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.