Magnaspartate 243 mg powder for oral solution - Summary of Product Characteristics (SmPC) (2023)

Each 6.5 g powder sachet contains magnesium aspartate dihydrate, equivalent to 243 mg (10 mmol) magnesium.

Excipient(s) with known effect:

Each sachet contains 2.706 g sucrose

For the full list of excipients see section 6.1.

Powder for oral solution

White powder with peach/apricot flavor.

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

It is recommended to check the serum magnesium level at regular intervals, e.g. every 3-6 months, especially in children and patients with impaired renal function.

dosage

Adults (> 18 years)

1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium)

Children and young people: 10 to 18 years

1 sachet daily (243 mg magnesium or 10 mmol magnesium)

Children: 4-10 years

One 5mL level scoop daily (109 mg magnesium) or one sachet daily (243 mg magnesium).

Children: 2 to 4 years

One level 5ml scoop daily. (109 mg magnesium or 4.5 mmol magnesium)

The safety and effectiveness of magnaspartate in children younger than 2 years of age have not been established

kidney patients:

Magnaspartat 243 mg is contraindicated in patients with severe renal impairment (see section 4.3).

No dose adjustment is required in patients with mild to moderate renal impairment.

old:

No dose adjustment is required.

type of administration

For oral use after dissolving in water, tea or orange juice.

Magnaspartate can be dissolved in 50-200 ml of water, tea or orange juice.

Stir until solution in water is cloudy to transparent. Inactive particles are visible in orange juice or tea. The solution should be taken immediately after reconstitution or within 24 hours if reconstituted in bottled water and stored below 25°C.

Discard the remaining contents of the sachet.

note

If necessary, magnaspartate can be administered in 200 ml of water via a gastric, duodenal and nasogastric tube. This should be administered immediately after reconstitution or within 24 hours if reconstituted in bottled water and stored below 25°C.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Severe renal impairment (glomerular filtration rate < 30 mL/min)

• Heart conduction disorders (bradycardia)

In the case of confirmed magnesium deficiency, concomitant hypocalcemia and hypokalemia should be suspected and corrected if confirmed, since magnesium deficiency is often secondary to these disorders.

If an undesirable effect occurs, e.g. B. diarrhea, the therapy should be temporarily interrupted and can be resumed with reduced dosage after improvement and/or resolution of the symptoms.

The bioavailability of magnesium supplements can vary; Therefore, care should be taken when switching between magnesium supplements to ensure tolerability and an equivalent therapeutic effect.

Excipients:

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicine.

Contains 2.706g sucrose per sachet. This should be taken into account in patients with diabetes mellitus. Frequent and long-term use can be harmful to teeth.

This medicinal product contains less than 1 mmol sodium (23 mg) per sachet, i.e. essentially 'sodium-free'. H. it is almost "sodium-free".

Since magnesium and other medicines can influence each other's absorption, a time interval of 2 to 3 hours should generally be observed if possible.

This applies in particular to:

•Cellulose-Sucrosephosphate; He eats disodium:simultaneous use with magnesium preparations can lead to magnesium binding; Patients should be advised not to take magnesium supplements within 1 hour of cellulose sodium phosphate or denatured disodium.

•fluorides and tetracycline:if they must be used, the doses must be separated by 2 to 3 hours or more to prevent their mixing in the gut.

•Aminochinoline, Chinidin und Chinidinderivate Nitrofurantoin, Penicillamin, Eisen, Bisphosphonate, Eltrombopag, Nitroxolin:To avoid interfering with absorption, magnesium supplements should be taken 3 to 4 hours before or after administration of these drugs.

Due to increased magnesium losses, the dose of magnesium may need to be adjusted when taking the following substances:

• Aminoglycoside antibiotics, cisplatin and ciclosporin A

• diuretics (such as thiazides and furosemide),

• EGF receptor antagonists (such as cetuximab and erlotinib),

• Proton pump inhibitors (such as omeprazole and pantoprazole) and

• Viral DNA polymerases that inhibit foscarnet, pentamidine, rapamycin and amphotericin B

For more information on mechanisms of drug-drug interactions see section 5.2.

pregnancy

A large amount of data from pregnant women over 16 weeks gestation (more than 1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of magnesium.

Magnaspartat can be used during pregnancy if clinically indicated.

The administration of aminoglycoside antibiotics should be avoided during this time as there are indications of interactions (see 4.5).

lactation

Magnaspartat can be used during breast-feeding.

Magnesium aspartate/metabolites are excreted in human milk, but no effects on the breastfed newborn/infant are expected at therapeutic doses of magnaspartate.

fertility

Based on many years of experience, no effects of magnesium on male and female fertility are to be expected.

The assessment of side effects is based on the following frequencies:

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);

not known (cannot be estimated from the available data).

High doses can cause diarrhea or gastrointestinal irritation. If diarrhea occurs, the daily dose should be reduced and later gradually increased if necessary.

Fatigue may occur with high doses and long-term use. This may be an indication that an elevated magnesium level has been achieved. Hypermagnesaemia is rare after oral administration of magnesium salts unless renal dysfunction is present.

