MAGNESIUM DIASPORAL

MAGNESIUM DIASPORAL 300 mg granules

Important notes (mandatory information)

Magnesium-Diasporal 300 mg, granules. Active ingredient: magnesium citrate. Areas of application: for the treatment and prevention of magnesium deficiency.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Magnesium-Diasporal 300 mg
Granules for making a solution for oral use
For adults

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after taking it, contact your doctor.

What this package leaflet contains

1. WHAT IS MAGNESIUM-DIASPORAL 300 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAGNESIUM-DIASPORAL 300 MG?
3. HOW TO TAKE MAGNESIUM-DIASPORAL 300 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE MAGNESIUM-DIASPORAL 300 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MAGNESIUM-DIASPORAL 300 MG AND WHAT IS IT USED FOR?

Magnesium-Diasporal 300 mg is a mineral supplement and contains the active ingredient magnesium citrate. Magnesium-Diasporal 300 mg is used for the treatment and prevention of magnesium deficiency. Signs of magnesium deficiency can include nervous system and muscle problems (tremors, muscle cramps, tetany) and personality changes. If you do not feel better or even worse after taking this medicine, contact a doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MAGNESIUM-DIASPORAL 300 MG?

Magnesium-Diasporal 300 mg must not be taken:

• if you are allergic to magnesium citrate or any of the other ingredients of this medicine listed in section 6,
• in case of severe renal impairment (glomerular filtration rate < 30 ml/min),
• in case of disturbances of the conduction of excitation in the heart, which lead to slow heartbeat (bradycardia).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Magnesium-Diasporal 300 mg.

Children and adolescents (0 -18 years)

There is no experience with the treatment of children and adolescents.

Taking Magnesium-Diasporal 300 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. You should avoid taking other medicines at the same time, if possible. Keep an interval of 2-3 hours between taking this and your other medicines to prevent possible interactions. In the case of fluorides and tetracyclines, a time interval of 2-3 hours should be strictly observed. Antibacterial agents (aminoglycoside antibiotics), diuretics (thiazides, furosemide) and agents that inhibit gastric acid production (omeprazole, pantoprazole), as well as the active substances cisplatin, cyclosporin A, foscarnet, cetuximab and erlotinib, pentamidine, rapamycin and amphotericin B can cause magnesium deficiency. Therefore, ask your doctor whether you need to adjust your daily dosage accordingly.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Magnesium-Diasporal 300 mg can be taken without hesitation during pregnancy and breast-feeding. Due to long-term experience, no effects on male and female fertility are to be expected.

Driving and using machines

Magnesium-Diasporal 300 mg has no or negligible influence on the ability to drive and use machines.

Magnesium-Diasporal 300 mg contains sucrose (sugar) and sodium

This medicine contains sucrose (sugar). Please only take this medicine after consulting your doctor if you are known to suffer from an intolerance to certain sugars. Frequent and prolonged use of MagnesiumDiasporal 300 mg can be harmful to the teeth (caries) due to the sugar it contains. One sachet contains 1.75 mmol (40 mg) sodium. If you need to follow a low-salt diet, you should take this into account.

3. HOW TO TAKE MAGNESIUM-DIASPORAL 300 MG?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Renal impairment

Magnesium must not be taken in case of severely impaired renal function.

The recommended dose is

for adults (> 18 years) 1 sachet daily (equivalent to 300 mg magnesium).

Method of administration

Please dissolve the granules in half a glass of water, juice or tea and drink the contents of the glass completely.

If you have taken more Magnesium Diasporal 300 mg than you should

No side effects are to be expected if renal function is intact. Excess magnesium is excreted via the kidneys. If you have taken more Magnesium-Diasporal 300 mg than you should or if someone with severe renal impairment or a child has accidentally taken this medicine, please contact your doctor or an emergency room for risks and advice.

If you forget to take Magnesium-Diasporal 300 mg

Do not take twice the amount if you have forgotten to take the previous dose.

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, this medicine can cause side effects, although not everybody gets them.

Occasionally (less than 1 in 100 but more than 1 in 1,000 treated)

Stool softening to diarrhoea at the beginning of treatment (these are harmless and usually subside on their own during treatment).

Very rarely (less than 1 in 10,000 treated)

Fatigue with prolonged use of Magnesium-Diasporal 300 mg

If a side effect occurs, therapy should be temporarily discontinued. After improvement or after the symptoms have subsided, the intake can be resumed with a reduced dose.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MAGNESIUM-DIASPORAL 300 MG?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and sachets. The expiry date refers to the last day of the month indicated.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Magnesium-Diasporal 300 mg contains

The active ingredient is magnesium citrate: One sachet (5.073g) contains 1856.6 mg magnesium citrate; equivalent to 300 mg magnesium. The other ingredients are: sucrose (sugar), citric acid, sodium hydrogen carbonate, riboflavin (E 101), orange flavour.

What Magnesium-Diasporal 300 mg looks like and contents of the pack

Yellow granules with orange smell. Magnesium-Diasporal 300 mg granules for making a solution for oral use are available in packs of 20 (N1), 50 (N2) and 100 (N3) sachets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Protina Pharmazeutische Gesellschaft mbH
Adalperostraße 37
85737 Ismaning
Germany

This medicine is authorised in the Member States of the European Community under the following names

Austria: Magnesium Diasporal 300 mg Granulat zur Herstellung einer Lösung zum Einnehmen
Denmark: Magnesium Diasporal
Germany: Magnesium-Diasporal 300 mg Granulat zur Herstellung einer Lösung zum Einnehmen
Sweden: Magnesium Diasporal 300 mg Granulat till orallösning

This leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 02/2019
Active ingredient: magnesium citrate. Areas of application: for the treatment and prevention of magnesium deficiency.