Package leaflet: Information for the patient

Racedryl, 10 mg, granules for oral suspension
Racecadotril
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

What Racedryl is and what it is used for
Important information before taking Racedryl
How to take Racedryl
Possible side effects
How to store Racedryl
Contents of the pack and other information

1. What Racedryl is and what it is used for

Racedryl is a medicine used as an adjunctive treatment for the symptomatic management of acute diarrhoea in infants (over 3 months of age) and children, together with oral rehydration and standard supportive care, when such treatment alone is insufficient to control clinical symptoms and when causal treatment is not possible. When causal treatment is feasible, Racedryl may be used as an adjunctive therapy.

2. Important information before taking Racedryl

When not to take Racedryl

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 severe skin rash, skin peeling, blisters and/or oral ulceration after taking racecadotril;
if the child has chronic diarrhoea or antibiotic-associated diarrhoea;
in children with impaired kidney or liver function, regardless of the severity of the condition;
if the child has prolonged, uncontrolled vomiting;
in infants under 3 months of age.

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

there is blood or pus in the child's stool and the child has a fever. This may be due to a bacterial infection or other serious illness;
the child has prolonged or uncontrolled vomiting;
the child has diabetes (see "Racedryl contains sucrose");
the child has a history of angioedema unrelated to racecadotril therapy, as such patients may be at increased risk of developing angioedema.

Extreme caution must be exercised when using racecadotril.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with racecadotril. If the patient notices any symptoms related to serious skin reactions described in section 4, treatment with racecadotril must be discontinued immediately and medical advice must be sought without delay.
Taking this medicine does not replace standard rehydration therapy.
It is very important to maintain adequate hydration in infants and children during treatment of acute diarrhoea.
The need for rehydration and the route of administration should be determined by a doctor according to the patient's age, stage of illness, body weight, and severity of symptoms, especially in cases of acute or prolonged diarrhoea associated with vomiting or loss of appetite.

Racedryl and other medicines
Inform the doctor about all medicines currently taken or recently taken by the child, as well as any medicines planned for administration.
Particularly inform the doctor about 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 assist heart function.

Pregnancy and breastfeeding
This medicine is intended for use in children.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Medical advice should be sought before using any medicine.
Racedryl must not be used during pregnancy or breastfeeding.

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

Racedryl contains sucrose
If the child has been diagnosed with intolerance to certain sugars, consult a doctor before administering Racedryl.
Racedryl 10 mg contains 0.98 g of sucrose per sachet.
If a doctor prescribes more than 5 sachets of Racedryl 10 mg per day (corresponding to more than 5 g of sucrose) for infants with diabetes, this should be taken into account when calculating the child's daily sugar intake.

3. How to take Racedryl

Always use this medicine exactly as recommended by the doctor. If in doubt, consult
a doctor or pharmacist.
Racedryl is a granulate for oral suspension, which forms a white suspension when dissolved in water.
The medicine may be added to food, sprinkled into a glass of water or into a bottle of feed, then mixed well and given immediately to the child.
This medicine is intended for children with body weight below 13 kg.
Infants with body weight below 9 kg: 1 sachet 3 times daily, at regular intervals.
Infants with body weight from 9 to 13 kg: 2 sachets 3 times daily, at regular intervals.
The duration of treatment with Racedryl 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 simultaneously with an adequate amount of fluids and salt solutions (electrolytes). The best way
to replace fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult a doctor or pharmacist).
Taking more Racedryl than recommended
If a child takes more Racedryl than recommended, contact a doctor or pharmacist immediately.
If a dose of Racedryl is missed
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 all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking Racedryl and seek immediate medical help if any of the following symptoms occur:

symptoms of angioedema, such as: swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties;
widespread rash, high fever and swollen lymph nodes (DRESS syndrome);
breathing difficulties, swelling, dizziness, rapid heartbeat, sweating and feeling faint, which are symptoms of a sudden, severe allergic reaction.

The following adverse reactions have been reported:
Common (may occur in less than 1 in 10 people):

headache.

Uncommon (may occur in less than 1 in 100 people):

tonsillitis;
rash;
erythema (redness of the skin).

Frequency not known (frequency cannot be estimated from the available data):

erythema multiforme (pink skin lesions on limbs and inside the mouth);
tongue swelling;
facial swelling;
lip swelling;
eyelid swelling;
urticaria;
erythema nodosum (inflammatory nodular lesions in subcutaneous tissue);
papular rash (skin eruptions with small, firm, nodular changes);
prurigo (itchy skin lesions);
pruritus (generalized itching);
toxic skin eruption.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 .
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Racedryl

No special storage instructions are required for this medicine.
The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and sachet following "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Racedryl contains

The active substance is racecadotril. Each Racedryl sachet, 10 mg, contains 10 mg of racecadotril.
The other ingredients are: sucrose, colloidal anhydrous silica, povidone K-30.

What Racedryl looks like and contents of the pack
Racedryl is available as a white or almost white granulate for oral suspension, which forms a white suspension when dissolved in water. The medicine is packed in sachets made of Paper/Polyester/Aluminium/Polyester, placed in a cardboard box.
Each pack contains: 16 sachets.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. +48 (42) 22-53-100

Importer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów