SULMETIN SIMPLE 150mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Sulmetin Simple 150 mg/ml Solution for Injection and Infusion

Magnesium Sulfate

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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contentsofthepackageleaflet

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

1. What is Sulmetin Simple and what is it used for

Sulmetin Simple is an anticonvulsant medicine.

Sulmetin Simple is indicated for:

• treatment of Torsades de Pointes(cardiac rhythm disorder)
• magnesium supplementation to balance electrolyte levels:
• • treatment of hypomagnesemia (low magnesium levels in the blood)
  • treatment of acute hypokalemia (low potassium levels in the blood) associated with hypomagnesemia (low magnesium levels in the blood)

• magnesium supplementation in parenteral nutrition
• eclampsia.

2. What you need to know before you use Sulmetin Simple

Do not use Sulmetin Simple

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

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

• If you have heart problems such as heart failure, myocardial injury, or altered heart rate (tachycardia).
• If you have had a heart attack.
• If you are being treated with any quinidine-derived medication (see section "Using Sulmetin Simple with other medicines").

Warnings and precautions

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

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

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

Your doctor should discontinue treatment if:

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

Precautions:

• Administration of this medicine should be performed in a hospital setting.
• It is recommended to monitor blood pressure during administration.
• It is recommended to monitor magnesium levels (magnesemia). Treatment should be discontinued 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 the antagonistic effect, see section "Using Sulmetin Simple with other medicines").

Using Sulmetin Simple with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy:

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

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

When administered by intravenous infusion (not to be administered during the 2 hours prior to delivery) in the case of pregnancy toxemia, the newborn may show signs of magnesium toxicity, including neuromuscular depression or respiratory depression.

Breastfeeding:

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

Driving and using machines

Not applicable.

3. How to use Sulmetin Simple

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

Sulmetin Simple can be administered:

• by slow intravenous injection
• by venous infusion, diluted in a glucose or saline solution.

To consult the instructions for diluting the medicine before administration, see section "Information for healthcare professionals", at the end of this leaflet.

The individual daily dose will be decided by your doctor. The following are the recommended doses that can serve as a guide.

• In adults:

Ventricular tachycardia withTorsades de Pointes:

A initial dose of 2 g of magnesium sulfate by intravenous route (IV) is recommended, in 1-2 minutes, followed by an infusion 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:

Administration of 8-12 g of magnesium sulfate by intravenous route in the first 24 hours is recommended, followed by 4-6 g/day, for 3 or 4 days, until magnesium deposits are replenished.

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

The maximum infusion rate should generally remain below 2 g/hour, except in cases of treatment of acute potentially life-threatening arrhythmias such as Torsades de Pointesand in eclampsia.

Parenteral nutrition:

The usual requirements are 2.4-3.6 g of magnesium sulfate (20-30 mEq of Mg)/24 hours, by intravenous infusion.

Eclampsia:

An initial dose of 4 g of magnesium sulfate IV (infusion in 5-10 minutes) should be administered; then, a continuous infusion of 1-4 g/hour of magnesium sulfate should be started.

• Special populations:

• Elderly population:

Although adequate and well-controlled studies have not been conducted in the elderly population, to date, no age-related problems have been described. However, elderly patients often require a lower dose due to decreased renal function.

Sulmetin Simple should be used under close clinical supervision. Electrocardiographic monitoring 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 by intravenous route in slow bolus is recommended,

With a pulse, the same dose can be administered by infusion, 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, by intravenous route. 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 by intravenous route (0.25-0.5 mEq of Mg/kg/24 hours).

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

Parenteral nutrition:

Generally, 30-60 mg/kg/24 hours of magnesium sulfate by intravenous route (0.25-0.5 mEq of Mg/kg/24 hours) is recommended.

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

If you use more Sulmetin Simple than you should

If you exceed the recommended doses, symptoms such as:

• nervous system disorders consisting of paralysis of the limbs, muscles that allow speech, swallowing, up to paralysis of the 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 intoxication is manifested by a sudden drop in blood pressure and central nervous system depression that can precede respiratory paralysis. The disappearance of the knee jerk reflex is a clinical sign that allows the detection of 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 case of overdose, your doctor will administer the most appropriate treatment.

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

If you forget to use Sulmetin Simple

Do not use a double dose to make up for forgotten doses.

This medicine will be administered to you in the hospital following the dose prescribed by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects have been grouped by system organ class:

General disorders and administration site conditions:

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

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

Nervous system disorders:

loss of reflex muscle movement to a small stimulus (loss of deep tendon reflex), headache, dizziness, coma, drowsiness, confusion, central nervous system depression that can 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 can be potentially fatal in cases of severe kidney function impairment (severe renal insufficiency) or if Sulmetin Simple is injected too quickly.

Post-marketing experience

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sulmetin Simple

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging and on the ampoule after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sulmetin Simple

• The active substance is magnesium sulfate. Each ml of solution contains 150 mg of magnesium sulfate heptahydrate.

• The other ingredients are: water for injections.

Appearance and packaging

Sulmetin Simple is a clear, colorless, and odorless solution for injection.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

DESMA Laboratorio Farmacéutico SL

Paseo de la Castellana 121, Escalera Izquierda 3ºB

28046 Madrid

Spain

Manufacturer

S.C. Zentiva S.A.

Theodor Pallady Blvd., nº 50, district 3

032266 Bucharest

Romania

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

Via Morolense 87,

Ferentino (FR), 03013

Italy

Date of last revision of this leaflet: June 2024

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

Information for healthcare professionals

Preparation of the intravenous solution

In the case of administration by intravenous injection or infusion, the Sulmetin Simple solution can be diluted in sodium chloride 0.9% injection.

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

For intravenous infusion, dilute 4-5 grams in 250 ml of physiological saline or glucose 5%.

Treatment of overdose:

Treatment consists of:

• rehydration, forced diuresis.
• intravenous injection of calcium salts: 1 g of calcium gluconate by intravenous route administered slowly to reverse cardiac block or respiratory depression. Artificial respiration may be necessary.
• in case of renal insufficiency, hemodialysis or peritoneal dialysis should be performed.

Hypermagnesemia in the newborn may require resuscitation and ventilation by endotracheal intubation or intermittent positive pressure ventilation, as well as intravenous calcium.