Tiorfanor

Package leaflet: Information for the user

Tiorfanor 175 mg film-coated tablets

Racecadotril
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Tiorfanor 175 mg film-coated tablets are and what they are used for
2. What you need to know before taking Tiorfanor 175 mg film-coated tablets
3. How to take Tiorfanor 175 mg film-coated tablets
4. Possible side effects
5. How to store Tiorfanor 175 mg film-coated tablets
6. Contents of the pack and other information

1. What Tiorfanor 175 mg film-coated tablets is and what it is used for

Tiorfanor 175 mg film-coated tablets is a medicinal product for the treatment of diarrhoea.
This medicine is indicated for the symptomatic treatment of acute diarrhoea in adults when causal
treatment is not possible.
Racecadotril may be administered as a complementary treatment when causal treatment is possible.

2. What you need to know before taking Tiorfanor 175 mg film-coated tablets

If your doctor has told you that you are intolerant to certain sugars, contact them before taking Tiorfanor 175 mg film-coated tablets.
Do not take Tiorfanor 175 mg film-coated tablets:

• If you are allergic to racecadotril (the active substance) or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously experienced a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking racecadotril.

Warnings and precautions
Diarrhoea leads to loss of fluids and electrolytes. To compensate for fluid loss due to diarrhoea, this medicine must be used together with adequate fluid and salt (electrolyte) replacement. The best way to replace fluids and salts is with an oral rehydration solution (if in doubt, consult your doctor or pharmacist).
Contact your doctor or pharmacist before taking Tiorfanor 175 mg film-coated tablets if:

• You notice blood or pus in your stools and have a fever. The cause of diarrhoea may be a bacterial infection that needs to be treated by a doctor.
• You suffer from chronic diarrhoea or diarrhoea caused by antibiotics.
• You have kidney disease or impaired liver function.
• You have prolonged or uncontrolled vomiting.

Tiorfanor 175 mg film-coated tablets contain 139.6 mg (0.4 mmol) of anhydrous lactose.
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.
Hypersensitivity/angioedema (swelling) has been reported in patients taking racecadotril (the active substance in this product). Angioedema may occur in the face, extremities, lips, and mucous membranes, or swelling of the upper airways, such as the tongue, glottis and/or larynx (throat). This may occur at any time during treatment. If these adverse events occur, stop treatment immediately and contact your doctor.
Patients with a history of angioedema (swelling) unrelated to racecadotril therapy may have an increased risk of angioedema.
Concomitant use of this medicine with other medicines may increase the risk of angioedema (see section “Other medicines and Tiorfanor 175 mg film-coated tablets”).
Skin reactions have been reported following the use of this product. In most cases, they are mild to moderate in severity. If severe skin reactions occur, treatment must be stopped immediately. Racecadotril must not be taken again.
Particular caution is advised when using racecadotril:
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with racecadotril treatment. Discontinue use of racecadotril and seek immediate medical attention if you experience any of the symptoms related to these severe skin reactions described in section 4.
Children and adolescents
Tiorfanor 175 mg film-coated tablets must not be used in children and adolescents. More appropriate formulations of racecadotril, such as granules in sachets, indicated for this population, should be used instead.
Other medicines and Tiorfanor 175 mg film-coated tablets
Tell your doctor if you are taking, have recently taken, or might take any other medicines, especially the following:

• ACE inhibitors (e.g. perindopril or ramipril), used to lower blood pressure or to help the heart work more easily.
• Angiotensin II receptor antagonists (e.g. candesartan or irbesartan), used to treat high blood pressure and heart failure.

Tiorfanor 175 mg film-coated tablets with food, drinks and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
Ask your doctor for advice before taking this medicine.
Given the available data, this medicine is not recommended during pregnancy or while breast-feeding.
Driving and using machines
Tiorfanor does not affect or affects negligibly the ability to drive and use machines.
Tiorfanor 175 mg film-coated tablets contain lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine does not contain gluten.

3. How to take Tiorfanor 175 mg film-coated tablets

Tiorfanor is available as film-coated tablets.
For adults only.

Dosage
Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

First day: Take one tablet immediately at any time of the day. Then, depending on the time of the first dose, take up to a maximum of 2 tablets in total during the day, including the first tablet taken.
Administration should preferably occur before meals.

Following days: Take one tablet in the morning and one tablet in the evening, i.e. 2 tablets per day, preferably before meals.

Your doctor will advise you on how long to continue treatment. Treatment should be continued until two normal bowel movements have occurred, but not for longer than 7 days.

To compensate for fluid loss due to diarrhoea, this medicine should be used together with adequate fluid and salt (electrolyte) replacement. The best fluid and electrolyte replacement is achieved with an oral rehydration solution (if you have any doubts, consult your doctor or pharmacist).

No dose adjustment is necessary in elderly patients.

Method of administration
Oral use. Swallow the tablet with a glass of water.

If you take more Tiorfanor 175 mg film-coated tablets than you should
Contact your doctor or pharmacist immediately.

If you forget to take Tiorfanor 175 mg film-coated tablets
Do not take a double dose to make up for the missed dose. Continue with the next scheduled dose.

If you stop taking Tiorfanor 175 mg film-coated tablets
Not applicable.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediately stop taking Tiorfanor 175 mg film-coated tablets and contact your doctor immediately if you experience symptoms of angioedema, such as:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• urticaria and breathing difficulties

Stop using racecadotril and seek immediate medical attention if you notice any of the following symptoms:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
• Breathing difficulties, swelling, dizziness, rapid heartbeat, sweating, and feeling faint, which are symptoms of a sudden and severe allergic reaction.

The following side effects have been reported:
Common (may affect up to 1 in 10 people): headache.
Uncommon ( may affect up to 1 in 100 people ): skin rash and erythema (redness of the skin).
Frequency not known :( frequency cannot be estimated from the available data) :
erythema multiforme (pinkish lesions on extremities and inside the mouth), inflammation of the tongue, inflammation of the lips, inflammation of the eyelids, facial swelling, angioedema (subcutaneous inflammation in various parts of the body), urticaria, erythema nodosum (inflammatory nodules under the skin), papular skin rash (skin eruption with small, firm, nodular lesions), prurigo (itchy skin lesions), pruritus (general itching sensation), toxic skin eruption.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tiorfanor 175 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tiorfanor 175 mg film-coated tablets contain
The active substance is racecadotril. Each tablet contains 175 mg of racecadotril.
The other components are: monohydrate lactose, caramel calcium, hydroxypropylcellulose, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate.
Coating: Opadray white (polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc).

Description of the appearance of Tiorfanor 175 mg film-coated tablets and pack contents
Tiorfanor 175 mg film-coated tablets are film-coated tablets.
The pack contains 3, 6 or 12 tablets (2 blisters of 6 tablets).
Not all pack sizes may be marketed.

Marketing Authorization Holder
BIOPROJET PHARMA
9, rue Rameau
75002 Paris
FRANCE

Selling Authorization Holder:
Bioprojet Italia S.r.l.
Via Giovanni Battista Pirelli, 11 – Milan

Manufacturer
BENTA LYON
29, avenue Charles de Gaulle
69230 Saint Genis Laval
France
or
MARTIN DOW PHARMACEUTICALS
Goualle Le Puy, Champs de Lachaud
19250 Meymac
France

This medicinal product is authorized in the European Economic Area countries under the following names:
FRANCE: Tiorfanor
GERMANY: Tiorfan
UNITED KINGDOM: Hidrasec
ITALY: Tiorfanor
BELGIUM: Tiorfix
NETHERLANDS: Hidrasec

Further sources of information