Hidrasec 10 mg

Package Leaflet: Information for the Patient

Hidrasec 10 mg, 10 mg, Granules for Oral Suspension

Racecadotril

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific child. Do not pass it on to others. It may harm them, even if their symptoms are the same as the child's.
• If the child experiences any side effects, including any possible side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse (see section 4).

Table of Contents of the Leaflet

• 1. What is Hidrasec 10 mg and what is it used for
• 2. Important information 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 is Hidrasec 10 mg and what is it used for

Hidrasec 10 mg is a medication used to treat diarrhea.
Hidrasec 10 mg is a medication used to treat symptoms of acute diarrhea in children over three months of age. The medication should be taken with a large amount of fluids and a supporting diet when these are not sufficient to control diarrhea and when the diarrhea cannot be treated causally.
Racecadotril may be used as an adjunctive treatment when causal treatment is possible.

2. Important information before taking Hidrasec 10 mg

When not to take 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 some sugars, consult a doctor before giving the child Hidrasec 10 mg
• if the patient has ever experienced a severe skin rash or skin peeling after taking racecadotril.

Warnings and precautions

Before taking Hidrasec 10 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 a fever. The cause may be a bacterial infection that should be treated by a doctor
• the child has chronic diarrhea or diarrhea caused by taking antibiotics
• the child has kidney or liver function disorders
• the child has prolonged or uncontrolled vomiting
• the child has diabetes (see "Hidrasec 10 mg contains sucrose").

Racecadotril, the active substance of Hidrasec, may cause an allergic reaction called angioedema, which can cause swelling of the face, lips, throat, or tongue. If the child experiences such side effects, stop the treatment and contact a doctor immediately. Angioedema may occur at any time during treatment with this medication.
Taking this medication and some other medications at the same time may increase the risk of angioedema (see "Hidrasec 10 mg and other medications").
Skin reactions have been reported in association with the use of this medication. In most cases, they are mild and do not require treatment. In some cases, severe skin reactions may occur.
In such cases, stop the treatment immediately and do not give the child racecadotril again.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril. If the patient notices any symptoms associated with severe skin reactions described in section 4, stop taking racecadotril and seek medical advice immediately.

Hidrasec 10 mg and other medications

Tell the doctor about all medications the child is taking or has recently taken, as well as any medications planned to be given to the child.
Especially tell the doctor about medications that may increase the risk of certain side effects (see "Warnings and precautions"):

• angiotensin-converting enzyme 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 to treat high blood pressure and heart failure
• sacubitril used to treat heart failure
• certain immunosuppressive medications (e.g., sirolimus or everolimus)
• certain medications used to treat diabetes (e.g., sitagliptin or wildagliptin)
• estramustine used to treat cancer
• aleptase used to treat blood clots.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.
Hidrasec 10 mg is not recommended during pregnancy and breastfeeding.

Driving and using machines

Hidrasec 10 mg has a minor or no influence on the ability to drive and use machines.

Hidrasec 10 mg contains sucrose

Hidrasec 10 mg contains approximately 1 g of sucrose per sachet.
If the doctor has informed that the child has intolerance to some sugars, consult a doctor before giving the child Hidrasec 10 mg.
If the doctor has prescribed more than 5 sachets of Hidrasec 10 mg per day for diabetic infants (which corresponds to more than 5 g of sucrose), consider this when calculating the child's daily sugar intake.

3. How to take Hidrasec 10 mg

Hidrasec 10 mg should always be given to the child as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Hidrasec 10 mg comes in the form of granules.
The granules should be added to food or mixed with water in a glass or feeding bottle, mixed well, and given to the child immediately.
The recommended dose depends on the child's body weight: 1.5 mg/kg per dose (which corresponds to 1-2 sachets), 3 times a day at regular intervals.
For children weighing up to 9 kg: one sachet per dose.
For 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 are passed and should not last longer than 7 days.
To replace lost fluids due to diarrhea, this medication should be used with an adequate amount of fluids and salts (electrolytes). The best way to replace fluids and electrolytes is to drink oral rehydration solutions (if in doubt, consult a doctor or pharmacist).

What to do if more than the recommended dose of Hidrasec 10 mg is taken

If the child takes more than the recommended dose of Hidrasec 10 mg, consult a doctor or pharmacist immediately.

What to do if a dose of Hidrasec 10 mg is missed

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible side effects

Like all medications, Hidrasec 10 mg can cause side effects, although not everybody gets them.
Stop giving the child Hidrasec 10 mg and contact a doctor immediately if the following symptoms of angioedema occur:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing

Stop taking racecadotril and seek medical help immediately 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 severe allergic reaction.

The following side effects have been reported:
Uncommon (occurring 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 patches on the skin, inside the mouth, and sometimes on the genitals), tongue, face, mouth, and eyelid swelling, urticaria, erythema nodosum (red nodules under the skin), papular rash (small bumps on the skin), pruritus (itching), and generalized pruritus.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Hidrasec 10 mg

Keep the medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the sachet and carton after: Expiry date (EXP). The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medications that are no longer needed. This will 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, polycarbophil, and peach flavor.

What Hidrasec 10 mg looks like and contents of the pack

Hidrasec 10 mg comes in the form of granules for oral suspension packaged in sachets.
Each pack contains: 10, 16, 20, 30, 50, or 100 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder

Bioprojet Europe Ltd.
101 Furry Park road
Killester
Dublin 5
Ireland

Manufacturer

Ferrer Internacional, S.A.
Gran Via Carlos III, 94
08028 Barcelona
Spain
Sophartex
21 rue du Pressoir
28500 Vernouillet
France
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

This medicinal product is authorized in the Member States of the European

Economic Area 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
Date of last revision of the leaflet:11/2024