RECENUM BABY

Package leaflet: Information for the user

Recenum Baby, 10 mg, granules for oral suspension in sachet
Racecadotril
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If your child experiences any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse (see section 4).

Table of contents

1. What Recenum Baby is and what it is used for
2. Important information before taking Recenum Baby
3. How to take Recenum Baby
4. Possible side effects
5. How to store Recenum Baby
6. Contents of the pack and other information

1. What Recenum Baby is and what it is used for
Recenum Baby is a medicine used to treat symptoms of acute diarrhoea in children over 3 months of age. The medicine should be taken together with plenty of fluids and a supportive diet when these measures 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. Important information before taking Recenum Baby

When not to take Recenum Baby

• if the child is allergic to racecadotril or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever experienced a severe skin rash, skin peeling, blisters, and/or oral mucosal ulceration after taking racecadotril
• if the child has intolerance to certain sugars, consult a doctor before giving Recenum Baby to the child
• the child is less than 3 months old.

Warnings and precautions
Before starting treatment with Recenum Baby, discuss with your doctor or pharmacist if:

• there is blood or pus in the stool and the child has a fever. This may indicate a bacterial infection requiring medical treatment
• the child has chronic diarrhoea or diarrhoea caused by antibiotic use
• the child has impaired kidney or liver function
• the child has persistent or uncontrolled vomiting
• the child has diabetes (see "Recenum Baby contains sucrose").

Special caution is required when using racecadotril.
Skin reactions have been reported during treatment with this medicine. In most cases, these were mild reactions.
However, severe skin reactions have also occurred with racecadotril treatment, including drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient notices any of the symptoms related to serious skin reactions described in section 4, treatment with racecadotril should be discontinued immediately and medical advice should be sought without delay.

Recenum Baby and other medicines
Inform the doctor about all medicines currently or recently taken by the child, as well as any medicines planned to be administered.
In particular, inform the doctor about medicines taken by the child:

• 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
This medicine is intended for children.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Medical advice should be sought before using any medicine.
Recenum Baby must not be used during pregnancy or breastfeeding.

Driving and operating machinery
Recenum Baby has no effect or negligible effect on the ability to drive and operate machinery.

Recenum Baby contains sucrose
Recenum Baby contains approximately 0.98 g of sucrose per sachet.
If the child has previously been diagnosed with intolerance to certain sugars, consult a doctor before administering Recenum Baby.
If a doctor prescribes more than 5 sachets per day for an infant with diabetes (corresponding to more than 5 g of sucrose), this should be taken into account when calculating the child's daily sugar intake.

3. How to take Recenum Baby

Recenum Baby should always be given to the child as directed by the doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Recenum Baby 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 immediately given to the child. When dissolved in water, it forms a white suspension.
The recommended dose depends on the child's body weight: 1.5 mg/kg body weight per dose (corresponding to 1–2 sachets), administered 3 times daily at regular intervals.
In children weighing up to 9 kg: one sachet per dose.
In children weighing 9–13 kg: two sachets per dose.
The duration of treatment with Recenum Baby 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.
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To replace fluids lost due to diarrhoea, this medicine should be used together with an appropriate amount of fluids and salts (electrolytes).
The best way to replace fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult a doctor or pharmacist).
If more Recenum Baby is taken than recommended
If the child takes more than the recommended dose of Recenum Baby, seek medical advice immediately from a doctor or pharmacist.
If a dose of Recenum Baby is missed
Do not take a double dose to make up for the 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 Recenum Baby to the child and contact a doctor immediately if any of the following symptoms of angioedema occur:

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

You should stop using racecadotril and seek immediate medical help 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 sudden, severe allergic reaction.

The following adverse reactions have been reported:
Not very common (occur in fewer than 1 in 100 patients):
tonsillitis, rash and erythema (redness of the skin).
Frequency unknown (cannot be estimated from available data):
erythema multiforme (pink 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 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 a doctor or pharmacist. Adverse reactions can be reported directly to:
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 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Recenum Baby

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Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the outer carton. The expiry date refers to the last day of the month indicated.
The label on the packaging shows the expiry date after the abbreviation EXP, and the batch number after the abbreviation Lot.
Store below 25°C.
Medicines should 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 packaging and other information

What Recenum Baby contains

• The active substance is racecadotril. Each sachet contains 10 mg of racecadotril.
• The other components are: sucrose, anhydrous colloidal silicon dioxide, povidone (K30).

What Recenum Baby looks like and contents of the pack
Recenum Baby is a white or almost white granulate for oral suspension.
The medicine is packed in sachets made of Paper/Polyester/Aluminium/Polyester, placed in a cardboard box.
Pack contents: 10, 16 or 30 sachets.
Marketing Authorisation Holder and Importer:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław
For further information, please contact:
USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, tel. +48 (22) 543 60 00.
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