NOTICE
ANSM - Updated on : 30/05/2014
Product name
MAYOLY SPINDLER CHILDREN GLYCERIN SUPPOSITORY, suppository
Glycerol
Box
Please read this leaflet carefully before using this medicine. It contains important information for your treatment.
If you have any further questions, please ask your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If symptoms worsen or persist, consult a doctor .
- If you notice any side effects not mentioned in this leaflet, or if you experience any of the effects mentioned as serious, please tell your doctor or pharmacist.
Contents
In this leaflet :
1. What is MAYOLY SPINDLER CHILDREN GLYCERIN SUPPOSITORY, suppository and what is it used for?
2. What do I need to know before using GLYCERIN SUPPOSITORY MAYOLY SPINDLER CHILDREN, suppository ?
3. How do I use MAYOLY SPINDLER CHILDREN'S GLYCERIN SUPPOSITORY, suppository?
4. What are the possible side effects?
5. How to store SUPPOSITOIRE A LA GLYCERINE MAYOLY SPINDLER ENFANTS, suppositoire?
6. Further information.
1. WHAT IS MAYOLY SPINDLER CHILDREN'S GLYCERIN SUPPOSITORY, suppository AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
OTHER LAXATIVES
(A: Digestive system and metabolism)
Therapeutic indications
This medicine is used in certain cases of constipation and as a preparation for certain examinations (rectoscopy).
2. WHAT DO I HAVE TO KNOW BEFORE USING MAYOLY SPINDLER CHILDREN'S GLYCERIN SUPPOSITORY, suppository?
List of information required before taking the medicine
For children only.
Contraindications
Never give MAYOLY SPINDLER CHILDREN GLYCERIN SUPPOSITORY in the following cases:
- Allergy (hypersensitivity) to glycerol or to any of the other ingredients listed under "Additional information".
Precautions for use; special warnings
Take special care with GLYCERIN SUPPOSITORY MAYOLY SPINDLER CHILDREN, suppository:
- If your child has a bowel disease called ulcerative colitis;
- If your child suffers from anal fissures or haemorrhoids.
In these situations, it is preferable to avoid using this medication.
Rectal laxatives should only be prescribed to children in exceptional cases, taking into account the risk of interfering with the normal functioning of the excretion reflex.
Interactions with other drugs
Taking or using other medicines:
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, even those obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breast-feeding
Not applicable.
Sportsmen
Not applicable.
Effects on ability to drive vehicles or use machines
Not applicable.
List of excipients
Not applicable.
3. HOW TO USE MAYOLY SPINDLER CHILDREN GLYCERIN SUPPOSITORY, suppository?
Instructions for proper use
Not applicable.
Posology, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Rectal route. The suppository should be inserted into the anus.
If necessary, the suppository can be soaked in cold water to facilitate introduction.
Children aged 2 to 6: the usual dose is 1 suppository 5 to 30 minutes before bowel movements.
Children over 6 years: the usual dose is 1 suppository 5 to 30 minutes before the time of bowel movement. This dose may be repeated once in the next half-hour or hour if your child is still constipated.
On average, treatment of constipation should not exceed 10 days.
Do not use this medicine for prolonged periods without consulting your doctor.
Symptoms and instructions in case of overdose
If you have given your child more MAYOLY SPINDLER CHILDREN GLYCERIN SUPPOSITORY than you should have :
Your child may have diarrhoea. In this case, reduce the dose or stop treatment and consult your doctor or pharmacist immediately.
Instructions in case of missed dose(s)
If you forget to give your child MAYOLY SPINDLER CHILDREN'S GLYCERIN SUPPOSITORY :
Do not give your child a double dose to make up for the single dose you forgot to give.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, GLYCERIN SUPPOSITORY MAYOLY SPINDLER CHILDREN, suppository is likely to have undesirable effects, although not everyone is subject to them:
- Sensation of anal burning;
- Exceptional cases of congestive rectitis.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system : Agence nationale de sécurité du médicament et des produits de santé (Ansm) and the network of Centres Régionaux de Pharmacovigilance. Website: www.ansm.sante.fr. By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE MAYOLY SPINDLER CHILDREN'S GLYCERIN SUPPOSITORY, suppository?
Keep out of sight and reach of children.
Expiration date
Do not use after the expiration date shown on the packaging.
Storage conditions
Store at temperatures not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of in the sewage system or with household waste. Ask your pharmacist what to do with unused medicines. These measures will help protect the environment.
6. FURTHER INFORMATION
Complete list of active ingredients and excipients
What does SUPPOSITORY WITH GLYCERIN MAYOLY SPINDLER CHILDREN, suppository contain?
The active substance is :
Glycerol .......................................................................................................................................... 1.290 g
For a 2.15 g suppository.
Other components are :
Gelatin, purified water.
Pharmaceutical form and contents
What is MAYOLY SPINDLER CHILDREN GLYCERIN SUPPOSITORY, suppository and what does it contain?
This medicine comes in suppository form in boxes of 10 or 30 suppositories.
Name and address of the marketing authorization holder and of the manufacturing authorization holder responsible for batch release, if different
Holder
LABORATOIRES MAYOLY SPINDLER
6 AVENUE DE LEUROPE
BP 51
78401 CHATOU CEDEX
Operator
LABORATOIRES MAYOLY SPINDLER
6 AVENUE DE LEUROPE
BP 51
78401 CHATOU CEDEX
Manufacturer
LABORATOIRES GALENIQUES VERNIN
20 RUE LOUIS-CHARLES VERNIN
77190 DAMMARIE-LES-LYS
Product names in member states of the European Economic Area
Not applicable.
Date of approval of the package leaflet
This leaflet was last approved on {date}.
MA under exceptional circumstances
Not applicable.
Internet information
Detailed information on this product is available on the INSM (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
ADVICE / THERAPEUTIC EDUCATION
Occasional constipation:
May be related to a recent change in lifestyle (travel). The drug can be used as a short-term treatment. Any recent constipation unexplained by a change in lifestyle, or any constipation accompanied by pain, fever or swelling of the abdomen, should be referred to a doctor.
Chronic constipation (long-term constipation):
There are two possible causes:
- or bowel disease, which requires medical attention,
- or an imbalance in intestinal function due to eating habits and lifestyle.
Special case of children:
The treatment of constipation in children is based on lifestyle and dietary measures, in particular:
- using the right amount of water with infant milk powders,
- a diet rich in plant-based products,
- adding fruit juice.
Consult your doctor or pharmacist for advice.