Reporting suspected side effects

It is important to report suspected side effects after the medicine has been approved. It allows continuous monitoring of the benefit-risk balance of the drug. 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 on Google Play or the Apple App Store

If the kidney function is intact, magnesium poisoning from an oral overdose of magnesium is not to be expected. An accumulation of magnesium can only occur in the case of severe renal insufficiency in combination with manifest intoxication.

In general, plasma concentrations up to 2 mmol/l are well tolerated.

Poisoning Symptoms:

Drop in blood pressure, nausea, vomiting, hyporeflexia, drowsiness, changes in the electrocardiogram, respiratory depression and cardiac arrest.

intoxication therapy:

Intravenous administration of calcium and slow intravenous administration of 0.5 - 2 mg neostigmine methyl sulfate;

Intravenous and peroral administration of isotonic sodium chloride solution; respiratory and circulatory support;

In renal failure: hemodialysis.

Pharmacotherapeutic group: mineral supplements, magnesium, ATC code: A12CC05

Magnesium is a cofactor in >300 enzymatic reactions. It functions as an essential cofactor for all ATP-binding enzymes.

Magnesium plays an important role in cellular electrolyte homeostasis and in stabilizing the neuromuscular membrane.

Magnesium:

• Acts as a physiological calcium antagonist and as such regulates the contractility of the heart and stabilizes the heart rhythm

• stabilizes the phospholipids of the cell membrane

• inhibits neuromuscular transmission

Absorption

Intestinal absorption is not directly proportional to magnesium intake, but mainly depends on magnesium status. The lower the magnesium level, the more magnesium is absorbed in the gut: so the relative magnesium intake is high when intake is low and vice versa.

Magnesium is absorbed slowly and incompletely - especially in the small intestine. The non-absorbable part can have a laxative effect.

Maximum serum levels are reached after 2-3 hours. After 6 hours, magnesium absorption is about 80% complete.

distribution

Magnesium is the major intracellular divalent cation and the normal adult human body content is about 22.6 g. About 60% of magnesium is found in bone, of which 30% is exchangeable and serves as a reservoir to stabilize serum levels. About 20% resides in skeletal muscle, 19% in other soft tissues, and less than 1% in extracellular fluid.

After oral administration, the distribution of magnesium in the body depends on the level of magnesium in the individual case. The classic method of determining bioavailability using plasma concentration curves cannot be applied to magnesium.

The concentration of magnesium in the blood serum is subject to fluctuations over the course of the day. Due to the balance between the magnesium concentration in the blood serum and the depot in the bones, no conclusions can be drawn about the depot in the body from the magnesium concentration in the blood serum. Neuromuscular hyperexcitability can be an indicator of magnesium deficiency.

elimination

Absorbed magnesium is practically only excreted via the kidneys.

Drug influence on magnesium homeostasis

Diuretics(eg, thiazide, furosemide) are commonly used to treat high blood pressure, heart failure, and kidney disease. They increase urinary output with hypermagnesiuria likely leading to hypomagnesemia and magnesium deficiency.

EGF receptor antagonist(e.g. cetuximab, erlotinib) are used to treat metastatic colorectal cancer. Because EGF is a magnesiotropic hormone, treatment with EGF receptor antagonists has been associated with severe hypomagnesemia.

Long-term treatment with proton pump inhibitors(e.g. omeprazole, pantoprazole) has been associated with severe hypomagnesaemia, probably due to malabsorption.

Aminoglykosid-Antibiotika(e.g. gentamycin, tobramycin) are commonly used to treat severe bacterial infections. Studies have shown that 25% of patients experience hypomagnesaemia due to renal magnesium depletion.

Foscarnetis a pyrophosphate analogue that inhibits many viral DNA polymerases.

Hypomagnesemia is one of the side effects of treatment with foscarnet, since foscarnet is a strong divalent cation chelating agent.

Magnesium homeostasis affected by disease

Excessive excretion of magnesium in the urine is one cause of magnesium deficiency. Osmotic diuresis due to glucosuria can lead to magnesium depletion, and diabetes mellitus is probably the most common clinical disorder associated with magnesium depletion. Therefore, diabetics have an increased need for magnesium.

It has been shown that a magnesium deficiency leads to cardiovascular diseases such as cardiac arrhythmia, which can manifest itself as a rapid heart rate (tachycardia), skipped heart beats (premature beats) or a completely irregular heart rhythm (atrial fibrillation). Low magnesium status leads to arterial vasoconstriction and platelet aggregation. Migraine sufferers often have low levels of magnesium, therefore magnesium deficiency seems to play a role in the pathogenesis of migraine. Magnesium supplementation was effective in migraine prophylaxis.

Sucrose

Citric Acid Monohydrate

Peach/Apricot Flavor

Saccharin-Natrium

Fumed silica

Media to be used for reconstitution; see section 4.2.

3 years.

Use immediately after reconstitution or within 24 hours if reconstituted in bottled water and stored below 25°C.

Sachets

Laminated film (paper/aluminum/polyethylene)

10 bags and 20 bags

Kora Corporation Ltd. t/a Kora Healthcare

20 Harcourt Street

Dublin 2

D02 H364

Ireland