Tiorfan 100 mg hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tiorfan 100 mg hard capsules
racecadotril
Read the entire leaflet carefully before you start taking this medicine.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Tiorfan is and what it is used for
- What you need to know 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 medication used for the treatment of diarrhoea.
Tiorfan is used to treat the symptoms of acute diarrhoea in adults when the underlying causes of the diarrhoea cannot be treated.
If causal treatment is possible, racecadotril may be administered as an adjunctive treatment.
2. What you need to know before taking Tiorfan
Do not take Tiorfan
- If you are allergic to racecadotril or to any of the other ingredients of Tiorfan (listed in section 6).
- If you have ever developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking racecadotril.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tiorfan if:
- There is blood or pus in your stools and if you have a fever. The cause of diarrhea may be a bacterial infection that needs to be treated by your doctor.
- You suffer from chronic diarrhea or diarrhea caused by antibiotics.
- You have kidney disease or impaired liver function.
- You have prolonged or uncontrolled vomiting.
- You have lactose intolerance (see "Important information about some of the components of Tiorfan").
Racecadotril, the active substance in Tiorfan, may cause an allergic reaction called angioedema, which can result in swelling of the face, lips, throat, or tongue. If you experience these adverse effects, stop treatment immediately and contact your doctor. Swelling may occur at any time during treatment with this product.
Concomitant use of this product with other medicines may increase the risk of angioedema (see "Other medicines and Tiorfan").
Skin reactions have been reported with the use of this product. In most cases, they are mild and do not require treatment. In some cases, severe skin reactions may occur. In such cases, treatment with Hidrasec must be stopped immediately and the patient should not take it again.
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with racecadotril treatment. Discontinue the use of racecadotril and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.
Taking Tiorfan with other medicines
Please inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Especially inform your doctor if you are taking any of the following medicines, as they may increase the risk of side effects (see "Warnings and precautions"):
- ACE inhibitors (e.g., captopril, enalapril, lisinopril, perindopril, ramipril), used to lower blood pressure or to treat heart failure.
- Angiotensin II antagonists (e.g., candesartan or irbesartan), used to treat high blood pressure and heart failure.
- Sacubitril, used to treat heart failure.
- Some immunosuppressants (e.g., sirolimus or everolimus).
- Some antidiabetic agents (e.g., sitagliptin or vildagliptin).
- Estramustine, used for cancer treatment.
- Alteplase, used for the treatment of blood clots.
Pregnancy and breastfeeding
The use of Tiorfan is not recommended if you are pregnant or think you may be pregnant, or if you are breastfeeding.
Consult your doctor or pharmacist before using any medicine.
Driving and using machines
Tiorfan has little or no effect on the ability to drive or operate machinery.
Tiorfan contains lactose
Tiorfan contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking Tiorfan.
This medicine does not contain gluten.
3. How to take Tiorfan
Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The usual dose is one capsule three times a day, which should be swallowed with a glass of water.
Tiorfan is available in capsule form.
The usual dose is one capsule three times a day, which should be swallowed with a glass of water. Tiorfan should preferably be taken before main meals; however, when starting treatment, you may take one Tiorfan capsule at any time of day.
Your doctor will determine the duration of treatment with Tiorfan. Treatment should continue until two normal bowel movements occur, without exceeding 7 days.
To compensate for fluid loss due to diarrhea, this medicine should be used together with adequate fluid and salt (electrolyte) replacement. The best fluid and salt replacement is achieved with an oral rehydration solution (please ask your doctor or pharmacist if you are unsure).
Dose adjustment is not required in elderly patients.
Children
Other formulations of Tiorfan are available for use in children and infants.
If you take more Tiorfan than you should
If you take more Tiorfan than you should, please 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. Simply continue your treatment as prescribed.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Stop taking Tiorfan and contact a doctor immediately if you experience symptoms of angioedema, such as:
- swelling of the face, tongue, or pharynx
- difficulty swallowing
- hives and difficulty breathing
Discontinue the use of racecadotril and seek immediate medical attention if you notice any of the following symptoms:
- Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
- Breathing difficulty, swelling, dizziness, tachycardia, sweating, and feeling faint—symptoms of a severe and sudden allergic reaction.
The following adverse effects have been reported:
Frequent (may affect up to 1 in 10 people): headache.
Uncommon (may affect up to 1 in 100 people): rash and erythema (redness of the skin).
Frequency not known (frequency cannot be estimated from the available data): erythema multiforme (reddish lesions on limbs and inside the mouth), tongue swelling, facial swelling, lip swelling, eyelid swelling, urticaria, erythema nodosum (inflammation appearing as lumps under the skin), papular rash (skin eruption with small, firm, raised lesions), prurigo (itchy skin lesions), pruritus (generalized itching), and toxic skin eruption.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tiorfan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tiorfan
The active substance is racecadotril. Each capsule contains 100 mg of racecadotril.
The other components are lactose, pregelatinized corn starch, magnesium stearate and anhydrous colloidal silica. The capsule shell contains gelatin, yellow iron oxide (E 172) and titanium dioxide (E171).
Appearance of Tiorfan and contents of the pack
Tiorfan is available as ivory-colored hard capsules.
Each pack contains 6, 10, 20, 100 or 500 hard capsules. The 100- and 500-capsule packs are hospital packs.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
BIOPROJET-FERRER, S.L.
Gran Vía Carlos III, 94
08028 Barcelona (Spain)
Manufacturer
FERRER INTERNACIONAL, S.A.
Joan Buscallà 1-9
08173 Sant Cugat del Vallès, Barcelona (Spain)
or
SOPHARTEX,
21 rue de Pressoir,
28500 Vernouillet (France)
This medicinal product is authorized in the European Economic Area member states under the following names:
GERMANY: Tiorfan
PORTUGAL: Tiorfan
GREECE: Hidrasec
ITALY: Tiorfix
AUSTRIA: Hidrasec
BELGIUM: Tiorfix
CZECH REPUBLIC: C Hidrasec
DENMARK: Hidrasec
ESTONIA: Hidrasec
FINLAND: Hidrasec
HUNGARY: Hidrasec
IRELAND: Hidrasec
LATVIA: Hidrasec
LITHUANIA: Hidrasec
LUXEMBOURG: Tiorfix
NETHERLANDS: Hidrasec
POLAND: Tiorfan
SLOVAK REPUBLIC: Hidrasec
SLOVENIA: Hidrasec
SWEDEN: Hidrasec
UNITED KINGDOM: Hidrasec
This leaflet was last approved on 24-11-2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es.