Leaflet: information for the user

Tiorfan Lactantes 10 mg powder for oral suspension

racecadotrilo

Read this leaflet carefully before starting to take the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for your child and should not be given to other people even if they have the same symptoms as your child, as it may harm them.
• If your child experiences adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this leaflet. See section 4.

1. What Tiorfan is and for what it is used

2. What you need to know before starting to take Tiorfan

3. How to take Tiorfan

4. Possible adverse effects

5. Storage of Tiorfan

6. Contents of the pack and additional information

Tiorfan is a medication for the treatment of diarrhea.

Tiorfan is used in the treatment of the symptoms of acute diarrhea in children over 3 months old. It should be used along with an abundant intake of liquid and usual dietary measures, when these measures alone are insufficient to control the diarrhea, and when the causes of the diarrhea cannot be treated.

If possible, the causal treatment, racecadotrilo may be administered as a complementary treatment.

No use Tiorfan

-If your child is allergic to racecadotrilo or any of the other components of Tiorfan (listed in section 6).

-If your doctor has told you that your child has an intolerance to some sugars, ask your doctor before giving Tiorfan to your child.

- If your child has ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking racecadotrilo

Warnings and precautions

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

-Your child is less than 3 months,

-There is blood or pus in your child's stool and if they have a fever. The cause of your child's diarrhea may be a bacterial infection that must 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 a kidney disease or insufficient liver function,

-Your child has diabetes (see “Important information about some of the components of Tiorfan”).

The 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 adverse effects, stop the treatment immediately and contact your doctor. The swelling can appear at any time during treatment with this product.

The concomitant use of this product and some other medications may increase the risk of angioedema (see "Other medications and Tiorfan").

Severe 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), associated with racecadotrilo treatment have been reported. Suspend the use of racecadotrilo and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Use of Tiorfan with other medications

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

Especially inform your doctor if your child is using any of the following medications:

• ACE inhibitor (e.g., perindopril or ramipril) used to lower blood pressure or to treat heart failure.
• Sacubitril, used to treat heart failure.
• Some immunosuppressants (e.g., sirolimus or everolimus).
• Some antidiabetics (e.g., sitagliptin or vildagliptin).
• Estramustine, used to treat cancer.
• Alteplase, used to treat blood clots.

Pregnancy and lactation

Tiorfan is not recommended for use during pregnancy and lactation.

Consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Tiorfan contains saccharose

Tiorfan contains approximately 1 g of saccharose per sachet.

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

In babies with diabetes, if your doctor has prescribed more than 5 sachets of Tiorfan per day (which corresponds to more than 5 g of saccharose), it should be taken into account in the total daily sugar intake of the child.

Follow exactly the administration instructions for Tiorfan as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Tiorfan is presented in granulated form.

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 up to9 kg:one sachet per dose.

In children weighing9 to 13 kg:two sachets per dose.

Your doctor will indicate the duration of treatment with Tiorfan.The treatment must be continued until two normal bowel movements occur, not exceeding 7 days.

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

If you give your child 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 compensate for a missed dose.Simply continue with the treatment.

Like all medications, this medication may produce adverse effects, although not all people may experience 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
• Rashes and difficulty breathing

Suspend use of racecadotrilo and seek medical attention immediately if you notice any of the following symptoms:

• Generalized skin eruption, elevated body temperature, and increased lymph nodes (DRESS syndrome)
• Respiratory difficulty, swelling, dizziness, tachycardia, sweating, and sensation of loss of consciousness, symptoms of a severe and sudden allergic reaction.

The following adverse effects have been described:

Rare (may affect up to 1 in 100 people):

Tonsillitis (inflammation of the tonsils), eruption, and erythema (redness of the skin).

Unknown frequency (frequency cannot be estimated from available data):

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keepthis medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tiorfan

The active substance is racecadotrilo.Cada sobre contiene 10 mg of racecadotrilo.

The other components are:

sacarosa,

silica colloidal anhydrous,

polycarboxylate dispersion at 30 percent,

orange blossom aroma.

Appearance of Tiorfan and contents of the packaging

Tiorfan is presented in the formgranulated for oral suspension in blisters.

Cada envase contains 10, 16, 20, 30, 50 or 100 blisters (100 blisterssólo comoenvase clínico).

It may only be marketed some sizes of packaging.

Marketing Authorization Holder

BIOPROJET-FERRER, S.L.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

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 with 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

Last review date 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 Medical Devices (AEMPS) www.aemps.gob.es.