NOTICE
ANSM - Updated: 30/05/2014
Name of the drug
GLYCERIN MAYOLY SPINDLER INFANT SUPPOSITORY, suppository
Glycerol
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If the symptoms get worse or persist, consult a doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary record
In this notice :
1. What is GLYCERIN MAYOLY SPINDLER INFANT SUPPOSITORY, suppository and in what cases is it used?
2. What you need to know before you give GLYCERIN MAYOLY SPINDLER INFANTS, suppository ?
3. How to use GLYCERINE MAYOLY SPINDLER NOURISHING SUPPOSITORY, suppository?
4. What are the possible side effects?
5. How to store GLYCERIN MAYOLY SPINDLER INFANT SUPPOSITORY, suppository?
6. Additional information.
1. WHAT IS SUPPOSITORY TO GLYCERIN MAYOLY SPINDLER INFANTS, suppository AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
OTHER LAXATIVES
(A: Digestive system and metabolism)
Therapeutic indications
This medicine is used in certain constipations and as preparation for certain examinations (rectoscopy).
2. BEFORE YOU USE GLYCERINE MAYOLY SPINDLER INFANT SUPPLEMENT, suppository?
List of information needed before taking the medication
Reserved for infants.
Cons-indications
Never give GLYCERINE MAYOLY SPINDLER INFANT SUPPOSITORY, suppository in the following cases:
· Allergy (hypersensitivity) to glycerol or any of the other ingredients mentioned in the "Additional Information" section.
Precautions for use; special warnings
Take special care with GLYCERIN MAYOLY SPINDLER INFANTS, suppository:
· If your child has bowel disease called ulcerative colitis;
· If your child is suffering from the anus (anal fissure, hemorrhoidal 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 hindering the normal functioning of the exoneration reflex.
Interactions with other drugs
Taking or using other medicines:
Tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, even those not prescribed.
Interactions with food and drinks
Not applicable.
Interactions with herbal products 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 GLYCERINE MAYOLY SPINDLER INFANT SUPPOSITORY, suppository?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Rectal way. The suppository must be introduced at the level of the anus.
If necessary, the suppository can be soaked in cold water to facilitate 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 medicine for long periods without consulting your doctor.
Symptoms and instructions in case of overdose
If you have given more GLYCERINE MAYOLY SPINDLER INFANTS than you should have:
Your baby may have diarrhea. In this case, reduce the dose or stop treatment and consult your doctor or pharmacist immediately.
Instructions for omitting one or more doses
If you forget to give GLYCERINE MAYOLY SPINDLER INFANT SUPPOSITORY:
Do not give your infant a double dose to make up for the single dose you forgot to give him.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, suppository can cause side effects, although not everybody gets them:
· Sensation of anal burns;
· Exceptionally congestive rectitises.
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system : National Agency for Drug and Health Product Safety (Ansm) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr . By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE GLYCERIN MAYOLY SPINDLER INFANTS SUPPLEMENT, suppository?
Keep this medicine out of the sight and reach 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, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does GLYCERIN MAYOLY SPINDLER INFANT SUPPOSITORY contain, 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 GLYCERIN MAYOLY SPINDLER INFANT SUPPOSITORY, suppository and contents of the pack?
This drug comes in the form of suppositories in boxes of 10 or 30 suppositories.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CEDEX SHATOU
exploiting
MAYOLY SPINDLER LABORATORIES
6 AVENUE OF EUROPE
BP 51
78401 CEDEX SHATOU
Maker
VERNIN GALENIC Laboratories
20 LOUIS-CHARLES VERNIN STREET
77190 DAMMARIE-LES-LYS
Names of the medicine in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm (France) website.
Information reserved for health professionals
Not applicable.
Other
ADVICE / THERAPEUTIC EDUCATION
Occasional constipation:
It may be related to a recent lifestyle change (travel). The drug can be a help in short treatment. Any recent constipation unexplained by the change of lifestyle, any constipation accompanied with pains, fever, swelling of the belly must seek the advice of the doctor.
Chronic constipation (long-term constipation):
It can be related to two causes:
· a bowel disease that requires management by the doctor,
· or an imbalance in bowel function due to dietary habits and lifestyle.
Special case of the infant:
In infants, the treatment of constipation is based on lifestyle and dietetic measures including:
· the use of the right amount of water with infant milk powders,
· a diet rich in products of plant origin,
· an addition of fruit juice.
It is helpful to consult your doctor or pharmacist.