NOTICE
ANSM - Updated on : 29/12/2015
Name of medicinal product
COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container
Glycerol
Box
Please read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need more information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult your doctor.
- If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
Leaflet summary
In this leaflet :
1. WHAT IS COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container AND WHAT IS IT USED FOR?
2. WHAT DO I HAVE TO KNOW BEFORE USING COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container?
3. HOW TO USE COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container?
6. ADDITIONAL INFORMATION
1. WHAT IS COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
This medicine is a laxative.
It is indicated in certain cases of constipation and in preparation for certain examinations (rectoscopy).
2. WHAT DO I HAVE TO KNOW BEFORE USING COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container?
List of information required before taking the medicine
Not applicable.
Contraindications
Not applicable.
Precautions for use; special warnings
Take special care with COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container:
DO NOT USE FOR PROLONGED PERIODS WITHOUT MEDICAL ADVICE.
Occasional constipation:
May be related to a recent change in lifestyle (travel). The drug can be used as a short-term treatment. Any recent constipation unexplained by a change in lifestyle, or any constipation accompanied by pain, fever or swelling of the abdomen, should be referred to your doctor.
Chronic constipation (long-term constipation) :
There are two possible causes of chronic constipation:
- or an intestinal disease requiring medical attention,
- or an imbalance in bowel function due to eating habits and lifestyle.
Treatment includes
- increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit),
- increased consumption of water and fruit juices,
- increased physical activity (sports, walking),
- reeducation of the defecation reflex,
- sometimes adding bran to the diet.
It is preferable to avoid using this medication in cases of digestive tract disease.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive vehicles or use machines
Not applicable.
List of excipients
Not applicable.
3. HOW TO USE COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
FOR ADULTS ONLY.
One suppository 5 to 30 minutes before bowel movements. This dose may be repeated once in the next half-hour or hour in the event of stubborn constipation.
If you feel that the effect of COOPER ADULT GLYCERIN SUPPOSITORY is too strong or too weak, consult your doctor or pharmacist.
Method of administration
Rectal route.
Suppositories may be soaked in cold water to facilitate insertion.
Duration of treatment
Treatment of constipation should not exceed 10 days.
Symptoms and instructions in case of overdose
Not applicable.
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, COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container is likely to have undesirable effects, although not everyone is subject to them:
Possibility of anal burning.
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 USE COOPER ADULT GLYCERIN SUPPOSITORY, suppository in multidose container?
Keep out of sight and reach of children.
Expiration date
Do not use SUPPOSITOIRES A LA GLYCERINE COOPER ADULTES, suppository in multidose container after the expiration date shown on the box. The expiry date refers to the last day of the month.
Storage conditions
Store at temperatures not exceeding +25ºC.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of down the drain or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. FURTHER INFORMATION
Complete list of active ingredients and excipients
What does SUPPOSITOIRES A LA GLYCERINE COOPER ADULTES, suppository in multidose container, contain?
The active substance is:
Glycerol ............................................................................................................................................ 1.98 g
For one suppository.
The other components are:
Gelatin, purified water, light liquid kerosene.
Pharmaceutical form and contents
Appearance of COOPER ADULTGLYCERINSUPPOSITORIES , suppository in multidose container and contents of packaging
This medicine comes in suppository form.
Box of 25 suppositories.
Box of 50 suppositories: 2 sachets of 25 suppositories in multidose container (PET/PVdC/PE).
Box of 100 suppositories: 4 sachets of 25 suppositories in multidose container (PET/PVdC/PE).
Not all presentations may be marketed.
Name and address of marketing authorization holder and manufacturing authorization 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 Cedex
Manufacturer
SOCIETE DE PRODUCTION PHARMACEUTIQUE ET DHYGIENE SPPH
7 IMPASSE DES BOUSSENOTS
21800 QUETIGNY LES DIJON
or
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Drug names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this drug is available on the ANSM (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.