Magnesium sulfate S.A.L.F.

Package leaflet: Information for the user

MAGNESIO SOLFATO S.A.L.F. 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

Magnesio solfato
Equivalent medicinal product
Please read all of this leaflet carefully before you start 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 adverse reaction, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

1. What MAGNESIO SOLFATO S.A.L.F. is and what it is used for
2. What you need to know before using MAGNESIO SOLFATO S.A.L.F.
3. How to use MAGNESIO SOLFATO S.A.L.F.
4. Possible side effects
5. How to store MAGNESIO SOLFATO S.A.L.F.
6. Contents of the pack and other information

1. What MAGNESIO SOLFATO S.A.L.F. is and what it is used for

MAGNESIO SOLFATO S.A.L.F. 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 (preeclampsia, eclampsia), characterized by high blood pressure, swelling due to fluid retention (edema), and the presence of protein in the urine;
• supplying magnesium to the body in case of deficiency of this substance in the blood (acute hypomagnesemia), particularly if you suffer from a condition characterized by muscle cramps and spasms (tetany);
• the prevention and treatment of magnesium deficiency in the blood (hypomagnesemia) during intravenous administration of nutrients (total parenteral nutrition).

2. What you should know before using MAGNESIO SOLFATO S.A.L.F.

Do not use MAGNESIO SOLFATO S.A.L.F.

• 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 S.A.L.F.
MAGNESIO SOLFATO S.A.L.F. must only be administered if the vial or ampoule is undamaged and the solution is clear, colourless, and free from visible particles.
The medicine must be administered at a controlled rate, after appropriate dilution.
Any unused medicine must be discarded (See section “How to use MAGNESIO SOLFATO S.A.L.F.”).
During treatment with MAGNESIO SOLFATO S.A.L.F., your doctor must periodically monitor your blood magnesium levels to prevent excessive increases.
MAGNESIO SOLFATO S.A.L.F. 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 S.A.L.F.”).
If you are pregnant and have eclampsia, the medicine will be administered intravenously only to control seizures, which can be life-threatening (See section “Pregnancy and breastfeeding”).

Children
For use of MAGNESIO SOLFATO S.A.L.F. 2 mEq/ml concentrate for solution for infusion in children under 3 years of age, see section “MAGNESIO SOLFATO S.A.L.F. 2 mEq/ml concentrate for solution for infusion contains benzyl alcohol”.

Other medicines and MAGNESIO SOLFATO S.A.L.F.
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.
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 S.A.L.F. 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 if treatment for magnesium intoxication becomes necessary;
• 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 relaxation (neuromuscular blockade) induced by magnesium;
• eltrombopag, used for certain blood disorders, as magnesium sulfate may reduce its effects;
• rocuronium, used for anesthesia during surgery, because it may cause excessive reduction in voluntary muscle contraction (neuromuscular blockade) and severe breathing problems (respiratory depression, apnea);
• labetalol, used to treat high blood pressure, as it may cause slow heart rate (bradycardia) and reduced volume of blood pumped by the heart (cardiac output), leading to shortness of breath, dizziness, and temporary loss of consciousness (fainting);
• medicines used to treat high blood pressure (calcium antagonists such as isradipine, felodipine, nicardipine, and nifedipine), as excessively low blood pressure (hypotension) may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before this medicine is administered.

Pregnancy
If you are pregnant, this medicine must be administered only when strictly necessary and under direct medical supervision, with continuous monitoring of your baby’s heart activity (fetal heart rate) (See section “Warnings and precautions”).
If you suffer from 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).
MAGNESIO SOLFATO S.A.L.F. must not be administered within 2 hours before delivery.

Breastfeeding
If you are breastfeeding, this medicine must be administered under direct medical supervision, as magnesium sulfate passes into breast milk.

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

MAGNESIO SOLFATO S.A.L.F. 2 mEq/ml concentrate for solution for infusion contains benzyl alcohol
The 30 ml vial contains 270 mg of benzyl alcohol; therefore, this medicine must not be administered to premature infants or newborns.
Exposures up to 90 mg/kg/day may cause toxic and allergic reactions in children up to 3 years of age.
Due to the risk of fatal toxic reactions associated with exposure to benzyl alcohol exceeding 90 mg/kg/day, this medicine must not be administered to children under 3 years of age.

