Hidrasec 30 mg

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Hidrasec 30 mg (Hidrasec), 30 mg, granules for oral suspension

Racecadotril
Hidrasec 30 mg and Hidrasec are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the child experiences any side effects, including any possible side effects not listed in the leaflet, you should tell the doctor, pharmacist, or nurse (see section 4).

Table of contents of the leaflet

• 1. What is Hidrasec 30 mg and what is it 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. Package contents and other information

1. What is Hidrasec 30 mg and what is it used for

Hidrasec 30 mg is a medicine used to treat diarrhea.
Hidrasec 30 mg is a medicine used to treat symptoms of acute diarrhea in children over 3 months old. The medicine should be taken simultaneously with a large amount of fluids and a supportive diet when they are not sufficient to control diarrhea and when diarrhea cannot be treated causally.
Racecadotril may be used as supportive treatment when causal treatment is possible.

2. Important information before taking Hidrasec 30 mg

When not to take Hidrasec 30 mg

Warnings and precautions

Before taking Hidrasec 30 mg, you should 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. 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 30 mg contains sucrose"). Skin reactions have been reported during treatment with the medicine. In most cases, they were mild. If severe skin reactions occur, treatment should be stopped immediately.

Hidrasec 30 mg and other medicines

You should tell the doctor about all medicines the child is currently taking or has recently taken, as well as any medicines planned to be given to the child.
Particularly, you should tell the doctor about medicines the child is taking:

• angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or facilitate heart function.

Pregnancy and breastfeeding

Hidrasec 30 mg should not be used during pregnancy and breastfeeding.
Before taking this medicine, you should consult a doctor or pharmacist.

Driving and using machines

Hidrasec 30 mg has a minor or no effect on the ability to drive and use machines.

Hidrasec 30 mg contains sucrose

Hidrasec 30 mg contains about 3 g of sucrose in one sachet.
If the doctor has informed you that the child has intolerance to some sugars, you should consult a doctor before giving the child Hidrasec 30 mg.
In children with diabetes, the amount of sucrose taken with Hidrasec 30 mg should be included in the child's daily sugar intake.

3. How to take Hidrasec 30 mg

Hidrasec 30 mg should always be given to the child according to the doctor's or pharmacist's recommendations.
In case of doubts, you should consult a doctor or pharmacist.
Hidrasec 30 mg comes in the form of granules for oral suspension.
The granules should be added to food or mixed with water in a glass or feeding bottle, well mixed, and immediately given to the child.
The recommended dose depends on the child's body weight: 1.5 mg/kg per dose (corresponding to 1-2 sachets), 3 times a day at regular intervals.
In children weighing between 13 kg and 27 kg: one sachet per dose.
In children weighing approximately over 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 are passed and should not last longer than 7 days.
To replace lost fluids due to diarrhea, this medicine should be used simultaneously with an adequate amount of fluids and salts (electrolytes). The best way to replace fluids and electrolytes is to drink so-called oral rehydration solutions (in case of doubts, consult a doctor or pharmacist).

Taking a higher dose of Hidrasec 30 mg than recommended

In case the child has taken a higher dose of Hidrasec 30 mg than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Hidrasec 30 mg

You should 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 medicines, this medicine can cause side effects, although not everybody gets them.
You should stop giving the child Hidrasec 30 mg and immediately contact a doctor if the following symptoms of angioedema occur:

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

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 and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (subcutaneous inflammatory conditions in the form of nodules), papular rash (rash on the skin with small, hard, and nodular changes), pruritus (itching skin), and pruritus (generalized itching).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help gather 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.
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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Hidrasec 30 mg contains

• The active substance of the medicine is racecadotril. Each sachet contains 30 mg of racecadotril.
• The other ingredients are: sucrose, colloidal anhydrous silica, polyacrylate dispersion 30%, and apricot flavor.

What Hidrasec 30 mg looks like and what the package contains

Hidrasec 30 mg comes in the form of granules for oral suspension, packaged in sachets.
Each package contains: 10, 16, 20, 30, 50, or 100 sachets.
To obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Ferrer Galenica A.E.
Eleftherias 4
145 64 Kifisia
Greece

Manufacturer:

FERRER Internacional S.A.
Gran Via Carlos III, 94-98
E-08028 Barcelona
Spain
Sophartex
21, Rue du Pressoir
28500 Vernouillet
France
Delpharm Reims
10 rue du Colonel Charbonneaux
51100 Reims
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:37057/5-6-08
96233/20-12-2016
Parallel import authorization number:269/23

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 30 mg
Portugal: Tiorfan
Slovakia: Hidrasec
Slovenia: Hidrasec
Sweden: Hidrasec

Date of leaflet approval: 24.11.2023

[Information about the trademark]