Magnesium sulfate Galenica Senese

Package leaflet: Information for the user

MAGNESIO SOLFATO GALENICA SENESE 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

magnesium sulfate
Equivalent medicinal product
Please read all of this leaflet carefully before you use 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 pass it on 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:

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

1. What MAGNESIO SOLFATO GALENICA SENESE is and what it is used for

MAGNESIO SOLFATO GALENICA SENESE 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 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 administration of nutrients directly into the vein (total parenteral nutrition).

2. What you need to know before using MAGNESIO SOLFATO GALENICA SENESE

Do not use MAGNESIO SOLFATO GALENICA SENESE

• 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 heart rhythm problems (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 GALENICA SENESE.
MAGNESIO SOLFATO GALENICA SENESE must be administered only if the vial is undamaged and the solution is clear. The medicine must be injected through a single, uninterrupted administration at a controlled rate. Any unused medicine must be discarded (See section “How to use MAGNESIO SOLFATO GALENICA SENESE”).
During treatment with MAGNESIO SOLFATO GALENICA SENESE, your doctor must periodically monitor your blood magnesium levels to prevent excessive increases.
MAGNESIO SOLFATO GALENICA SENESE must be administered with particular caution if:

• you have kidney problems (less severe degree of renal impairment);
• you have a serious muscle disease (severe myasthenia gravis).

This medicine must not be administered if you have severe kidney problems (renal failure), as this may lead to excessive increase in blood magnesium levels (magnesium intoxication) (See section “Do not use MAGNESIO SOLFATO GALENICA SENESE”).
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”).

Other medicines and MAGNESIO SOLFATO GALENICA SENESE
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
Pay particular 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 GALENICA SENESE to be administered may need to be adjusted;
• medicines used for certain heart conditions (cardiac glycosides such as digitalis), as serious heart rhythm disturbances may occur (alterations in cardiac conduction);
• 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 muscle relaxation (neuromuscular blockade) induced by magnesium;
• eltrombopag, used for circulatory disorders, as magnesium sulfate may reduce its effects;
• rocuronium, used for anesthesia during surgical procedures, 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 it may cause: reduced heart rate (bradycardia), reduced heart activity (cardiac output), 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, 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 should be administered only when strictly necessary and under direct medical supervision, with monitoring of your baby’s heart activity (fetal heart rate) (See section “Warnings and precautions”).
If you have a condition characterized by high blood pressure, protein in the urine, and fluid accumulation in various parts of the body (pregnancy toxemia), and this medicine is administered to control seizures before delivery (especially for more than 24 hours 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 the baby may experience adverse skeletal effects.
MAGNESIO SOLFATO GALENICA SENESE must not be administered within 2 hours before delivery.

Breastfeeding
If you are breastfeeding, this medicine should be administered only 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 GALENICA SENESE

This medicine must be administered to you exactly as instructed by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
MAGNESIO SOLFATO GALENICA SENESE will be administered to you after appropriate dilution (5% glucose solution or 0.9% sodium chloride solution) by a doctor or trained medical personnel.
Magnesium sulfate must not be mixed with certain solutions, as precipitates may form (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.
The medicine must be administered via a single, uninterrupted infusion, and any remaining solution must be discarded.

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

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 GALENICA SENESE than you should
This medicine will be administered to you by a doctor or trained medical personnel; therefore, it is unlikely that you will receive an excessive dose. However, if you think you have been given an excessive dose of MAGNESIO SOLFATO GALENICA SENESE, inform your doctor or another healthcare professional immediately.
Following administration of an excessive dose 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 GALENICA SENESE, 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 (hypersensitivity), such as urticaria;
• increased levels of acidic substances in the blood (metabolic acidosis), reduced levels of calcium in the blood (hypocalcemia);
• sudden feeling of warmth (hot flushes), sweating, drop in 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAGNESIO SOLFATO GALENICA SENESE

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 to the product in intact packaging stored correctly. The solution must be clear, colourless and free from particles.
No special storage conditions are required for this medicine.
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 GALENICA SENESE contains

MAGNESIO SOLFATO GALENICA SENESE 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).
• The other component is water for injections.

MAGNESIO SOLFATO GALENICA SENESE 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).
• The other component is water for injections.

MAGNESIO SOLFATO GALENICA SENESE 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).
• The other component is water for injections.

Description of the appearance of MAGNESIO SOLFATO GALENICA SENESE and contents of the
package
MAGNESIO SOLFATO GALENICA SENESE 1 g/10 ml, 2 g/10 ml and 2.5 g/10 ml concentrate for
solution for infusion
Pack containing 1 or 10 vials of 10 ml.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l. - Via Cassia Nord, 351 - 53014 Monteroni D'Arbia (Siena) - Italy