- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Adults (> 18 years)1-2 sachets daily (243-486 mg magnesium or 10-20 mmol magnesium)
Children and adolescents: 10 to 18 years1 sachet daily, (243 mg magnesium or 10 mmol magnesium)
Children: 4-10 yearsOne level 5ml spoon daily (109 mg magnesium) or One sachet daily (243 mg magnesium).
Children: 2 to 4 yearsOne level 5ml spoon daily. (109 mg magnesium or 4.5mmol magnesium) The safety and efficacy of Magnaspartate in children below 2 years has not been established
Renal patients:Magnaspartate 243 mg is contraindicated in patients with severe renal impairment (see section 4.3). There is no dose adjustment necessary in patients with mild to moderate renal impairment. Elderly: No dose adjustment is necessary.
Method of administrationFor oral use after solution in water, tea or orange juice. Magnaspartate can be dissolved in 50-200mL water, tea or orange juice. Stir until the solution in water is cloudy to transparent. In orange juice or tea inactive particles will be visible. The solution should be taken immediately after being prepared. Discard any remaining content of the sachet.
NoteIf necessary, Magnaspartate in 200ml water can be administered via a gastric, duodenal, and nasal feeding tube. This should be administered immediately after preparation.
PregnancyA large amount of data on pregnant women over 16 weeks gestation (more than 1000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of magnesium.Magnaspartate can be used during pregnancy if clinically needed. Administration of aminoglycoside antibiotics should be avoided during this period, as there are indications of interactions (see 4.5).
LactationMagnaspartate can be used during breast-feeding. Magnesium aspartate/metabolites are excreted in human milk, but at therapeutic doses of Magnaspartate no effects on the breastfed newborns/infants are anticipated.
FertilityBased on long-term experience, no effects of magnesium on male and female fertility are anticipated.
|MedDRA System Organ Class||Frequency||Undesirable Effects|
|Gastrointestinal disorders||Uncommon||Soft stools or diarrhoea following high dosage|
|General disorders and administration site conditions||Very rare||fatigue if used long-term|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation 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
Intoxication symptoms:Blood pressure fall, nausea, vomiting, hyporeflexia, somnolence, 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 methylsulfate; Intravenous and per-oral administration of isotonic sodium chloride solution; ventilatory and circulatory support; In case of renal insufficiency: haemodialysis.
AbsorptionIntestinal absorption is not directly proportional to magnesium intake but is dependent mainly on magnesium status. The lower the magnesium level, the more magnesium is absorbed in the gut: thus, relative magnesium absorption is high when intake is low and vice versa. Magnesium is slowly and incompletely absorbed primarily in the small intestine. The non-absorbable portion can produce a laxative effect. Peak serum levels are reached after 2-3 hours. At 6h, magnesium absorption is approximately 80% complete.
DistributionMagnesium is the main intracellular divalent cation, and the normal adult human body content is around 22.6g. About 60% of the magnesium is present in bone, of which 30% is exchangeable and functions as a reservoir to stabilise the serum concentration. About 20% is in skeletal muscle, 19% in other soft tissues and less than 1% in the extracellular fluid. After oral administration the distribution of magnesium within the body depends on the filling state of magnesium levels in each individual case. The classical method of determining bioavailability using plasma concentration curves cannot be applied to magnesium. The concentration of magnesium in the blood serum is subject to variations during the day. Due to the equilibrium between magnesium concentration in the blood serum and the depot in the bones, no conclusions concerning the depot in the body can be drawn from the concentration of magnesium in the blood serum. Neuromuscular hyper-excitability can be an indicator of magnesium deficiency.
EliminationAbsorbed magnesium is practically only secreted via the kidney.
Magnesium homeostasis influenced by medicationDiuretics (e.g. thiazide, furosemide) are widely used in the treatment of hypertension, heart failure and kidney diseases. They increase urinary output with hypermagnesuria probably leading to hypomagnesaemia and magnesium depletion. EGF-receptor antagonist (e.g. cetuximab, erlotinib) are used in the treatment of metastatic colorectal cancer. As EGF is a magnesiotropic hormone, treatment with EGF-receptor antagonists was related to severe hypomagnesaemia. Long-term treatment with proton pump inhibitors (e.g. omeprazole, pantoprazole) has been related to severe hypomagnesaemia, probably due to disturbances in absorption. Aminoglycoside antibiotics (e.g. gentamycin, tobramycin) are widely used in the treatment of severe bacterial infections. Studies showed that in 25 % of the patients, hypomagnesaemia occurs due to renal magnesium loss. Foscarnet is a pyrophosphate analogue that inhibits many viral DNA polymerases. Hypomagnesaemia is among others a side effect of foscarnet treatment as foscarnet is a potent chelator of divalent cations.
Magnesium homeostasis influenced by medical conditionsExcessive excretion of magnesium into the urine is a cause of magnesium depletion. Osmotic diuresis due to glucosuria can result in magnesium depletion, and diabetes mellitus is probably the most common clinical disorder associated with magnesium depletion. Therefore, diabetics have an increased requirement for magnesium.Magnesium deficiency has been shown to result in cardiovascular disorders such as cardiac dysrhythmias, which may be manifested by a rapid heart rate (tachycardia), skipped heart beats (premature beats), or a totally irregular cardiac rhythm (fibrillation). A low magnesium status leads to arterial vasoconstriction and thrombocyte aggregation. Migraine patients often show low magnesium levels, therefore, magnesium deficiency seems to play a role in the pathogenesis of migraine. Magnesium supplementation was effective in migraine prophylaxis.
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