NOTICE
ANSM - Last updated: 07/06/2017
Description of the Medicine
MOVICOL, powder for oral solution in sachet
Macrogol 3350, sodium bicarbonate, potassium chloride, sodium chloride
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Please read this leaflet carefully before you start taking this medication because it contains important information for you.
You should always take this medication exactly as prescribed by your doctor or pharmacist.
AT· Keep this leaflet. You might need to read it again.
AT· Contact your pharmacist for advice or information.
AT· If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. See section 4.
AT· You should contact your doctor if you experience no improvement or feel less well after a few days.
What is in this leaflet?
1. What is MOVICOL powder for oral solution in sachets and in which cases is it used?
2. What should be known before taking MOVICOL powder for oral solution in sachets?
3. How to take MOVICOL powder for oral solution in sachet?
4. What are the possible undesirable effects?
5. How to store MOVICOL powder for oral solution in sachets?
6. Contents of the package and other information.
1. WHAT IS MOVICOL powder for oral solution in sachets AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code: A06AD65.
This medication is indicated in:
AT· Symptomatic treatment of constipation in the adult.
AT· Treatment of fetal impaction in adults. The fecal impaction is defined as an accumulation of matter in the rectum with absence of evasion for several days.
2. BEFORE YOU TAKE MOVICOL powder for oral solution in sachet?
Never take MOVICOL powder for oral solution in sachets:
AT· If you are allergic (hypersensitive) to active substances (eg macrogol) or to any of the other ingredients of MOVICOL mentioned in section 6.
AT· If you suffer from severe inflammatory bowel or bowel disease.
AT· If you have abdominal pain with an undiagnosed cause or if you are suffering from intestinal obstruction (stopping material in a part of the intestine).
Warnings and Precautions
Talk to your doctor or pharmacist before taking MOVICOL.
The liquid contained in MOVICOL after reconstitution with water does not replace the regular water supply. Sufficient water intake must be maintained.
Your doctor may decide to interrupt your treatment if you show signs of a change in the amount of mineral salts and water in your body (especially if you have dehydration or outbreaks of cardiac insufficiency).
MOVICOL may decrease the absorption of other medicines (see Other medicines and MOVICOL powder for oral solution in sachets).
One of the active ingredients of this medication is macrogol (also called polyethylene glycol). Very rare allergic manifestations (rash on skin, swelling, swelling) have been reported with products containing polyethylene glycol. If any of these signs occur, contact a physician immediately.
In case of diet without salt or low salt, take into account the sodium content: each sachet contains 190 mg of sodium.
This medicine contains 26.38 mg of potassium per sachet, so tell your doctor if you have any kidney problems.
NO EXTENDED USE WITHOUT MEDICAL ADVICE.
The efficacy and safety of MOVICOL in the treatment of fecal have not been studied.
children
Not applicable.
Other medicines and MOVICOL, powder for oral solution in sachet
MOVICOL may decrease the absorption of other medicines taken simultaneously, for example, medicines that treat epilepsy, which may reduce their effectiveness. If you are taking a treatment against epilepsy, talk to your doctor before taking MOVICOL.
The usual oral treatments should not be taken in the hour prior to the intake of MOVICOL.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MOVICOL, powder for oral solution in sachets with food and beverages
Not applicable.
Pregnancy and breast feeding
MOVICOL can be used during pregnancy and breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Driving and using machines
MOVICOL does not influence the ability to drive or operate machinery.
MOVICOL powder for oral solution in sachet contains potassium and sodium.
3. HOW TO TAKE MOVICOL powder for oral solution in sachet?
Dosage
RESERVED FOR ADULTS.
The dosage is 1 to 2 sachets per day to take preferably in a single dose, in the morning. It is usually useless to exceed 1 sachet per day in the elderly. The effect of MOVICOL is manifested within 24 to 48 hours of administration.
In case of fecal impaction, the recommended dose is 8 sachets per day, divided into 2 daily intakes of 4 sachets in 500 ml of water, morning and evening, for a period of e ranging from 1 to 3 days. The administration will be arrested once a satisfactory evacuation of the accumulated fecal matter has been obtained. Particular measures will be put in place to minimize the risk of re-infection.
