DIARETYL 2MG BOX OF 12 GELULES: Short-term treatment of transient acute diarrhea in adults (15 years and over). Loperamide hydrochloride 2.00 mg.
For warnings, precautions for use and contraindications, please consult the package leaflet.
This medicine is indicated for the treatment of acute transient diarrhea in adults.
Treatment does not dispense with dietary measures and rehydration if necessary.
The extent of rehydration by oral or intravenous rehydration solution must be adapted to the intensity of the diarrhoea, the patient's age and particularities (associated illnesses, etc.).
Acute transient diarrhea can be caused by 4 mechanisms:
Initial dose: 2 capsules,
Then 1 additional capsule, to be taken after each loose stool,
Loperamide (2 mg per capsule). Loperamide slows intestinal transit to allow greater reabsorption of water.
Hypersensitivity to any of the ingredients.
Acute attacks of ulcerative colitis.
Patients should be advised to rehydrate with plenty of salty or sweet drinks.
Box of 12 capsules.
Warning: this medicine is not like any other. Read the package insert carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, ask your doctor or pharmacist for advice. Beware of incompatibilities with your current products.
Diaretyl 2mg is specially designed for the short-term treatment of transient acute diarrhea in adults aged 15 and over. This medicine acts quickly to help you regain normal intestinal transit.
Fast-acting : Acute diarrhoea can be uncomfortable and disrupt your daily routine. Diaretyl works quickly to reduce the frequency of loose stools and relieve your symptoms.
Suitable for adults: Diaretyl is reserved for adults aged 15 and over, offering an effective solution for controlling episodes of diarrhoea.
Convenient format: The 12-capsule box is easy to carry and use, making it an ideal choice for when you're on the move.
For Adults: Diaretyl is suitable for adults aged 15 and over who wish to control acute diarrhoea.
Simple dosage: Follow the instructions on the packaging for safe use.
Available in pharmacies: You can order Diaretyl 2mg from our online pharmacy for a convenient solution at your fingertips.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 05/07/2017
Loperamide Hydrochloride
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 2 days.
1. What is DIARETYL 2 mg, capsule and in which cases it is used?
2. What should I tell you before taking DIARETYL 2 mg capsule?
3. How to take DIARETYL 2 mg capsule?
4. What are the possible side effects?
5. How to store DIARETYL 2 mg capsule?
6. Package contents and other information.
1. WHAT IS DIARETYL 2 mg, hard capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: ANTI-DIARRHEA (A: digestive system and metabolism).
ATC code: A07DA03.
Short-term treatment of transient acute diarrhea in adults (from 15 years of age).
This treatment is a complement to the dietary measures: read carefully the precautions of use .
2. BEFORE YOU TAKE DIARETYL 2 Mg, capsule?
Do not take DIARETYL 2 mg capsule:
· if you suffer from chronic bowel and colon disease, especially during acute recto-colitis hemorrhagic outbreaks,
· in case of allergy to one of the constituents of the capsule.
IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Warnings and Precautions
Take special care with DIARETYL 2 mg capsule:
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
CAUTION: Do not take this medication:
· in case of fever, vomiting,
· in the presence of blood or mucus in the stools,
· if your diarrhea occurs during an antibiotic treatment (risk of severe bowel disease).
Similarly you should stop this treatment and consult your doctor promptly in the following cases:
· in case of fever, vomiting,
· in the presence of blood or mucus in the stools,
· in the absence of improvement after 2 days of treatment,
· in the case of constipation or abdominal distension,
· in case of intense thirst, sensation of dry tongue. Indeed, these signs show a beginning of dehydration, that is to say a large loss of fluid due to diarrhea. Your doctor will then judge the need to prescribe rehydration that can be done either orally or intravenously.
Precautions for use
Use this medication only with caution.
TAKE ADVICE OF YOUR DOCTOR in case of liver disease because medical supervision during treatment is necessary.
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 (drink at least 2 liters).
· feeding on diarrhea;
o remove raw vegetables, fruits, green vegetables, spicy dishes, as well as frozen foods or drinks.
o favor grilled meats, rice.
