Hidrasec 30 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Hidrasec 30 mg (Tiorfan)
30 mg, granules for oral suspension
Racecadotril
Hidrasec 30 mg and Tiorfan are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for a particular child. Do not give it to anyone else. The medicine may harm another person, even if their symptoms are the same as the child's.
• 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

1. What Hidrasec 30 mg is and what it is used for
2. Important information before using Hidrasec 30 mg
3. How to use Hidrasec 30 mg
4. Possible side effects
5. How to store Hidrasec 30 mg
6. 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 indicated for the symptomatic treatment of acute diarrhoea in children over three months of age.
The medicine should be taken together with increased fluid intake and supportive diet, when these measures alone are insufficient 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 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 ever experienced severe skin rash, skin peeling, blisters and/or oral mucosal ulceration after taking racecadotril.

Warnings and precautions
Before starting treatment with Hidrasec 30 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 indicate 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”).

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 a doctor should be contacted. 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 30 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.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with racecadotril. If the patient experiences any of the symptoms associated with serious skin reactions described in section 4, treatment with racecadotril must be stopped immediately and medical advice must be sought without delay.

Hidrasec 30 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 given.
Particularly 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 to treat 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 to treat diabetes (e.g. sitagliptin or vildagliptin),
• estramustine used in the treatment of cancer,
• alaptase used to treat blood clots.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Hidrasec 30 mg is not recommended during pregnancy or breastfeeding.

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 doctor has informed that the child has intolerance to certain sugars, consult a doctor before administering Hidrasec 30 mg to the child.
In children with diabetes, the amount of sucrose ingested from 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 the child as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Hidrasec 30 mg is available as granules.
The granules should be added to food or mixed with water in a glass or feeding bottle, well stirred, and administered to the child immediately.
The recommended dose depends on the child's body weight: 1.5 mg/kg per dose (equivalent to 1–2 sachets), given 3 times daily at regular intervals.
For children weighing between 13 kg and 27 kg: one sachet per dose.
For children weighing approximately more than 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 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 replace 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 the 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 product may cause adverse reactions, although not everyone experiences them.
You should 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,
• urticaria and breathing difficulties.

Treatment with racecadotril should be discontinued and immediate medical help sought 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:
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), glossitis, facial swelling, swelling of 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 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, 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 increase knowledge about the safety of this 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package 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, anhydrous colloidal 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 package 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, the country of export:
Bioprojet Pharma
9 rue Rameau
75002 Paris
France

Manufacturer:
Laboratoires Sophartex
21 rue de Pressoir
28500 Vernouillet
France
Ferrer International, S.A.
Cl Joan Buscalla, 1-9
08190 Sant Cugat del Valles Barcelona
Spain

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 France, the country of export: 34009 352 114 2 2
Parallel Import Licence Number: 384/25

This medicinal product is authorised for sale in the European Economic Area under the following trade 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