TIORFAN 100 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tiorfan 100 mg Hard Capsules

racecadotril

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Tiorfan and what is it used for

Tiorfan is a medicine for the treatment of diarrhea.

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

If causal treatment is possible, racecadotril may be administered as complementary treatment.

2. What you need to know before you take Tiorfan

Do not take Tiorfan

• If you are allergic to racecadotril or any of the other ingredients of Tiorfan (listed in section 6).
• If you have ever developed a severe skin rash, blistering, or peeling of the skin after taking racecadotril.

Warnings and precautions

Consult your doctor or pharmacist before taking Tiorfan if:

• there is blood or pus in your stools and if you have a fever. The cause of the diarrhea may be a bacterial infection that needs to be treated by your doctor.
• you suffer from 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 ingredients of Tiorfan").

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

Concomitant use of this product and 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 with Tiorfan 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 reported in association with treatment with racecadotril. Stop using racecadotril and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Using Tiorfan with other medicines

Please inform your doctor if you are using, have recently used, or might use any other medicines.

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

• ACE inhibitor (e.g., captopril, enalapril, lisinopril, perindopril, 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., sitagliptina or vildagliptina).
• Estramustine, used to treat cancer.
• Alteplase, used to treat blood clots.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Tiorfan has little or no effect on the ability to drive or use machines.

Tiorfan contains lactose

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

This medicine does not contain gluten.

3. How to take Tiorfan

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Tiorfan is presented in the form of hard capsules.

The usual dose is one capsule three times a day, which should be swallowed with a glass of water. Tiorfan should be taken preferably before main meals, but to start 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 maintained until two normal stools are produced, not exceeding 7 days.

To compensate for fluid loss due to diarrhea, this medicine should be used along 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 unsure).

No dose adjustment is required in the elderly.

Children

For use in children and infants, other forms of Tiorfan are 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 forgotten dose. Simply continue with the treatment.

4. Possible side effects

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

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

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

Stop using racecadotril and seek medical attention immediately if you notice any of the following symptoms:

• Widespread skin rash, high body temperature, and increased lymph nodes (DRESS syndrome)
• Breathing difficulties, 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:

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

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

Frequency not known (frequency cannot be estimated from the 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), pruritus (generalized itching), and toxic skin rash.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System (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 expiry date stated on the carton after EXP.

The expiry date is the last day of the month stated.

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 no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Tiorfan

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

The other ingredients are lactose, pregelatinized corn starch, magnesium stearate, and anhydrous colloidal silica. The capsule contains gelatin, yellow iron oxide (E 172), and titanium dioxide (E 171).

Appearance of Tiorfan and contents of the pack

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

Each pack contains 6, 10, 20, 100, or 500 hard capsules. The 100 and 500 capsule packs are for hospital use only.

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: Tiorfix

CZECH REPUBLIC: Hidrasec

DENMARK: Hidrasec

ESTONIA: Hidrasec

FINLAND: Hidrasec

HUNGARY: Hidrasec

IRELAND: Hidrasec

LATVIA: Hidrasec

LITHUANIA: Hidrasec

LUXEMBOURG: Tiorfix

NETHERLANDS: Hidrasec

POLAND: Tiorfan

SLOVAKIA: Hidrasec

SLOVENIA: Hidrasec

SWEDEN: Hidrasec

UNITED KINGDOM: Hidrasec

This leaflet was approved on 24-11-2024

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