Defaspmag 10 mmol (243 mg) soluble tablets – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Defaspmag 10 mmol (243 mg) soluble tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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).

Excipient(s) with known effect:

1 soluble tablet contains 257 mg sorbitol, 6 mg aspartame and 256.5 mg sodium. For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Soluble tablet.

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. The soluble tablet can be divided into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Defaspmag10 mmol (243 mg) soluble tablets are indicated for:

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

4.2 Posology and method of administration

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

It is recommended that serum magnesium levels should be monitored at regular intervals e.g. every 3-6 months, particularly in children and in patients with renal impairment.

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

Posology

Adults (over 18 years)

1-2 soluble tablets, equivalent to 243-486 mg magnesium (10-20 mmol magnesium) per day.

Paediatric population

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

Children aged 10 to 11 years (30 to 43 kg of body weight): 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): ½ soluble tablet equivalent to 121.5 mg magnesium (5 mmol magnesium) per day.

Elderly

No dose adjustment is necessary, except in renal impairment (see section 4.4).

Method of administration

Oral use.

The soluble tablets should be dissolved in least half a glass of tap water. Once dissolved, the solution should be administered immediately.

It is recommended to handle the tablet with dry hands.

The tube should be tightly closed immediately after use.

4.3 Contraindications

Defaspmag 10 mmol (243 mg) soluble tablets should not be used in patients with:

• hypersensitivity to the active substance or any of the excipients listed in section 6.1
• severe renal failure
• an inherited metabolic disorder: phenylketonuria (PKU), because this medicinal product contains aspartame, a sweetener which is converted to phenylalanine
• disorders of cardiac conduction (eg. AV block, bradycardia)

4.4 Special warnings and precautions for use

Use with caution in patients:

• with impaired renal function (only under medical supervision)
• on concomitant use of antacids or laxatives containing magnesium salts, especially in case of renal failure
• with a tendency for calculus formation during a urinary tract infection
• with dehydration

In the case of confirmed magnesium deficiency, concomitant hypocalcaemia and hypokalaemia should be suspected and corrected if confirmed since magnesium deficiency is frequently secondary to those conditions. When calcium deficiency is also present, magnesium replacement should be initiated prior to calcium replacement (generally 2-3 hours prior).

In subjects with severe magnesium deficiency or malabsorption, treatment should start with intravenous magnesium replacement.

Excipients

The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

This medicinal product contains 256.5 mg sodium per effervescent tablet, equivalent to 12.8% of the WHO recommended maximum daily intake for sodium.

The maximum daily dose of this product is equivalent to 25.6% of the WHO recommended maximum daily intake for sodium.

Defaspmag 10 mmol (243 mg) soluble tablets are considered high in sodium. This should be particularly taken into account for those on a low salt diet.

Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

4.5 Interaction with other medicinal products and other forms of interaction

Magnesium forms complexes with certain medicines and may reduce their absorption. A 2–3 hour interval between magnesium and other medicinal products should generally be respected.

• Do not take magnesium within 1 hour of cellulose sodium phosphate or edetate disodium.
• Separate by 2–3 hours: fluorides, tetracycline.
• Take magnesium 3–4 hours before or after: aminoquinolines, quinidine and derivatives, nitrofurantoin, penicillamine, iron, bisphosphonates (e.g. alendronate, risedronate), eltrombopag, nitroxoline.

Digitalis glycosides: concomitant magnesium may reduce digitalis absorption; separate dosing as above. Magnesium deficiency may enhance digoxin toxicity.

Medicines increasing magnesium losses: aminoglycosides, cisplatin, ciclosporin A, diuretics (e.g. thiazides, furosemide), EGFR antagonists (e.g. cetuximab, erlotinib), proton pump inhibitors (e.g. omeprazole, pantoprazole), foscarnet, pentamidine, rapamycin, amphotericin B. Magnesium dose adjustment may be necessary. Evaluate for associated hypokalaemia and hypocalcaemia.

