


Ask a doctor about a prescription for Tiorfan
Racecadotril
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.
Before taking Tiorfan, consult your doctor or pharmacist if:
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.
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"):
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.
Tiorfan has a minor or no influence on the ability to drive and use machines.
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.
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.
Other forms of the medication are available for children and infants.
If you take more than the recommended dose of Tiorfan, contact your doctor or pharmacist immediately.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
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:
Stop taking racecadotril and seek medical attention immediately if you experience any of the following symptoms:
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.
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.
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.
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).
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.
Bioprojet Europe Ltd.
101 Furry Park Road
Killester
Dublin 5
Ireland
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
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
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for Tiorfan – subject to medical assessment and local rules.