Magnesium sulfate Bioindustria L.I.M.

Package leaflet: Information for the user

MAGNESIO SOLFATO Bioindustria L.I.M. 1 g/10 ml concentrate for solution for infusion, L.I.M. 2 g/10 ml concentrate for solution for infusion, L.I.M. 2 mEq/ml concentrate for solution for infusion

Magnesium sulfate
Equivalent medicine
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 give it to other people, even if their symptoms are the same as yours, because 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 Bioindustria L.I.M. is and what it is used for
2. What you need to know before using MAGNESIO SOLFATO Bioindustria L.I.M.
3. How to use MAGNESIO SOLFATO Bioindustria L.I.M.
4. Possible side effects
5. How to store MAGNESIO SOLFATO Bioindustria L.I.M.
6. Contents of the pack and other information

1. What MAGNESIO SOLFATO Bioindustria L.I.M. is and what it is used for

MAGNESIO SOLFATO Bioindustria L.I.M. 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 the presence of protein in the urine;
• supplying magnesium to the body in case of low blood magnesium levels (acute hypomagnesemia), particularly if you have a condition characterized by muscle cramps and spasms (tetany);
• the prevention and treatment of low magnesium levels in the blood (hypomagnesemia) during total parenteral nutrition (administration of nutrients directly into a vein).

2. What you need to know before using MAGNESIO SOLFATO Bioindustria L.I.M.

Do not use MAGNESIO SOLFATO Bioindustria L.I.M.

• 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 (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 Bioindustria L.I.M.
MAGNESIO SOLFATO Bioindustria L.I.M. must only be administered if the ampoule or vial
is undamaged and the solution is clear. The medicine must be injected via a single, uninterrupted
administration, at a controlled rate and after appropriate dilution. Any unused medicine must be discarded (See section “How to use MAGNESIO SOLFATO Bioindustria L.I.M.”).
MAGNESIO SOLFATO Bioindustria L.I.M. must be administered with particular caution if:

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

This medicine must not be administered intravenously if you have severe kidney problems (renal failure), as this may lead to excessive levels of magnesium in the blood (magnesium intoxication) (See section “Do not use MAGNESIO SOLFATO Bioindustria L.I.M.”).
During treatment with MAGNESIO SOLFATO Bioindustria L.I.M., your doctor must periodically monitor magnesium levels in your blood to prevent excessive increases, especially in cases of eclampsia.
If you are pregnant and suffer from 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 Bioindustria L.I.M.
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 Bioindustria L.I.M. 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 heart rhythm disturbances (cardiac arrhythmias) 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 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) with 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, are planning a pregnancy, or are breastfeeding, consult your doctor before this medicine is administered.
Pregnancy
This medicine should only be administered when absolutely 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 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).
MAGNESIO SOLFATO Bioindustria L.I.M. 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
Not applicable.

3. How to use MAGNESIO SOLFATO Bioindustria L.I.M.

This medicine will be administered to you after appropriate dilution (5% glucose solution or 0.9% sodium chloride solution) by a doctor or trained medical personnel.
The medicine must be administered through a single, uninterrupted infusion, and any remaining solution must be discarded.

Prevention and control of seizures in severe gestational toxemia (pre-eclampsia and eclampsia)
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 receive 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 (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 Bioindustria L.I.M. than you should
This medicine will be administered by a doctor or trained medical personnel; therefore, it is unlikely that you will receive an excessive dose. However, if you think that an excessive dose of MAGNESIO SOLFATO Bioindustria L.I.M. has been administered, inform your doctor or another healthcare professional immediately.

Following administration of an excessive dose of this medicine, excessive increase in blood pressure (hypertensive spike) and respiratory arrest (respiratory paralysis) may occur. The disappearance of the involuntary reflex causing leg extension after stimulation below the knee (patellar reflex) is a clinical sign of early intoxication.
In such a case, the doctor will determine the appropriate treatment.

If you have any doubts about the use of MAGNESIO SOLFATO Bioindustria L.I.M., consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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 reactions), urticaria;
• increased levels of acidic substances in the blood (metabolic acidosis), reduced levels of calcium in the blood (hypocalcemia);
• sudden sensation of warmth (hot flushes), sweating, lowering of blood pressure (hypotension), loss of muscle 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, please 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 Bioindustria L.I.M.

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, unopened packaging stored under the recommended conditions.
Store this medicine in its original containers, tightly closed.
The medicine should be administered immediately after opening the ampoule/vial, 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 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. Contents of the pack and other information

What MAGNESIO SOLFATO Bioindustria L.I.M. contains
MAGNESIO SOLFATO Bioindustria L.I.M. 1 g/10 ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. One vial (10 ml) contains 1 g of magnesium sulfate heptahydrate (equivalent to 811 mEq/litre of Mg).
• The other component is water for injections.

MAGNESIO SOLFATO Bioindustria L.I.M. 2 g/10 ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. One vial (10 ml) contains 2 g of magnesium sulfate heptahydrate (equivalent to 1623 mEq/litre of Mg).
• The other component is water for injections.

MAGNESIO SOLFATO Bioindustria L.I.M. 2 mEq/ml concentrate for solution for infusion

• The active substance is magnesium sulfate heptahydrate. Each ml contains 0.246 g (equivalent to 2 mEq of Mg).
• The other component is water for injections.

Description of the appearance of MAGNESIO SOLFATO Bioindustria L.I.M. and contents of the pack
MAGNESIO SOLFATO Bioindustria L.I.M. 1 g/10 ml and 2 g/10 ml concentrate for solution for infusion
10 vials of 10 ml.

MAGNESIO SOLFATO Bioindustria L.I.M. 2 mEq/ml concentrate for solution for infusion
10 vials of 10 ml.
1 bottle of 30 ml and 10 bottles of 30 ml.

Marketing Authorization Holder and Manufacturer
BIOINDUSTRIA Laboratorio Italiano Medicinali S.p.A.
Via De Ambrosiis, 2 – 15067 Novi Ligure (AL).

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Overdose
Symptoms
Magnesium intoxication manifests with a drop in arterial pressure and respiratory paralysis.
The disappearance of the patellar reflex is a useful clinical sign indicating the onset of intoxication.
Treatment
Artificial ventilation is required. To counteract the effects of hypermagnesemia, calcium gluconate must be administered intravenously (10–20 mL of a 5% solution).
Subcutaneous administration of 0.5–1 mg of physostigmine may be helpful.
Hypermagnesemia in newborns may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation, as well as intravenous administration of calcium gluconate.
Incompatibilities
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.
For further information, please refer to the Summary of Product Characteristics.