Hidrasec 30 mg

Patient Information Leaflet

Warning! Keep this 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 brand names of 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 doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in a child, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse (see section 4).

Table of Contents

1. What Hidrasec 30 mg is and what it is used for
2. What you need to know 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 used to treat symptoms of acute diarrhoea in children over 3 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 diarrhoea cannot be treated causally.
Racecadotril may be used as an adjunctive treatment when causal treatment is possible.

2. 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.

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 a fever. This may indicate a bacterial infection requiring treatment by a doctor;
• 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"). Skin reactions have been reported during treatment with this medicine. In most cases, these were mild reactions. If severe skin reactions occur, treatment must be stopped immediately.

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 administered.
Particularly inform the doctor about medicines the child is taking:

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

Pregnancy and breastfeeding
Hidrasec 30 mg is not recommended during pregnancy or breastfeeding.
Before using this medicine, consult a doctor or pharmacist.

Driving and operating machinery
Hidrasec 30 mg has no or negligible influence on the ability to drive vehicles or operate machinery.

Hidrasec 30 mg contains sucrose
Hidrasec 30 mg contains approximately 3 g of sucrose per sachet.
If the child has been diagnosed with intolerance to certain sugars, consult a doctor before administering Hidrasec 30 mg.
In children with diabetes, the amount of sucrose ingested with Hidrasec 30 mg should be included in the child's daily sugar intake.

3. How to use Hidrasec 30 mg

Hidrasec 30 mg should always be given to the child as directed by the doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Hidrasec 30 mg is available as granules for oral administration.
The granules 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 is based 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 duration of treatment with Hidrasec 30 mg will be determined by the doctor. 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 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 immediate medical advice from a doctor or pharmacist.
Missed dose of Hidrasec 30 mg
Do not give 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 they do not occur in everyone.
You should stop giving the child the medicine 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.

The following adverse reactions have been reported:
Not very common (occur less frequently than in 1 patient out of 100):
tonsillitis, rash and erythema (redness of the skin).
Frequency unknown (cannot be estimated from the available data):
erythema multiforme (pinkish skin lesions on limbs and inside the mouth), tongue swelling,
facial swelling, lip swelling, eyelid swelling, urticaria, nodular erythema (subcutaneous inflammatory
nodules), papular rash (skin eruptions with small, firm, nodular lesions), eczematous rash (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 a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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 enables further collection of information on the safety of the 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. Such measures help protect the environment.

6. Contents of the pack 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, colloidal anhydrous silica, 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 responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Greece, country of export: 37057/5-6-08
96233/20-12-2016

Parallel Import Authorisation Number: 269/23

This medicinal product is authorised for marketing 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