NOTICE
ANSM - Last updated: 23/08/2010
Name of the medicinal product
MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet
Magnesium lactate dihydrate / Pyridoxine hydrochloride
framed
Read this leaflet carefully before you start taking this medicine. It contains important information about 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 your doctor.
· 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 MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet?
3. HOW TO TAKE MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
This medication is indicated in adults and children over 6 years in the magnesium deficiencies confirmed by your doctor.
2. BEFORE YOU TAKE MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-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 MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablets in the following cases:
· ( see What contains MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg, film-coated tablet? );
· 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.
Precautions for use; special warnings
Take special care with MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet:
Special warnings
In case of severe deficiency, treatment should be started by the venous route. It is the same in case of malabsorption.
In the case of associated calcium deficiency, it is advisable to proceed in most cases with magnesium repletion before calcithapy.
The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Precautions for use
The dosage is not suitable for children under 20 kg (about 6 years).
Dosage forms are more suitable for children under 6 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.
Interaction 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 nonprescription medicine.
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
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.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
The use of this medication should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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 MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS.
In adults: 6 to 8 tablets per day to be divided into 2 or 3 doses during meals.
In children over 6 years (about 20 kg): 4 to 6 tablets per day to be divided into 2 or 3 doses during meals.
If you feel that the effect of MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet 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 should preferably be divided into several doses during the meal.
Duration of the treatment
Treatment will be discontinued once the amount of magnesium in the blood has returned to normal.
Symptoms and Instructions for Overdose
If you take more MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablets than you should:
Overdosage of magnesium by the oral route does not generally lead to toxic reactions in normal kidney function. Magnesium poisoning, however, can develop in patients with renal insufficiency.
Instructions for omission of one or more doses
If you forget to take MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-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, MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablets may have side effects, although not everyone is subject to it:
· diarrhea,
· abdominal pain,
· skin reactions,
· allergic reactions.
If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablets after the expiry date which is stated on the carton.
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 contains MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablet?
The active substances are:
Magnesium lactate dihydrate .............................................. .................................................. ... 470.00 mg
(either magnesium element .............................................. .................................................. ................... 48 mg)
Pyridoxine hydrochloride (vitamin B6) ........................................... ................................................ 5, 00 mg
For a film-coated tablet.
The other components are:
Core : lactose monohydrate, macrogol 6000, talc, magnesium stearate.
Laminating : Dry premix for white-colored coating 37781 RBC *, macrogol 6000.
* Glycerol, hypromellose, macrogol 6000, titanium dioxide (E171), magnesium stearate.
Pharmaceutical form and content
What is MAGNESIUM / VITAMIN B6 BIOGARAN 48 mg / 5 mg film-coated tablets and contents of the pack?
This medication is in the form of film-coated tablets. Box of 36, 40, 50, 60, 100, 150 or 180.
Not all pack sizes 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
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
exploiting
BIOGARAN LABORATORIES
15 BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Maker
UNITHER DEVELOPMENT BORDEAUX
ZA TECH ESPACE
AVENUE TOUSSAINT CATROS
33187 LE HAILLAN CEDEX
or
DELPHARM EVREUX
5 AVENUE OF THE GUESCLIN
BP 285
27000 EVREUX
or
LABORATOIRES SERVIER INDUSTRIE
905 ROUTE DE SARAN
45520 GIDY
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.