Hidrasec 10 mg

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Hidrasec 10 mg (Tiorfan Lactente)
10 mg, granules for oral suspension
Racecadotril
Hidrasec 10 mg and Tiorfan Lactente 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, as you may need to read it again.
• 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 someone else, 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).

Leaflet contents

1. What Hidrasec 10 mg is and what it is used for
2. What you need to know before taking Hidrasec 10 mg
3. How to take Hidrasec 10 mg
4. Possible side effects
5. How to store Hidrasec 10 mg
6. 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 treatment of symptoms 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 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 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 giving Hidrasec 10 mg to the child.

Warnings and precautions
Before starting treatment with Hidrasec 10 mg, consult a doctor or pharmacist if:

• the child is less than 3 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

Page 1 of 4

• the child has prolonged or uncontrolled vomiting
• the child has diabetes (see "Hidrasec 10 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 stopped immediately.

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 for administration.
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 help heart function.

Pregnancy and breastfeeding
Hidrasec 10 mg is not recommended during pregnancy or breastfeeding.
Before using this medicine, consult a doctor or pharmacist.
Driving and operating machinery
Hidrasec 10 mg has minor or no influence on the ability to drive or operate machinery.
Hidrasec 10 mg contains sucrose
Hidrasec 10 mg contains approximately 1 g of sucrose per sachet.
If the doctor has informed you that the child has intolerance to certain sugars, consult a doctor before giving Hidrasec 10 mg to the child.
If a doctor has prescribed more than 5 sachets of Hidrasec 10 mg per day (corresponding to more than 5 g of sucrose) for infants with diabetes, this should be taken into account in the child's daily sugar intake.

3. How to use Hidrasec 10 mg

Hidrasec 10 mg should always be given to a child as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Hidrasec 10 mg is available as a granulate for oral administration.
The granulate should be added to food or mixed with water in a glass or feeding bottle, stirred well, and administered 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), given 3 times daily at regular intervals.
In children weighing up to 9 kg: one sachet per dose.
In 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 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).
Use of a higher than recommended dose of Hidrasec 10 mg
If a child has taken more than the recommended dose of Hidrasec 10 mg, seek immediate advice from a doctor or pharmacist.
Page 2 of 4
Missed dose of Hidrasec 10 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop giving the child Hidrasec 10 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

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 not known (cannot be estimated from available data):
erythema multiforme (pinkish 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 not listed in this leaflet, tell a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Hidrasec 10 mg

Keep this medicine out of 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 specified month.
No special storage instructions are required for this medicine.
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 10 mg contains

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

Page 3 of 4
What Hidrasec 10 mg looks like and contents of the pack
Hidrasec 10 mg is available as a granulate for oral suspension 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 Portugal, the 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, 21 rue de Pressoir, 28500 Vernouillet, France
DELPHARM Reims, 10 rue du colonel Charbonneaux, 51100 Reims, France
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Portugal, the country of export: 5108881
Parallel import authorisation number: 271/24
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 10 mg
Portugal: Tiorfan
Slovakia: Hidrasec
Slovenia: Hidrasec
Sweden: Hidrasec
United Kingdom: Hidrasec
Page 4 of 4