Leaflet: information for the user

Sulmetin simple 150 mg/ml injectable solution and for infusion

Magnesium sulfate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contentsoftheleaflet

1. What Sulmetin simple is and what it is used for
2. What you need to know before you start using Sulmetin simple
3. How to use Sulmetin simple
4. Possible side effects
5. Storage of Sulmetin simple
6. Contents of the pack and additional information

Sulmetin simpleis an anticonvulsant medication.

Sulmetin simple is indicated for:

• the treatment oftorsade de pointes(a heart rhythm disorder)
• the administration of magnesium to balance electrolyte levels:
• • treatment of hypomagnesemia (low levels of magnesium in the blood)
  • treatment of acute hypokalemia (low levels of potassium in the blood) associated with hypomagnesemia (low levels of magnesium in the blood)

• the administration of magnesium in parenteral nutrition
• eclampsia.

No use Sulmetin simple

• If you are allergic to magnesium sulfate or any of the other components of thismedication (listed in section 6).

• If you have a kidney function disorder (severe renal insufficiency).
• If you have a liver function disorder (hepatic insufficiency).

• If you have heart problems such as heart failure, myocardial injury, altered heart rate (tachycardia).
• If you have had a heart attack.
• If you are being treated with any quinidine-derived medication (see section “Use of Sulmetin simple with other medications”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before using this medication if:

• You have heart conduction disorders,
• You have gastrointestinal motility problems,
• You have kidney function problems (renal insufficiency),
• You have myasthenia gravis or Lambert-Eaton syndrome, diseases characterized by muscle weakness.

Patients with mild to moderate magnesium deficiency can be treated with diet or oral magnesium supplements. Sulmetin simple administration via intravenous route is reserved for emergency situations.

Your doctor should interrupt treatment if:

• blood pressure decreases (hypotension),
• heart rate decreases (bradycardia),
• magnesium levels in the blood increase above normal values.
• the deep tendon reflex disappears.

Precautions:

• This medication should be administered in a hospital setting.
• It is recommended to monitor blood pressure during administration.
• It is recommended to monitor magnesium levels (magnesemia). Treatment should be interrupted once magnesemia has normalized.
• In cases of renal insufficiency (see section “3. How to use Sulmetin simple”), the dose should be reduced and closer monitoring of renal function, blood pressure, and magnesemia should be performed.

• Sulmetin simple should not be administered with calcium salts (due to antagonistic effect (see section “Use of Sulmetin simple with other medications”).

Use of Sulmetin simple with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with Sulmetin Simple. In these cases, it may be necessary to change the dose or interrupt treatment with one of the medications.

It is especially important to inform your doctor if you are being treated with any of the following medications:

• Aminoglycoside antibiotics(for the treatment of certain infections).
• Neuromuscular blockers: magnesium sulfate potentiates the effect of neuromuscular blockers such as tubocurarine, suxamethonium, and vecuronium. It may prolong neuromuscular blockade and increase the risk of respiratory depression.
• Nifedipine(medication for the treatment of angina pectoris): it potentiates the effect of magnesium sulfate.
• Quinidine derivatives(medications for the treatment of heart rhythm disorders):concomitant administration of magnesium sulfate and quinidine derivatives may increase quinidine plasma concentrations and increase the risk of overdose due to decreased renal elimination of quinidine.
• Medications that cause central nervous system depression: the effects of central nervous system depression may be potentiated when these medications are used simultaneously with magnesium sulfate.
• Digitalis glycosides(medications for the treatment of heart function problems):extreme caution should be exercised when administering magnesium sulfate to patients being treated with digitalis glycosides, especially if calcium salts are also administered intravenously; changes in cardiac conduction and cardiac block may occur.
• Calcium: simultaneous use may neutralize the effects of magnesium sulfate administered parenterally.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy:

Sulmetin simple treatment during pregnancy should only be considered if absolutely necessary. In these cases, it is recommended to monitor plasma magnesium levels, blood pressure, respiratory rate, and deep tendon reflexes.

