Tiorfan

Package Leaflet: Information for the Patient

Tiorfan, 100 mg, Hard Capsules

Racecadotril

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This medication should always be taken exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse.
• Keep this leaflet, as you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If you do not feel better or feel worse after a maximum of 7 days, contact your doctor.

Table of Contents of the Leaflet

• 1. What is Tiorfan and What is it Used For
• 2. Important Information Before Taking Tiorfan
• 3. How to Take Tiorfan
• 4. Possible Side Effects
• 5. How to Store Tiorfan
• 6. Other Information

1. What is Tiorfan and What is it Used For

Tiorfan is a medication used to treat diarrhea.
Tiorfan is used to treat the symptoms of acute diarrhea in adults when the diarrhea cannot be treated causally.
Racecadotril may be used as a supportive treatment when causal treatment is possible.

2. Important Information Before Taking Tiorfan

When Not to Take Tiorfan

• if you are allergic to racecadotril or any of the other ingredients of Tiorfan (listed in section 6)
• if you have ever experienced a severe skin rash or skin peeling, blisters, and (or) mouth ulcers after taking racecadotril.

Warnings and Precautions

Before taking Tiorfan, consult your doctor or pharmacist if:

• you have blood or pus in your stool and a fever. The cause may be a bacterial infection that should be treated by a doctor
• you have chronic diarrhea or diarrhea caused by taking antibiotics
• you have kidney or liver function disorders
• you have prolonged or uncontrolled vomiting
• you have lactose intolerance (see "Tiorfan contains lactose").

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 such side effects, stop the treatment and contact your doctor immediately. Angioedema can occur at any time during treatment with this medication.
Taking this medication and certain other medications may increase the risk of angioedema (see "Tiorfan and Other Medications").
Skin reactions have been reported in association with the use of this medication. In most cases, they are mild and do not require treatment. In some cases, severe skin reactions may occur.
In such cases, stop the treatment and do not take racecadotril again.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril. If you notice any symptoms of severe skin reactions described in section 4, stop taking racecadotril and seek medical attention immediately.

Tiorfan and Other Medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Particularly, inform your doctor if you are taking any of the following medications, as they may increase the risk of certain side effects (see "Warnings and Precautions"):

• angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril, lisinopril, 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
• certain immunosuppressive medications (e.g., sirolimus or everolimus)
• certain medications used to treat diabetes (e.g., sitagliptin or wildagliptin)
• estramustine used to treat cancer
• aleptase used to treat blood clots.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Tiorfan should not be used during pregnancy, suspected pregnancy, or breastfeeding.

Driving and Using Machines

Tiorfan has a minor or no influence on the ability to drive and use machines.

Tiorfan Contains Lactose

Tiorfan contains lactose (a type of sugar). If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking Tiorfan.
The medication does not contain gluten.

3. How to Take Tiorfan

Always take this medication exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Tiorfan is available 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 when starting treatment, you can take one capsule at any time of the day.
Your doctor will decide on the duration of treatment with Tiorfan. Treatment should be continued until two normal stools are passed and should not exceed 7 days.
To replace lost fluids due to diarrhea, this medication should be taken with an adequate amount of fluids and salts (electrolytes). The best way to replace fluids and electrolytes is to drink oral rehydration solutions (if you are unsure, consult your doctor or pharmacist).
No dose adjustment is necessary for elderly patients.

Use in Children

Other forms of the medication are available for children and infants.

Overdose of Tiorfan

If you take more than the recommended dose of Tiorfan, contact your doctor or pharmacist immediately.

Missed Dose of Tiorfan

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

4. Possible Side Effects

Like all medications, Tiorfan can cause side effects, although not everybody gets them.
Stop taking Tiorfan and contact your doctor immediately if you experience symptoms of angioedema, such as:

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

Stop taking racecadotril and seek medical attention immediately if you experience any of the following symptoms:

• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome);
• difficulty breathing, swelling, dizziness, rapid heartbeat, sweating, and feeling faint, which are symptoms of a severe allergic reaction.

The following side effects have been reported:
Common (occurring in less than 1 in 10 patients): headaches.
Uncommon (occurring in less than 1 in 100 patients): rash and erythema (redness of the skin).
Frequency not known (cannot be estimated from the available data):
erythema multiforme (pink patches on the skin, inside the mouth, and sometimes on the genitals), tongue, face, mouth, and eyelid swelling, hives, erythema nodosum (lumps under the skin), papular rash (small bumps on the skin), pruritus (itching), and toxic epidermal necrolysis.

Reporting Side Effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Tiorfan

Keep the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the blister pack and carton after: Expiration Date (EXP). The expiration date refers to the last day of the month.
No special precautions for storage are necessary.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Tiorfan Contains

The active substance of Tiorfan is racecadotril. Each capsule contains 100 mg of racecadotril.
Other ingredients are: lactose, corn starch, magnesium stearate, and anhydrous colloidal silica.
Cap shell: gelatin, yellow iron oxide (E172), titanium dioxide (E171).

What Tiorfan Looks Like and Contents of the Pack

Tiorfan is available in the form of hard, ivory-colored capsules.
Pack sizes: 6, 10, 20, 100, or 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Bioprojet Europe Ltd.
101 Furry Park Road
Killester
Dublin 5
Ireland

Manufacturer

Ferrer Internacional, S.A.
Gran Via Carlos III, 94
08028 Barcelona
Spain
Sophartex
21 rue du Pressoir
28500 Vernouillet
France
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Spain: Tiorfan
Austria: Hidrasec
Belgium: Tiorfix
Czech Republic: Hidrasec
Denmark: Hidrasec
Estonia: Hidrasec
Finland: Hidrasec
Germany: Tiorfan
Greece: Hidrasec
Hungary: Hidrasec
Ireland: Hidrasec
Italy: Tiorfix
Latvia: Hidrasec
Lithuania: Hidrasec
Luxembourg: Tiorfix
Netherlands: Hidrasec
Norway: Hidrasec
Poland: Tiorfan
Portugal: Tiorfan
Slovakia: Hidrasec
Slovenia: Hidrasec
Sweden: Hidrasec
United Kingdom: Hidrasec
Date of Last Revision of the Leaflet:11/2024