Patient Information Leaflet: Information for the User

MAGNESIO SOLFATO MONICO

1 g/10 ml concentrate for solution for infusion
2 g/10 ml concentrate for solution for infusion
2.5 g/10 ml concentrate for solution for infusion
2 mEq/ml concentrate for solution for infusion
Magnesium sulfate
Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

What MAGNESIO SOLFATO MONICO is and what it is used for
What you need to know before using MAGNESIO SOLFATO MONICO
How to use MAGNESIO SOLFATO MONICO
Possible side effects
How to store MAGNESIO SOLFATO MONICO
Contents of the pack and other information

1. What MAGNESIO SOLFATO MONICO is and what it is used for

MAGNESIO SOLFATO MONICO contains the active substance magnesium sulfate, which is a magnesium salt.
Magnesium plays an essential role in nerve impulse transmission and muscle contraction.
This medicinal product is indicated for:

the prevention and control of seizures that may occur during pregnancy if you suffer from a condition called pregnancy toxemia (pre-eclampsia, eclampsia), characterized by high blood pressure, swelling due to fluid retention (edema), and presence of protein in the urine;
supplying magnesium to the body in cases where it is deficient and blood levels become low (acute hypomagnesemia), particularly if you suffer from a condition characterized by muscle cramps and spasms (tetany);
the prevention and treatment of low magnesium levels in the blood (hypomagnesemia), during the administration of nutrients directly into the vein (total parenteral nutrition).

2. What you should know before using MAGNESIO SOLFATO MONICO

Do not use MAGNESIO SOLFATO MONICO

if you are allergic to magnesium sulfate or to any of the other ingredients of this medicine (listed in section 6);
if you have heart disorders (myocardial damage) or irregular heartbeat (cardiac arrhythmias);
if you have severe kidney problems (severe renal impairment) (See section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or nurse before using MAGNESIO SOLFATO MONICO.
MAGNESIO SOLFATO MONICO must only be administered if the ampoule or vial is undamaged and the solution is clear. The medicine must be injected as a single, uninterrupted administration, at a controlled rate, after appropriate dilution. Any unused medicine must be discarded (See section “How to use MAGNESIO SOLFATO MONICO”).
During treatment with MAGNESIO SOLFATO MONICO, your doctor must periodically monitor magnesium levels in your blood to prevent excessive increases.
MAGNESIO SOLFATO MONICO must be administered with particular caution if:

you have kidney problems (less severe renal impairment);
you suffer from a serious muscle disease (severe myasthenia gravis).

This medicine must not be administered if you have severe kidney problems (renal failure), as intravenous administration may lead to excessive increase in blood magnesium levels (magnesium intoxication) (See section “Do not use MAGNESIO SOLFATO MONICO”).
If you are pregnant and have eclampsia, the medicine will be administered intravenously only to control seizures, which may otherwise be fatal (See section “Pregnancy and breastfeeding”).

Other medicines and MAGNESIO SOLFATO MONICO
Inform your doctor if you are currently taking, have recently taken, or might take any other medicine.
Pay special attention and consult your doctor if you are taking:

medicines that reduce brain activity (such as barbiturates, narcotics, other hypnotics, systemic anesthetics), as the dose of MAGNESIO SOLFATO MONICO may need to be adjusted to avoid further reduction in brain activity;
medicines used for certain heart conditions (cardiac glycosides such as digitalis), as serious disturbances in heart rhythm (alterations in cardiac conduction) may occur;
medicines that reduce muscle contraction (competitive and depolarizing neuromuscular blockers), used before surgery, as magnesium sulfate may enhance their effects;
certain antibiotics used to treat bacterial infections (aminoglycoside antibiotics), as they may enhance the muscle-relaxing effect (neuromuscular blockade) induced by magnesium;
eltrombopag, used for circulation disorders, as magnesium sulfate may reduce its blood concentration and thus its effects;
rocuronium, used for anesthesia during surgery, as it may cause excessive reduction in voluntary muscle contraction (neuromuscular blockade) and serious breathing problems (respiratory depression, apnea);
labetalol, used for heart rhythm disorders, as reduced heart activity (bradycardia) and reduced blood volume pumped by the heart (cardiac output) may occur, leading to shortness of breath, dizziness, and temporary loss of consciousness (fainting);
medicines used to treat high blood pressure (calcium antagonists such as isradipine, felodipina, nicardipine, and nifedipine), as excessive lowering of blood pressure (hypotension) may occur.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before this medicine is administered.

Pregnancy
If you are pregnant, this medicine should only be administered in cases of absolute necessity and under direct medical supervision, with continuous monitoring of your baby’s heart activity (fetal heart rate) (See section “Warnings and precautions”).
If you have a condition called pregnancy toxemia and this medicine is administered to control seizures before delivery, your baby may experience serious muscle and breathing problems (neuromuscular and respiratory depression).
If used repeatedly during pregnancy, your doctor may recommend monitoring mineral levels, as your baby may experience adverse effects on skeletal development.
MAGNESIO SOLFATO MONICO must not be administered within 2 hours before delivery.

Breastfeeding
If you are breastfeeding, this medicine should only be administered under direct medical supervision.