Magnesium sulfate may cause fetal abnormalities, such as decreased calcium levels (hypocalcemia) and skeletal demineralization alterations, when administered for more than 5-7 days to pregnant women.

When administered via intravenous infusion (not to be administered during the 2 hours prior to delivery) in cases of preeclampsia, the newborn may exhibit signs of toxicity due to magnesium, including neuromuscular depression or respiratory depression.

Lactation:

Magnesium sulfate is excreted in breast milk during treatment. It is recommended to discontinue treatment during lactation.

Driving and operating machinery

Not applicable.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Sulmetin simple can be administered:

• via slow intravenous injection
• in venous perfusion, diluted in a glucose or saline solution.

To consult the medication dilution instructions before administration, see the "Information for healthcare professionals" section at the end of this prospectus.

Your doctor will decide on your individual daily dose. The following recommended doses may serve as a guide.

• For adults:

Ventricular tachycardia withtorsades de pointes:

A recommended initial dose of 2 g of magnesium sulfate via intravenous (IV) injection, in 1 - 2 minutes, followed by a perfusion of 2 - 4 mg/minute, or the initial dose can be repeated up to a total of 6 g, with intervals of 5 - 15 minutes between doses.

Hypomagnesemia:

A recommended dose of 8 - 12 g of magnesium sulfate via intravenous injection in the first 24 hours, followed by 4 - 6 g/day, for 3 or 4 days, until magnesium stores are replenished.

In cases of severe hypomagnesemia, but not life-threatening, an alternative perfusion of 1 - 2 g/h of magnesium sulfate, for 3 - 6 hours, decreasing to 0.5 - 1 g/h, as maintenance, can be administered.

The maximum perfusion, generally, should remain below 2 g/h, except in cases of acute potentially fatal arrhythmias such astorsades de pointesand eclampsia.

Parenteral nutrition:

The usual requirements are 2.4 g - 3.6 g of magnesium sulfate (20 - 30 mEq of Mg)/24 h, via intravenous perfusion.

Eclampsia:

Initially, 4 g of magnesium sulfate IV (perfusion in 5 - 10 minutes) should be administered; then switch to continuous perfusion of 1 - 4 g/h of magnesium sulfate.

• Special populations:

• Geriatric population:

Although no adequate and well-controlled studies have been conducted in the geriatric population, to date, no problems related to age have been described. However, elderly patients often require a lower dose due to decreased renal function.

Sulmetin simple should be used under strict clinical supervision.Monitoring electrocardiography is recommended in elderly patients receiving high doses of magnesium sulfate.

• Patients with renal insufficiency:

In patients with renal insufficiency, the initial dose should be reduced by 25% - 50% of the recommended dose for patients with normal renal function.

• Pediatric population:

Ventricular tachycardia withtorsades de pointes:

If there is no pulse, a dose of 25 - 50 mg of magnesium sulfate/kg of body weight via IV injection, in slow bolus,

With pulse, the same dose can be administered via perfusion, over 10 - 20 minutes.

The maximum dose is 2 grams of magnesium sulfate.

Hypomagnesemia:

Recommended dose: 25 - 50 mg of magnesium sulfate/kg of body weight, via intravenous injection. The dose can be repeated every 4 - 6 hours, up to a maximum of 3 - 4 doses. The maximum single dose is 2 grams of magnesium sulfate.

Daily maintenance dose: 30 - 60 mg/kg/24 hours of magnesium sulfate via intravenous injection (0.25 - 0.5 mEq of Mg/kg/24 hours).

The maximum dose is 1 gram/24 hours of magnesium sulfate.

Parenteral nutrition:

Generally, it is recommended to administer30 - 60 mg/kg/24 hours of magnesium sulfate via IV (0.25 - 0.5 mEq of Mg/kg/24 hours).

The maximum dose is 1 gram/24 hours of magnesium sulfate.