Method of Administration
Oral use.
Each sachet should be dissolved in a glass of water.
If you have taken more MOVICOL powder for oral solution in sachet than you should have
Diarrhea may occur. This usually disappears 24 to 48 hours after the treatment has stopped or after the dose has been reduced. In case of severe fluid loss by vomiting and / or diarrhea, stomach pain, consult your doctor.
If you forget to take MOVICOL, powder for oral solution in sachet
Not applicable.
If you stop taking MOVICOL, powder for oral solution in sachet
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
AT· Diarrha © e,
AT· Abdominal pain, nausea, vomiting, bloating,
AT· Very rare cases of allergic manifestations of type of eruption, disorientation, urticaria, respiratory disorders and of edema or even exceptionally anaphylactic reactions,
AT· redness,
AT· Headaches,
AT· Hyperkalemia or hypokalemia,
AT· Edema (swelling) of limbs, especially lower limbs.
Declaration of side effects
If you experience any undesirable effects, talk to your doctor or pharmacist. This also applies to any undesirable effects not mentioned in this leaflet. You can also report undesirable effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (NSAH) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting adverse effects, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MOVICOL powder for oral solution in sachet?
Keep this medication out of the reach and sight of children.
Do not use this medicine after the expiration date stated on the outer packaging after EXP. The redemption date refers to the last day of that month.
Keep in the outer package, away from moisture.
After reconstitution: the reconstituted solution is stored for 6 hours at + 2 ° C to + 8 ° C (in a closed container).
Any solution not used within 6 hours should be discarded.
Do not throw any medicines into the sewer or the household garbage. Ask your pharmacist to discontinue the medications you are no longer using. These measures will help to protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MOVICOL contains, powder for oral solution in sachet
AT· The active substances are:
Macrogol 3350 ................................................ .................................................. ... 13,1250 g
Sodium bicarbonate............................................... .................................................. .. 0.1785 g
Potassium chloride............................................... .................................................. .. 0.0466 g
Sodium Chloride ............................................... .................................................. ....... 0.3507 g
For a sachet.
AT· The other components are: lemon tree *, potassium acesulfame (E950).
* Composition of lemon tree: vegetable gum (E414), maltodextrin, lemon essential oil, lime essential oil, citral and citric acid (E330).
What is MOVICOL powder for oral solution in sachets and contents of the outer packaging
This medication is in powder form for oral solution. Box of 20 bags.
Holder of the marketing authorization
NORGINE PHARMA
2 RUE JACQUES DAGUERRE
92500 RUEIL-MALMAISON
Operator of the marketing authorization
NORGINE PHARMA
2 RUE JACQUES DAGUERRE
92500 RUEIL-MALMAISON
Maker
MACORS LABORATORIES
RUE DES CAILLOTTES
ZI PLAINE DES ISLES
89000 AUXERRE
Or
Sophartex
21 RUE DU PRESSOIR
28500 VERNOUILLET
Or
NORGINE LIMITED
NEW ROAD
TIR-Y-BETH, HENGOED
MID GLAMORGAN
WALES CF82 8SJ
UK
Names of medicines in the Member States of the European Economic Area
Not applicable.
The last day on which this notice was revised is as follows:
[To be completed subsequently by the Contractor]
Other
Detailed information on this medicinal product can be found on the website of the ANSM (France).
HOW TO REDUCE THE RISK OF RECOVERY?
Occasional constipation
It may be related to a recent change in lifestyle (eg travel). The medication can be an aid in short treatment. Any recent constipation unexplained by the change in lifestyle, any constipation accompanied by pain, fever, swelling of the belly should have the physician's opinion sought.
Chronic constipation (long-lasting constipation)
It can be related to two causes:
AT· or to a disease of the bowel which requires a care by the doctor,
AT· or to an imbalance in intestinal function due to eating habits and lifestyle.
Treatment includes:
AT· an increase in dietary intakes of products of vegetable origin (green vegetables, raw vegetables, wholemeal bread, fruits ...);
AT· increased consumption of water and fruit juices;
AT· an increase in physical activities (sport, market, etc.);
AT· a re-education of the defecation reflex;
AT· sometimes, the addition of sound to food.