NOTICE
ANSM - Last updated: 06/01/2012
Name of the medicinal product
HEPARGITOL, oral powder in bi-pocket pouch
framed
Read this leaflet carefully before you start taking 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 HEPARGITOL, oral powder in a dual-bag pouch AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE HEPARGITOL, oral powder in a bi-pocket sachet?
3. HOW TO TAKE HEPARGITOL, oral powder in a bi-pocket pouch?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HEPARGITOL, oral powder in a bi-pocket pouch?
6. ADDITIONAL INFORMATION
1. WHAT IS HEPARGITOL, oral powder in a dual-bag pouch AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication helps digestion and is laxative.
It is recommended in case of difficult digestion and in case of constipation.
2. BEFORE YOU TAKE HEPARGITOL, oral powder in a bi-pocket sachet?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take HEPARGITOL oral powder in a two-pocket sachet in the following cases:
· certain diseases of the intestine and colon
· in case of abdominal pain (stomach pains).
IN CASE OF DOUBT, IT IS ESSENTIAL TO REQUEST THE NOTICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with HEPARGITOL, oral powder in a bi-pocket pouch:
Warnings
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, any 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 bowel disease that requires management by the physician
· or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
· an increase in dietary intakes of products of vegetable origin (green vegetables, raw vegetables, whole bread, fruits ...)
· an increase in the consumption of water and fruit juices:
· an increase in physical activities (sports, walking ...)
· rehabilitation of defecation reflex
· sometimes, adding sound to the diet.
It is helpful to seek advice from your doctor or pharmacist.
Special cases in children:
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, addition of Juice.
Long-term treatment with a laxative is not recommended in children because regular intake may interfere with the normal functioning of the defecation reflex.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use
· In the case of a desiccated diet, take into account in the daily diet 0,277 g of sodium per bi-pocket package.
· Notify doctor in cases of gallbladder stones.
· In case of colitis, decrease the dosage and avoid taking the medication on an empty stomach.
· In case of diabetes, take into account the presence of 0.500 g of sucrose per bipodal package.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
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 thinking 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
List of excipients with known effect: sucrose, sodium
3. HOW TO TAKE HEPARGITOL, oral powder in a bi-pocket pouch?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Pour the contents of the 2 pockets of the package into a half glass of water and shake.
For additional treatment of constipation: take two packages on an empty stomach.
In case of difficult digestion: take the product before meals or at the time of the troubles in half a glass of water.
In adults: 2 to 4 packs per day.
In children over 2 years: 1 to 2 packs per day according to age.
Symptoms and Instructions for Overdose
If you take more HEPARGITOL, oral powder in a bi-pocket pouch than you should:
· risk of diarrhea in case of excessive use.
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, HEPARGITOL, oral powder in a bi-pocket sachet is likely to have undesirable effects, although not everyone is subject to it:
· diarrhea
· abdominal pain.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE HEPARGITOL, oral powder in a bi-pocket pouch?
Keep out of the reach and sight of children.
Expiration date
Do not use HEPARGITOL, oral powder in a bi-pocket sachet after the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
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 HEPARGITOL, oral powder in a bi-pocket pouch contain?
The active substances are :
Pocket A
Sorbitol ................................................. .................................................. ....................................... 1.8450 g
Citric acid ................................................ .................................................. 0.8780 g
For a pocket.
Pocket B
Arginine Hydrochloride .............................................. .................................................. .................... 0.5000 g
Sorbitol ................................................. .................................................. ....................................... 1.5700 g
Anhydrous sodium sulfate .............................................. .................................................. .............. 0.0660 g
Sodium hydrogenphosphate ............................................... .................................................. ..... 0.190 g
For a pocket.
The other components are :
Pocket A: Sucrose, essential oil of orange, essential oil of concentrated natural lemon.
Pocket B: sodium bicarbonate, sucrose.
Pharmaceutical form and content
What is HEPARGITOL, oral powder in bi-pocket sachets and contents of the pack?
This medication is in the form of an oral powder in a bi-pocket sachet. Box of 10 or 20 bags.
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
LABORATORY OF ELERT THERAPEUTIC ACHIEVEMENTS
181 - 183, ANDRE KARMAN STREET
BP 101
93303 AUBERVILLIERS CEDEX
exploiting
Not specified.
Maker
Not specified.
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.