Defaspmag 10 mmol (243 mg) soluble tablets – patient leaflet, side effects, dosage

1. What Defaspmag is and what it is used for

The name of your medicine is Defaspmag 243 mg (10 mmol) soluble tablets.

Each Defaspmag 243 mg (10 mmol) soluble tablet contains 1,193.57 mg magnesium citrate and 667.56 mg magnesium aspartate dihydrate, equivalent to 243 mg magnesium (10 mmol magnesium).

Defaspmag 243 mg (10 mmol) soluble tablets are indicated for:

• treatment of magnesium deficiency conditions, when dietary supplement ation is insufficient
• prevention of magnesium deficiency in high-risk patients

2. What you need to know before you take Defaspmag

Do not take Defaspmag

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• If you have severe kidney failure
• If you have an inherited metabolic disorder: phenylketonuria (PKU), because Defaspmag contains aspartame, a sweetener which is converted to phenylalanine
• If you have a very slow heart rhythm (called ‘bradycardia’ or ‘atrioventricular block’)

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Defaspmag.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Defaspmag: • If you have kidney problems (you can use Defaspmag only under medical supervision)

• If you are taking antacids or laxatives containing magnesium salts, especially if you have kidney problems leading to failure • If you are a patient with a tendency to develop kidney stones during a urinary tract infection
• If you have dehydration

If you have confirmed magnesium deficiency, you may also have calcium deficiency and potassium deficiency since magnesium deficiency is frequently secondary to those conditions. Your doctor will treat those conditions if confirmed. If you also have calcium deficiency, your magnesium treatment should generally start 2-3 hours before your calcium treatment. If you have severe magnesium deficiency or if the absorption of magnesium into your blood is usually poor when you take magnesium orally, you should not start taking this medicine unless you have received intravenous magnesium treatment first.

Children

Do not give this medicine to children under the age of 6 years.

Other medicines and Defaspmag

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription.

In general, you should not take Defaspmag at the same time as other medicines. A 2-3 hour interval between Defaspmag and any other medicine should generally be respected with additional precautions as follows:

Do not take Defaspmag within one hour of taking cellulose sodium phosphate or edetate disodium.

Separating Defaspmag and the following medicines by 2-3 hours is mandatory:

• Fluorides
• Tetracyclines: antibiotics to treat infections
• Cardiac glycosides such as digoxin: magnesium taken at the same time may reduce absorption of these medicines used to treat heart conditions

Take Defaspmag 3-4 hours before or after taking:

• Aminoquinolines: medicines used to treat malaria
• Quinidine and quinidine derivatives: medicines used to treat heart rhythm disorders
• Nitrofurantoin and nitroxoline antibiotics
• Penicillamine: medicine used to treat severe rheumatoid arthritis and used in Wilson's disease
• Iron: to treat anaemia
• Bisphophonates such as alendronate and risedronate: medicines used to treat bone disorders
• Eltrombopag: medicine used to correct bleeding deficiency

The following medicines may cause magnesium deficiency which may also enhance the adverse effects of digoxin even when the 2-3 hour interval between Defaspmag and digoxin is respected. Your doctor may decide to adjust your daily dose of Defaspmag to be taken 2-3 hours before or after taking the following medicines (especially if you are also taking digoxin): • Aminoglycoside antibiotics such as gentamicin, streptomycin and neomycin

• Cisplatin and EGF-receptor antagonists such as cetuximab and erlotinib: medicines used to treat cancer
• Ciclosporin A and rapamycin: medicine used to suppress the body’s immune system e.g. following an organ transplant
• Water tablets (Diuretics) such as thiazides and furosemide: medicines used to treat blood pressure or heart failure
• Proton pump inhibitors such as omeprazole and pantoprazole: medicines used to treat high levels of acid coming from the stomach • Foscarnet: antiviral medication
• Pentamidine: medicine to treat infections
• Amphotericin B: medicine to treat fungal infections

Antacids, laxatives and other medicines containing magnesium may cause magnesium overload. Your doctor may decide to adjust your daily dose of Defaspmag to be taken 2-3 hours before or after taking all other medicines containing magnesium (especially if you have kidney problems leading to failure).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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Based on long-term experience, no adverse effects of magnesium on pregnancy or on the health of the foetus or newborn child are anticipated.

Defaspmag can be used during pregnancy and lactation. Driving and using machines

Defaspmag has no known influence on the ability to drive and use machines.

Defaspmag contains sodium

This medicine contains 256.5 mg sodium (main component of cooking/table salt) in each soluble tablet. This is equivalent to 12.8% of the recommended maximum daily dietary intake of sodium for an adult.

Talk to your doctor or pharmacist if you need 1 or more soluble tablets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

Defaspmag contains aspartame

This medicine contains 6 mg aspartame in each soluble tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Defaspmag contains sorbitol

This medicine contains 257 mg sorbitol in each soluble tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

Sorbitol may cause discomfort in the stomach or gut and a mild laxative effect.

3. How to take Defaspmag

Always take this medicine exactly as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The duration of magnesium treatment required will depend on the clinical circumstances of each patient.

It is recommended that blood magnesium levels should be monitored at regular intervals (for example every 3-6 months), particularly in children and in patients with kidney problems.

Treatment should be discontinued as soon as magnesium deficiency is remedied. In cases of chronic magnesium deficiency, treatment should last at least 4 weeks.

The recommended dose for adults (over 18 years) is one or two (1-2) soluble tablets, equivalent to 243 -486 mg magnesium (10-20 mmol magnesium) per day.

Use in children

Adolescents (12 years to 18 years weighing more than 43 kg): One (1) soluble tablet, equivalent to 243mg (10 mmol magnesium) per day.

Children aged 10 to 11 years (30 to 43 kg of body weight): One (1) soluble tablet equivalent to 234 mg magnesium (10 mmol magnesium) per day.

Children aged 6 to 9 years (20 to 29 kg of body weight): Half (½) soluble tablet equivalent to 121.5 mg magnesium (5 mmol magnesium) per day.

Dissolve the soluble tablet in least half a glass of tap water and drink it immediately. Handle the soluble tablet with dry hands.

The soluble tablet can be divided into equal doses.

After use ensure that the tube is well closed.

If you take more Defaspmag than you should

No side effects are expected, if your kidneys work properly. Any excessive amount of magnesium will be excreted through your kidneys. Symptoms due to any overdose may include gastro-intestinal disorders, such as diarrhoea and abdominal discomfort, urinary retention, heart symptoms and breathing problems. Magnesium overdose is treated with intravenous calcium. If necessary, artificial respiratory support is used. If you take more Defaspmag than you should or if a child accidentally has taken this medicine, contact a doctor immediately.

If you forget to take Defaspmag

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you stop taking Defaspmag

Do not stop taking your tablets unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

When high doses are taken, diarrhoea or stomach or gut irritation may be observed. If you get any side effects such as diarrhoea, you should temporarily interrupt the treatment. After the symptoms improve you can restart treatment, with a reduced dosage.

If you are a patient with kidney failure, fatigue may occur, which may mean that you have higher than normal levels of magnesium. This can also happen if Defaspmag is used in the long-term in patients with kidneys working properly.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Defaspmag

Keep this medicine out of the sight and reach 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.

This medicine does not require any special temperature storage conditions. Keep this medicine in the original package in order to protect from moisture. After first opening you should use this medicine within 40 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Defaspmag contains

• The active substance(s) is magnesium. 1 soluble tablet contains 1,193.57 mg magnesium citrate and 667.56 mg magnesium aspartate dihydrate, equivalent to 243 mg magnesium (10 mmol magnesium). • The other ingredients are: sodium hydrogen carbonate, citric acid, sodium sulphate anhydrous, sorbitol, aspartame, saccharin sodium, lemon flavour (containing lemon oil, citral, l-menthol, butylated hydroxyanisole, maize maltodextrin, gum arabic and ascorbic acid), simeticone emulsion (containing simeticone, methylcellulose, sorbic acid and water).

What Defaspmag looks like and contents of the pack

Defaspmag is a cylindrical, white to off-white, biplane soluble tablet of approximately 25 mm diameter with bevelled edges and a single break score line in one side.

It is available in carton box with 1 or 2 polypropylene tubes with polyethylene cap, containing 20 soluble tablets each.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Kora Healthcare

20 Harcourt Street, Dublin 2, D02 H364, Ireland

Manufacturer

IASIS PHARMACEUTICALS HELLAS S.A. - KOROPI

Archimidous Street, Koropi Attikis 194 00, Greece

This leaflet was last revised in August 2026.

This leaflet is available in formats appropriate for the blind and partially sighted. Healthcare professionals and patients should contact the Marketing Authorisation Holder for further information.

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