3. How to use MAGNESIO SOLFATO S.A.L.F.

MAGNESIO SOLFATO S.A.L.F. will be administered to you by a doctor or trained medical personnel after appropriate dilution (5% glucose solution or 0.9% sodium chloride solution).
The solution must be clear, colourless, and free from particles.
Due to the possible formation of precipitates, magnesium sulfate must not be mixed with solutions containing: high-concentration 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.
Magnesio solfato S.A.L.F. 1 g/10 ml concentrate for infusion solution
Magnesio solfato S.A.L.F. 2 g/10 ml concentrate for infusion solution
Magnesio solfato S.A.L.F. 2.5 g/10 ml concentrate for infusion solution
The medicine must be used immediately after opening the vial; any unused 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.
You must not receive more than 30–40 g in one day.
To control convulsions, a certain blood magnesium level must be achieved (6 mg/100 ml).

Prevention and treatment of magnesium deficiency in patients receiving total parenteral nutrition
The recommended dose ranges from 1 g to 3 g of magnesium sulfate per day.

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 S.A.L.F. than you should
This medicine will be administered by a doctor or trained medical personnel, so it is unlikely that you will receive an excessive dose. However, if you think you have been given too much MAGNESIO SOLFATO S.A.L.F., inform your doctor or another healthcare professional immediately.
Following an overdose of this medicine, excessive increase in blood pressure (blood pressure spike) and respiratory arrest (respiratory paralysis) may occur.

If you have any doubts about how to use MAGNESIO SOLFATO S.A.L.F., consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• intestinal disorders (paralytic ileus, delayed intestinal transit);
• allergic reactions, urticaria;
• increased levels of acidic substances in the blood (metabolic acidosis), reduced levels of calcium in the blood (hypocalcemia);
• sudden feeling of warmth (flushing), sweating, lowering of blood pressure (hypotension), loss of voluntary motor function (flaccid paralysis), lowering of body temperature (hypothermia), severe problems affecting the heart, circulation, and brain (circulatory collapse, cardiac 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 may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAGNESIO SOLFATO S.A.L.F.

Keep this medicine out of 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 to the product kept in its original sealed packaging and properly stored.
Store this medicine in its original packaging.
No special temperature requirements for storage. Do not freeze.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MAGNESIO SOLFATO S.A.L.F. contains
MAGNESIO SOLFATO S.A.L.F. 1 g/10 ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. One vial (10 ml) contains 1000 mg of magnesium sulfate heptahydrate (equivalent to 811 mEq/litre of Mg). pH between 5.5 and 7.0.
• The other component is water for injections.

MAGNESIO SOLFATO S.A.L.F. 2 g/10 ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. One vial (10 ml) contains 2000 mg of magnesium sulfate heptahydrate (equivalent to 1623 mEq/litre of Mg). pH between 5.5 and 7.0.
• The other component is water for injections.

MAGNESIO SOLFATO S.A.L.F. 2.5 g/10 ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. One vial (10 ml) contains 2500 mg of magnesium sulfate heptahydrate (equivalent to 2028 mEq/litre of Mg). pH between 5.5 and 7.0.
• The other component is water for injections.

MAGNESIO SOLFATO S.A.L.F. 2 mEq/ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. Each ml contains 0.246 g of magnesium sulfate heptahydrate (equivalent to 2 mEq of Mg). pH between 5.5 and 7.0.
• The other components are benzyl alcohol and water for injections.

Description of the appearance of MAGNESIO SOLFATO S.A.L.F. and contents of the pack
MAGNESIO SOLFATO S.A.L.F. 1 g/10 ml, 2 g/10 ml and 2.5 g/10 ml concentrate for solution for infusion
5 vials of 10 ml.
MAGNESIO SOLFATO S.A.L.F. 2 mEq/ml concentrate for solution for infusion
1 bottle of 30 ml.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) - Tel. 035 - 940097