Hidrasec 10 mg

Leaflet attached to the packaging: patient information

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

Hidrasec 10 mg (Tiorfan Lactente)

10 mg, granules for oral suspension

Racecadotril
Hidrasec 10 mg and Tiorfan Lactente 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 has the same symptoms.
• 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 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 packaging and other information

1. What is Hidrasec 10 mg and what is it used for

Hidrasec 10 mg is a medicine used to treat diarrhea.
Hidrasec 10 mg is a medicine used to treat symptoms of acute diarrhea in children over 3 months old. The medicine 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 a supportive 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.

Warnings and precautions

Before taking Hidrasec 10 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 10 mg contains sucrose"). Skin reactions have been reported during treatment with the medicine. In most cases, these were mild reactions. If severe skin reactions occur, treatment should be stopped immediately.

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

Hidrasec 10 mg contains sucrose

Hidrasec 10 mg contains about 1 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 10 mg.
If the doctor has prescribed more than 5 sachets of Hidrasec 10 mg per day for infants with diabetes (which corresponds to more than 5 g of sucrose), you should take this into account 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 according to the doctor's or pharmacist's recommendations.
In case of doubts, you should consult a doctor or pharmacist.
Hidrasec 10 mg comes in the form of granules for oral use.
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 (which corresponds to 1-2 sachets), 3 times a day at regular intervals.
For children with a body weight of up to 9 kg: one sachet per dose.
For children with a body weight of 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 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 10 mg than recommended

In case the child takes a higher dose of Hidrasec 10 mg than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Hidrasec 10 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 10 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 lesions), pruritus (itching skin lesions), 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 Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Hidrasec 10 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 containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hidrasec 10 mg contains

• The active substance of the medicine is racecadotril. Each sachet contains 10 mg of racecadotril.
• The other ingredients are: sucrose, colloidal anhydrous silica, polyacrylate dispersion 30%, apricot flavor.

What Hidrasec 10 mg looks like and what the packaging contains

Hidrasec 10 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 Portugal, the country of export:

Ferrer Internacional, S.A.
Gran Via 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 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
Authorization number in Portugal, the country of export:5108881
5108980
5109087

Parallel import authorization number: 281/23

This medicinal product is authorized for sale 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

Date of leaflet approval: 30.11.2023

[Information about the trademark]