If you use more Sulmetin simplethan you should

If the recommended doses are exceeded, symptoms such as:

• neurological disturbances consisting of paralysis of limbs, muscles that allow speaking, swallowing, up to paralysis of respiratory muscles.
• cardiovascular manifestations consisting mainly of a decrease in blood pressure, accompanied by an increase in heart rate (tachycardia) or a decrease in heart rate (bradycardia).

Magnesium toxicity manifests as a sudden drop in blood pressure and depression of the central nervous system, which can precede respiratory paralysis. The disappearance of the patellar reflex is a clinical sign that allows detecting the onset of magnesium overdose.

Symptoms may include: disappearance of deep tendon reflexes, drowsiness, confusion, lethargy, etc. Inform your doctor if you notice any of these symptoms.

In the case of overdose, your doctor will administer the most appropriate treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately orcall the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to use Sulmetin simple

Do not use a double dose to compensate for the missed doses.

This medication will be administered in the hospital following the dose prescribed by your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects have been grouped according to the following organ classification:

General disorders and administration site conditions:

pain at the injection site, decrease in body temperature below normal limits (hypothermia), vasodilation with sensation of heat

If magnesium sulfate is administered parenterally at high doses, it may cause hypermagnesemia, whose symptoms are as follows:

Nervous system disorders:

loss of reflex muscle movement to a small stimulus of contusion or blow (loss of tendon reflex), headache, dizziness, coma, drowsiness, confusion, depression of the central nervous system that may precede respiratory paralysis

Cardiac disorders:

cardiac arrest or circulatory collapse

Vascular disorders:

decrease in blood pressure (hypotension), decrease in heart rate (bradycardia), flushing

Respiratory, thoracic and mediastinal disorders:

difficulty breathing (respiratory depression)

Gastrointestinal disorders:

nausea, vomiting

Musculoskeletal and connective tissue disorders:

muscle weakness

Other disorders:

speech problems, vision problems, excessive sweating, and thirst.

Hypermagnesemia may be potentially fatal in cases of severe kidney function impairment (severe renal insufficiency) or if Sulmetin is administered too quickly.

Post-marketing experience

There are studies and clinical cases documenting fetal anomalies such as decreased calcium levels (hypocalcemia) and bone alterations.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging and on the ampule after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Sulmetin Simple Composition

- The active ingredient is magnesium sulfate. Eachml of solution contains 150 mg of heptahydrated magnesium sulfate.

- The other components are: water for injectable preparations.

Appearance of the product and contents of the package

Sulmetin Simple is a clear, colorless, and odorless injectable solution.

Each package contains 5 ampoules of 10 ml and 10 ampoules of 10 ml.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

DESMA Pharmaceutical Laboratory SL

Paseo de la Castellana 121, Escalera Izquierda 3ºB

28046 Madrid

Spain

Responsible manufacturer

S.C. Zentiva S.A.

Theodor Pallady Blvd., nº 50, district 3

032266 Bucharest

Romania

BIOMEDICA FOSCAMA Industrial Chimico-Farmaceutica S.p.A.

Via Morolense 87,

Ferentino (FR), 03013

Italy

Last review date of this leaflet:June 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

Information for healthcare professionals

Preparation of the intravenous solution

In the case of administration by intravenous injection or intravenous perfusion, the Sulmetin Simple solution may be diluted in sodium chloride injectable solution at 0.9%.

In the case of intravenous perfusion, the Sulmetin Simple solution may also be diluted in 5% glucose.

To prepare the intravenous perfusion, dilute 4 - 5 grams in 250 ml of physiological serum or 5% glucose.

Treatment of overdose:

The treatment consists of:

• rehydration, forced diuresis.
• intravenous injection of calcium salts: 1 g of calcium gluconate administered slowly intravenously to reverse cardiac arrest or respiratory depression. Respiratory assistance may be necessary.
• in the case of renal insufficiency, hemodialysis or peritoneal dialysis should be performed.

Hyper magnesiumemia in newborns may require resuscitation and assisted ventilation by endotracheal intubation or intermittent positive pressure ventilation, as well as intravenous calcium.