NOTICE
ANSM - Last updated: 30/11/2015
Description of the Medicine
MAGNEVA B6 100 mg / 10 mg film-coated tablets
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Please read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
AT· This medication can be used in automation ie it is used without consultation or prescription of a doctor.
AT· If symptoms persist beyond 1 month, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
AT· This leaflet is designed to help you use this medication properly. Keep it there, you might need to re-read it.
AT· DO NOT LEAVE THIS MEDICINE FOR CHILDREN
Summary sheet
In this notice :
1. WHAT IS MAGNEVA B6 100 mg / 10 mg film-coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE MAGNEVA B6 100 mg / 10 mg film-coated tablets.
3. HOW TO TAKE MAGNEVA B6 100 mg / 10 mg film-coated tablets?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MAGNEVIE B6 100 mg / 10 mg film-coated tablets?
6. ADDITIONAL INFORMATION
1. WHAT IS MAGNEVA B6 100 mg / 10 mg film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
MINERAL SUPPLEMENT.
Therapeutic Indications
This medication contains magnesium.
The association of a number of the following symptoms may indicate a magnesium deficit:
AT· nervousness, irritability, anxiety, temporary fatigue, minor sleep disturbances,
AT· manifestations of anxiety, such as digestive spasms or palpitations (healthy heart),
AT· muscle cramps, tingling.
The intake of magnesium can improve these symptoms.
If these symptoms do not improve after one month of treatment, it is not worth pursuing.
2. BEFORE YOU TAKE MAGNEVA B6 100 mg / 10 mg film-coated tablets.
List of information needed before taking the medication
If your doctor has informed you of an intolerance to certain sugars, contact him / her before taking this medication.
Cons-indications
Do not take MAGNEVIE B6 100 mg / 10 mg film-coated tablets in the following cases:
AT· allergy known to any of the constituents of this medication ( see composition ),
AT· severe renal failure (failure of kidney functions).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment precautions; special warnings
Take special care with MAGNEVIE B6 100 mg / 10 mg film-coated tablets:
Special warnings
The use of this medication is disliked in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (hepatitis Rarity).
High doses of pyridoxine (or vitamin B6) over a long period of time (several months or even years) can cause tingling and disturbances of balance, shaking hands and feet, and difficulties in coordinating movements. These effects are usually reversible at the end of treatment.
Employment Precautions
The dosage is not suitable for children under 12 years of age.
In case of moderate renal insufficiency, precautions should be taken to avoid the risk of increased magnesium in the blood.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including phosphate or calcium salts, even if it is a medication order.
Interactions with food and beverages
Not applicable.
Interactions with phytotherapeutic products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
The use of this medication can be considered during pregnancy if necessary, whatever the term.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
feeding
It is recommended not to exceed the 20 mg / day dose of vitamin B6 in lactating women.
Ask your doctor or pharmacist for advice 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 known effect: lactose.
3. HOW TO TAKE MAGNEVA B6 100 mg / 10 mg film-coated tablets?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
This medication is reserved for adults and children aged 12 to 15 years.
Dosage
In adults: 3 to 4 tablets per day to be taken 2 or 3 times during meals.
In children 12 to 15 years: 2 to 4 tablets per day to be taken in 2 or 3 times during meals.
If you feel that the effect of MAGNEVIE B6 100 mg / 10 mg film-coated tablets is too strong or too weak, talk to your doctor or pharmacist.
Administration mode
Oral use.
The tablets should be swallowed as is with a glass of water.
Frequency of administration
The daily dose is to be taken preferably in several doses before or during the meal.
Duration of treatment
If symptoms do not improve after one month of treatment, there is no need to continue.
Symptoms and Instructions for Overdose
If you take more MAGNEVIE B6 100 mg / 10 mg tablets you should not have: oral overdosage of magnesium generally does not toxic reactions in normal kidney function. Magnesium poisoning, however, may develop in cases of renal insufficiency.
Instructions for omission of one or more doses
If you forget to take MAGNEVIE B6 100 mg / 10 mg, film-coated tablets: do not take a double dose to make up for a forgotten dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines , MAGNEVIE B6 100 mg / 10 mg film-coated tablets is likely to have undesirable effects, although not everyone is subject to it:
AT· Diarrha © es,
AT· abdominal pain,
AT· skin reactions,
AT· allergic reactions.
If you notice any side effects not listed in this leaflet, or if certain undesirable effects become serious, please inform your doctor or pharmacist.
5. HOW TO STORE MAGNEVIE B6 100 mg / 10 mg film-coated tablets?
Keep out of the reach and sight of children.
Date of filing
Do not use MAGNEVIE B6 100 mg / 10 mg film-coated tablet after the date of expiration mentioned on the carton. The expiry date refers to the last day of the month.
Storage conditions
No special precautions for storage.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away or washed with household garbage. Ask your pharmacist what to do with unused medications. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What MAGNEVIE B6 contains: 100 mg / 10 mg film-coated tablets
The active substances are:
Magnesium ............................................... .................................................. ................................ 100.00 mg
In the form of anhydrous magnesium citrate
Pyridoxine hydrochloride ............................................... .................................................. 10.00 mg
For a film-coated tablet.
The other components are:
Core: lactose anhydrous, macrogol 6000, magnesium stearate.
Pelleting: hypromellose, macrogol 6000, titanium dioxide (E171), talc.
Pharmaceutical form and content
What is MAGNEVIE B6 100 mg / 10 mg film-coated tablets and contents of the pack?
This medication is in the form of film-coated tablets. Box of 30, 60, 90 or 120.
Not all presentations may be marketed.
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
SANOFI-AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
exploiting
SANOFI AVENTIS FRANCE
82 AVENUE RASPAIL
94250 GENTILLY
Maker
SANOFI WINTHROP INDUSTRIE
1, RUE DE LA VIERGE
AMBARES AND LAGRAVE
33565 CARBON BLANC CEDEX
or
SANOFI WINTHROP INDUSTRIE
56, CHOISY ROUTE AT THE BAC
60205 COMPIEGNE
or
CHINOIN PRIVATE CO LTD
LEVAI U. 5.
VERESEGYHAZ 2112
HUNGARY
Names of medicines in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last day this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicinal product can be found on the website of AFssaps (France).
Information for health professionals
Not applicable.
Other
SANITARY EDUCATION COUNCILS
Recommended health education guidelines for a combination of symptoms that may indicate a magnesium deficiency:
AT· a balanced diet rich in green vegetables, meat, cocoa, milk, dried vegetables,
AT· a moderate consumption of alcohol, coffee or tea, stops smoking, limits exposure to stress,
AT· a regular physical activity,
AT· a sufficient sleep time, respecting the daily rhythm.
Warning signs requiring medical consultation:
Do not try to take charge yourself if:
AT· your symptoms are accompanied by other general signs (loss of appetite, slimming, fever),
AT· your symptoms persist beyond one month, or if they worsen,
AT· your symptoms are accompanied by other disorders including: deep sadness, felt like moral pain, loss of pleasure or interest for all activities.
These signs can be symptoms of a more serious illness, a medical opinion is needed.