg: one sachet per dose.
For children weighing 9–13 kg: two sachets per dose.
The doctor will decide on the duration of treatment with Hidrasec 10 mg. 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 appropriate amount of fluids and salts (electrolytes). The best way to replace fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult a doctor or pharmacist).
Use of a higher than recommended dose of Hidrasec 10 mg
If the child has taken more than the recommended dose of Hidrasec 10 mg, seek immediate advice from a doctor or pharmacist.
Missed dose of Hidrasec 10 mg
Do not use a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop giving the child the medicine Hidrasec 10 mg and contact a doctor immediately if any symptoms of angioedema occur, such as:

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

You should stop using racecadotril and immediately seek medical help 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 faint, which are symptoms of a sudden, severe allergic reaction.

The following adverse reactions have been reported:
Uncommon (occur in fewer than 1 in 100 patients):
tonsillitis, rash and erythema (reddening of the skin).
Frequency unknown (cannot be estimated from available data):
erythema multiforme (pinkish skin lesions on limbs and inside the mouth), inflammation of the tongue, face, lips and eyelids, urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin eruptions with small, firm, nodular lesions), 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 your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Hidrasec 10 mg

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

6. Contents of the package and other information

What Hidrasec 10 mg contains

The active substance is racecadotril. Each sachet contains 10 mg of racecadotril.
The other ingredients are: sucrose, anhydrous colloidal silica, polyacrylate dispersion 30%, peach flavour.

What Hidrasec 10 mg looks like and contents of the pack
Hidrasec 10 mg is a granulate for oral suspension, supplied 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 Bulgaria, country of export:
Bioprojet Pharma
9 rue Rameau
75002 Paris
France

Manufacturer:
Laboratoires Sophartex
21 rue de Pressoir
28500 Vernouillet
France

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20050195
Parallel Import Licence Number: 86/26

This medicinal product is authorised for sale in the European Economic Area (EEA) 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 10 mg
Portugal: Tiorfan
Slovakia: Hidrasec
Slovenia: Hidrasec
Sweden: Hidrasec