Tiorfan

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Tiorfan, 100 mg, Hard Capsules

Racecadotril

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by the Doctor, Pharmacist, or Nurse.
• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or More Information, Ask your Pharmacist.
• If you Experience any Side Effects, including those not Listed in the Leaflet, Tell your Doctor, Pharmacist, or Nurse. See Section 4.
• If there is no Improvement or you Feel Worse after a Maximum of 7 Days, Contact your Doctor.

Table of Contents of the Leaflet

• 1. What is Tiorfan and what is it Used for
• 2. Important Information Before Taking Tiorfan
• 3. How to Take Tiorfan
• 4. Possible Side Effects
• 5. How to Store Tiorfan
• 6. Other Information

1. What is Tiorfan and what is it Used for

Tiorfan is a Medication Used to Treat Diarrhea.
Tiorfan is Used to Treat 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.

2. Important Information Before Taking Tiorfan

When not to Take Tiorfan

• If you are Allergic to Racecadotril or any of the other Ingredients of Tiorfan (Listed in Section 6).

Warnings and Precautions

Before Taking Tiorfan, Consult your Doctor or Pharmacist if:

• There is Blood or Pus in the Stool and Fever. The Cause may be a Bacterial Infection that Should be Treated by a Doctor;
• There is Chronic Diarrhea or Diarrhea Caused by Taking Antibiotics;
• There are Kidney or Liver Function Disorders;
• There are Prolonged or Uncontrolled Vomiting;
• There is Lactose Intolerance (See "Tiorfan Contains Lactose Monohydrate"). Skin Reactions have been Reported During Treatment with Tiorfan. In most Cases, these were Mild Reactions. If Severe Skin Reactions Occur, Treatment Should be Stopped Immediately.

Tiorfan and other Medications

Tell your Doctor about all Medications you are Currently Taking or have Recently Taken, as well as any Medications you Plan to Take.
Especially Tell your Doctor if you are Taking any of the Following Medications:

• Angiotensin-Converting Enzyme Inhibitors (e.g., Captopril, Enalapril, Lisinopril, Perindopril, Ramipril) Used to Lower Blood Pressure or Facilitate Heart Function.

Pregnancy and Breastfeeding

Tiorfan Should not be Taken During Pregnancy, Suspected Pregnancy, and Breastfeeding.
Before Taking this Medication, Consult your Doctor or Pharmacist.

Driving and Operating Machines

Tiorfan has a Minor or no Influence on the Ability to Drive and Operate Machines.

Tiorfan Contains Lactose Monohydrate

Tiorfan Contains Lactose Monohydrate (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.

3. How to Take Tiorfan

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by the Doctor or Pharmacist. If you are Unsure, Consult your Doctor or Pharmacist.
Tiorfan is 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, one Capsule can be Taken 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 Last Longer than 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 so-called Oral Rehydration Solutions (in Case of Doubt, Consult your Doctor or Pharmacist).
No Dose Adjustment is Needed in Elderly Patients.

Use in Children

Other Forms of the Medication are Available for Children and Infants.

Overdose of Tiorfan

If you have Taken more than the Recommended Dose of Tiorfan, Contact your Doctor or Pharmacist Immediately.

Missed 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 Side Effects

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:

• Swelling of the Face, Tongue, or Throat;
• Difficulty Swallowing;
• Hives and Difficulty Breathing.

The Following Side Effects have been Reported:
Common (Occur in Less than 1 in 10 Patients): Headache.
Uncommon (Occur in Less than 1 in 100 Patients): Rash and Redness (Redness of the Skin).
Frequency not Known (Cannot be Estimated from the Available Data):
ERYthema Multiforme (Pink Spots on the Skin and Inside the Mouth), Tongue Swelling, Face Swelling, Lip Swelling, Eyelid Swelling, Hives, Redness, Erythema Nodosum (Subcutaneous Inflammatory Conditions in the Form of Nodules), Papular Rash (Rash on the Skin with Small, Hard, and Nodular Lesions), Pruritus (Itching Skin), Itching (Generalized Itching), Toxic Epidermal Necrolysis.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in the Leaflet, Tell your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl.
Reporting Side Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Tiorfan

Keep the Medication out of Sight and Reach of Children.
Do not Use this Medication after the Expiration Date Stated on the Packaging. The Expiration Date refers to the Last Day of the Specified Month.
There are no Special Storage Precautions.
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.

6. Contents of the Packaging and other Information

What Tiorfan Contains

The Active Substance of Tiorfan is Racecadotril. Each Capsule Contains 100 mg of Racecadotril.
Other Ingredients are: Lactose Monohydrate, Maize Starch, Magnesium Stearate, Colloidal Silica.
Capsule Shell: Gelatin, Yellow Iron Oxide (E 172), Titanium Dioxide (E 171).

What Tiorfan Looks like and Contents of the Packaging

Tiorfan is Available in the Form of Hard Capsules, Ivory-colored.
Packaging of 10, 20, 100, or 500 Capsules.
For more Detailed Information, Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in Portugal, the 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization Number in Portugal, the Country of Export:5756689
5756788

Parallel Import Authorization Number: 283/23

This Medication is Authorized for Marketing in the Member States of the European Economic Area

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

Date of Approval of the Leaflet: 30.11.2023

[Information about the Registered Trademark]