TIORFAN NIÑOS 30 mg ORAL SUSPENSION GRANULES

2. What you need to know before taking Tiorfan

Do not use Tiorfan

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

Warnings and precautions

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

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

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

The concomitant use of this product and some 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. In some cases, severe skin reactions may occur. In these cases, treatment should 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 treatment with racecadotril. 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.

Using Tiorfan with other medicines

Tell your doctor if your child is using, has recently used, or may need to use any other medicine.

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

• ACE inhibitor (e.g., perindopril or ramipril) used to lower blood pressure or treat heart failure.
• Angiotensin II receptor 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 antidiabetics (e.g., sitagliptin or vildagliptina).
• Estramustine, used to treat cancer.
• Alteplase, used to treat blood clots.

Pregnancy and breastfeeding

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

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 intolerance to some sugars, ask your doctor before giving Tiorfan to your child.

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

3. How to take Tiorfan

Follow the instructions for administering Tiorfan indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Tiorfan is presented in the form of granules.

The granules can be added to food or mixed in a glass of water or in the baby 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 a day at regular intervals.

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

In children weighing over 27 kg: approximately two sachets per dose.

Your doctor will indicate the duration of treatment with Tiorfan. Treatment should be continued until two normal stools are produced, without exceeding 7 days.

To compensate for the loss of fluid due to your child's diarrhea, this medicine should be used in conjunction with adequate fluid and electrolyte replacement. The best replacement of fluids and salts is achieved with an oral rehydration solution (please ask your doctor or pharmacist if you are not sure).

If you give more Tiorfan than you should

If your child has taken more Tiorfan than they should, 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 forgotten dose. Simply continue with the treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Stop administering 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 of loss of consciousness, symptoms of a severe and sudden allergic reaction.

The following side 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 available data):

erythema multiforme (red lesions on the extremities and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (inflammation in the form of lumps under the skin), papular rash (rash on the skin with small, hard, and raised lesions), prurigo (lesions on the skin with itching), and pruritus (generalized itching).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website (www.notificaram.es). By reporting side 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 expiration date stated on the sachet and carton after EXP. The expiration 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 the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Tiorfan

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

The other ingredients are:

sucrose,

colloidal anhydrous silica,

30% polyacrylate dispersion,

apricot flavor.

Appearance of Tiorfan and package contents

Tiorfan is presented in the form of granules for oral suspension in sachets.

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

Not all pack sizes may be marketed.

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 medicine 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

SLOVAKIA: Hidrasec

SLOVENIA: Hidrasec

SWEDEN: Hidrasec

UNITED KINGDOM: Hidrasec

Date of the last revision of this leaflet 24-11-2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.