Hidrasec 30 mg

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Hidrasec 30 mg (Hidrasec)
30 mg, granulate for oral suspension
Racecadotril
Hidrasec 30 mg and Hidrasec 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, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for a particular child. Do not give it to others. The 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 or pharmacist (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 indicated for the symptomatic treatment 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 measures alone are not sufficient to control diarrhoea and when the underlying cause of diarrhoea cannot be treated directly.
Racecadotril may be used as adjunctive treatment when causal therapy 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 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 3 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 antibiotics
• 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 result in 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 consulted. Angioedema may occur at any time during treatment with this medicine.
Concomitant use of this medicine with certain other drugs 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. However, 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 with racecadotril treatment. If the patient notices any of the symptoms associated with serious skin reactions described in section 4, they should stop taking racecadotril and seek immediate medical advice.

Hidrasec 30 mg and other medicines
Inform the doctor about all medicines currently or recently taken by the child, as well as any medicines planned to be given.
Particularly 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 to treat 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 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 administering Hidrasec 30 mg to the child.
In children with diabetes, the amount of sucrose ingested with Hidrasec 30 mg should be taken into account when calculating the child's daily sugar intake.

3. How to use Hidrasec 30 mg

Hidrasec 30 mg should always be given to a child according to the doctor's or pharmacist's instructions.
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, 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.
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 electrolytes. The best way to replace fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult a doctor or pharmacist).
Taking more Hidrasec 30 mg than recommended
If a child takes more Hidrasec 30 mg than recommended, 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 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 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 immediately seek medical help if any of the following symptoms occur:

• extensive 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 less than 1 in 100 patients):
tonsillitis, rash and erythema (redness of the skin).
Frequency not known (cannot be estimated from the available data):
erythema multiforme (pink skin lesions on limbs and inside the mouth),
glossitis, facial swelling, swelling of lips and eyelids, urticaria, nodular erythema (subcutaneous inflammatory nodules),
papular rash (skin lesions with small, firm, nodular changes), 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this 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 packaging. The expiry date refers to the last day of the stated month.
No special storage conditions 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 does Hidrasec 30 mg contain?

• The active substance in this medicine is racecadotril. Each sachet contains 30 mg of racecadotril.
• The other ingredients are: sucrose, anhydrous colloidal 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 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 Via Carlos III, 94-98, E-08028 Barcelona, Spain
Manufacturer
Ferrer Internacional S.A., Gran Via Carlos III, 94-98, E-08028 Barcelona, Spain
Sophartex, 21, Rue de Pressoir, 28500 Vernouillet, France
Parallel Importer:
Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Cesky Tesin
Czech Republic
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wl. Żeleńskiego 45
31-353 Kraków
Marketing Authorisation Number in Greece, country of export: 37057/5-6-08
96233/20-12-2016
Parallel Import Authorisation Number: 206/25
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