TIORFAN NIÑOS 30 MG GRANULES FOR ORAL SUSPENSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tiorfan Niños 30 mg granules for oral suspension

racecadotril

Read all of this leaflet carefully before your child starts taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Tiorfan is and what it is used for
2. What you need to know before your child takes Tiorfan
3. How to take Tiorfan
4. Possible side effects
5. How to store Tiorfan
6. Contents of the pack and other information

1. What Tiorfan is and what it is used for

Tiorfan is a medication used for the treatment of diarrhoea.

Tiorfan is used to treat the symptoms of acute diarrhoea in children over 3 months of age. It should be used in conjunction with adequate fluid intake and standard dietary measures, when these measures alone are insufficient to control the diarrhoea, and when the underlying causes of diarrhoea cannot be treated.

If causal treatment is possible, racecadotril may be administered as an adjunctive therapy.

2. What you need to know before starting Tiorfan

Do not use Tiorfan

• If your child is allergic to racecadotril or to any of the other components of Tiorfan (listed in section 6).
• If your doctor has told you that your child has an intolerance to certain sugars, consult your doctor before giving Tiorfan to your child.
• If your child has ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking racecadotril.

Warnings and precautions

Consult your doctor or pharmacist before starting to give Tiorfan to your child if:

• your child is less than 3 months old,
• there is blood or pus in your child's stools, or if your child has a fever. The cause of the diarrhoea may be a bacterial infection that needs to be treated by your doctor,
• your child suffers from chronic diarrhoea or diarrhoea caused by antibiotics,
• your child has prolonged or uncontrolled vomiting,
• your child has kidney disease or impaired liver function,
• your child has diabetes (see "Important information about some of the components of Tiorfan").

Racecadotril, the active substance in Tiorfan, may cause an allergic reaction called angioedema, which can lead to swelling of the face, lips, throat, or tongue. If your child experiences these adverse effects, stop treatment immediately and contact your doctor. Swelling may occur at any time during treatment with this product.

Concomitant use of this product with certain other medicines may increase the risk of angioedema (see "Other medicines and Tiorfan").

Skin reactions have been reported with the use of this product. In most cases, they are mild and do not require treatment. However, severe skin reactions may occur in some cases. If this happens, treatment must be stopped immediately, and the child should not be treated with racecadotril again.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with racecadotril treatment. Discontinue the use of racecadotril and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Taking Tiorfan with other medicines

Inform your doctor if your child is taking, has recently taken, or might need to take any other medicines.

Especially inform your doctor if your child is taking any of the following medicines, as they may increase the risk of side effects (see "Warnings and precautions"):

• ACE inhibitors (e.g., perindopril or ramipril), used to lower blood pressure or to treat heart failure.
• Angiotensin II antagonists (e.g., candesartan or irbesartan), used to treat high blood pressure and heart failure.
• Sacubitril, used to treat heart failure.
• Some immunosuppressants (e.g., sirolimus or everolimus).
• Some antidiabetic medicines (e.g., sitagliptin or vildagliptin).
• Estramustine, used in the treatment of cancer.
• Alteplase, used to treat blood clots.

Pregnancy and breastfeeding

The use of Tiorfan during pregnancy and breastfeeding is not recommended.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Tiorfan has little or no effect on the ability to drive or operate machinery.

Tiorfan contains sucrose

Tiorfan contains approximately 3 g of sucrose per sachet.

If your doctor has told you that your child has an intolerance to certain sugars, consult your doctor before giving Tiorfan to your child.

In children with diabetes, the amount of sucrose ingested with Tiorfan should be taken into account when calculating the child's total daily sugar intake.

3. How to take Tiorfan

Follow exactly the instructions for administering Tiorfan provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Tiorfan is available as a granular formulation.

The granules may be added to food or mixed in a glass of water or in a bottle. Mix well and give it to your child immediately.

The recommended daily dose depends on your child's weight: 1.5 mg/kg per dose (corresponding to 1–2 sachets), three times daily at regular intervals.

In children weighing 13 to 27 kg: one sachet per dose.

In children weighing more than 27 kg, approximately: two sachets per dose.

Your doctor will determine the duration of treatment with Tiorfan. Treatment should be continued until two normal bowel movements occur, without exceeding 7 days.

To compensate for fluid loss due to your child's diarrhea, this medicine should be used together with adequate fluid and electrolyte replacement. The best fluid and electrolyte replacement is achieved with an oral rehydration solution (please ask your doctor or pharmacist if you are unsure).

If you give more Tiorfan than you should

If your child has taken more Tiorfan than they should have, contact your doctor or pharmacist immediately.

If you forget to give Tiorfan

Do not give your child a double dose to make up for a missed dose. Simply continue with the treatment as scheduled.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop giving Tiorfan to your child and contact a doctor immediately if your child experiences symptoms of angioedema, such as:

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

Discontinue the use of racecadotril and seek immediate medical attention if you notice any of the following symptoms:

• Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
• Difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and feeling faint—symptoms of a severe and sudden allergic reaction.

The following adverse effects have been reported:

Uncommon (may affect up to 1 in 100 people): tonsillitis (inflammation of the tonsils), rash, and erythema (redness of the skin).

Frequency not known (frequency cannot be estimated from the available data):
erythema multiforme (reddish lesions on the limbs and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, nodular erythema (inflammation appearing as lumps under the skin), papular rash (skin eruption with small, firm, raised lesions), prurigo (itchy skin lesions), and pruritus (generalized itching).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tiorfan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the sachet and on the carton after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tiorfan

The active substance is racecadotril. Each sachet contains 30 mg of racecadotril.

The other components are:

sucrose,

anhydrous colloidal silica,

30 percent polyacrylate dispersion,

apricot flavoring.

Presentation of Tiorfan and pack contents

Tiorfan is presented as granules for oral suspension in sachets.

Each pack contains 10, 16, 20, 30, 50 or 100 sachets (100 sachets only as hospital pack).

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

BIOPROJET-FERRER, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

FERRER INTERNACIONAL, S.A.

Joan Buscallà 1-9

08173 Sant Cugat del Vallès, Barcelona (Spain)

or

SOPHARTEX,

21 rue de Pressoir,

28500 Vernouillet (France)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

GERMANY: Tiorfan

PORTUGAL: Tiorfan

GREECE: Hidrasec

ITALY: Tiorfix

AUSTRIA: Hidrasec

BELGIUM: Tiorfast

CZECH REPUBLIC: Hidrasec

DENMARK: Hidrasec

ESTONIA: Hidrasec

FINLAND: Hidrasec

HUNGARY: Hidrasec

IRELAND: Hidrasec

LATVIA: Hidrasec

LITHUANIA: Hidrasec

LUXEMBOURG: Tiorfast

NETHERLANDS: Tiorfan

POLAND: Hidrasec

SLOVAK REPUBLIC: Hidrasec

SLOVENIA: Hidrasec

SWEDEN: Hidrasec

UNITED KINGDOM: Hidrasec

Date of the most recent review of this leaflet: 24-11-2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.