Hidrasec 30 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Hidrasec 30 mg (TIORFAN 30 mg ENFANTS)
30 mg, granules for oral suspension
Racecadotril
Hidrasec 30 mg and TIORFAN 30 mg ENFANTS 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 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 specifically for a particular child. Do not give it to anyone else. This 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 side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse (see section 4).

Contents of this 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 used to treat symptoms of acute diarrhoea in children over three months of age.
The medicine should be taken together with plenty of fluids and supportive diet, when these alone are not sufficient to control diarrhoea and when the underlying cause of diarrhoea cannot be treated directly.
Racecadotril may be used as an adjunctive treatment when causal 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 giving Hidrasec 30 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 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 persistent or uncontrolled vomiting
• the child has diabetes (see "Hidrasec 30 mg contains sucrose").

Racecadotril, the active substance in Hidrasec 30 mg, 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 given again to the child.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with racecadotril. If the patient notices any of the symptoms associated with serious skin reactions described in section 4, racecadotril must be discontinued 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 used by the child, as well as any medicines planned to be given to the child.
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
• aleplase 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 30 mg is not recommended during pregnancy or while breastfeeding.

Driving and using machines
Hidrasec 30 mg has minor or no influence on the ability to drive and use machines.

Hidrasec 30 mg contains sucrose
Hidrasec 30 mg contains approximately 3 g of sucrose per sachet.
If the doctor has informed you that the child has an intolerance to certain sugars, consult a doctor before giving Hidrasec 30 mg to the child.
In children with diabetes, the amount of sucrose contained in Hidrasec 30 mg should be taken into account in 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 a granulate.
The granulate should be added to food or mixed with water in a glass or feeding bottle, thoroughly stirred 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 between 13 kg and 27 kg: one sachet per dose.
For 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 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 a higher than recommended dose of Hidrasec 30 mg
If the child has taken more than the recommended dose of Hidrasec 30 mg, seek medical advice immediately 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
You must 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 must 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:
Uncommon (occur in fewer than 1 in 100 patients):
tonsillitis, rash, erythema (skin redness).
Frequency not known (cannot be estimated from available data):
erythema multiforme (pinkish skin lesions on limbs and inside the mouth), glossitis (inflammation of the tongue), facial swelling, inflammation of the lips and eyelids, urticaria (hives), 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 a doctor, pharmacist, or nurse. Adverse reactions can 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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables better collection of information on the medicine's safety profile.

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 instructions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 flavor.

What Hidrasec 30 mg looks like and contents of the pack
Hidrasec 30 mg is available as granules for oral suspension, packed in sachets.
Each pack contains: 10, 16, 20, 30, 50, or 100 sachets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in France, the country of export:
Bioprojet Pharma
9 rue Rameau
75002 Paris
France
Manufacturer:
Ferrer Internacional, S.A.
CL Joan Buscallà, 1-9
08190 Sant Cugat del Vallès (Barcelona), Spain
Laboratoires Sophartex
21 rue du Pressoir
28500 Vernouillet, France
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorization Number in France, the country of export: 3400935211422
Parallel Import Authorization Number: 358/24
This medicinal product is authorized 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