NOTICE
ANSM - Updated on : 12/11/2013
Name of medicinal product
GIFRER ADULT GLYCERIN SUPPOSITORY, suppository
Glycerol
Box
Please read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have any further questions or doubts, please ask your doctor or pharmacist for more information.
- Keep this leaflet as you may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult a 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.
Contents
In this leaflet :
1. WHAT IS GIFRER ADULT GLYCERIN SUPPOSITORY, suppository AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU KNOW BEFORE USING SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTES, suppository?
3. HOW DO I USE GIFRER ADULT GLYCERIN SUPPOSITORY, suppository?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTES, suppository?
6. ADDITIONAL INFORMATION
1. WHAT IS GLYCERIN SUPPOSITORY GIFRER ADULTS, suppository AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Rectal laxative.
(A: Digestive system and metabolism)
Therapeutic indications
This medicine is recommended for certain forms of constipation and as preparation for certain examinations (rectoscopy).
2. WHAT DO I HAVE TO KNOW BEFORE USING GIFRER ADULT GLYCERIN SUPPOSITORY, suppository?
List of information required before taking the medicine
Not applicable.
Contraindications
Never use SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTE, suppository:
- If you are allergic to glycerol or to any of the other ingredients of SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTE, suppository;
- If you suffer from obstructive colopathy, due to the laxative effect of the drug.
- If you suffer from abdominal pain syndrome of undetermined inflammatory cause (ulcerative colitis, Crohn's disease, etc.).
Precautions for use; special warnings
Take special care with SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTE, suppository:
Take special precautions with SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTE, suppository:
Special warnings
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:
- or an intestinal disease requiring medical attention,
- or an imbalance in bowel function due to dietary and lifestyle habits.
Treatment includes
- increasing dietary intake of plant-based products (green vegetables, raw vegetables, wholemeal bread, fruit, etc.),
- increased consumption of water and fruit juices,
- increased physical activity (sports, walking, etc.),
- reeducation of the defecation reflex,
- sometimes adding bran to the diet.
Ask your doctor or pharmacist for advice.
Precautions for use
- If you have colonic disease, anal fissures or haemorrhagic rectocolitis;
- If you have a hemorrhoidal crisis.
If in doubt, ask your doctor or pharmacist for advice.
KEEP OUT OF REACH OF CHILDREN
Interactions with other drugs
Use of other medicines
If you are taking or have recently taken any other medicines, including those obtained without a prescription, talk to your pharmacist.
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
This medicine should be used with caution during pregnancy and while breast-feeding.
In general, 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 GIFRER ADULT GLYCERIN SUPPOSITORY, suppository?
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
- Treatment of low-grade constipation :
1 to 2 suppositories per day to obtain one bowel movement per day.
- Preparation for endoscopic rectal examinations:
1 suppository 5 to 30 minutes before exoneration.
Method and route of administration
The suppository can be soaked in cold water to facilitate introduction.
Symptoms and instructions in case of overdose
If you have used more GLYCERIN SUPPOSITORY GIFRER ADULTE than you should have :
Risk of rectitis and/or diarrhea.
Reduce doses or stop treatment. Consult your doctor or pharmacist.
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 SUPPOSITORY WITH GLYCERIN GIFRER ADULTE, suppository is likely to have undesirable effects, although not everyone is subject to them: sensation of anal burning.
Reporting side effects
If you experience any side effects, please tell 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 : Agence nationale de sécurité du médicament et des produits de santé (Ansm) and the network of Centres Régionaux de Pharmacovigilance. Website: www.ansm.sante.fr. By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE GIFRER ADULT GLYCERIN SUPPOSITORY, suppository?
Keep out of sight and reach of children.
Expiration date
Do not use SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTE, suppository after the expiration date stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of in the sewage system 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 SUPPOSITOIRE A LA GLYCERINE GIFRER ADULTE, suppositoire contain?
The active substance is :
Glycerol ............................................................................................................................................ 1.98 g
For one suppository
The other components are :
Gelatin, purified water.
Pharmaceutical form and contents
What is GIFRER ADULT GLYCERIN SUPPOSITORY, suppository and what is in the pack?
This medicine comes in suppository form. Sachets (Polyester/PE) of 25, 50 and 100 suppositories. Blister pack (PVC/PE): box of 10, 20, 60 and 100 suppositories.
Name and address of marketing authorization holder and manufacturing authorization holder responsible for batch release, if different
Holder
GIFRER BARBEZAT
8 to 10 rue Paul Bert
69150 Décines-CHARPIEU
Operator
GIFRER BARBEZAT
8 - 10 rue Paul Bert
69153 Décines CEDEX
Manufacturer
GIFRER BARBEZAT
8 - 10 rue Paul Bert
69153 Décines CEDEX
or
SOCIETE DE PRODUCTION PHARMACEUTIQUE ET D'HYGIENE - SPPH
7, impasse des Boussenots
21800 QUETIGNY LES DIJON
Drug names in member states of the European Economic Area
Not applicable.
Date of approval of package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this product is available on the INSM (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.