NOTICE
ANSM - Last updated: 22/07/2016
Name of the medicinal product
TIORFAST 100 mg capsule
racecadotril
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
Do not use this medication for children.
Review summary
What this leaflet contains:
1. What is TIORFAST 100 mg capsule and in which case is it used?
2. What should I know before using TIORFAST 100 mg capsule?
3. How to use TIORFAST 100 mg capsule?
4. What are the possible side effects?
5. How to store TIORFAST 100 mg capsule?
6. Additional information.
1. WHAT IS TIORFAST 100mg, capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
This medication is an antidiarrheal.
Therapeutic indications
This medication is indicated for the symptomatic and short-term treatment of transient (acute) diarrhea in adults as a complement to dietary measures.
2. BEFORE YOU TAKE TIORFAST 100 Mg, capsule?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take TIORFAST
· if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medication mentioned in section 6.
· if you are taking an ACE inhibitor and you have a history of angioedema under ACE inhibitors.
Precautions for use; special warnings
Take special care with TIORFAST 100 mg capsule: Health Education Council
The diarrhea causes a loss of liquids and of salts minerva x. he East necessary of :
· rehydrate with abundant salty or sweetened beverages to compensate for fluid losses due to diarrhea (the adult's average daily water intake is 2 liters).
· maintain diet the time of diarrhea:
Excluding certain intakes and especially raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks. By favoring grilled meats and rice.
Precautions for use:
You should tell your doctor if:
· you notice the presence of blood or pus in your stool and if you have a fever (temperature above 38 ° C), or dehydration (which can result in weight loss, fatigue, discomfort, the eyes are hollowed out and surrounded)
· you have diarrhea occurring during broad-spectrum antibiotic treatment
· you have a kidney or liver disease
· in case of prolonged or uncontrolled vomiting
Warnings :
This medication is not suitable for children.
This medicine contains lactose.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases).
If diarrhea persists after 3 days, contact your doctor.
Skin reactions have been reported with the use of this drug. In most cases, these reactions are mild and moderate. If severe skin reactions occur, treatment with racecadotril should be discontinued immediately.
Interaction with other medicines
Other medicines and TIORFAST
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medications, including an ACE inhibitor to lower your blood pressure and help your heart work.
This medicine contains racecadotril.
Another medicine, Tiorfan 100 mg contains. Do not combine them to exceed the maximum recommended doses ( see HOW TO TAKE TIORFAST 100 mg capsule ).
Interactions with food and beverages
Food and drinks
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Based on available data, caution should be exercised in avoiding use of racecadotril during pregnancy at any time.
feeding
In the absence of data on the passage of racecadotril in milk, this drug should not be administered during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
This medicinal product has no or negligible influence on the ability to drive and use machines.
List of excipients with known effect
TIORFAST contains lactose.
This medication does not contain gluten
3. HOW TO TAKE TIORFAST 100 mg capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
RESERVED FOR ADULTS
Dosage
Start with one capsule at any time, then one capsule three times a day, preferably before or at the beginning of the three main meals.
A dosage adjustment for the elderly is not necessary.
Administration mode
Oral, to swallow with a glass of water.
Duration of treatment
Stop treatment as soon as the stools are again consistent or even hard, or if no saddle is issued for more than 12 hours.
Do not exceed 3 days of treatment.
Symptoms and Instructions for Overdose
If you took more TIORFAST than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take TIORFAST
Do not take a double dose to make up for the missed dose.
Continue with the next dose.
Risk of withdrawal syndrome
If you stop taking TIORFAST
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
You should stop TIORFAST and seek medical attention immediately if you experience symptoms of angioedema such as:
- Swelling of the face, tongue or pharynx;
- Difficulty swallowing;
- Urticaria and difficulty breathing.
Common side effects (reported in at least 1 in 100 patients but in less than 1 in 10 patients):
cephalalgia
Uncommon side effects (reported in at least 1 in 1,000 patients but less than 1 in 100 patients):
Rash and erythema (redness of the skin)
Frequency not known (can not be estimated from the available data):
erythema multiforme (pinkish lesions at the extremities and in the mouth), edema of the tongue, edema of the lips, edema of the eyelids, edema of the face, angioedema (subcutaneous inflammation affecting various parts of the body) urticaria, erythema nodosum (inflammation in the form of a nodule under the skin), papular rash (rash with small hard and pustular lesions), pruritus (itching affecting the whole body), prurigo (skin lesions causing itching) drug eruption.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr .
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE TIORFAST 100 mg capsule?
Keep this medicine out of the reach and sight of children.
Expiration date
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 this month.
Storage conditions
This medicine does not require special precautions for storage.
If necessary, warnings against visible signs of deterioration
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What TIORFAST contains
· The active substance is:
Racécadotril ................................................. .................................................. ................................. 100 mg
For a capsule.
· The other components are:
Lactose monohydrate, pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica.
Composition of the capsule shell: gelatin, titanium dioxide (E171), yellow iron oxide (E172).
Pharmaceutical form and content
Aspect of TIORFAST and contents of the pack
This medication is in the form of an ivory colored capsule containing a white powder with a sulfur odor.
Box of 10.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Marketing Authorization Holder and Manufacturer
Holder
BIOPROJET PHARMA
9, RUE RAMEAU
75002 PARIS
exploiting
BIOPROJET PHARMA
9 RUE RAMEAU
75002 PARIS
Maker
Sophartex
21 RUE DU PRESSOIR
28500 VERNOUILLET
Names of the medicinal product in the Member States of the European Economic Area
Not applicable
Date of approval of the notice
The last date on which this leaflet was revised is {MM / YYYY}.
AMM under exceptional circumstances
Not applicable
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable
Other
Health Education Council:
Diarrhea causes loss of liquids and mineral salts. It is necessary that :
· rehydrate with abundant, salty or sweetened beverages to compensate for fluid losses due to diarrhea (drinking at least 2 liters per day),
· feeding the time of diarrhea:
o remove raw vegetables, fruits, green vegetables, spicy dishes, and frozen foods or drinks;
o favor grilled meats and rice.
