NOTICE
ANSM - Last updated: 17/08/2017
Name of the medicinal product
CHLORUMAGENE, oral powder
Magnesium (hydroxide)
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is CHLORUMAGENE, oral powder and in which cases it is used?
2. What should be known before taking CHLORUMAGENE, oral powder?
3. How to take CHLORUMAGENE, oral powder?
4. What are the possible side effects?
5. How to store CHLORUMAGENE, oral powder?
6. Package contents and other information.
1. WHAT IS CHLORUMAGENE, ORAL POWDER AND IN WHAT CASES IS IT USED?
This medication is a laxative (it stimulates intestinal evacuation).
This medication is recommended in occasional constipation, it usually works in 6 to 8 hours.
You should talk to your doctor if you do not feel better or feel less well.
2. BEFORE YOU TAKE CHLORUMAGENE, oral powder?
Do not take CHLORUMAGENE, oral powder:
· in case of chronic constipation,
· in the case of certain diseases of the intestine and the colon (rectocolitis, Crohn's disease ...),
· in case of abdominal pain (stomach pains),
· in patients with severe renal insufficiency,
· in children under 12 years of age without the prescription of a doctor.
Warnings and Precautions
Caution
NO EXTENDED USE (ABOVE 8 DAYS) 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 should not be treated with a stimulant laxative.
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 products of vegetable origin (green vegetables, raw vegetables, wholemeal bread, fruits ...)
· 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 food
It is helpful to seek advice from your doctor or pharmacist.
Precautions for use
This medicine may cause loss of potassium. Combination with other medications (such as certain diuretics or certain heart medicines) can be dangerous.
Talk to your doctor or pharmacist before taking CHLORUMAGENE, oral powder .
children
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 vegetable products, of fruit juice.
Treatment with a stimulatory laxative without medical advice is contraindicated. (Regular intake of laxatives in young age may interfere with the normal functioning of the defecation reflex).
Other medicines and CHLORUMAGENE, oral powder
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
CHLORUMAGENE, oral powder with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist > before taking this medication.
Driving and using machines
Not applicable.
CHLORUMAGENE, oral powder contains
Not applicable.
3. HOW TO TAKE CHLORUMAGENE, oral powder?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
The recommended dose is an average of 1 teaspoonful in the evening at bedtime or in the morning on an empty stomach.
Take diluted in a glass of water.
Treatment should be short-term (8 to 10 days maximum).
If the effect of the treatment is insufficient, do not increase the dose or prolong the use, but ask your doctor.
In all cases strictly comply with your doctor's prescription.
If you take more CHLORUMAGENE, oral powder than you should have
Diarrhea can be observed in case of overdose. If you have taken or given more CHLORUMAGENE, oral powder than it was needed, or longer, contact your doctor.
If you forget to take CHLORUMAGENE, oral powder
Not applicable.
If you stop taking CHLORUMAGENE, oral powder
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· diarrhea, stomach pain: in this case stop treatment and seek advice from your doctor.
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 CHLORUMAGENE, oral powder?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What CHLORUMAGENE contains, oral powder
· The active substance is:
Magnesium hydroxide ............................................... .................................................. 100 g
What is CHLORUMAGENE, oral powder and contents of the pack
This medication is in the form of an oral powder.
Box of 100 g.
Marketing Authorization Holder
SOCIETY OF STUDIES AND PHARMACEUTICAL RESEARCH (SERP)
5, RUE DU GABIAN
BUILDING "LE TRITON"
98000 MONACO
MONACO
Marketing Authorization Operator
SOCIETY OF STUDIES AND PHARMACEUTICAL RESEARCH (SERP)
5, RUE DU GABIAN
BUILDING "LE TRITON"
98000 MONACO
MONACO
Maker
SOCIETY OF STUDIES AND PHARMACEUTICAL RESEARCH (SERP)
5, RUE DU GABIAN
BUILDING "LE TRITON"
98000 MONACO
MONACO
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
<{MM / YYYY}> <{YYYY month}.>
Other
Detailed information on this medicine is available on the ANSM website (France).