Recenum Iunior

Leaflet attached to the packaging: patient information

Recenum Junior, 30 mg, granules for oral suspension, in a sachet

Racecadotril

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

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 2 days there is no improvement or the patient feels worse, a doctor should be contacted.

Table of contents of the leaflet

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

1. What is Recenum Junior and what is it used for

Recenum Junior is a medicine used for the symptomatic treatment of diarrhea.
Recenum Junior is a medicine used for the symptomatic treatment of acute diarrhea in children
over 6 years of age. The medicine should be taken simultaneously with a large amount of fluids and a supporting diet,
when these are not sufficient to control diarrhea and when diarrhea cannot be treated causally.
Racecadotril may be used as a supportive treatment when causal treatment is possible.

2. Important information before taking Recenum Junior

When not to take Recenum Junior

• if the child is allergic to racecadotril or any of the other ingredients of Recenum Junior (listed in section 6)
• if the patient has ever experienced a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking racecadotril
• if the child has an intolerance to some sugars, a doctor should be consulted before giving the child Recenum Junior
• if the child is under 6 years old.

Warnings and precautions

Before taking Recenum Junior, a doctor or pharmacist should be consulted if:

• 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

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• 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 "Recenum Junior contains sucrose")
• the child's diarrhea is very voluminous, vomiting persists, signs of dehydration appear (pallor, dryness of mucous membranes, lethargy) or there is a lack of appetite - in such cases, intravenous rehydration may be necessary and the child may require hospital treatment.

Particular caution should be exercised when taking racecadotril.
During treatment with the medicine, skin reactions have been reported. In most cases, these were
mild reactions.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have also been reported with racecadotril treatment. If the patient notices any symptoms of serious skin reactions described in section 4,
they should stop taking racecadotril and immediately consult a doctor.

Recenum Junior and other medicines

A doctor or pharmacist should be informed about all medicines the child is currently taking or has recently taken, as well as any medicines planned to be given to the child.
In particular, a doctor should be informed 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

This medicine is intended for children.
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 medicine.
Recenum Junior should not be taken during pregnancy or breastfeeding.

Driving and using machines

Recenum Junior has a minor or no effect on the ability to drive and use machines.

Recenum Junior contains sucrose

Recenum Junior contains approximately 2.9 g of sucrose in one sachet.
If the child has an intolerance to some sugars, a doctor should be consulted before giving the child Recenum Junior.
In diabetic children, the amount of sucrose taken with Recenum Junior should be taken into account in the child's daily sugar intake.

3. How to take Recenum Junior

Recenum Junior should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
Recenum Junior comes in the form of granules for oral use.
The granules should be added to food or mixed with water in a glass, well mixed, and given to the child immediately.
After dissolution in water, it forms a white suspension.
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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 and 27 kg: one sachet per dose. The dose should be taken 3 times a day, i.e., the daily dose is 3 sachets (3 times a day, 1 sachet each time).
In children weighing between 27 and 40 kg: two sachets per dose. The dose should be taken 3 times a day, i.e., the daily dose is 6 sachets (3 times a day, 2 sachets each time).
In children under 13 kg, the doctor may recommend using Recenum Baby 10 mg, granules for oral suspension, in a sachet.
Treatment should be continued until two normal stools are passed and should not last longer than 7 days.
If after 2 days there is no improvement or the patient feels worse, a doctor should be contacted.
To replace lost fluids due to diarrhea, this medicine should be taken 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 doubt, a doctor or pharmacist should be consulted).

In some cases, intravenous rehydration may be necessary - see section 2

Warnings and precautions.

Taking a higher dose of Recenum Junior than recommended

In case the child takes a higher dose of Recenum Junior than recommended, a doctor or pharmacist should be consulted immediately.

Missing a dose of Recenum Junior

A double dose should not be taken to make up for a missed dose. The next dose should be taken at the usual time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment with Recenum Junior should be stopped and a doctor consulted immediately if symptoms of angioedema occur, such as:

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

Treatment with racecadotril should be stopped and medical help sought immediately if any of the following symptoms occur:

• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome);
• difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and feeling of fainting, 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 and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (subcutaneous inflammatory conditions
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in the form of nodules), papular rash (rash with small, hard, and nodular lesions), pruritus (itching skin lesions), pruritus (generalized itching).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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 the medicine.

5. How to store Recenum Junior

The medicine should be stored out of sight and reach of children.
This medicine should not be taken after the expiry date stated on the sachet and carton. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked 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 Recenum Junior contains

• The active substance of the medicine is racecadotril. Each sachet contains 30 mg of racecadotril.
• The other ingredients are: sucrose, colloidal anhydrous silica, povidone (K30).

What Recenum Junior looks like and what the pack contains

Recenum Junior comes in the form of white or almost white granules for oral suspension. The medicine is packaged in paper/polyester/aluminum/polyester sachets in a carton box.
Each pack contains: 10, 16, 30 sachets.

Marketing authorization holder and importer:

US Pharmacia Sp. z o.o.
ul. Ziębicka 40,
50-507 Wrocław

For more detailed information, please contact:

USP Zdrowie Sp. z o.o., ul. Poleczki 35, 02-822 Warszawa, tel.+48 (22) 543 60 00.

Date of the last update of the leaflet:

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