NOTICE
ANSM - Updated on: 12/13/2010
Drug Name
MAG 2, powder for oral solution in a packet
Magnesium
Box
Please read this package insert carefully before taking this medication. It contains important information about your treatment.
If you have any other questions or are unsure about anything, ask your doctor or pharmacist for more information.
· Keep this package insert; you may need to read it again.
· If you need more information or advice, consult your pharmacist.
· If your symptoms worsen or persist, see a doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the listed side effects that are severe, please inform your doctor or pharmacist.
Package Insert Summary
In this package insert:
1. WHAT IS MAG 2, powder for oral solution in sachets, AND WHAT IS IT USED FOR?
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING MAG 2, powder for oral solution in a packet?
3. HOW SHOULD YOU TAKE MAG 2, powder for oral solution in a packet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW SHOULD YOU STORE MAG 2, powder for oral solution in sachets?
6. ADDITIONAL INFORMATION
1. WHAT IS MAG 2, powder for oral solution in sachets, AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Mineral supplement.
Therapeutic Indications
This medication contains magnesium.
A combination of some of the following symptoms may indicate a magnesium deficiency:
· nervousness, irritability, mild anxiety, temporary fatigue, minor sleep disturbances,
· symptoms of anxiety, such as digestive spasms or heart palpitations (healthy heart),
· muscle cramps, tingling sensations.
Magnesium supplementation may help alleviate these symptoms.
If these symptoms do not improve after one month of treatment, consult your doctor or pharmacist.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING MAG 2, powder for oral solution in sachets?
List of information you need to know before taking this medication
If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medication.
Contraindications
Never take MAG 2 powder for oral solution in a packet in the following cases:
· if you have severe kidney disease.
· if you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients in MAG 2.
Precautions; Special Warnings
Use caution with MAG 2 oral solution powder in sachets:
Special Warnings
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase/isomaltase deficiency (rare hereditary disorders).
Precautions
The dosage is not suitable for infants weighing less than 12 kg (approximately 2 years of age).
IF IN DOUBT, IT IS ESSENTIAL TO CONSULT YOUR DOCTOR OR PHARMACIST.
Interactions with Other Medications
Taking or Using Other Medications
If you are taking or have recently taken any other medication, including over-the-counter medications, tell your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Products or Alternative Therapies
Not applicable.
Use During Pregnancy and Breastfeeding
Pregnancy
This medication should only be used during pregnancy under your doctor’s guidance.
If you discover that you are pregnant during treatment, consult your doctor, as only he or she can determine whether to continue treatment.
Consult your doctor or pharmacist before taking any medication.
Breastfeeding
This medication passes into breast milk; therefore, breastfeeding should be avoided during treatment.
Ask your doctor or pharmacist for advice before taking any medication.
Athletes
Not applicable.
Effects on the ability to drive or operate machinery
Not applicable.
List of excipients with known effects
List of excipients known to have an effect: sucrose .
3. HOW TO TAKE MAG 2, powder for oral solution in sachets?
Instructions for Proper Use
Not applicable.
Dosage, Method and/or Route(s) of Administration, Frequency of Administration, and Duration of Treatment
Dosage
For adults: 2 packets per day.
For children: 9.6 to 28.8 mg/kg/day, or 1 to 2 packets per day.
Method and Route of Administration
Oral administration.
The packets should be dissolved in a large glass of water, preferably divided into several doses to be taken before or during meals.
Duration of treatment
Treatment should not be continued for more than one month.
Symptoms and Instructions in Case of Overdose
If you have taken more MAG 2 powder for oral solution in sachets than you should have:
Consult your doctor or pharmacist immediately
Instructions if you miss one or more doses
If you forget to take MAG 2 powder for oral solution in a packet:
Do not take a double dose to make up for the single dose you missed.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MAG 2, powder for oral solution in sachets, may cause side effects, although not everyone experiences them, including diarrhea, abdominal pain, and allergic-type reactions.
If you notice any side effects not listed in this leaflet, or if any side effects become severe, please tell your doctor or pharmacist.
5. HOW SHOULD MAG 2, powder for oral solution in sachets, BE STORED?
Keep out of the reach and sight of children.
Expiration Date
Do not use MAG 2, powder for oral solution, after the expiration date printed on the packet or box.
Storage Conditions
No special storage precautions.
If necessary, warnings regarding certain visible signs of deterioration
Do not flush medications down the drain or dispose of them with household trash. Ask your pharmacist how to properly dispose of unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does MAG 2, powder for oral solution in a packet, contain?
The active ingredient is:
Magnesium pyrrolidone carboxylate .............................................................................................. 2.250 g
Equivalent to magnesium ............................................................................................................. 0.184 g
Per 6 g sachet.
This product provides 184 mg of elemental magnesium per packet, or 7.60 mmol of magnesium.
Other ingredients include:
Sodium saccharin, citric acid monohydrate, sucrose, lemon flavoring.
Dosage Form and Contents
What is MAG 2, powder for oral solution in a sachet, and what is included in the outer packaging?
This medication is available as a powder for oral solution.
Box of 20, 30, 50, or 100 sachets.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the manufacturing authorization holder responsible for batch release, if different
Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Manufacturer
MACORS LABORATORIES
Rue des Caillottes
ZI PLAINES DES ISLES
8900 Auxerre
or
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
or
RHONE POULENC RORER GMBH
NATTERMANNALEE 1
50829 Cologne
GERMANY
Drug names in the member states of the European Economic Area
Not applicable.
Date of approval of the package insert
The most recent date on which this package insert was approved is {date}.
Marketing Authorization under Exceptional Circumstances
Not applicable.
Online Information
Detailed information about this medication is available on the Afssaps (France) website.
Information for Healthcare Professionals
Not applicable.
Other
Not applicable.