Package leaflet: Information for the user

Recenum Junior, 30 mg, granules for oral suspension in sachet
Racecadotril
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
Keep this leaflet as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 2 days, or if you feel worse, consult your doctor.

Contents of the leaflet

What Recenum Junior is and what it is used for
What you need to know before taking Recenum Junior
How to take Recenum Junior
Possible side effects
How to store Recenum Junior
Contents of the pack and other information

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

Recenum Junior is a medicine used for the acute treatment of diarrhoea.
Recenum Junior is indicated for the acute symptomatic treatment of acute diarrhoea in children above 6 years 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 aetiological treatment is not possible.
Racecadotril may be used as an adjunctive treatment when aetiological treatment is feasible.

2. Important information before using Recenum Junior

When not to use 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 previously experienced severe skin rash, skin peeling, blisters and/or oral ulceration after taking racecadotril
if the child has intolerance to certain sugars, consult a doctor before administering Recenum Junior to the child
if the child is under 6 years of age.

Warnings and precautions
Before starting treatment with Recenum Junior, consult a doctor or pharmacist if:

there is blood or pus in the stool and the child has fever. This may be due to a bacterial infection requiring medical treatment

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the child has chronic diarrhoea or diarrhoea caused by antibiotics
the child has impaired kidney or liver function
the child experiences prolonged or uncontrolled vomiting
the child has diabetes (see "Recenum Junior contains sucrose")
the child's diarrhoea is very severe, vomiting persists, signs of dehydration appear (pale skin, dry mucous membranes, lethargy) or loss of appetite occurs – in such cases intravenous rehydration may be necessary and hospital treatment may be required.

Particular 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, including drug reaction with eosinophilia and systemic symptoms (DRESS), have also been associated with racecadotril treatment. 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 must be sought without delay.

Recenum Junior and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently taken by the child, as well as any medicines planned for future use.
Particular attention should be paid to medicines taken by the child such as:

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

Pregnancy and breastfeeding
This medicine is intended for children.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Recenum Junior must not be used during pregnancy or breastfeeding.

Driving and operating machinery
Recenum Junior has minor or no influence on the ability to drive vehicles or operate machinery.

Recenum Junior contains sucrose
Recenum Junior contains approximately 2.9 g of sucrose per sachet.
If the child has been diagnosed with intolerance to certain sugars, consult a doctor before administering Recenum Junior to the child.
In children with diabetes, the amount of sucrose contained in Recenum Junior should be taken into account when calculating the child's daily sugar intake.

3. How to take Recenum Junior

Recenum Junior should always be taken exactly as described in this patient leaflet or
as directed by a doctor or pharmacist. If in doubt, consult
your doctor or pharmacist.
Recenum Junior is available as granules for oral administration.
The granules should be added to food or mixed with water in a glass, stirred well, and administered immediately
to the child. When dissolved 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), administered 3 times daily at regular intervals.
In children weighing from 13 to 27 kg: one sachet per dose. This dose should be taken 3 times daily,
i.e. the daily dose is 3 sachets (1 sachet 3 times daily).
In children weighing from 27 to 40 kg: two sachets per dose. This dose should be taken 3 times daily,
i.e. the daily dose is 6 sachets (2 sachets 3 times daily).
In children weighing less than 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 bowel movements have occurred and should not
last longer than 7 days.
If there is no improvement after 2 days, or if the patient feels worse, consult a doctor.
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 replace fluids and electrolytes is by drinking oral rehydration solutions
(in case of doubt, consult a doctor or pharmacist).
In some cases, intravenous rehydration may be necessary – see section 2
Warnings and precautions.
Taking more Recenum Junior than recommended
If a child takes more Recenum Junior than recommended, seek immediate advice from a doctor or pharmacist.
Missing a dose of Recenum Junior
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.

Discontinue administration of Recenum Junior to the child and immediately contact a doctor if any symptoms of angioedema occur, such as:

swelling of the face, tongue, or throat
difficulty swallowing
urticaria (hives) and breathing difficulties

Discontinue the use of racecadotril and immediately seek 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:
Uncommon (occur in less than 1 in 100 patients):
pharyngitis, rash, and erythema (reddening of the skin).

Frequency not known (cannot be estimated from available data):
erythema multiforme (rose-colored 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
Phone: +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 to provide more information on the safety of this medicine.

5. How to store Recenum Junior

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the carton. The expiry date refers to the last day of the specified month.
The labelling on the packaging shows EXP followed by the expiry date, and Lot followed by the batch number.
Store below 25°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Recenum Junior contains

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

What Recenum Junior looks like and contents of the pack
Recenum Junior is a white or almost white granulate for oral suspension.
The medicine is packed in sachets made of Paper/Polyester/Aluminum/Polyester and placed in a cardboard box.
Each package contains: 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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