NOTICE
ANSM - Updated on: 16/09/2015
Name of the medicinal product
MAG 2 WITHOUT SUGAR 122 mg, drinkable solution in saccharine sodium sweetener
Magnesium
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener AND WHAT IS IT USED FOR?
2. BEFORE YOU TAKE MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener.
3. HOW TO TAKE MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener?
6. ADDITIONAL INFORMATION
1. WHAT MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener AND WHAT IS IT USED FOR?
Pharmacotherapeutic group
Mineral supplement.
Therapeutic indications
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.
If symptoms do not improve after one month of treatment, ask your doctor or pharmacist for advice.
2. BEFORE YOU TAKE MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener.
List of information needed before taking the medication
Not applicable.
Cons-indications
Never take MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium saccharin in the following cases:
· if you have severe kidney damage.
· if you are allergic to any of the ingredients in MAG 2.
Precautions for use; special warnings
Warnings and Precautions
The dosage is not suitable for infants under 12 kg (about 2 years).
MAG2 WITHOUT SUGAR 122 mg contains 7.7 mg of sodium benzoate, which can aggravate jaundice (yellowing of the skin and eyes) of newborns (term or premature babies) who already have jaundice.
This medicine contains sulfite and can cause severe allergic reactions and respiratory discomfort.
This medication contains an azo dye (E110) and may cause allergic reactions.
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per ampoule.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy
This medication will 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.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
This medication passes into breast milk, therefore breast-feeding should be avoided during treatment.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener contains sodium benzoate, ethanol, sulphite, orange-yellow (E110).
3. HOW TO TAKE MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Dilute the ampoules in half a glass of water.
The usual dose for an adult is 3 to 4 ampoules per day to be divided into 2 or 3 doses during meals.
In children and infants over 12 kg (approximately 2 years), the dose is 10 to 30 mg / kg / day, ie 1 to 3 ampoules per day to be divided into 1-3 times during meals.
Caution, the dosage is not suitable for infants under 12 kg (about 2 years).
Administration mode
Oral use.
Duration of treatment
Treatment should not be extended beyond one month.
Symptoms and Instructions for Overdose
If you take more MAG 2 WITHOUT SUGAR 122 mg, drinkable solution in sodium-saccharin sweetener you should not: see your doctor or pharmacist immediately.
Instructions for omission of one or more doses
If you forget to take MAG 2 WITHOUT SUGAR 122 mg, drinkable solution in saccharine sodium sweetener: do not take a double dose to compensate for the dose you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them, including diarrhea, abdominal pain, allergic reactions.
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium sweetener?
Keep out of the reach and sight of children.
Expiration date
Do not use MAG 2 WITHOUT SUGAR 122 mg oral solution in saccharine sodium saccharine after the expiry date stated on the ampoule or on the box.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What MAG 2 contains SANS SUGAR 122 mg oral solution in saccharine sodium sweetener
· The active substance is:
Magnesium element ................................................ .................................................. ....................... 122 mg
In the form of magnesium pidolate ............................................ ................................................. 1500 mg
For a 10 ml ampoule of solution.
· The other components are:
Sodium benzoate (E211), potassium sorbate (E202), sodium saccharin, anhydrous citric acid, orange flavor IFF 32K182 *, purified water.
* Containing in particular: ethanol, sulfite, orange yellow (E110), sodium benzoate.
Pharmaceutical form and content
What is MAG 2 WITHOUT SUGAR 122 mg oral solution saccharine sodium saccharine and contents of the pack?
This medicine is in the form of a drinkable solution in a 10 ml ampoule. Box of 20 or 30 light bulbs.
Not all pack sizes may be marketed.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
exploiting
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this notice was revised is <{MM / YYYY}> <{month YYYY}.>
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.