NOTICE
ANSM - Last updated: 07/03/2014
Name of the medicinal product
MODANE, coated tablet
Sene (alcoholic solids extract) / calcium pantothenate
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 a physician.
· 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 IS MODANE, coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE MODANE, coated tablet?
3. HOW TO TAKE MODANE, coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MODANE, coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS MODANE, coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication is a stimulant laxative. It stimulates intestinal evacuation.
It is recommended in occasional constipation.
2. BEFORE YOU TAKE MODANE, 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 MODANE, coated tablets in the following cases:
· certain diseases of the intestine and colon,
· in case of abdominal pain (stomach pains),
· in the case of chronic constipation (long-lasting constipation),
· child under 12 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 MODANE, 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 the change in lifestyle, constipation accompanied by pain, fever, swelling of the abdomen must make seek the opinion of the doctor.
Chronic constipation (long-lasting 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 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.
It is helpful to seek advice from your doctor or pharmacist.
Precautions for use
This medication is highly inadvisable in breastfeeding women.
This medicine may cause loss of potassium. Combination with other medications (such as certain diuretics or certain heart medicines) can be dangerous.
The use of this medication is not recommended in patients with galactose or fructose intolerance, lapp lactase deficiency or glucose or galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
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:
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR 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
This medication should be used with caution during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a known effect: sucrose, lactose.
3. HOW TO TAKE MODANE, coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
1 to 2 coated tablets to swallow without chewing in the evening at bedtime.
This treatment should only be taken for a short period (maximum 8 to 10 days).
If the effect of the treatment is insufficient, do not increase the dose or prolong the use of the medication, but seek the advice of your doctor.
Symptoms and Instructions for Overdose
If you take more MODANE, coated tablet than you should:
In case of overdose: diarrhea and abdominal pain, consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take MODANE, coated tablet:
Do not take a double dose to make up for the single dose that you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, MODANE, a coated tablet is likely to have undesirable effects, although not everyone is subject to it:
· possibility of diarrhea, abdominal pain, hypokalemia (decreased potassium in the blood); in this case stop treatment and seek advice from your doctor.
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 MODANE, coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use MODANE, coated tablet after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 25 ° C.
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 does MODANE, Coated Tablet contain?
The active substances are :
Séné alcoholic dry extract ............................................. .................................................. ........ 26.00 mg
Quantity corresponding to Sennoside B to ............................................ ........................................... 11.70 mg
Calcium pantothenate ............................................... .................................................. 12.50 mg
For a coated tablet.
The other components are :
Corn starch, anhydrous colloidal silica, hydrated silica, talc, magnesium stearate, film-forming shellac and polyvidone *, sucrose, gelatin, gum arabic, polysorbate 80, red pigment concentrate **, carnauba wax.
* Composition of the film-forming solution of shellac and polyvidone = shellac, polyvidone K 30.
** Composition of the red pigment concentrate = titanium dioxide, orange-yellow aluminum laquer S, new coccine aluminum lacquer, sucrose, sodium benzoate.
Pharmaceutical form and content
What is MODANE, coated tablet and contents of the pack?
This medication is in the form of a coated tablet. Box of 20 or 100 coated tablets.
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
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
GALENIC LABORATORIES VERNIN
20, RUE LOUIS CHARLES VERNIN
77190 DAMMARIE-LES-LYS
or
FRENCH PHARMACEUTICAL COOPERATION
Place de Lucien Auvert
77020 MELUN
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 Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.