NOTICE
ANSM - Updated on: 13/11/2017
Name of the drug
MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet
Magnesium lactate dihydrate / Pyridoxine hydrochloride (vitamin B6)
Box
Read all of this leaflet carefully before taking this medicine as it contains important information for you .
You should always take this medicine by carefully following the information provided in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel any improvement or if you feel worse after 1 month.
What does this booklet contain ?
1. What is MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet and what is it used for?
2. What you need to know before you take MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet?
3. How to take MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet?
4. What are the possible side effects?
5. How to store MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet?
6. Contents of the pack and other information.
1. WHAT MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group : mineral supplements - ATC code: A12
This medicine contains magnesium. It is indicated in adults and children over 12 years old (about 30 kg).
The combination of a number of the following symptoms may suggest 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.
Intake of magnesium can improve these symptoms.
If these symptoms do not improve after one month of treatment, it is not worth continuing.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet?
Never take MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet:
· if you are allergic to magnesium or vitamin B6 or any of the other ingredients of this medicine (listed in section 6);
· in severe renal failure (failure of kidney functions).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet.
Special warnings
Consuming high doses of pyridoxine (or vitamin B6) for a long period (several months or even years) can cause tingling and balance disturbances, tremors in the hands and feet, and difficulties in coordinating movements . These effects are generally reversible when treatment is stopped.
Precautions for use
The dosage is not suitable for children under 30 kg (around 12 years old).
In children under 12, a medical diagnosis is recommended.
In moderate renal failure, precautions should be taken to avoid the risk of an increase in magnesium in the blood.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Children and adolescents
Not applicable.
Other medicines and MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially phosphate or calcium salts, even if they are obtained without a prescription.
MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
Pregnancy
The use of this drug can be considered during pregnancy if necessary, whatever the term.
If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue it.
Ask your doctor or pharmacist for advice before taking any medicine.
Feeding with milk
It is recommended not to exceed the dose of 20 mg / day of vitamin B6 in lactating women.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablets contain sucrose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
3. HOW TO TAKE MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet?
RESERVED FOR ADULTS AND CHILDREN OVER 12 YEARS OLD.
In adults: 6 to 8 tablets per day to be divided into 2 or 3 taken during meals.
In children over 12 years old (about 30 kg): 4 to 6 tablets per day to be divided into 2 or 3 doses during meals.
If you have the impression that the effect of MAGNESIUM / VITAMIN B6 MYLAN 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 are to be swallowed with a full glass of water.
Duration of treatment
Do not extend the treatment beyond 1 month without medical advice: in the absence of improvement as in the case of persistent symptoms, take medical advice.
If you take more MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet than you should
Overdosage of oral magnesium does not, in general, cause toxic reactions in normal kidney function. Magnesium poisoning can, however, develop in kidney failure.
If you forget to take MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· diarrhea,
· abdominal pain,
· skin reactions,
· allergic reactions.
DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box. The expiration date refers to the last day of this month.
No special storage conditions.
Do not throw away any medicines via wastewater. Ask your pharmacist to discard any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg contains, film-coated tablet
· The active substances are:
Magnesium lactate dihydrate .............................................. ............................................. 470 mg
(i.e. element magnesium .............................................. .................................................. ....... 48 mg)
Pyridoxine hydrochloride (vitamin B6) ........................................... ........................................ 5 mg
For a film-coated tablet.
· The other components are:
Core: talc, carbomers, gum arabic, sucrose, heavy kaolin, magnesium stearate
Coating : Sepifilm white LP 770 *.
* Hydroxypropylmethylcellulose, microcrystalline cellulose, stearic acid, titanium dioxide (E171).
What is MAGNESIUM / VITAMIN B6 MYLAN 48 mg / 5 mg film-coated tablet and contents of the pack
This drug is in the form of film-coated tablet.
Box of 50, 100, 150 or 180 tablets.
Marketing authorization holder
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT-PRIEST
Marketing authorization operator
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT-PRIEST
Maker
EUROPHARTECH
1 HENRI MATISSE STREET
BP 23
63370 LEMPDES
or
MYLAN SAS
ZAC DES GAULNES
10 BOULEVARD DE LATTRE TASSIGNY
69330 MEYZIEU
or
MYLAN SAS
117 ALLEE DES PARCS
69800 SAINT-PRIEST
or
BTT LABORATORIES
ZI DE KRAFFT
67150 ERSTEIN
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
{MM / YYYY} {month YYYY}.
Other
Detailed information on this medicine is available on the ANSM website (France).
HEALTH EDUCATION TIPS
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, stopping smoking, limiting exposure to stress,
· regular physical activity,
· sufficient sleep time, respecting the daily rhythm.
Warning signs requiring medical consultation:
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 a month, or if they get worse,
· your symptoms are accompanied by other disorders in particular: deep sadness, felt like moral pain, loss of pleasure or interest in all activities.
These signs may be symptoms of a more serious illness, medical advice is required.