Tiorfan

Patient Information Leaflet

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

• Always take this medicine exactly as described in this patient leaflet or as your doctor, pharmacist, or nurse has advised.
• 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

1. What Tiorfan is and what it is used for
2. What you need to know before taking Tiorfan
3. How to take Tiorfan
4. Possible side effects
5. How to store Tiorfan
6. 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 causal treatment is not possible.
Racecadotril may be used as adjunctive therapy when causal treatment is feasible.

2. 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).

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 indicate a bacterial infection requiring medical treatment.
• chronic diarrhoea or diarrhoea associated with antibiotic use occurs.
• kidney or liver function disorders are present.
• prolonged or uncontrolled vomiting occurs.
• lactose intolerance is present (see "Tiorfan contains monohydrate lactose"). Skin reactions have been reported during treatment with this medicine. In most cases, these reactions were mild. If severe skin reactions occur, treatment must be stopped immediately.

Tiorfan with other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
In particular, inform the doctor if the patient is taking any of the following medicines:

• angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood pressure or to help heart function.

Pregnancy and breast-feeding
Tiorfan is not recommended during pregnancy, suspected pregnancy, or breast-feeding.
Before using this medicine, consult a doctor or pharmacist.

Driving and operating machinery
Tiorfan has minor or no influence on the ability to drive or operate machinery.

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 the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Tiorfan is available in the form of capsules.
The usual dose is one capsule three times daily, 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 be continued until two normal bowel movements have occurred 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 replace fluids and electrolytes is by drinking oral rehydration solutions (in case of doubt, consult a doctor or pharmacist).
There is no need to adjust the dose in elderly patients.
Use in children
Other formulations of this 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.
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 symptoms of angioedema occur, such as:

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

The following adverse reactions have been reported:
Common (occur in fewer than 1 in 10 patients): headache.
Uncommon (occur in fewer than 1 in 100 patients): rash and erythema (redness of the skin).
Frequency not known (cannot be estimated from available data):
erythema multiforme (pink skin lesions on limbs and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, nodular erythema (subcutaneous inflammatory nodules), papular rash (skin lesions with small, firm, nodular changes), 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 be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
By reporting adverse reactions, more information on the safety of this medicine can be collected.

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 instructions apply.
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 packaging and other information

What Tiorfan contains
The active substance in Tiorfan is racecadotril. Each capsule contains 100 mg of racecadotril.
Other ingredients of the medicine are: monohydrate lactose, 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 packaging
Tiorfan is available as hard ivory-coloured capsules.
Pack sizes: 10, 20, 100 or 500 capsules.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

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

Marketing Authorisation Number in Portugal, country of export: 5756689
Parallel Import Licence Number: 268/24

This medicinal product is authorised in the European Economic Area countries under the following trade 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

Page 4 of 4