Take this product only for the intended use (see section 1) and never take more than the recommended dose (see section 3). Severe heart problems (symptoms may include a rapid or irregular heartbeat) have been reported in patients who have taken too much of loperamide, the active ingredient of DIARETYL 2 mg, capsule.
Children and Youth
Not applicable.
Other medicines and DIARETYL 2 mg capsule
This medicine contains LOPERAMIDE . Other medicines contain ... Do not combine them, in order not to exceed the maximum recommended doses (see Dosage ).
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
DIARETYL 2 mg, capsule with food, drink and alcohol
Not applicable.
If you are pregnant or breastfeeding:
Do not take this medicine without consulting your doctor or pharmacist.
This medication will only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue this treatment.
Breast-feeding is still possible if this medication is used for short periods.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Caution, this medication sometimes causes a discrete and transient somnolence or dizziness that can be dangerous when driving vehicles and using certain machines.
DIARETYL 2 mg capsule contains
Not applicable.
3. HOW TO TAKE DIARETYL 2 Mg, capsule?
Do not use this medication in children (less than 15 years of age).
Reserved for adults (from 15 years).
· Start with 2 capsules in a single dose (4 mg loperamide).
· If diarrhea continues: after each unmolded saddle, take 1 extra capsule, but:
o never exceed 6 capsules per day,
o never exceed 2 days of treatment.
Administration mode
Oral use
Swallow the capsules with a glass of water.
Frequency of Administration
Space the catches, take 1 capsule after each unmolded saddle but:
· never exceed 6 capsules per day,
· never exceed 2 days of treatment.
Duration of treatment
The duration of use is limited to 2 days
If you take more DIARETYL 2 mg capsule than you should have
If you have taken too much DIARETYL 2 mg capsule, seek immediate advice from a doctor or a hospital. Symptoms may include: increased heart rate, irregular heartbeat, changes in your heart rate (these symptoms may have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movement, drowsiness, difficulty passing urine or respiratory distress.
Children react more strongly to high doses of DIARETYL 2 mg capsule than adults. If a child takes too much or has any of the above symptoms, contact a doctor immediately.
In case of accidental overdose, STOP TREATMENT AND SEEK YOUR DOCTOR QUICKLY.
If you forget to take DIARETYL 2 mg capsule
If you stop taking DIARETYL 2 mg capsule
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Constipation and / or stomach distension,
· Stomach pain, bloating, nausea, vomiting, dry mouth,
· Allergic reactions (rash, urticaria and exceptionally severe allergic shock),
· Fatigue, drowsiness, dizziness.
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 via 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 DIARETYL 2 mg, capsule?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton.
KEEP THIS MEDICINE at a temperature not exceeding 30 ° C
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. PACKAGE CONTENTS AND OTHER INFORMATION
What DIARETYL 2 mg contains: capsule
· The active substance is:
Loperamide Hydrochloride ............................................... .............................................. 2.00 mg
Amount corresponding to loperamide base ............................................. .......................... 1.86 mg
For a capsule.
· The other components are:
Corn starch (STARCH 1500), microcrystalline cellulose (AVICEL pH 102), talc.
Composition of the capsule shell : quinoline yellow, indigotine, patent blue V.
What is DIARETYL 2 mg capsule and contents of the pack
This medication is in the form of a capsule. Box of 6 or 12 capsules.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN
115 AVENUE LACASSAGNE
75003 PARIS
or
Delpharm
USINE OF PETIT PARIS
91220 BRETIGNY SUR ORGE
or
RHONE POULENC RORER PHARMASPECIALITES
20 AVENUE RAYMOND ARON
92160 ANTONY
or
BTT LABORATORIES
KRAFFT ZI
67150 ERSTEIN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
antidiarrheal
loperamide
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
DIARETTYL: Capsule (dark green and light green); box of 12.
-
French Pharmaceutical Cooperation Laboratory
| p gel | |
| Loperamide hydrochloride | 2 mg |
Usual dosage:
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