Hidrasec 30 mg

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the outer packaging 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.
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 particular child. Do not pass it on to others. This medicine may harm someone else, 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 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 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 three months of age.
The medicine should be taken together with adequate fluid intake and supportive diet when these alone are not sufficient to control diarrhoea and when aetiological treatment is not possible.
Racecadotril may be used as 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 administering Hidrasec 30 mg to the child
• 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 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 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. In some cases, severe skin reactions may occur. In such cases, treatment must be stopped immediately and racecadotril must not be administered again to the child.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril treatment. If the patient notices any of the symptoms related to serious skin reactions described in section 4, racecadotril treatment should be discontinued and immediate medical advice should be sought.

Hidrasec 30 mg and other medicines
Inform the doctor about all medicines currently used or recently used by the child, as well as any medicines planned to be given to the child.
Especially 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
• aletpase 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.
Use of Hidrasec 30 mg is not recommended during pregnancy or breastfeeding.

Driving and operating machinery
Hidrasec 30 mg has minor or no 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 with Hidrasec 30 mg should be included in the child's daily sugar intake.

3. How to use Hidrasec 30 mg

Hidrasec 30 mg should always be given to the child according to the doctor's instructions. In case of
doubt, consult a doctor or pharmacist.
Hidrasec 30 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.
In children weighing between 13 kg and 27 kg: one sachet per dose.
In children with an approximate body weight above 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 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 more than the recommended dose of Hidrasec 30 mg
If the child takes more than the recommended dose of Hidrasec 30 mg, seek immediate advice from a
doctor or pharmacist.
Missed 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 will experience them.
You should stop giving the child Hidrasec 30 mg and contact a doctor immediately if any symptoms of angioedema occur, such as:

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

You should 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);
• 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:
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), inflammation of the tongue, face, lips and eyelids, urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin lesions with small, firm, nodular changes), eczematous rash (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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Hidrasec 30 mg

Keep this medicine out of the 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 stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Ferrer Internacional, S.A.
Gran Via Carlos III, 94
08028- Barcelona
Spain

Manufacturer:
Ferrer Internacional, S.A.
Joan Buscallà, 1-9, 08173 Sant Cugat del Vallès, Barcelona, Spain
Sophartex S.A.
21, Rue du Pressoir, F- 28500 Vernouillet, France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Portugal, country of export: 5109186
Parallel Import Licence Number: 814/15

This medicinal product is authorised in the European Economic Area (EEA) member states 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