For the risk of hypermagnesaemia with other magnesium-containing products and in renal impairment, see Section 4.4.

4.6 Fertility, pregnancy and lactation

The effectiveness and safety of Defaspmag 10 mmol (243 mg) soluble tablets has not been established in pregnant women. Defaspmag 10 mmol (243 mg) soluble tablets should only be used in pregnancy if the benefits of the treatment outweigh any potential risks. However, long-term data available from treatment of pre-eclampsia do not indicate malformative or foeto/neonatal toxicity of magnesium. Defaspmag 10 mmol (243 mg) soluble tablets can be used during pregnancy and lactation.

Based on long-term experience, no effects of magnesium on male and female fertility are anticipated.

4.7 Effects on ability to drive and use machines

Defaspmag 10 mmol (243 mg) soluble tablets have no known influence on the ability to drive and use machines.

4.8 Undesirable effects

Tabulated list of adverse reactions

Adverse reactions reported in clinical trials and in post-marketing surveillance are listed by system organ class and by frequency.

Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from available data).

When high doses are taken, diarrhoea or gastro-intestinal irritation may be observed. If diarrhoea is observed, the daily dose should be reduced or administration should be temporarily withheld.

Hypermagnesemia may occur after oral administration of magnesium salts especially in the case of renal failure. Therefore, in case of high doses and long-term administration, fatigue may occur. This may be an indication that increased levels of magnesium have already been achieved.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9 Overdose

In subjects with normal renal function, no poisoning symptoms are expected to occur even in overdose.

Symptoms due to any overdose may include gastro-intestinal disorders, such as diarrhoea and abdominal discomfort, urinary retention, heart symptoms (delayed atrioventricular transmission and ventricular stimulus transmission), respiratory insufficiency. Magnesium overdose is treated with intravenous calcium. If necessary, artificial respiratory support is used.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Magnesium (different salts in combination)

ATC code: A12CC30

Among intracellular cations, magnesium is the fourth most important cation in the body and the second most important intracellular cation after potassium. Magnesium is a cofactor in more than 300 enzyme systems involved, among other things, in all reactions that require ATP. Magnesium plays an important role in intracellular electrolyte homeostasis and in neuromuscular membrane stabilisation.

Magnesium:

• acts as a physiological calcium antagonist and as such regulates the

  contractility of the heart and stabilises cardiac rhythm

• stabilizes the phospholipids of the cell membrane
• inhibits neuromuscular transmission

5.2 Pharmacokinetic properties

Magnesium is rapidly absorbed in the duodenum and upper jejunum. 30% to 40% of the administered dose is absorbed, which is increased to 70% in a state of magnesium deficiency. Absorption also depends on various other factors such as surface intestinal lesions, bowel movement, transit time and normal intestinal flora. Peak serum levels are achieved after 2-3 hours.

Magnesium plasma concentrations are between 0.8 and 1.1 mmol/l. Approximately 40% of plasma magnesium is bound to plasma proteins; only free magnesium is biologically active.

Magnesium is almost exclusively excreted via the kidneys, whereas biliary excretion is limited. Reabsorption by the kidneys ranges normally between 95% and 100%, which allows regulation of magnesium balance in the body. Excretion of magnesium is increased in subjects with osmotic diuresis (patients with inadequately controlled diabetes, mannitol, urea) or on various medicines (loop diuretics, long-term treatment with mineralocorticoids, growth hormone and thyroid hormones).

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

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)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

Shelf life after first opening of the tube: 40 days.

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

6.5 Nature and contents of container

Carton box with 1 or 2 polypropylene tubes with polyethylene cap, containing 20 soluble tablets each.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Kora Corporation Ltd t/a Kora Healthcare

20 Harcourt Street

Dublin 2

D02 H364

Ireland

8 MARKETING AUTHORISATION NUMBER(S)

PL 39972/0027

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

18/09/2026

10 DATE OF REVISION OF THE TEXT

18/09/2026