NOTICE
ANSM - Last updated: 12/11/2013
Name of the medicinal product
SUPPOSITORY FOR GLYCERINE GIFRER INFANTS, suppository
Glycerol
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT SUPPOSITORY TO GLYCERINE GIFRER INFANTS, suppository AND IN WHAT CASES IS IT USED?
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE USING SUPPOSITORY FOR GLYCERINE GIFRER INFANTS, suppository?
3. HOW TO USE SUPPOSITORY WITH GLYCERINE GIFRER INFANTS, suppository?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SUPPOSITORY FOR GLYCERINE GIFRER INFANTS, suppository?
6. ADDITIONAL INFORMATION
1. WHAT SUPPOSITORY TO GLYCERINE GIFRER INFANTS, suppository AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Laxative rectally.
(A: Digestive System and Metabolism)
Therapeutic indications
This medication is recommended in certain forms of constipation and as preparation for certain examinations (rectoscopy).
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE USING SUPPOSITORY FOR GLYCERINE GIFRER INFANTS, suppository?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use SUPPOSITORY WITH GLYCERINE GIFRER INFANT, suppository:
· If your child is allergic to glycerol or any of the other ingredients in the suppository;
· If your child has obstructive colopathy, considering the laxative effect of the drug.
· If your child has indeterminate and inflammatory bowel syndrome (ulcerative colitis, Crohn's disease, ...).
Precautions for use; special warnings
Take special care with GLYCERINE GIFRER INFANT SUPPOSITORY, suppository:
Take special precautions with SUPPOSITORY FOR GLYCERINE GIFRER INFANT, suppository:
Special warnings
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
In infants, treatment with rectal laxatives without medical advice is contraindicated, as regular intake may interfere with the normal functioning of the defecation reflex.
Any constipation accompanied by pain, fever, or swelling of the abdomen should have the physician's advice sought.
In infants, the treatment of constipation is based on lifestyle and
diet: especially use of the right amount of water with infant milk powders, diet rich in vegetable products, addition of fruit juices.
Precautions for use
It is best to avoid the use of this drug in some cases of digestive tract disease, anal fissure.
· If your child has a colic disease, an anal fissure or a hemorrhagic ulcerative colitis.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
NEVER LEAVE TO CHILDREN
Interaction with other medicines
Use of other medicines
If your child is taking or has recently taken any other medicines, including medicines obtained without a prescription, talk to your pharmacist
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
SUPPOSITORIES TO GLYCERINE GIFRER INFANTS, do not have any indication in pregnant or lactating women. In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE SUPPOSITORY WITH GLYCERINE GIFRER INFANTS, suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
· Treatment of low constipation:
1 to 2 suppositories per day to get one saddle per day.
· Preparation for endoscopic examination of the rectum:
1 suppository 5 to 30 minutes before the time chosen by the exemption.
Method and route of administration
The suppository can be soaked in cold water to facilitate its introduction.
Duration of treatment
DO NOT EXCEED ON THE PACKAGE LIMITED INDICATED ON THE PACKAGE
Symptoms and Instructions for Overdose
If your child used more SUPPOSITORY TO GLYCERINE GIFRER INFANT, suppository than it should:
Risk of proctitis and / or diarrhea.
Lower doses or discontinue treatment. Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines SUPPOSITORY TO GLYCERINE GIFRER INFANTS, suppository is likely to have undesirable effects, although not everybody is subject to it: sensation of anal burns.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system : National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance. Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE SUPPOSITORY FOR GLYCERINE GIFRER INFANTS, suppository?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use SUPPOSITORY WITH GLYCERINE GIFRER INFANTS, suppository after the expiry date stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What contains SUPPOSITORY TO GLYCERINE GIFRER INFANTS, suppository?
The active substance is:
Glycerol ................................................. .................................................. ......................................... 0.65 g
For suppository
The other components are:
Gelatin, purified water.
Pharmaceutical form and content
What is GLYCERINE GIFRER SUPPOSITORY INFANTS, suppository and contents of the outer packaging?
This medication is in the form of a suppository. Box of 10 and 20 suppositories.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
GIFRER BARBEZAT
8 to 10 rue Paul Bert
69150 Décines-CHARPIEU
exploiting
GIFRER BARBEZAT
8 - 10 rue Paul Bert
69153 Décines CEDEX
Maker
GIFRER BARBEZAT
8 - 10 rue Paul Bert
69153 Décines CEDEX
or
PHARMACEUTICAL PRODUCTION AND HYGIENE PRODUCTION COMPANY - SPPH
7, impasse of the Boussenots
21800 QUETIGNY LES DIJON
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 is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.