NOTICE
ANSM - Last updated: 13/02/2013
Name of the medicinal product
JAMYLENE 50 mg coated tablet
Sodium Docusate
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 your doctor.
· 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 JAMYLENE 50 MG, coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE JAMYLENE 50 mg coated tablet?
3. HOW TO TAKE JAMYLENE 50 mg coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE JAMYLENE 50 mg, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT JAMYLENE 50 MG, coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication is a laxative that essentially works by altering the consistency of the stool.
It is indicated in occasional constipations.
2. BEFORE YOU TAKE JAMYLENE 50 mg coated tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take JAMYLENE 50 mg coated tablets in the following cases:
· certain diseases of the intestine and colon (rectocolitis, crohn's disease),
· in case of abdominal pain (stomach pains) of unexplained cause,
· in the case of chronic constipation (long-lasting constipation),
· in children under 6 years of age.
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 JAMYLENE 50 mg coated tablet:
Special 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 a change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen, must have the physician's opinion sought.
· Chronic constipation (long-term constipation):
It can be linked to two causes:
o or to a bowel disease that requires treatment by the physician,
o or an imbalance in intestinal function due to dietary habits and lifestyle.
Treatment includes:
o an increase in dietary intakes of vegetable origin (green vegetables, raw vegetables, wholemeal bread, fruits ...)
o an increase in the consumption of water and fruit juices,
o an increase in physical activities (sports, walking ...)
o a rehabilitation of the defecation reflex,
o sometimes adding sound to the diet.
It is helpful to seek advice from the doctor or pharmacist.
· Special case of the child :
In children, the treatment of constipation is based on lifestyle and dietary measures: in particular, use of the right amount of water with infant milk powders, a diet rich in plant-based products, addition of fruit juice.
Regular intake of laxatives in young age may interfere with the normal functioning of the defecation reflex.
This medicine contains castor oil and can cause digestive problems (mild laxative effect, diarrhea).
This medicine contains sucrose. Its use is not recommended in patients with intolerance to sucrose (rare hereditary disease).
This medicine contains an azo agent (E 110) and may cause allergic reactions.
Precautions for use
· This medication is not recommended during the first trimester of pregnancy and during the breastfeeding period.
· Taking paraffin oil at the same time as this treatment is discouraged.
· As this medication may cause loss of potassium, the combination with other medicines may be hazardous in particular with:
o certain diuretics: medicines prescribed in high blood pressure, and in certain heart diseases.
o certain medicines for the heart (digitalis, antiarrhythmics ...)
o corticosteroids
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
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
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: peanut oil, castor oil, sucrose.
3. HOW TO TAKE JAMYLENE 50 mg coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage / Mode of Administration / Administration Frequency / Duration of Treatment
· This treatment should be of short duration.
· The usual dosage is 2 to 6 tablets per day to be divided into one or two doses.
· In children over six years of age, this dose will be reduced by half.
· The effect of this drug usually only occurs after 24 hours.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
Not applicable.
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, JAMYLENE 50 mg coated tablet is likely to have side effects, although not everyone is subject to it:
· Possibility of diarrhea, abdominal pain, decreased blood potassium (monitoring of this treatment may include control of potassium in the blood).
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 JAMYLENE 50 mg, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use JAMYLENE 50 mg coated tablets after the expiry date which is stated on the carton.
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 contains JAMYLENE 50 mg coated tablet?
The active substance is:
Sodium docusate ............................................... .................................................. ......................... 50 mg
For a coated tablet.
The other components are:
Hydrated silica, neutral calcium phosphate, polyvidone excipient, crosslinked polyvidone (vinyl-1-pyrrolidone-2 homopolymer), hydrogenated castor oil.
Coating : shellac, gum arabic, talc, cellulose acetophthalate, sucrose, polysorbate 60, titanium dioxide, orange yellow S (E 110), wax E (Montan ester) (1) , carnauba wax.
(1)Composition of wax E (ester of Montan) : ethylene glycol esterified by acids extracted from Montan wax, mainly montanic acid.
Pharmaceutical form and content
What is JAMYLENE 50 mg, coated tablet and contents of the pack?
This medication is in the form of a coated tablet. Boxes of 40 or 400.
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
AJC INVEST
6, rue de la Rochefoucauld
16000 ANGOULEME
exploiting
PHARMA DEVELOPMENT
Industrial Zone of Corbigny
Chemin de Marcy
58800 CORBIGNY
Maker
LABORATORY AJC PHARMA
Fontaury Factory
16120 Chateauneuf-sur-Charente
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.