Tiorfan

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tiorfan, 100 mg, hard capsules

Racecadotril

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.
• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after a maximum of 7 days or the patient feels worse, they should contact their 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 medicine used to treat diarrhea.
Tiorfan is a medicine used to treat symptoms of acute diarrhea in adults, if the diarrhea
cannot be treated causally.
Racecadotril may be used as adjunctive treatment when causal treatment is possible.

2. Important information before taking Tiorfan

When not to take Tiorfan

• if the patient is allergic to racecadotril or any of the other ingredients of Tiorfan (listed in section 6).

Warnings and precautions

Before taking Tiorfan, the patient should consult a doctor or pharmacist if:

• there is blood or pus in the stool and fever. The cause may be a bacterial infection that should be treated by a doctor
• there is chronic diarrhea or diarrhea caused by taking antibiotics
• there are kidney or liver function disorders
• there are prolonged or uncontrolled vomiting
• there is lactose intolerance (see "Tiorfan contains lactose monohydrate"). Skin reactions have been reported during treatment with Tiorfan. In most cases, they were mild. If severe skin reactions occur, treatment should be stopped immediately.

Tiorfan and other medicines

The patient should tell their doctor about all medicines they are currently taking or
have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor if they are taking any of the following
medicines:
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• angiotensin-converting enzyme inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or facilitate heart function.

Pregnancy and breastfeeding

Tiorfan should not be taken during pregnancy, suspected pregnancy, or breastfeeding.
Before taking this medicine, the patient should consult a doctor or pharmacist.

Driving and using machines

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

Tiorfan contains lactose monohydrate

Tiorfan contains lactose monohydrate (a type of sugar). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Tiorfan.
The medicine does not contain gluten.

3. How to take Tiorfan

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.
Tiorfan is 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, one capsule can be taken at any time of the day.
The doctor will decide on the duration of treatment with Tiorfan. Treatment should be continued until two normal stools have been passed and should not last longer than 7 days.
To replenish lost fluids due to diarrhea, this medicine should be taken simultaneously with an adequate amount of fluids and salts (electrolytes). The best way to replenish fluids and electrolytes is to drink so-called oral rehydration solutions (in case of doubt, the patient should consult a doctor or pharmacist).
There is no need to adjust the dose in elderly patients.

Use in children

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

Overdose of Tiorfan

In case of taking a higher dose of Tiorfan than recommended, the patient should immediately contact their doctor or pharmacist.

Missed dose of Tiorfan

The patient should not take a double dose to make up for a missed dose. The next dose should be taken at the usual time.

4. Possible side effects

Like all medicines, Tiorfan can cause side effects, although not everybody gets them.
The patient should stop taking Tiorfan and immediately contact their doctor if they experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing. Page 2 4

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 in the eyes), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (lumps under the skin), papular rash (small, raised patches on the skin), pruritus (itching skin), and toxic epidermal necrolysis (a severe skin condition).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tiorfan

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tiorfan contains

The active substance of Tiorfan is racecadotril. Each capsule contains 100 mg of racecadotril.
Other ingredients of the medicine are: lactose monohydrate, corn starch, magnesium stearate, and colloidal silica.
Capsole shell: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171).

What Tiorfan looks like and contents of the pack

Tiorfan is available in the form of hard capsules, ivory-colored.
Packaging of 10, 20, 100, or 500 capsules.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Portugal, the country of export:

Ferrer Internacional, S.A., Gran Via Carlos III, 94, 08028 – Barcelona, Spain

Manufacturer:

Ferrer Internacional, S.A., Gran Via Carlos III, 94, 08028 – Barcelona, Spain
Sophartex, 21 rue du Pressoir, 28500 Vernouillet, France

Parallel importer:

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Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Portugal, the country of export: 5756689

Parallel import authorization number: 268/24

This medicine is authorized for marketing 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

Date of approval of the leaflet: 04.07.2024

[Information about the trademark]
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