Hidrasec 30 mg

Patient Information Leaflet

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

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific child only. Do not pass it on to others. This medicine may harm other people, 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).

Leaflet Contents

1. What Hidrasec 30 mg is and what it is used for
2. What you need to know 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 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 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 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 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 called angioedema, which may lead to swelling of the face, lips, throat or tongue. If such adverse reactions occur in the child, treatment must be stopped immediately and a doctor should be consulted. 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.
Serious 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 immediately and medical advice should 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, breastfeeding, suspects she may be pregnant, or plans 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 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 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 the child's daily sugar intake.

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3. How to use Hidrasec 30 mg

Hidrasec 30 mg should always be given to the child as directed by the doctor. 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),
administered 3 times daily at regular intervals.
In children weighing from 13 kg to 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 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 all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 (reddening of the skin).
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, stomatitis (inflammation of the mouth), periorbital oedema (swelling around the eyes), urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin eruptions with small, firm, nodular changes), pityriasis (itchy skin lesions), pruritus (generalised 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 also be reported directly to the Department for 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 provide more information on the safety of the medicine.

5. How to store Hidrasec 30 mg

The medicine should be stored out of sight and reach of children.
No special storage instructions 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. Following this advice helps 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 silicon dioxide, polyacrylate dispersion 30%, peach flavour.

What Hidrasec 30 mg looks like and contents of the pack
Hidrasec 30 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 Greece, country of export:
Ferrer Internacional, S.A., Gran Vía 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Greece, country of export: 96233/20-12-16
37057/5-6-08
Parallel Import Licence Number: 96/22
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 30 mg
Portugal: Tiorfan
Slovakia: Hidrasec
Slovenia: Hidrasec
Sweden: Hidrasec
United Kingdom: Hidrasec
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