In this manual :
1. WHAT IS DIARETYL 2 mg, capsule AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DIARETYL 2 mg, capsule?
3. HOW DO I TAKE DIARETYL 2 mg, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE DIARETYL 2 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS DIARETYL 2 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
ANTI-DIARRHOEA
(A: digestive system and metabolism)
Short-term treatment of acute transient diarrhoea in adults (15 years and older).
This treatment is a complement to dietary measures.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING DIARETYL 2 mg, capsule?
List of information needed before taking the medicine
Not applicable.
Never take DIARETYL 2 mg, capsule:
- if you have chronic bowel and colon disease, especially during acute flare-ups of ulcerative colitis,
- in case of allergy to any of the ingredients of the capsule.
IN CASE OF DOUBT, YOU SHOULD SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take care with DIARETYL 2 mg, capsule:
Special warnings
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
CAUTION: you must not take this medicine:
- · if you have a fever, vomiting,
- · if you have blood or mucus in your stools,
- · if your diarrhoea occurs during antibiotic treatment (risk of severe colon damage).
You must also stop this treatment and consult your doctor quickly in the following cases:
- in case of fever, vomiting,
- in case of blood or mucus in the stools,
- if there is no improvement after 2 days of treatment,
- in case of constipation or abdominal distension,
- in case of intense thirst or a feeling of dry tongue. Indeed, these signs indicate the beginning of dehydration, i.e. a significant loss of liquid due to diarrhoea. Your doctor will then judge the need to prescribe rehydration, which may be oral or intravenous.
Precautions for use
Use this medicine only with caution (Precautions for use)
TAKE THE ADVICE OF YOUR DOCTOR in case of liver disease, as medical supervision during treatment is necessary
Diarrhea causes loss of fluids and mineral salts.
It is necessary to:
- rehydrate with abundant drinks, salty or sweet, in order to compensate for the loss of fluids due to diarrhoea (drink at least 2 litres)
- eat during the diarrhoea,
o eliminate raw vegetables, fruits, green vegetables, spicy dishes, as well as iced foods or drinks.
o choose grilled meats, rice.
Interactions with other medicines
Taking or using other medications
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This medicine contains LOPERAMIDE. Other medicines contain it... Do not combine them, so as not to exceed the maximum recommended doses (see Dosage).
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Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy and breastfeeding
If you are pregnant or breastfeeding,
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Do not take this medicine without asking your doctor or pharmacist.
This medicine should only be used during pregnancy on the advice of your doctor.
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If you discover that you are pregnant during treatment, consult your doctor, as only he or she can decide whether or not to continue the treatment.
Breast-feeding is still possible during brief treatment with this medicine.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Driving and using machines
Caution: This drug may cause discrete and transient drowsiness or dizziness which may be dangerous when driving and using certain machines.
List of excipients with a known effect
Not applicable.
3. HOW DO I TAKE DIARETYL 2 mg, capsule?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
|
Do not use in children (under 15 years of age)
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Dosage
For adults only (15 years and older).
- Start with 2 capsules in a single dose (i.e. 4 mg of loperamide),
- If diarrhoea continues: after each unformed stool, take 1 additional capsule, but:
o never exceed 6 capsules per day,
o never exceed 2 days of treatment.
Method of administration
Oral use
Swallow the capsules with a glass of water.
Frequency of administration
Take at intervals,
Take 1 capsule after each unmolded bowel movement:
- never exceed 6 capsules per day,
- never exceed 2 days of treatment.
Duration of treatment
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The duration of use is limited to 2 days.
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Symptoms and instructions in case of overdose
If you have taken more DIARETYL 2 mg, capsule than you should have:
In case of accidental overdose, STOP THE TREATMENT AND CONSULT YOUR DOCTOR ASAP.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DIARETYL 2 mg, capsule is likely to have side effects, although not everyone is susceptible:
- Constipation and/or distension of the belly,
- Belly pain, bloating, nausea, vomiting, dry mouth,
- Allergic reactions (skin rash, hives and exceptionally severe allergic shock),
- Fatigue, drowsiness, dizziness.
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE DIARETYL 2 mg, capsule
Keep out of the reach and sight of children.
Do not use DIARETYL 2 mg, capsule after the expiry date stated on the box.
STORE THIS MEDICATION at a temperature not exceeding 30°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does DIARETYL 2 mg, capsule contain?
The active substance is:
Loperamide hydrochloride .............................................................................................................. 2.00 mg
Amount corresponding to loperamide base ........................................................................................ 1.86 mg
For one capsule.
Other components are:
Corn starch (STARCH 1500), microcrystalline cellulose (AVICEL pH 102), talc.
Capsule shell composition: quinoline yellow, indigotine, patent blue V.
Pharmaceutical form and content
What is DIARETYL 2 mg, capsule and what does it contain?
This medicine is presented in capsule form. Box of 6 or 12 capsules.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Operator
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN
Manufacturer
LABORATOIRES LIPHA
115, AVENUE LACASSAGNE
75003 PARIS
or
DELPHARM
PETIT PARIS FACTORY
91220 BRETIGNY SUR ORGE
or
RHONE POULENC RORER PHARMASPECIALITES
20, AVENUE RAYMOND ARON
92160 ANTONY
or
LABORATOIRES BTT
Z.I. DE KRAFFT
67150 ERSTEIN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information for healthcare professionals only
Not applicable.
Not applicable.
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