TIORFANOR 175 mg Tabletki Powlekane
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Treść ulotki
- Tiorfanor 175 mg film-coated tablets
- What is Tiorfanor 175 mg film-coated tablets and what are they for?
- What you need to know before you take Tiorfanor 175 mg film-coated tablets
- How to take Tiorfanor 175 mg film-coated tablets
- Possible side effects
- How to store Tiorfanor 175 mg film-coated tablets
- Contents of the pack and other information
Tiorfanor 175 mg film-coated tablets
Racecadotril
Read this leaflet carefully before taking this medicine as 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, 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 is and what it is used for
- 2. What you need to know before you take 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 is Tiorfanor 175 mg film-coated tablets and what are they for?
Tiorfanor 175 mg film-coated tablets is a medicine 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 can be administered as complementary treatment when causal treatment is possible.
2. What you need to know before you take 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).
Warnings and precautions
Diarrhoea involves 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 fluid and salt replacement is achieved with a so-called oral rehydration solution (if you have
any doubts, consult your doctor or pharmacist).
Consult your doctor or pharmacist before taking Tiorfanor 175 mg film-coated tablets if:
- You find blood or pus in your stools and have a fever. The cause of the 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 suffer from kidney disease or impaired liver function,
- You suffer from prolonged or uncontrolled vomiting,
Tiorfanor 175 mg film-coated tablets contains 139.6 mg (0.4 mmol) of anhydrous lactose.
It is not recommended in patients with rare hereditary problems of galactose intolerance, Lapp
lactase deficiency or glucose-galactose malabsorption (a rare hereditary condition).
The occurrence of hypersensitivity/angioedema (swelling) has been reported in patients taking
racecadotril (the active substance of this product). Angioedema of the face, extremities,
lips and mucous membranes, etc., or swelling of the upper airways, such as tongue, glottis and/or larynx
(throat) may occur. This can occur at any time during therapy. If these adverse events occur,
immediately stop treatment and consult your doctor.
Patients with a history of angioedema (swelling) not related to therapy with racecadotril may have
an increased risk of angioedema.
Concomitant use of this medicine and ACE inhibitors (e.g. captopril, enalapril, lisinopril, perindopril,
ramipril) may increase the risk of angioedema (see section “Other medicines and Tiorfanor 175 mg
film-coated tablets”).
The occurrence of skin reactions has been reported following the use of this product. In most
cases they are mild to moderate in severity. When severe skin reactions occur, treatment should be
discontinued immediately.
Children and adolescents
Tiorfanor 175 mg film-coated tablets cannot be used in children and adolescents.
More appropriate formulations of racecadotril, such as granules in sachets, indicated
for this population must be used.
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 if you are taking the following medicines:
ACE inhibitors (e.g. captopril, enalapril, lisinopril, perindopril, ramipril) used to lower blood
pressure or to help the heart work.
Tiorfanor 175 mg film-coated tablets with food, drinks and alcohol
Not applicable
Pregnancy, breastfeeding and fertility
Ask your doctor for advice before taking this medicine.
Based on available data, this medicine is not recommended if you are pregnant or
breastfeeding.
Driving and operating machinery
Tiorfanor does not alter or alters negligibly the ability to drive vehicles or operate machinery.
Tiorfanor 175 mg film-coated tablets contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
racecadotril.
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
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet to be taken at any time of the day. Subsequently
continue the treatment by taking 2 tablets a day, one in the morning and one in the evening, preferably before
meals.
The doctor will tell you how long to continue the treatment. The treatment must be continued until the
production of two normal bowel movements, not exceeding 7 days.
To compensate for fluid loss due to diarrhea, this medicine must be used together with
adequate fluid and salt (electrolyte) replacement. The best fluid and salt replacement is achieved with
a so-called oral rehydration solution (if you have any doubts, ask your doctor or pharmacist).
No dosage adjustment is necessary in the elderly.
Method of administration
Oral use. Swallow 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 a missed dose. Continue with the next
dose.
If you stop taking Tiorfanor 175 mg film-coated tablets
Not applicable
If you have any further questions on the use of this medicine, ask your doctor
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Tiorfanor 175 mg film-coated tablets immediately and contact your doctor if you experience symptoms of angioedema, such as:
- swelling of the face, tongue or throat
- difficulty swallowing
- urticaria and difficulty breathing
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): rash and erythema (redness of the skin).
Frequency not known:( the frequency of which cannot be estimated based on the available data): erythema multiforme (pink lesions on the extremities and inside the mouth), glossitis (inflammation of the tongue), cheilitis (inflammation of the lips), blepharitis (inflammation of the eyelids), facial inflammation, angioedema (inflammation under the skin in various parts of the body), urticaria, erythema nodosum (inflammation in the form of a nodule under the skin), papular rash (rash on the skin with small, hard and nodular lesions), prurigo (itchy skin lesions), pruritus (general sensation of itching), toxic skin eruption.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
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 pack 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 in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment
6. Contents of the pack and other information
What Tiorfanor 175 mg film-coated tablets contain
The active ingredient is racecadotril. Each tablet contains 175 mg of racecadotril.
The other ingredients are: lactose monohydrate, calcium carmellose, hydroxypropylcellulose, microcrystalline
cellulose, pregelatinized corn starch, magnesium stearate
Coating: white Opadray (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 presented as film-coated tablets.
The pack contains 12 tablets (2 blisters of 6 tablets) .
Marketing Authorisation Holder
BIOPROJET PHARMA
9, rue rameau
75002 Paris
FRANCE
Manufacturer
FAMAR LYON
29, avenue Charles de Gaulle
69230 Saint Genis Laval
FRANCE
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
FRANCE: Tiorfanor
GERMANY: Tiorfan
SPAIN: Tiorfan
UNITED KINGDOM: Hidrasec
ITALY Tiorfanor
BELGIUM Tiorfanor
NETHERLANDS: Hidrasec
Other sources of information
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- Kraj rejestracji
- Postać farmaceutycznaFilm-coated tablet, 175 MG
- Kod ATCA07XA04
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TIORFANORPostać farmaceutyczna: Oral suspension, 4 MG/MLSubstancja czynna: racecadotrilProducent: BIOPROJET PHARMABez receptyPostać farmaceutyczna: Hard capsule, 100 MGSubstancja czynna: racecadotrilProducent: BIOPROJET EUROPE LTDWymaga receptyPostać farmaceutyczna: Enteric-coated tablet, 400 MGSubstancja czynna: mesalazineProducent: DICOFARM S.P.A.Wymaga recepty
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TIORFANOR wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w TIORFANOR jest racecadotril. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
TIORFANOR jest produkowany przez BIOPROJET PHARMA. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie TIORFANOR jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić TIORFANOR w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (racecadotril) to m.in. TIORFAN, TIORFIX, ARGONAL. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
