NOTICE
ANSM - Last updated: 30/05/2014
Name of the medicinal product
SUPPOSITORY FOR GLYCERINE MAYOLY SPINDLER 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 is SUPPOSITORY FOR GLYCERINE MAYOLY SPINDLER INFANTS, suppository and in which cases is it used?
2. What should be known before giving SUPPOSITORY TO GLYCERINE MAYOLY SPINDLER INFANTS, suppository ?
3. How to use SUPPOSITORY FOR GLYCERINE MAYOLY SPINDLER INFANTS, suppository?
4. What are the possible side effects?
5. How to store SUPPOSITORY FOR GLYCERINE MAYOLY SPINDLER INFANTS, suppository?
6. Additional information.
1. WHAT SUPPOSITORY TO GLYCERINE MAYOLY SPINDLER INFANTS, suppository AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
OTHER LAXATIVE
(A: Digestive System and Metabolism)
Therapeutic indications
This medication is used in certain constipations and as preparation for certain examinations (rectoscopy).
2. BEFORE YOU USE SUPPOSITORY WITH GLYCERINE MAYOLY SPINDLER INFANTS, suppository?
List of information needed before taking the medication
For infants only.
Cons-indications
Never give SUPPOSITORY TO GLYCERINE MAYOLY SPINDLER INFANTS, suppository in the following cases:
· Allergy (hypersensitivity) to glycerol or any of the other ingredients mentioned in "Additional Information".
Precautions for use; special warnings
Take special care with GLYCERINE MAYOLY SPINDLER INFANTS, 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.
In children the prescription of rectal laxatives must be exceptional: it must take into account the risk of impeding the normal functioning of the exemption reflex.
Interaction with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medication, even if it is a nonprescription medicine.
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 MAYOLY SPINDLER INFANTS, suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Rectal route. The suppository should be inserted at the anus.
If necessary, the suppository can be soaked in cold water to facilitate its introduction.
Infants: 1 suppository 5 to 30 minutes before the time chosen for the exemption with interruption of 24 hours every 3 days.
The treatment of constipation should not, on average, exceed 10 days.
You should not use this medication for long periods of time without consulting your doctor.
Symptoms and Instructions for Overdose
If you have given more SUPPOSITORY TO GLYCERINE MAYOLY SPINDLER INFANTS than you should:
Your infant may have diarrhea. In this case, decrease the dose or stop the treatment and consult your doctor or pharmacist immediately.
Instructions for omission of one or more doses
If you forget to give SUPPOSITORY TO GLYCERINE MAYOLY SPINDLER INFANTS:
Do not give your infant double dose to make up for the single dose you have forgotten to give it.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, suppository is likely to have undesirable effects, although not everyone is subject to it:
· Sensation of anal burns;
· Exceptionally rectified congestive.
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 MAYOLY SPINDLER INFANTS, suppository?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use after the expiry date stated on the package.
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 FOR GLYCERINE MAYOLY SPINDLER INFANTS, suppository?
The active substance is :
Glycerol ................................................. .................................................. ......................................... 0.69 g
For a suppository of 1.15 g.
The other components are :
Gelatin, purified water.
Pharmaceutical form and content
What is SUPPOSITORY FOR GLYCERINE MAYOLY SPINDLER INFANTS, suppository and contents of the outer packaging?
This medication is in the form of 10 or 30 suppository 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
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CHATOU CEDEX
exploiting
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CHATOU CEDEX
Maker
Laboratories GALENICS VERNIN
20 RUE LOUIS-CHARLES VERNIN
77190 DAMMARIE-LES-LYS
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 infant:
In infants, 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.