Hidrasec 30 mg

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Hidrasec 30 mg (Tiorfan Infantil)
30 mg, granulate for oral suspension
Racecadotril
Hidrasec 30 mg and Tiorfan Infantil are different trade names for the same medicine.
Please read the leaflet carefully before taking the 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 doubts, 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 any adverse reactions occur in the child, 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

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 a medicine used for the symptomatic treatment of acute diarrhoea in children over 3 months of age. The medicine should be taken together with a large amount of fluids and a supportive diet, when these alone are not sufficient to control diarrhoea and when aetiological treatment is not possible.
Racecadotril may be used as an adjunctive treatment when aetiological treatment 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 administering Hidrasec 30 mg to the child.
• if the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral mucosal ulcers after taking racecadotril.

Warnings and precautions
Before starting treatment with Hidrasec 30 mg, consult a doctor or pharmacist if:

• the child is under 3 months of age
• 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 suffers from 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"). Skin reactions have been reported during treatment with this medicine. In most cases, these reactions were mild. If severe skin reactions occur, treatment must be discontinued 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 notices any symptoms related to 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 used or recently taken by the child, as well as any medicines planned for future use.
Particularly 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 minor or no influence on the ability to drive or 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 instructions of the doctor or pharmacist.
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 administered immediately to the child.
The recommended dose is based 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 from 13 kg to 27 kg: one sachet per dose.
For 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).
Use of more than the recommended dose of Hidrasec 30 mg
If the child has taken 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 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 everyone will experience 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
• 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);
• 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 (affects less than 1 in 100 patients): tonsillitis, rash and erythema (skin redness).
Frequency not known (cannot be estimated from the available data): erythema multiforme (pinkish skin lesions on limbs and inside the mouth), swelling of the tongue, facial swelling, lip swelling, eyelid swelling, 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Medical Devices and Biocidal Products, 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.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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%, apricot 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: 16 sachets.
For more detailed 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.
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 in:
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
Portugal marketing authorisation number, country of export: 5109186
Parallel import authorisation number: 339/19
This medicinal product is authorised for marketing 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
United Kingdom: Hidrasec