In this manual :
1. WHAT IS MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE TAKING MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet
3. HOW DO I TAKE MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
MINERAL SUPPLEMENTS.
This medicine contains magnesium. It is indicated for adults and children over 12 years of age (approximately 30 kg).
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.
Magnesium intake 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 MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him/her before taking this medicine.
Never take MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg film-coated tablets in the following cases:
- known allergy to any component of this medication (see What does MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg film-coated tablet contain?);
- severe renal insufficiency (failure of kidney function).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet:
Special warnings
This medicine should not be used 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 30 kg (about 12 years).
In children under 12 years of age, medical diagnosis is recommended.
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 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 whether it is necessary to continue the treatment.
Breastfeeding
The use of this medicine should be avoided during breast-feeding.
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 MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 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
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS OF AGE.
In adults: 6 to 8 tablets per day to be divided into 2 or 3 intakes during meals.
For children over 12 years of age (approximately 30 kg): 4 to 6 tablets per day, divided into 2 or 3 doses with meals.
If you feel that the effect of MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 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 intakes during a meal.
Duration of treatment
Do not prolong the treatment beyond 1 month without medical advice: if the symptoms do not improve or persist, seek medical advice.
Symptoms and instructions in case of overdose
If you have taken more MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg film-coated tablets than you should have
Overdosage of oral magnesium does not usually lead to toxic reactions if the kidney is functioning normally. Magnesium intoxication may, however, develop in cases of renal failure.
Instructions in case of missed dose(s)
If you forget to take MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet is likely to have undesirable effects, although not everyone is susceptible:
- 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 USE MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet
Keep out of the reach and sight of children.
Do not use MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg film-coated tablets after the expiry date stated on the box.
Store at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer 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 MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet contain?
The active ingredients are
Magnesium lactate dihydrate ...................................................................................................... 470 mg
(i.e. magnesium element ................................................................................................................. 48 mg)
Pyridoxine hydrochloride (vitamin B6) ............................................................................................. 5 mg
For one film-coated tablet.
Other components are:
Core: lactose monohydrate, macrogol 6000, talc, magnesium stearate.
Coating: Dry premix for white-colour coating 37781 RBC*, macrogol 6000.
*Glycerol, hypromellose, macrogol 6000, titanium dioxide (E171), magnesium stearate.
Pharmaceutical form and content
What is MAGNESIUM/VITAMIN B6 BIOGARAN CONSEIL 48 mg/5 mg, film-coated tablet and what does it contain?
This medicine is presented as a film-coated tablet.
Box of 36, 40, 50, 60, 80, 100, 120, 150 or 180 tablets.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
LABORATOIRES BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Operator
LABORATOIRES BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
UNITHER DEVELOPPEMENT BORDEAUX
Z.A TECH ESPACE
AVENUE TOUSSAINT CATROS
33187 LE HAILLAN CEDEX
or
DELPHARM EVREUX
5 AVENUE DU GUESCLIN
BP 285
27000 EVREUX
or
LES 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 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 try 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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