Driving and using machines
No data are available regarding the ability to drive vehicles or operate machinery.
Therefore, consult your doctor if you intend to drive or operate machinery.

3. How to use MAGNESIO SOLFATO MONICO

This medicinal product will be administered to you by a doctor or trained healthcare professional, after appropriate dilution (with 5% glucose solution or 0.9% sodium chloride solution).
Due to the possible formation of precipitates, magnesium sulfate must not be mixed with solutions containing: high concentrations of alcohol, heavy metals, carbonates and bicarbonates, sodium hydrocortisone, succinates, phosphates, polymyxin B sulfate, procaine hydrochloride, calcium salicylate, clindamycin phosphate, tartrates. Potential incompatibility is often influenced by changes in the concentration of reactants and the pH of solutions.
The medicinal product must be administered through a single, uninterrupted infusion, and any remaining solution must be discarded.

Prevention and control of convulsions in severe pregnancy toxemia
Treatment of magnesium deficiency, especially when accompanied by tetany
In these cases, at the beginning of treatment, the total dose is 10–14 g of magnesium sulfate.
To control convulsions, a certain blood magnesium level must be achieved (6 mg/100 ml).
You must not receive more than 30–40 g in one day (24 hours).

Prevention and treatment of magnesium deficiency in patients receiving total parenteral nutrition
The recommended dose ranges from 1 g to 3 g (8–24 mEq) of magnesium sulfate per day (24 hours).

Use in patients with kidney problems
If you suffer from impaired kidney function (severe renal insufficiency), the maximum dose of magnesium sulfate is 20 g every 2 days (48 hours).

If you use more MAGNESIO SOLFATO MONICO than you should
This medicinal product will be administered to you by a doctor or trained healthcare professional; therefore, it is unlikely that you will receive an excessive dose. However, if you think that you have been given too much MAGNESIO SOLFATO MONICO, inform your doctor or another healthcare professional immediately.
Following administration of an excessive dose of this medicinal product, signs of toxicity may occur, such as excessive increase in blood pressure (hypertensive spike) and respiratory arrest (respiratory paralysis).

If you have any doubts about the use of MAGNESIO SOLFATO MONICO, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

intestinal disorders (paralytic ileus, delayed intestinal transit);
allergic reactions (hypersensitivity reactions such as urticaria);
increased levels of acidic substances in the blood (metabolic acidosis) or reduced levels of calcium in the blood (hypocalcemia);
sudden feeling of warmth (hot flushes), sweating, low blood pressure (hypotension), loss of voluntary motor function (flaccid paralysis), decreased body temperature (hypothermia), severe heart, circulation and brain problems (circulatory collapse, cardiac depression and central nervous system depression), and, in the most severe cases, respiratory arrest (respiratory paralysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAGNESIO SOLFATO MONICO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month and applies to the product in its original, undamaged packaging and correctly stored.
Store this medicine in its original packaging.
No special temperature requirements for storage.
The medicine must be administered immediately after opening the vial/bottle, in a single, uninterrupted administration, and only if the solution is clear, colourless, and free from particles. Any unused medicine must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What MAGNESIO SOLFATO MONICO contains
MAGNESIO SOLFATO MONICO 1 g/10 ml concentrate for solution for infusion

The active substance is magnesium sulfate heptahydrate. 10 ml of solution contain 1000 mg of magnesium sulfate heptahydrate. Each liter of solution contains 811 mEq of magnesium. pH: 5.5 ÷ 7.0.
The other component is water for injections.

MAGNESIO SOLFATO MONICO 2 g/10 ml concentrate for solution for infusion

The active substance is magnesium sulfate heptahydrate. 10 ml of solution contain 2000 mg of magnesium sulfate heptahydrate. Each liter of solution contains 1623 mEq of magnesium. pH: 5.5 ÷ 7.0.
The other component is water for injections.

MAGNESIO SOLFATO MONICO 2.5 g/10 ml concentrate for solution for infusion

The active substance is magnesium sulfate heptahydrate. 10 ml of solution contain 2500 mg of magnesium sulfate heptahydrate. Each liter of solution contains 2028 mEq of magnesium. pH: 5.5 ÷ 7.0.
The other component is water for injections.

MAGNESIO SOLFATO MONICO 2 mEq/ml concentrate for solution for infusion

The active substance is magnesium sulfate heptahydrate. 30 ml of solution contain 7390 mg of magnesium sulfate heptahydrate. Each liter of solution contains 2000 mEq of magnesium. pH: 5.5 ÷ 7.0.
The other component is water for injections.

Description of the appearance of MAGNESIO SOLFATO MONICO and contents of the
package
MAGNESIO SOLFATO MONICO 1 g/10 ml, 2 g/10 ml and 2.5 g/10 ml concentrate for
solution for infusion
Carton containing 5 or 10 glass vials of 10 ml.
MAGNESIO SOLFATO MONICO 2 mEq/ml concentrate for solution for infusion
Pack containing 10 glass vials of 30 ml.
Marketing Authorization Holder and Manufacturer
Monico spa
Via Ponte di Pietra 7, 30173 Venezia Mestre – Italy