Racedril

Package Leaflet: Information for the Patient

Racedryl, 10 mg, Granules for Oral Suspension

Racecadotril

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse (see section 4).

Table of Contents of the Leaflet

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

1. What is Racedryl and what is it used for

Racedryl is a medication used as a supplementary symptomatic treatment of acute diarrhea in infants (over 3 months of age) and children, with concurrent use of oral rehydration and standard supportive treatment, if such treatment alone does not allow control of clinical symptoms, and if causal treatment is not possible. When causal treatment is possible, Racedryl may be used as supplementary treatment.

2. Important information before taking Racedryl

When not to take Racedryl

• if your child is allergic to racecadotril or any of the other ingredients of this medicine (listed in section 6);
• if your child has ever had a severe skin rash or skin peeling, blisters, and (or) mouth sores after taking racecadotril;
• if your child has chronic diarrhea or diarrhea caused by taking antibiotics;
• in children with kidney or liver function disorders, regardless of the severity of the disease;
• if your child has prolonged, uncontrolled vomiting;
• in infants under 3 months of age.

Warnings and precautions

Before starting treatment with Racedryl, tell your doctor or pharmacist if:

• your child has blood or pus in their stool and has a fever. The cause may be a bacterial infection or the presence of other serious diseases;
• your child has prolonged or uncontrolled vomiting;
• your child has diabetes (see "Racedryl contains sucrose");
• your child has a history of angioedema not related to racecadotril treatment, as they may be at increased risk of angioedema.

Special caution is advised when using racecadotril.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have 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 seek medical advice immediately.
Taking the medicine does not change the standard method of rehydration.
It is very important to rehydrate infants and children during treatment for acute diarrhea.
The need for rehydration and the route of administration should be tailored by the doctor to the patient's age, disease progression, body weight, and severity of symptoms, especially in cases of acute or prolonged diarrhea with vomiting or loss of appetite.

Racedryl and other medicines

Tell your doctor about all medicines your child is taking or has recently taken, as well as any medicines planned for your child.
Especially tell your doctor about medicines your child is taking, such as:

• 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Before taking any medicine, consult your doctor or pharmacist.
Do not use Racedryl during pregnancy or breastfeeding.

Driving and using machines

Racedryl has no or negligible influence on the ability to drive and use machines.

Racedryl contains sucrose

If your child has been diagnosed with intolerance to some sugars, consult your doctor before giving your child Racedryl.
Racedryl, 10 mg contains 0.98 g of sucrose in each sachet.
If your child has diabetes and the doctor has prescribed more than 5 sachets of Racedryl, 10 mg per day (which corresponds to more than 5 g of sucrose), this should be taken into account in the child's daily sugar intake.

3. How to take Racedryl

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
Racedryl is a granule for oral suspension, which, after dissolution in water, forms a white suspension.
The medicine can be added to food, poured into a glass of water, or into a bottle with food, then mixed well and given to the child immediately.
The medicine is intended for children weighing less than 13 kg.
Infants weighing less than 9 kg: 1 sachet 3 times a day, at equal intervals.
Infants weighing 9 to 13 kg: 2 sachets 3 times a day, at equal intervals.
The doctor will decide on the duration of treatment with Racedryl.
Treatment should be continued until two normal stools are passed and should not last longer than 7 days.
To supplement lost fluids due to diarrhea, this medicine should be used concurrently with an adequate amount of fluids and electrolyte solutions. The best way to supplement fluids and electrolytes is to drink oral rehydration solutions (in case of doubt, consult your doctor or pharmacist).

Taking more Racedryl than prescribed

If your child takes more Racedryl than prescribed, consult your doctor or pharmacist immediately.

Missing a dose of Racedryl

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible side effects

Like all medicines, Racedryl can cause side effects, although not everybody gets them.
Stop taking Racedryl and seek medical help immediately if your child experiences any of the following symptoms:

• symptoms of angioedema, such as: swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing;
• 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.

Reported side effects

Frequent(may affect up to 1 in 10 people):

• headache.

Uncommon(may affect up to 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 patches on the skin and inside the mouth);
• tongue swelling;
• face swelling;
• lip swelling;
• eyelid swelling;
• hives;
• nodular erythema (lumpy, red patches on the skin);
• papular rash (small, hard, and lumpy patches on the skin);
• pruritus (itching);
• prurigo (generalized itching);
• toxic epidermal necrolysis.

Reporting side effects

If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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 .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Racedryl

There are no special precautions for storage.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after "EXP". The expiry date refers to the last day of the month.
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 pack and other information

What Racedryl contains

• The active substance is racecadotril. Each sachet of Racedryl, 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 a white or almost white granule for oral suspension, which, after dissolution in water, forms a white suspension. The medicine is packaged in paper/polyester/aluminum/polyester sachets in a cardboard box.
Each pack contains: 16 sachets.

Marketing authorization holder

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

Importer

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

Date of last revision of the leaflet: