Package Insert: Information for the User

Tiorfan 100 mg Hard Capsules

racecadotrilo

Read this package insert carefully before starting to take the medicine.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. 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 side effects

5. Storage of Tiorfan

6. Contents of the pack and additional informationl

Tiorfan is a medication for the treatment of diarrhea.

Tiorfan is used in the treatment of the symptoms of acute diarrhea in adults, when the causes of diarrhea cannot be treated.

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

Do not take Tiorfan

• If you are allergic to racecadotrilo or any of the other components of Tiorfan (listed in section 6).
• If you have 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 to take Tiorfan if:

-there is blood or pus in your stools and you have a fever. The cause of the diarrhea may be a bacterial infection that must be treated by your doctor,

-you have chronic diarrhea or diarrhea caused by antibiotics,

-you have kidney disease or insufficient liver function,

-you have prolonged or uncontrolled vomiting,

-you have lactose intolerance(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 you experience these adverse 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 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 with Hidrasec should be stopped immediately and the patient should not take it again.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been associated with racecadotrilo treatment. Discontinue 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

Please inform your doctor if you are using, have used recently, or may need to use any other medication.

Especially inform your doctor if you take any of the following medications, as they may increase the risk of side effects (see “Warnings and precautions”):

• ACE inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or treat heart failure.
• Angiotensin II antagonists (e.g., candesartán or irbesartán) 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., sitagliptina or vildagliptina).
• Estramustina, used to treat cancer.
• Altepasa, used to treat blood clots.

Pregnancy and breastfeeding

Tiorfan is not recommended for use if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Tiorfan contains lactose

Tiorfan contains lactose (a type of sugar). If your doctor has told you that you have intolerance to some sugars, ask your doctor before taking Tiorfan.

This medication does not contain gluten.

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

The usual dose is one capsule taken three times a day, which should be swallowed with a glass of water.

Tiorfan is presented in the form of capsules.

The usual dose is one capsule taken three times a day, which should be swallowed with a glass of water. Tiorfan should be taken preferably before the main meals, but to start your treatment, you can take a Tiorfan capsule at any time of the day.

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

To compensate for the loss of fluid due to your diarrhea, this medication should be used together with an adequate replacement of fluids and salts (electrolytes). The best replacement of fluids and salts is achieved with an oral rehydration solution (please ask your doctor or pharmacist if you are unsure).

No dose adjustment is required for the elderly.

Children

For use in children and babies, there are other forms of Tiorfan available.

If you take more Tiorfan than you should

If you take more Tiorfan than you should, please contact your doctor or pharmacist immediately.

If you forget to take Tiorfan

Do not take a double dose to make up for a missed dose. Simply continue with the treatment.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Stop taking Tiorfan and immediately contact a doctor if you experience symptoms of angioedema, such as:

• Swelling of the face, tongue, or pharynx
• Difficulty swallowing
• Rashes and difficulty breathing

Suspend the use of racecadotrilo and seek immediate medical attention 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:

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

Less frequent (may affect up to 1 in 100 people): rash and erythema (skin redness).

Unknown frequency (frequency cannot be estimated from available data): erythema multiforme (red lesions on extremities and interior of the mouth), tongue swelling, facial 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), pruritus (generalized itching), and toxic skin eruption.

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 not listed 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.

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

Do not use this medication after the expiration date that appears 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 trash. Ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tiorfan

The active substance is racecadotrilo. Each capsule contains 100 mg of racecadotrilo.

The other components are lactose, pregelatinized cornstarch, magnesium stearate, and anhydrous colloidal silica. The capsule contains gelatin, yellow iron oxide (E 172) and titanium dioxide (E171).

Appearance of Tiorfan and contents of the packaging

Tiorfan is presented in the form of hard, ivory-colored capsules.

Each package contains 6, 10, 20, 100, or 500 hard capsules. The formats of 100 or 500 are clinical packages.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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: Tiorfix

CZECH REPUBLIC: C Hidrasec

DENMARK: Hidrasec

ESTONIA: Hidrasec

FINLAND: Hidrasec

HUNGARY: Hidrasec

IRELAND: H idrasec

LATVIA: Hidrasec

LITHUANIA: Hidrasec

LUXEMBOURG: Tiorfix

NETHERLANDS: Hidrasec

POLAND: Tiorfan

SLOVAK REPUBLIC: Hidrasec

SLOVENIA: Hidrasec

SWEDEN: Hidrasec

UNITED KINGDOM: Hidrasec

This leaflet was approved on 24-11-2024

The 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.