NOTICE
ANSM - Last updated: 30/05/2017
Name of the medicinal product
UVIMAG B6, oral solution
Magnesium acid glycerophosphate / Pyridoxine hydrochloride
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· This medication can be used in self-medication, ie without consultation or prescription from a doctor. Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 1 month of treatment.
What is in this leaflet?
1. What is UVIMAG B6 , oral solution and in which case is it used?
2. What should be known before taking UVIMAG B6 , oral solution ?
3. How to take UVIMAG B6 , oral solution ?
4. What are the possible side effects?
5. How to store UVIMAG B6 , oral solution ?
6. Package contents and other information.
1. WHAT IS UVIMAG B6, oral solution AND WHAT IT IS USED FOR?
MINERAL SUPPLEMENT (A. Digestive System and Metabolism)
UVIMAG B6 , oral solution contains magnesium and vitamin B6 (pyridoxine hydrochloride). Magnesium is a mineral supplement.
Reserved for adults
This medicine contains magnesium.
The association of a number of the following symptoms may evoke 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.
In the absence of improvement of these symptoms after one month of treatment, it is not useful to continue.
2. BEFORE YOU TAKE UVIMAG B6, oral solution?
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Do not take UVIMAG B6, oral solution:
· A history of allergy to any constituent of the oral solution, including parabens,
· In case of certain diseases of the kidneys
This medication MUST NOT BE GENERALLY USED, unless directed to do so by your doctor, if you are taking quinidinic acid.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Take special care with UVIMAG B6, oral solution:
Special warnings
This medicinal product contains sodium parahydroxybenzoate (E219) and sodium propyl paraben (E217) and may cause allergic reactions.
This medicine contains sucrose. Its use is not recommended in patients with intolerance to sucrose (rare hereditary disease).
Precautions for use:
There are specialties more adapted to the child.
In case of moderate renal insufficiency, precautions should be taken to avoid the risk of an increase in magnesium in your blood.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Children and Youth
Not applicable.
Other drugs and UVIMAG B6, oral solution
Tell your doctor if you are taking:
· Quinidines (medicines used for heart rhythm disorders or malaria)
· Calcium
· Tetracyclines (antibiotics)
UVIMAG B6, oral solution with food and beverages
Not applicable.
Pregnancy and breast feeding
Pregnancy
This medication can only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.
feeding
The use of this medication should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Not applicable.
UVIMAG B6, oral solution contains sucrose, sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217)
3. HOW TO TAKE UVIMAG B6, oral solution?
Dosage
RESERVED FOR ADULTS.
2 to 3 ampoules per day to be divided into 2 or 3 doses during meals.
Method and route of administration
ORAL WAY.
The ampoules are diluted in a little water.
Duration of treatment
Do not prolong treatment beyond 1 month without medical advice: in the absence of improvement as in the case of persisting symptoms, take a medical opinion
If you take more UVIMAG B6, oral solution 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.
If you forget to take UVIMAG B6, oral solution:
Do not take a double dose to make up for the missed dose.
If you stop taking UVIMAG B6, oral solution
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Diarrhea, abdominal pain, skin reactions, allergic reactions.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE UVIMAG B6, oral solution?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store at a temperature below 25 ° C.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What UVIMAG B6 contains, oral solution
· The active substances are:
Pyridoxine hydrochloride (or vitamin B6) .......................................... .................................. 0.04 g
Magnesium acid glycerophosphate .............................................. .................................. 1.895 g
For a 10 ml bulb
The total magnesium-element content is 125 mg (5.13 mmol) per ampoule.
· The other components are:
Sucrose, the natural aromatic composition of grape juice, sodium methyl parahydroxybenzoate (E 219), soda propyl paraben (E 217) and purified water.
What is UVIMAG B6, oral solution, and contents of the pack
This medication is in the form of a drinkable solution in an ampoule. Each box contains 20 ampoules of 10 ml of solution.
Marketing Authorization Holder
G2D PHARMA
COURCERIN PARK
ALLEE LECH WALESA
77185 LOGNES
Marketing Authorization Operator
LAPHAL INDUSTRIES
Avenue of Provence
13190 ALLAUCH
Maker
LAPHAL INDUSTRIES
Avenue of Provence
13190 ALLAUCH
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
March 2015
Other
Detailed information on this medicine is available on the ANSM website (France).
SANITARY EDUCATION COUNCILS
Recommended health education recommendations for a combination of symptoms suggestive of magnesium deficiency:
o A balanced diet, rich in green vegetables, meats, cocoa, milk, pulses,
o Moderate consumption of alcohol, coffee or tea, cessation of smoking, limiting stress exposures,
o Regular physical activity,
o A sufficient sleep time, respecting the daily rhythm.
Warning signs requiring medical consultation:
Do not try to take care of yourself if:
o Your symptoms are accompanied by other general signs (loss of appetite, slimming, fever),
o Your symptoms persist beyond one month, or if they worsen,
o Your symptoms are accompanied by other disorders including: deep sadness, felt like moral pain, loss of pleasure or interest in any activities.
These signs may be the symptoms of a more serious illness, medical advice is required.