NOTICE
ANSM - Last updated: 07/09/2015
Name of the medicinal product
EDUCTYL CHILDREN, effervescent suppository
Potassium Acid Tartrate / Sodium Bicarbonate
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 EDUCTYL CHILDREN, effervescent suppository AND WHAT IT IS USED FOR?
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE USING EDUCTYL CHILDREN, effervescent suppository?
3. HOW TO USE EDUCTYL CHILDREN, effervescent suppository?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE EDUCTYL CHILDREN, effervescent suppository?
6. ADDITIONAL INFORMATION
1. WHAT IS EDUCTYL CHILDREN, effervescent suppository AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication is a rectal laxative. It acts by triggering the defecation reflex.
This medication is recommended in certain constipations and as preparation for certain examinations of the rectum (rectoscopy).
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE USING EDUCTYL CHILDREN, effervescent suppository?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use EDUCTYL CHILDREN, effervescent suppository in the following cases:
· Hypersensitivity to the active substance or to any of the components.
· If your child is suffering from severe abdominal pain of undetermined origin.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with EDUCTYL CHILDREN, effervescent suppository:
Caution
NO PROLONGED USE WITHOUT MEDICAL ADVICE
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.
Treatment includes:
· an increase in dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruit ...)
· an increase in the consumption of water and fruit juices
· an increase in physical activities (sports, walking ...)
· rehabilitation of defecation reflex
· sometimes, the addition of sound to the diet.
It is helpful to seek advice from your doctor or pharmacist.
Special case of the child:
In children the treatment of constipation is based on lifestyle and dietary measures: in particular the use of the right amount of water with infant milk powders, a diet rich in vegetable products, Juice.
Treatment with rectal laxatives without medical advice is contraindicated (regular intake may interfere with the normal functioning of the defecation reflex).
Precautions for use
In case of anal fissure, ask your doctor for advice.
NEVER LEAVE TO CHILDREN.
Interaction with other medicines
Taking or using other medicines:
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - breastfeeding
This medication under normal conditions of use can be used occasionally during pregnancy and lactation.
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 EDUCTYL CHILDREN, effervescent suppository?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
The dosage is on average 1 suppository per day, a few minutes before the time chosen for the exemption.
Symptoms and Instructions for Overdose
If you used more EDUCTYL CHILDREN, effervescent suppository than you should:
Prolonged use may cause anal burns and inflammation of the rectum.
If you have given your child more EDUCTYL CHILDREN, an effervescent suppository that should not be used, consult your doctor.
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, this medicine may cause side effects, although not everybody gets them.
· rarely 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 via 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 EDUCTYL CHILDREN, effervescent suppository?
Keep out of the reach and sight of children.
Expiration date
Do not use EDUCTYL CHILDREN, effervescent suppository after the expiry date stated on the outer packaging.
Storage conditions
Keep away from heat and moisture.
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 EDUCTYL ENFANTS contain, effervescent suppository?
The active substances are :
Potassium Acid Tartrate .............................................. .................................................. ........... 0.5750 g
Sodium bicarbonate ............................................... .................................................. ................. 0.3500 g
For a suppository.
The other components are :
Soy lecithin, talc, solid hemi-synthetic glycerides (Witepsol H 15).
Pharmaceutical form and content
What is EDUCTYL ENFANTS, effervescent suppository and contents of the outer packaging?
This medication is in the form of an effervescent suppository. Box of 12 effervescent 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
TECHNI-PHARMA LABORATORIES
7, RUE DE L'INDUSTRIE
BP 717
98014 MONACO CEDEX
exploiting
TECHNI-PHARMA LABORATORIES
7, RUE DE L'INDUSTRIE
MC 98000 MONACO
Maker
TECHNI-PHARMA LABORATORIES
7, RUE DE L'INDUSTRIE
MC 98000 MONACO
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.