Package leaflet

SOLUMAG 2.25 g powder for oral solution

Magnesium pidolate
Oral use
PHARMACOTHERAPEUTIC CATEGORY
Nervous system depressant.
Reduces neuronal hyperexcitability and muscular hypercontractility.
THERAPEUTIC INDICATIONS
In neurology and paediatrics: clinical conditions expressing a state of hyperexcitability of the central and peripheral nervous system sustained by magnesium deficiency.
In obstetrics: vomiting, insomnia, irritability, muscle cramps, painful uterine contractions, eclampsia.
CONTRAINDICATIONS
Severe renal insufficiency.
Hypersensitivity to the active substance or to any of the excipients.
Must not be administered to patients receiving digitalis therapy.
PRECAUTIONS FOR USE
No special precautions are required. If symptoms persist or worsen, consult your doctor.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.
Administration of magnesium may reduce the absorption of tetracyclines; therefore, it is recommended not to administer SOLUMAG simultaneously with tetracycline-containing medicines, but rather at an interval of 3–4 hours between administrations. Quinolones should be administered at least 2 hours before or 6 hours after administration of magnesium-containing products to avoid interference with their absorption.
In case of concomitant administration of magnesium and colecalciferol, monitoring of serum calcium levels is recommended to prevent possible episodes of hypercalcemia.
Concomitant use of preparations containing calcium or phosphate salts is discouraged, as these products prevent magnesium absorption. Concurrent administration of magnesium-containing products with central nervous system (CNS) depressants may enhance the CNS effects of magnesium and should be carefully evaluated.
SPECIAL WARNINGS
In patients with renal insufficiency, dosage reduction and monitoring of renal function and serum magnesium levels are necessary.
It is advisable to consider the possibility of cardiovascular and respiratory depression occurring during treatment.
SOLUMAG contains sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Pregnancy and breastfeeding
It is advisable that administration of the medicine during pregnancy and breastfeeding occurs under medical supervision and only when clearly needed.
Effects on ability to drive and use machines
SOLUMAG does not impair the ability to drive vehicles or operate machinery.
Important information about certain excipients
SOLUMAG contains sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
As prescribed by the physician. The recommended dosage is one sachet twice daily (for a total of 4.5 g of magnesium pidolate/day). Dissolve the contents of one sachet in half a glass of water.
OVERDOSE
In case of overdose, consult your doctor immediately.
Cases of hypermagnesemia have been reported following massive administration of magnesium or during treatment of patients with severe renal insufficiency. Observed symptoms include: cardiac rhythm disturbances, respiratory depression, and neuromuscular transmission disorders.
Treatment involves rehydration to restore abundant diuresis or forced diuresis.
In case of renal insufficiency, dialysis treatment is recommended.
In case of accidental ingestion or overdose of SOLUMAG, contact your doctor immediately or go to the nearest hospital.
FOR ANY QUESTIONS OR CLARIFICATIONS REGARDING THE USE OF THIS PRODUCT, CONSULT YOUR DOCTOR OR PHARMACIST.
UNDESIRABLE EFFECTS
Like all medicines, SOLUMAG can cause side effects, although not everybody gets them.
Rare gastrointestinal disturbances; diarrhoea, abdominal pain.
Exceptional cases of individual intolerance to the ion have been reported, which can be treated with oral or parenteral antihistamines.
Following the instructions provided in this leaflet reduces the risk of undesirable effects.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
Warning: do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under appropriate storage conditions.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
COMPOSITION
One sachet contains: Magnesium pidolate 2.25 g.
Excipients: sucrose; anhydrous citric acid; sodium saccharin; orange flavour.
PHARMACEUTICAL FORM AND CONTENT
Powder for oral solution, 20 sachets.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
DYMALIFE PHARMACEUTICAL SRL
Via Bagnulo, 95
80063 Piano di Sorrento (NA) - Italy
Manufacturer
LA.FA.RE. S.r.l. Via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA)