In this manual :
1. WHAT IS IMODIUMCAPS 2 mg, capsule AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING IMODIUMCAPS 2 mg, capsule
3. HOW DO I TAKE IMODIUMCAPS 2 mg, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW DO I USE IMODIUMCAPS 2 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS IMODIUMCAPS 2 mg, capsule AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
ANTI-DIARRHEAL
(A: digestive system and metabolism)
Short-term treatment of acute transient diarrhoea in adults (15 years and older).
This treatment is a supplement to dietary measures: please read the chapter on "precautions for use" carefully.
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING IMODIUMCAPS 2 mg, capsule?
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Do not take IMODIUMCAPS 2 mg, capsule:
- if you suffer from chronic bowel and colon disease, particularly during acute attacks of ulcerative colitis,
- if you are allergic to any of the ingredients in the capsule.
IN CASE OF DOUBT, YOU SHOULD SEEK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take caution with IMODIUMCAPS 2 mg, capsule:
Special warnings
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
CAUTION: Do 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, sensation of dry tongue. In fact, 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.
This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (a rare hereditary disease).
Precautions for use
Use this medicine only with caution:
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 medicines
|
This medicine contains LOPERAMIDE. Other medicines contain it... Do not combine them, so as not to exceed the maximum recommended doses (see Dosage).
|
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,
|
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.
|
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 Use of Machinery
Caution: This medicine 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
List of excipients with a notable effect: lactose.
3. HOW TO TAKE IMODIUMCAPS 2 mg, capsule
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
For adults and children over 15 years of age only.
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:
- never exceed 6 capsules per day,
- never exceed 2 days of treatment.
Method of administration
Oral use
Swallow the capsules with a glass of water.
Space out the doses
Take 1 capsule after each unmolded bowel movement:
- never exceed 6 capsules per day,
- never exceed 2 days of treatment.
Duration of treatment
The duration of use is limited to 2 days.
Symptoms and instructions in case of overdose
If you have taken more IMODIUMCAPS 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, IMODIUMCAPS 2 mg, capsule is likely to have side effects, although not everyone is susceptible.
- Constipation and/or distension of the stomach,
- Belly pain, bloating, nausea, vomiting, dry mouth,
- Allergic reactions (rash, hives and exceptionally severe allergic shock),
- Fatigue, drowsiness, dizziness.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO CONSERVE IMODIUMCAPS 2 mg, capsule
Keep out of the reach and sight of children.
Do not use IMODIUMCAPS 2 mg, capsule after the expiry date stated on the box.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in your 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 IMODIUMCAPS 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:
Lactose monohydrate, corn starch, talc, magnesium stearate.
Capsule shell compositionGelatin, indigotine, yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), erythrosine.
Pharmaceutical form and content
What is IMODIUMCAPS 2 mg, capsule and what does it contain?
This medicine is in capsule form. Box of 6 or 12.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY-LES-MOULINEAUX
Operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, rue Camille Desmoulins
92130 ISSY-LES-MOULINEAUX
Manufacturer
JANSSEN CILAG
DOMAINE DE MAIGREMONT
27100 VAL DE REUIL
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 reserved for health professionals
Not applicable.
ADVICE / HEALTH EDUCATION
Diarrhoea causes a loss of fluids and mineral salts.
This medicine treats the symptoms of acute diarrhoea in adults, but does not dispense with rehydration, accompanied by dietary hygiene.
It is thus necessary to drink abundantly sweetened drinks (fruit juices) and salty broths to compensate for these losses. Avoid milk, green vegetables, raw vegetables, fruits, spices, until the diarrhea disappears.
Français
English
