In this manual :
1. WHAT IS MAGNEVIE B6 100 mg/10 mg, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAGNEVIE B6 100 mg/10 mg film-coated tablet
3. HOW TO TAKE MAGNEVIE B6 100 mg/10 mg, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO CONSERVE MAGNEVIE B6 100 mg/10 mg, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS MAGNEVIE B6 100 mg/10 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
MINERAL SUPPLEMENT.
This medicine contains magnesium.
The combination of a number of the following symptoms may indicate a magnesium deficiency:
- nervousness, irritability, mild anxiety, transient fatigue, minor sleep disturbances,
- manifestations of anxiety, such as digestive spasms or palpitations (healthy heart),
- muscle cramps, tingling.
The intake of magnesium can improve these symptoms.
If there is no improvement in these symptoms after one month of treatment, it is not worth continuing.
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAGNEVIE B6 100 mg/10 mg, film-coated tablet
List of information needed before taking this medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Never take MAGNEVIE B6 100 mg/10 mg, film-coated tablet in the following cases:
- known allergy to any of the components of this medication (see composition),
- severe renal insufficiency (failure of kidney functions).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with MAGNEVIE B6 100 mg/10 mg, film-coated tablet:
Special warnings
This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency or glucose/galactose malabsorption syndrome (rare hereditary diseases).
High doses of pyridoxine (or vitamin B6) over a long period of time (months or years) may cause tingling and disturbance of balance, tremors of the hands and feet, and difficulties in the coordination of movements. These effects are usually reversible when treatment is stopped.
Precautions for use
The dosage is not suitable for children under 12 years.
In case of moderate renal insufficiency, precautions should be taken to avoid the risk of increased magnesium in the blood.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
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 they are obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
The use of this medicine may be considered during pregnancy if necessary, regardless of the term.
If you discover that you are pregnant during treatment, consult your doctor as only he/she can judge the need to continue the treatment.
Breastfeeding
It is recommended that the dose of 20 mg/day of vitamin B6 not be exceeded in women who are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medication.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect: lactose.
3. HOW TO TAKE MAGNEVIE B6 100 mg/10 mg, film-coated tablet
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
This medicine is intended for adults and children aged 12 to 15 years.
Dosage
In adults: 3 to 4 tablets per day divided into 2 or 3 intakes during meals.
For children aged 12 to 15 years: 2 to 4 tablets per day, divided into 2 or 3 doses with meals.
If you feel that the effect of MAGNEVIE B6 100 mg/10 mg, film-coated tablet is too strong or too weak, consult your doctor or pharmacist.
How to take it
Take by mouth.
The tablets should be swallowed as they are with a glass of water.
Frequency of administration
The daily dose should preferably be divided into several doses before or during a meal.
Duration of treatment
If the symptoms do not improve after one month of treatment, there is no need to continue the treatment.
Symptoms and instructions in case of overdose
If you have taken more MAGNEVIE B6 100 mg/10 mg film-coated tablets than you should have: Oral magnesium overdose does not usually lead to toxic reactions in cases of normal kidney function. Magnesium intoxication may, however, develop in cases of renal failure.
Instructions in case of missed dose(s)
If you forget to take MAGNEVIE B6 100 mg/10 mg, film-coated tablet: do not take a double dose to make up for the one you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MAGNEVIE B6 100 mg/10 mg, film-coated tablet is likely to have undesirable effects, although not everyone is subject to them:
- diarrhea,
- abdominal pain,
- skin reactions,
- allergic reactions.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE MAGNEVIE B6 100 mg/10 mg, film-coated tablet
Keep out of the reach and sight of children.
Do not use MAGNEVIE B6 100 mg/10 mg, film-coated tablet after the expiry date stated on the box. The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does MAGNEVIE B6 100 mg/10 mg, film-coated tablet contain?
The active ingredients are:
Magnesium ................................................................................................................................. 100.00 mg
As anhydrous magnesium citrate
Pyridoxine hydrochloride ............................................................................................................. 10.00 mg
For one film-coated tablet.
The other components are:
Core: anhydrous lactose, macrogol 6000, magnesium stearate.
Film coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc.
Pharmaceutical form and content
What is MAGNEVIE B6 100 mg/10 mg, film-coated tablet and what does it contain?
This medicine is presented as film-coated tablets. Boxes of 30, 60, 90 or 120.
All presentations may not be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
SANOFI-AVENTIS FRANCE
1-13, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Operator
SANOFI-AVENTIS FRANCE
9, BOULEVARD ROMAIN ROLLAND
75014 PARIS
Manufacturer
SANOFI WINTHROP INDUSTRIE
1, RUE DE LA VIERGE
AMBARES ET LAGRAVE
33565 CARBON BLANC CEDEX
or
SANOFI WINTHROP INDUSTRIE
56 ROUTE DE CHOISY AU BAC
60205 COMPIEGNE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
HEALTH EDUCATION ADVICE
Health education advice recommended in the case of a combination of symptoms that may suggest a magnesium deficiency:
- a balanced diet, rich in green vegetables, meat, cocoa, milk, pulses,
- moderate consumption of alcohol, coffee or tea, stop smoking, limit exposure to stress,
- regular physical activity,
- sufficient sleep, respecting the daily rhythm.
Warning signs that require medical attention:
Do not attempt to take care of yourself if:
- your symptoms are accompanied by other general signs (loss of appetite, weight loss, fever),
- your symptoms persist beyond one month, or if they get worse,
- your symptoms are accompanied by other disturbances such as: profound sadness, felt as moral pain, loss of pleasure or interest in any activity.
These signs may be symptoms of a more serious disease, a medical opinion is necessary.
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