NOTICE
ANSM - Last updated: 30/04/2014
Name of the medicinal product
SUPPOSITORY TO GLYCERINE GIFRER CHILDREN, suppository
Glycerol
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
· Keep this leaflet, you may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Do not give it to other people. It could be harmful to them, even if the signs of their illness are the same as yours.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet.
Review summary
In this notice :
1. WHAT SUPPOSITORY TO GLYCERINE GIFRER CHILDREN, suppository AND WHAT IT IS USED FOR?
2. BEFORE YOU USE SUPPOSITORY FOR GLYCERINE GIFRER CHILDREN, suppository?
3. HOW TO USE SUPPOSITORY FOR GLYCERINE GIFRING CHILDREN, suppository?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SUPPOSITORY FOR GLYCERINE GIFRER CHILDREN, suppository?
6. ADDITIONAL INFORMATION
1. WHAT SUPPOSITORY TO GLYCERINE GIFRER CHILDREN, suppository AND WHAT IT IS USED FOR?
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. BEFORE YOU USE SUPPOSITORY FOR GLYCERINE GIFRER CHILDREN, suppository?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never give your child SUPPOSITORY TO GLYCERINE GIFRING CHILDREN, suppository:
· If your child is allergic to glycerol or to any of the other ingredients listed under "Additional Information";
· If your child has obstructive colopathy, given 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 CHILDREN GIFRER, suppository:
· If your child has an intestinal disease called ulcerative colitis;
· If your child is suffering at the anus (anal fissure, hemorrhoid crisis).
In these situations, it is best to avoid the use of this drug.
The use of rectal laxatives in children must be exceptional: it must take into account the risk of impairing the normal functioning of the defecation reflex.
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
Not applicable.
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 FOR GLYCERINE GIFRING CHILDREN, suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Always take the dose indicated in this leaflet. If in doubt, consult your pharmacist.
· If your child is constipated : The usual dose is 1 to 2 suppositories per day to get one saddle per day.
· If your child prepares an examination of the rectum : The usual dose is 1 suppository, to use 5 to 30 minutes before the hour of the examination.
The treatment of constipation should not, on average, exceed 10 days.
Mode of Administration
This drug is used rectally. The suppository should be inserted at the anus. If necessary, you can soften the suppository in cold water to facilitate its introduction.
Symptoms and Instructions for Overdose
If you have given your child more SUPPOSITORY TO GLYCERINE GIFER CHILDREN, suppository you should:
Risk of proctitis and / or diarrhea.
Lower doses or discontinue treatment. 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 CHILDREN, 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 CHILDREN, suppository?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use SUPPOSITORY WITH GLYCERINE GIFRER CHILDREN, 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 does SUPPOSITORY TO GLYCERINE GIFRAGE CHILDREN contain, suppository?
The active substance is:
Glycerol ................................................. .................................................. ......................................... 1.25 g
For a suppository of 2.08 g.
The other components are:
Gelatin, purified water.
Pharmaceutical form and content
What is GLYCERINE GIFRER CHILD SUPPOSITORY, suppository and contents of the outer packaging?
This medication is in the form of a 10, 30 or 60 suppository suppository.
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
8-10 RUE PAUL BERT
69150 DECINES-CHARPIEU
exploiting
GIFRER BARBEZAT
8-10 RUE PAUL BERT
69153 DECINES CEDEX
Maker
GIFRER BARBEZAT
8-10 RUE PAUL BERT
69153 DECINES CEDEX
or
PHARMACEUTICAL PRODUCTION AND HYGIENE PRODUCTION COMPANY - SPPH
7 IMPASSE OF 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
TIPS / THERAPEUTIC EDUCATION
Occasional constipation:
It may be related to a recent change in lifestyle (travel). The drug may be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-term constipation):
It can be linked to two causes:
· a disease of the intestine that requires treatment by the physician,
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Special case of the child:
In children, the treatment of constipation is based on lifestyle and dietary measures and in particular:
· the use of the right amount of water with infant milk powders,
· a diet rich in products of vegetable origin,
· an addition of fruit juice.
It is helpful to seek advice from your doctor or pharmacist.