NOTICE
ANSM - Last updated: 05/07/2017
Name of the medicinal product
MOVICOL WITHOUT AROMA, 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 WITHOUT AROMA, powder for oral solution in sachets and in which cases it is used?
2. What should I know before taking MOVICOL WITHOUT AROMA powder for oral solution in sachets?
3. How to take MOVICOL WITHOUT AROMA, powder for oral solution in sachet?
4. What are the possible side effects?
5. How to store MOVICOL WITHOUT AROMA powder for oral solution in sachet?
6. Package contents and other information.
1. WHAT IS MOVICOL WITHOUT AROMA, powder for oral solution in sachets AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group - ATC code: A06AD65.
MOVICOL WITHOUT AROMA 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 matter in the rectum with no evacuation for several days.
MOVICOL SANS AROME is for adults only.
2. BEFORE YOU TAKE MOVICOL WITHOUT AROMA, powder for oral solution in sachet?
Never take MOVICOL WITHOUT AROMA, powder for oral solution in sachet:
· If you are allergic (hypersensitive) to active substances (eg macrogol) or to any of the other ingredients of MOVICOL SANS AROMA mentioned 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 WITHOUT AROMA powder for oral solution in sachets.
The liquid contained in MOVICOL WITHOUT AROMA 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 WITHOUT AROMA may decrease the absorption of other medicines (see Other medicines and MOVICOL WITHOUT AROMA, 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 the 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 WITHOUT AROMA in the treatment of fecal matter have not been studied.
children
Not applicable.
Other medicines and MOVICOL WITHOUT AROMA, powder for oral solution in sachet
MOVICOL WITHOUT AROMA can decrease the absorption of other medicines taken simultaneously, for example medicines treating epilepsy, which can decrease their effectiveness. If you are taking a treatment for epilepsy, talk to your doctor before taking MOVICOL WITHOUT AROMA.
Usual oral treatments should not be taken within 1 hour of ingesting MOVICOL WITHOUT AROMA.
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
MOVICOL WITHOUT AROMA, powder for oral solution in sachets with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication can be used during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
MOVICOL WITHOUT AROMA does not influence the ability to drive or use machines.
MOVICOL WITHOUT AROMA, powder for oral solution in sachet contains <{name excipient (s)}>
Not applicable.
3. HOW TO TAKE MOVICOL WITHOUT AROMA, powder for oral solution in sachet?
How many bags should you take?
If you take MOVICOL WITHOUT AROMA 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 WITHOUT AROMA to treat a fecal 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 bag.
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 WITHOUT AROMA manifests itself 24 to 48 hours after its 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 WITHOUT AROMA, powder for oral solution in a sachet you should not have
Diarrhea may occur. This usually disappears 24 to 48 hours after discontinuation or 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 WITHOUT AROMA, powder for oral solution in sachet
Do not take a double dose to make up for a missed dose.
If you stop taking MOVICOL WITHOUT AROMA, 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 WITHOUT AROMA, 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 SANS AROME contains, powder for oral solution in sachet
· The active substances are:
Macrogol 3350 ................................................ .................................................. ... 13,1250 g
Sodium bicarbonate............................................... .................................................. .. 0.1786 g
Potassium chloride............................................... .................................................. .. 0.0502 g
Sodium Chloride ............................................... .................................................. ....... 0.3508 g
For a sachet.
· The other components are:
Not applicable.
What is MOVICOL WITHOUT AROMA, powder for oral solution in sachet and contents of the pack
This medicine is in powder form for oral solution in sachets, the powder is white. 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
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:
· increased dietary intakes of vegetable products (green vegetables, raw vegetables, wholemeal bread, fruits, etc.);
· increased consumption of water and fruit juices;
· an increase in physical activities (sports, walking, etc.);
· 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.