Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Tiorfan, 100 mg, hard capsules
Racecadotril
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor, pharmacist, or nurse.
Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement within a maximum of 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet

What Tiorfan is and what it is used for
Important information before taking Tiorfan
How to take Tiorfan
Possible side effects
How to store Tiorfan
Contents of the pack and other information

1. What Tiorfan is and what it is used for

Tiorfan is a medicine used in the treatment of diarrhoea.
Tiorfan is a medicine used to treat symptoms of acute diarrhoea in adults when the diarrhoea cannot be treated causally.
Racecadotril may be used as an adjunctive treatment when causal therapy is possible.

2. Important information before using Tiorfan

When not to use Tiorfan

if the patient is allergic to racecadotril or any of the other ingredients of Tiorfan (listed in section 6);
if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral mucosal ulceration after taking racecadotril.

Warnings and precautions
Before starting treatment with Tiorfan, consult a doctor or pharmacist if:

there is blood or pus in the stool and fever is present. This may be due to a bacterial infection requiring medical treatment;
the patient has chronic diarrhoea or diarrhoea caused by antibiotic use;
the patient has impaired kidney or liver function;
the patient has persistent or uncontrolled vomiting;
the patient has lactose intolerance (see "Tiorfan contains lactose monohydrate").

Racecadotril, the active substance in Tiorfan, may cause an allergic reaction called angioedema, which may result in swelling of the face, lips, throat or tongue. If such adverse reactions occur, treatment must be stopped immediately and medical advice sought. Angioedema may occur at any time during treatment with this medicine.
Concomitant use of this medicine with certain other medicines may increase the risk of angioedema (see "Tiorfan with other medicines").
Skin reactions have been reported with the use of this medicine. In most cases, they are mild and do not require treatment. However, in some cases, severe skin reactions may occur. In such cases, treatment must be stopped immediately and racecadotril must not be taken again.
Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril treatment. If the patient experiences any of the symptoms associated with serious skin reactions described in section 4, treatment with racecadotril must be stopped immediately and medical advice must be sought without delay.

Tiorfan with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for use.
In particular, inform the doctor if the patient is taking any of the following medicines, as they may increase the risk of certain adverse reactions (see "Warnings and precautions"):

angiotensin-converting enzyme (ACE) 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 in the treatment of high blood pressure and heart failure;
sacubitril used in the treatment of heart failure;
certain immunosuppressive medicines (e.g. sirolimus or everolimus);
certain medicines used to treat diabetes (e.g. sitagliptin or vildagliptin);
estramustine used in the treatment of cancer;
aleplase used to treat blood clots.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Tiorfan is not recommended during pregnancy, suspected pregnancy, or while breastfeeding.

Driving and using machines
Tiorfan has 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 certain sugars, the patient should consult a doctor before taking Tiorfan.
The medicine does not contain gluten.

3. How to use Tiorfan

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tiorfan is available in the form of hard capsules.
The usual dose is one capsule three times a day, to be swallowed with a glass of water.
Tiorfan should preferably be taken before main meals; however, when starting treatment, one capsule may be taken at any time of day.
Your doctor will decide on the duration of treatment with Tiorfan. Treatment should continue until two normal stools have been passed and should not last longer than 7 days.
To replenish fluids lost due to diarrhoea, this medicine should be used together with an adequate amount of fluids and salts (electrolytes). The best way to replenish fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult your doctor or pharmacist).
There is no need to adjust the dose in elderly patients.
Use in children
Other dosage forms of the medicine are available for children and infants.
Taking more than the recommended dose of Tiorfan
If you take more than the recommended dose of Tiorfan, contact your doctor or pharmacist immediately.
Missing a 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Tiorfan and contact your doctor immediately if any symptoms of angioedema occur, such as:

swelling of the face, tongue or throat;
difficulty swallowing;
hives and breathing difficulties.

You should discontinue the use of racecadotril and seek immediate medical help if any of the following symptoms occur:

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

The following adverse reactions have been reported:
Common (occurring in less than 1 in 10 patients): headache.
Uncommon (occurring in less than 1 in 100 patients): rash and erythema (redness of the skin).
Frequency unknown (cannot be estimated from available data):
erythema multiforme (pink skin lesions on limbs and inside the mouth), inflammation of the tongue, face, lips and eyelids, urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin eruptions with small, firm, nodular lesions), eczematous dermatitis (itchy skin lesions), pruritus (generalized itching), toxic skin eruption.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Tiorfan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must 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 package and other information

What Tiorfan contains
The active substance is racecadotril. Each capsule contains 100 mg of racecadotril.
Other components of the medicine are: monohydrate lactose, pregelatinized maize starch,
magnesium stearate, anhydrous colloidal silicon dioxide.
Capsule shell: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171).

What Tiorfan looks like and contents of the pack
Tiorfan is available as hard ivory-coloured capsules.
Pack sizes: 10, 20, 100 or 500 capsules.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in France, the country of export:
Bioprojet Pharma
9 rue Rameau
75002 Paris, France

Manufacturers:
Laboratoires Sophartex
21 rue du Pressoir
28500 Vernouillet, France
Ferrer International, S.A.
CL Joan Buscalla, 1-9
08190 Sant Cugat del Valles (Barcelona)
Spain

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in France, the country of export: 34009 334 967 7 7
Parallel import authorisation number: 371/25

This medicine is authorised for sale in the European Economic Area countries 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