MAGNESIOCARD

MAGNESIOCARD 5 mmol powder for oral solution

Important notes (mandatory information)

Magnesiocard 5 mmol. Active ingredient: Magnesium aspartate hydrochloride. Areas of application: Treatment of magnesium deficiencies requiring therapy that do not require injection/infusion. Proven magnesium deficiency, if it is the cause of muscle activity disorders (neuromuscular disorders, calf cramps). Notes: contains sucrose (sugar) (equivalent to approx. 0.26 BE).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.

Patient information: Information for the user

Magnesiocard 5 mmol
Powder for oral solution
Active ingredient: Magnesium aspartate hydrochloride

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, Magnesiocard 5 mmol must be used as directed in order to achieve the best possible treatment results.
- Keep the package leaflet. You may want to read it again later.
- Ask your doctor or pharmacist if you need more information or advice.
- If your symptoms worsen or do not improve after 4-6 weeks, you must see a doctor.
- If any of the side effects listed here affect you severely or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. What is Magnesiocard 5 mmol and what is it used for?
2. What should you be aware of before taking Magnesiocard 5 mmol?
3. How should Magnesiocard 5 mmol be taken?
4. What side effects are possible?
5. How should Magnesiocard 5 mmol be stored?
6. Further information

1. What is Magnesiocard 5 mmol and what is it used for?
Magnesiocard 5 mmol is a mineral supplement.
Magnesiocard 5 mmol is used
- for the treatment of magnesium deficiencies requiring therapy that do not require injection/infusion;
- for proven magnesium deficiency, if it is the cause of muscle activity disorders (neuromuscular disorders, calf cramps).

2. What should you be aware of before taking Magnesiocard 5 mmol?
Magnesiocard 5 mmol must not be taken,
- if you are hypersensitive (allergic) to magnesium aspartate hydrochloride or any of the other ingredients of Magnesiocard 5 mmol,
- if you suffer from severe renal impairment with impaired excretion or dehydration of the body or are prone to infection stones (calcium-magnesium-ammonium phosphate stones).

Special care should be taken when taking Magnesiocard 5 mmol,
if your renal function is impaired; in this case, you should ask your doctor before taking Magnesiocard 5 mmol.

Children

Only give this medicine to children under 4 years of age after consulting a doctor, as there is not yet sufficient experience for this age group.

When taking Magnesiocard 5 mmol with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.
The effect of the following medicines or groups of preparations can be influenced by simultaneous treatment with Magnesiocard 5 mmol. Certain antibiotics (tetracyclines) and sodium fluoride preparations should be taken 3-4 hours apart from Magnesiocard 5 mmol to avoid mutual interference with absorption into the blood.

Pregnancy and breast-feeding

Magnesiocard 5 mmol can be used during pregnancy and breast-feeding.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Magnesiocard 5 mmol

This medicine contains sucrose. Please only take Magnesiocard 5 mmol after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

1 sachet (5 g) of Magnesiocard 5 mmol contains 3.2 g of sucrose (sugar) corresponding to approx. 0.26 bread units (BE). If you are on a diabetic diet, you should take this into account. Frequent and prolonged use of Magnesiocard 5 mmol can be harmful to the teeth (caries).

3. How should Magnesiocard 5 mmol be taken?
Always take Magnesiocard 5 mmol exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. The recommended average daily dose is 0.185 mmol of magnesium (4.5 mg) per kg of body weight. In chronic and severe acute magnesium deficiency states, the daily dose can be safely increased to 0.37 mmol of magnesium (9 mg) per kg of body weight until the deficiency is eliminated, if there are no contraindications.

Dosage

Unless otherwise prescribed by your doctor, the usual dose is

Age	Daily dose
Adults and adolescents:	1 sachet 3 times a day (equivalent to 364.5 mg of magnesium)
Children aged 10 - 14 years	1 sachet 2 times a day (equivalent to 243.0 mg of magnesium)
Children aged 4 - 9 years	1 sachet 1-2 times a day (equivalent to 121.5 - 243.0 mg of magnesium)

Method of administration
Please stir the contents of one sachet in half a glass of water, tea or fruit juice and drink the entire contents of the glass. Magnesiocard 5 mmol should be taken before meals, as this improves absorption from the gastrointestinal tract into the bloodstream.

Duration of use
Magnesiocard 5 mmol should be taken daily for at least 4 weeks. Long-term therapy with Magnesiocard 5 mmol (over years) is also safe in patients with normal renal function, as excess magnesium is excreted via the kidneys. Please talk to your doctor or pharmacist if you have the impression that the effect of Magnesiocard 5 mmol is too strong or too weak.

If you have taken more Magnesiocard 5 mmol than you should, the side effects listed under section 4 may be more severe. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. What side effects are possible?
Like all medicines, Magnesiocard 5 mmol can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	frequency cannot be estimated from the available data.

Soft stools may occasionally occur, which are harmless. They can be a consequence of high-dose magnesium treatment. If bothersome diarrhoea occurs, the daily dose should be reduced. Please inform your doctor or pharmacist if any of the side effects listed here affect you severely or if you notice any side effects not listed in this package leaflet.

5. How should Magnesiocard 5 mmol be stored?
Keep out of reach of children. Do not use the medicine after the expiry date which is stated on the folding box and sachet.

Storage conditions

Do not store above 25°C.

6. Further information

What Magnesiocard 5 mmol contains

The active ingredient is: Magnesium aspartate hydrochloride
1 sachet of 5 g powder for oral solution contains: Magnesium aspartate hydrochloride 3 H2O 1229.6 mg.
Magnesium content: 5 mmol = 121.5 mg.

The other ingredients are

Sucrose, citric acid, saccharin sodium, macrogol 6000, lemon flavouring.

Magnesiocard 5 mmol contains no gluten or lactose.

What Magnesiocard 5 mmol looks like and contents of the pack

White powder in sachets.

Magnesiocard 5 mmol is available in packs of 20, 50, 100 and 500 sachets, each containing 5 g of powder for oral solution.

Pharmaceutical entrepreneur and manufacturer

Verla-Pharm Arzneimittel GmbH & Co. KG,
82324 Tutzing,
www.verla.de

This leaflet was last revised in March 2011.

Source: www.verla.de
Version: 07/2014
Active ingredient: Magnesium aspartate hydrochloride. Areas of application: Treatment of magnesium deficiencies requiring therapy that do not require injection/infusion. Proven magnesium deficiency, if it is the cause of muscle activity disorders (neuromuscular disorders, calf cramps). Notes: contains sucrose (sugar) (equivalent to approx. 0.26 BE).