Patient Information Leaflet

Warning! Keep this leaflet, information on the outer packaging in a foreign language!
Tiorfan
100 mg, hard capsules
Racecadotril
Please read carefully the entire leaflet 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 for future reference.
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 after a maximum of 7 days, or if your condition worsens, contact your doctor.

Table of contents

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 indicated for the symptomatic treatment of acute diarrhoea in adults when aetiological treatment is not possible.
Racecadotril may be used as adjunctive treatment when aetiological treatment is feasible.

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 ulcers 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, which should be treated by a doctor
chronic diarrhoea or diarrhoea caused by antibiotic use occurs
the patient has impaired kidney or liver function
prolonged or uncontrolled vomiting occurs
the patient has lactose intolerance (see "Tiorfan contains monohydrate lactose").

Racecadotril, the active substance in Tiorfan, may cause an allergic reaction known as angioedema, which may lead to 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 notices any of the symptoms associated with serious skin reactions described in section 4, treatment with racecadotril must be discontinued immediately and medical advice sought without delay.

Tiorfan with other medicines
Inform the doctor about all medicines currently used, recently taken, or planned to be taken.
Especially inform the doctor if the patient is taking any of the following medicines, as they may increase the risk of certain adverse effects (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 have a child, she should consult her 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 monohydrate lactose
Tiorfan contains monohydrate lactose (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 this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tiorfan is available in the form of capsules.
The usual dose is one capsule three times a day, taken 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 be continued 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 Tiorfan than recommended
If you take more Tiorfan than recommended, 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. Take the next dose at the usual time.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets 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 stop using 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 (affects less than 1 in 10 patients): headache.
Uncommon (affects less than 1 in 100 patients): rash and erythema (redness of the skin).
Frequency unknown (cannot be estimated from available data):
erythema multiforme (pinkish skin lesions on limbs and inside the mouth), glossitis (inflammation of the tongue), facial inflammation, inflammation of lips and eyelids, urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin eruptions with small, firm, nodular lesions), prurigo (itchy skin lesions), pruritus (generalized itching), toxic skin eruption.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 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 stated month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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 corn 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 or 100 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

Manufacturer:
Sophartex
21 Rue du Pressoir
28500 Vernouillet
France
Ferrer International, S.A.
Cl Joan Buscalla, 1-9
08190 Sant Cugat del Vallès (Barcelona)
Spain

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in France, the country of export: 34009 334 967 7
334 967-7

Parallel Import Authorisation Number: 359/25

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