NOTICE
ANSM - Last updated: 05/07/2017
Name of the medicinal product
MOVICOL CHOCOLAT, powder for oral solution in sachet
Macrogol 3350, sodium bicarbonate, potassium chloride, sodium chloride
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 MOVICOL CHOCOLAT powder for oral solution in sachets and in which cases it is used?
2. What should I know before taking MOVICOL CHOCOLAT powder for oral solution in sachets?
3. How to take MOVICOL CHOCOLAT powder for oral solution in sachet?
4. What are the possible side effects?
5. How to store MOVICOL CHOCOLAT powder for oral solution in sachets?
6. Package contents and other information.
1. WHAT IS MOVICOL CHOCOLATE, Powder for oral solution in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group - ATC code: A06AD65.
MOVICOL CHOCOLAT belongs to the class of osmotic laxatives. Osmotic laxatives are drugs that keep water in your gut.
This medication is used if you are suffering from:
· of constipation,
· of fecal impaction. Fecal impaction is defined as an accumulation of fecal matter in the rectum with no evacuation for several days.
MOVICOL CHOCOLAT is for adults only.
2. BEFORE YOU TAKE MOVICOL CHOCOLATE, powder for oral solution in sachet?
Never take MOVICOL CHOCOLAT powder for oral solution in sachet:
· If you are allergic (hypersensitive) to active substances (eg macrogol) or any of the other ingredients of MOVICOL CHOCOLAT listed in section 6.
· If you are suffering from a severe inflammatory bowel or bowel disease.
· If you have abdominal pain of indeterminate 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 CHOCOLAT powder for oral solution in sachets.
The liquid contained in MOVICOL CHOCOLAT after reconstitution with water does not replace the regular water supply. Sufficient water intake must be maintained.
· Your doctor may decide to discontinue your treatment if you have signs of a change in the amount of mineral salts and water in your body (such as dehydration or heart failure).
· MOVICOL CHOCOLAT may decrease absorption of other medicines (see Other medicines and MOVICOL CHOCOLAT powder for oral solution in sachets).
· One of the active ingredients of this drug is macrogol (also called polyethylene glycol). Very rare allergic manifestations (rash on the skin, itching, swelling) have been reported with products containing polyethylene glycol. If any of these signs occur, contact a doctor immediately.
· In case of diet without salt or low in salt, take into account the sodium content; each sachet contains 190 mg of sodium.
· This medication contains 26.38 mg potassium per sachet, tell your doctor if you have kidney failure.
NO PROLONGED USE WITHOUT MEDICAL ADVICE.
The efficacy and safety of MOVICOL CHOCOLAT in the treatment of fecal matter have not been studied.
children
Not applicable.
Other medicines and MOVICOL CHOCOLAT, powder for oral solution in sachet
MOVICOL CHOCOLAT may decrease the absorption of other medicines taken simultaneously, for example medicines treating epilepsy, which may decrease their effectiveness. If you are taking a treatment for epilepsy, talk to your doctor before taking MOVICOL CHOCOLATE.
Usual oral treatments should not be taken within 1 hour of ingesting MOVICOL CHOCOLAT.
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
MOVICOL CHOCOLAT, powder for oral solution in sachets with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication may be used during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
MOVICOL CHOCOLAT does not influence the ability to drive or use machines.
MOVICOL CHOCOLAT powder for oral solution in sachet contains benzyl alcohol
This medicine contains 14.1 mg of benzyl alcohol per sachet. It may cause allergic reactions.
3. HOW TO TAKE MOVICOL CHOCOLATE, powder for oral solution in sachet?
How many bags should you take?
If you take MOVICOL CHOCOLAT to treat constipation: the usual dose is 1 to 2 sachets per day, preferably in a single dose, in the morning.
The elderly usually do not need to exceed 1 sachet per day.
If you take MOVICOL CHOCOLAT to treat a faecal impaction: the usual dose is 8 sachets per day (4 sachets morning and evening, in 2 doses).
Administration mode
This medication is used orally.
To use this medicine, please follow the instructions below:
Open the sachet.
Pour the contents of the sachet into a glass of water.
Mix the powder with a clean spoon until the mixture becomes clear.
Swallow the mixture.
The mixture can be stored in a closed container for 6 hours in a refrigerator.
Duration of treatment
In the case of constipation, the effect of MOVICOL CHOCOLAT occurs 24 to 48 hours after administration.
In case of fecal impaction, you should take this medication until a satisfactory evacuation of the accumulated fecal matter is obtained. The duration of treatment is on average 1 to 3 days.
To avoid the recurrence of these problems, refer to the section '' How to reduce the risk of recidivism? ''.
If you take more MOVICOL CHOCOLATE powder for oral solution in a sachet than you should have
Diarrhea may occur. This usually disappears 24 to 48 hours after dose reduction. In case of severe fluid loss by vomiting and / or diarrhea, stomach pain, consult your doctor.
If you forget to take MOVICOL CHOCOLAT, powder for oral solution in sachet
Do not take a double dose to make up for a missed dose.
If you stop taking MOVICOL CHOCOLAT, powder for oral solution in sachet
It is possible that faecal impaction returns after stopping treatment. This risk should nevertheless be evaluated by your doctor.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Diarrhea,
· Abdominal pain, nausea, vomiting, bloating,
· Very rare cases of allergic manifestations such as rash, itching, urticaria, respiratory disorders and edema or exceptionally anaphylactic reactions,
· redness,
· Headache,
· Hyperkalemia or hypokalaemia,
· Edema (swelling) of the limbs, especially the lower limbs.
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 MOVICOL CHOCOLAT, powder for oral solution in sachet?
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 outer packaging after EXP. The expiry date refers to the last day of that month.
No special storage conditions.
After reconstitution in water, the solution obtained can be stored for up to 6 hours at a temperature between + 2 ° C and + 8 ° C (in the refrigerator) in a closed container. After this time, you must discard the solution that has not been used.
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 MOVICOL CHOCOLAT contains, powder for oral solution in sachet
· The active substances are:
Macrogol 3350 ................................................ .................................................. ... 13,1250 g
Sodium bicarbonate............................................... .................................................. .. 0.1785 g
Potassium chloride............................................... .................................................. 0.0317 g
Sodium Chloride ............................................... .................................................. ....... 0.3507 g
For a sachet.
· The other ingredients are: potassium acesulfame (E950) and chocolate flavor.
Composition of chocolate flavor: maltodextrin (potato), gum arabic, vegetable oils and fats (coconut), propylene glycol and benzyl alcohol (see section 2).
What is MOVICOL CHOCOLAT, powder for oral solution in sachet and contents of the pack
This medicinal product is in the form of a powder for oral solution in sachets; the powder is white to light brown. Box of 14, 20 or 100 sachets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
NORGINE BV
HOGEHILWEG 7
1101 CA AMSTERDAM ZO
NETHERLANDS
Marketing Authorization Operator
NORGINE SAS
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-BERTH HENGOED
MID GLAMORGAN
WALES CF82 8SJ
UK
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]
Other
Detailed information on this medicine is available on the ANSM website (France).
HOW TO REDUCE THE RISK OF RECOVERY?
Occasional constipation
It may be related to a recent change in lifestyle (eg 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:
· or to a bowel disease 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 ...),
· a rehabilitation of the defecation reflex,
· sometimes, adding sound to the diet.
In all cases and if you have any doubts, do not hesitate to seek advice from your doctor or pharmacist.