In this manual :
1. WHAT IS IMODIUMLINGUAL 2 mg, oral lyophilisate AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING IMODIUMLINGUAL 2 mg, oral lyophilisate
3. HOW DO I TAKE IMODIUMLINGUAL 2 mg, oral lyophilisate?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE IMODIUMLINGUAL 2 mg, oral lyophilisate?
6. ADDITIONAL INFORMATION
1. WHAT IS IMODIUMLINGUAL 2 mg, oral lyophilisate AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
Short-term treatment of acute transient diarrhoea in adults (15 years and older).
This treatment is a complement to dietary measures: please read carefully the chapter "Taking special precautions".
2. WHAT YOU SHOULD KNOW BEFORE TAKING IMODIUMLINGUAL 2 mg, oral lyophilisate
List of information needed before taking the medicine
Not applicable.
Do not take IMODIUMLINGUAL 2 mg, oral lyophilisate:
- 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 this medicine.
- in case of phenylketonuria (hereditary disease detected at birth), due to the presence of aspartam.
Precautions for use; special warnings
Take caution with IMODIUMLINGUAL 2 mg, oral lyophilisate:
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
CAUTION: you must not take this medicine:
- in case of fever, vomiting,
- if there is blood or mucus in the stools,
- if your diarrhoea occurs during antibiotic treatment (risk of severe colon damage).
You should 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 severe swelling of the abdomen,
- in case of intense thirst, sensation 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 can be done orally or intravenously.
TAKE THE ADVICE OF YOUR DOCTOR in case of liver disease as medical supervision during treatment is necessary.
Diarrhoea causes loss of fluids and minerals.
It is necessary to:
- rehydrate with abundant drinks, salty or sweet, to compensate for the loss of fluids due to diarrhoea (drink at least 2 litres)
- eat during the diarrhea,
- cut out raw vegetables, fruit, green vegetables, spicy dishes, as well as iced food or drinks.
- choose grilled meats and rice.
Interactions with other medicines
Taking or using other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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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 directions for use and dosage).
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Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breastfeeding
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Do not take this medicine without asking your doctor or pharmacist.
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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 you should 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 medicine sometimes causes 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 known effect: aspartam (E951): source of phenylalanine.
3. HOW TO TAKE IMODIUMLINGUAL 2 mg, oral lyophilisate
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
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In children (under 15 years): Do not use this medicine.
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RESERVED FOR ADULTS and CHILDREN from 15 years of age.
Start with 2 lyophilisates in a single dose (4 mg of loperamide). If the diarrhoea continues: after each unmoulded stool, take 1 additional lyophilisate, but:
- never exceed 6 lyophilisats per day,
- never exceed 2 days of treatment.
If you feel that the effect of IMODIUMLINGUAL 2 mg, oral lyophilisate is too strong or too weak, consult your doctor or pharmacist.
How to take it
Oral use.
The lyophilisates are fragile and should not be pushed through the foil.
Proceed as follows to remove the lyophilisates from the blister pack.
SCHEMES to be included here.
Allow the oral lyophilisate to melt on the tongue for rapid effect (do not chew) or drink immediately after complete dissolution in a small amount of water.
Symptoms and instructions in case of overdose
If you have used more IMODIUMLINGUAL 2 mg, oral lyophilisate than you should have: consult your doctor or pharmacist immediately.
Instructions in case of missed doses
If you forget to take IMODIUMLINGUAL 2 mg, oral lyophilisate: do not take a double dose to make up for the one you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, IMODIUMLINGUAL 2 mg, oral lyophilisate 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 (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 DO I USE IMODIUMLINGUAL 2 mg, oral lyophilisate?
Keep out of the reach and sight of children.
Do not use IMODIUMLINGUAL 2 mg, oral lyophilisate after the expiry date stated on the box.
Store in the original outer packaging in a dry place.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of medicines 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 IMODIUMLINGUAL 2 mg, oral lyophilisate contain?
The active substance is:
Loperamide hydrochloride .............................................................................................................. 2.00 mg
For one oral lyophilisate.
The other components are:
Gelatine, aspartam (E951), mint flavour, sodium bicarbonate, mannitol.
Pharmaceutical form and content
What is IMODIUMLINGUAL 2 mg, oral lyophilisate and what does it contain?
This medicine is presented in the form of oral lyophilisates. Boxes of 5, 6, 10 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 PHARMACEUTICA N.V
Turnhoutseweg, 30
2340 BEERSE
BELGIUM
or
JANSSEN CILAG S.P.A.
Via C. Janssen
Borgo San MICHELE
04010 LATINA (LT)
ITALY
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 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.
Not applicable.
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