Sulmetin Simple 150 mg/ml solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sulmetin simple 150 mg/ml solution for injection and infusion

Magnesium sulfate

Read the entire 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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Sulmetin simple is an anticonvulsant medicine.

Sulmetin simple is indicated for:

• the treatment of torsade de pointes (a cardiac rhythm disorder)

• magnesium supplementation to correct 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 using 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 impaired kidney function (severe renal failure).

• If you have impaired liver function (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 “Use of Sulmetin simple with other medicines”).

Warnings and precautions

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

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

Patients with mild to moderate magnesium deficiency may be treated with diet or oral magnesium supplements. Intravenous administration of Sulmetin simple is reserved for emergency situations.

Your doctor must discontinue treatment if:

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

Precautions:

• Administration of this medicine should be carried out in a hospital setting.

• Blood pressure should be monitored during administration.

• Magnesium levels (magnesemia) should be monitored. 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 is required.

• Sulmetin simple must not be administered with calcium salts (due to antagonistic effects) (see section “Use of Sulmetin simple with other medicines”).

Use of Sulmetin simple with other medicines

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

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

It is especially important that you inform your doctor if you are taking any of the following medicines:

• Aminoglycoside antibiotics (used to treat certain infections).
• Curare agents: magnesium sulfate enhances the effect of neuromuscular blockers such as tubocurarine, suxamethonium, and vecuronium. This may prolong neuromuscular blockade, increasing the risk of respiratory depression.
• Nifedipine (a medicine used to treat angina pectoris): enhances the effect of magnesium sulfate.
• Quinidine derivatives (medicines used to treat heart rhythm disorders): concomitant administration of magnesium sulfate and quinidine derivatives may increase plasma concentrations of quinidine and increase the risk of overdose due to reduced renal elimination of quinidine.
• Medicines causing central nervous system depression: the central nervous system depressant effects may be enhanced when these medicines are used simultaneously with magnesium sulfate.
• Digitalis glycosides (medicines used to treat heart function disorders): magnesium sulfate should be administered with extreme caution in patients receiving 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 parenteral magnesium sulfate.

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 absolutely necessary. In such cases, monitoring of plasma magnesium levels, blood pressure, respiratory rate, and deep tendon reflexes is recommended.

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

When administered by intravenous infusion (must not be administered during the 2 hours preceding delivery) in cases of pregnancy toxemia, the newborn may show signs of magnesium-related 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 exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.

Sulmetin simple can be administered:

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

For instructions on dilution of the medicine before administration, see section "Information for healthcare professionals" at the end of this leaflet.

The individual daily dose will be determined by your doctor. The recommended doses below may serve as a guide.

• In adults:

Ventricular tachycardia with torsade de pointes:

An initial dose of 2 g of magnesium sulfate intravenously (IV) over 1–2 minutes is recommended, followed by a continuous infusion of 2–4 mg/minute. Alternatively, the initial dose may be repeated up to a total of 6 g, with doses repeated at intervals of 5–15 minutes.

Hypomagnesemia:

It is recommended to administer 8–12 g of magnesium sulfate intravenously within 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 that are not life-threatening, an alternative regimen is an infusion of 1–2 g/h of magnesium sulfate for 3–6 hours, followed by a maintenance infusion of 0.5–1 g/h.

The maximum infusion rate should generally remain below 2 g/h, except in the treatment of potentially life-threatening acute arrhythmias such as torsades de pointes and in eclampsia.

Parenteral nutrition:

The usual requirement is 2.4–3.6 g of magnesium sulfate (20–30 mEq of Mg)/24 h, administered by intravenous infusion.

Eclampsia:

Initially, 4 g of magnesium sulfate should be administered IV (infused over 5–10 minutes), followed by a continuous infusion of 1–4 g/h of magnesium sulfate.

• Special populations:

• Elderly population:

Although adequate and well-controlled studies have not been conducted in elderly patients, age-related problems have not been reported to date. However, elderly patients often require lower doses due to reduced renal function.

Sulmetin simple should be used under strict clinical monitoring. Electrocardiographic monitoring is advisable in elderly patients receiving high doses of magnesium sulfate.

• Patients with renal impairment:

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

• Paediatric population:

Ventricular tachycardia with torsade de pointes:

If no pulse is present, administer a dose of 25–50 mg of magnesium sulfate/kg body weight intravenously as a slow bolus.

If a pulse is present, the same dose may 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 body weight, administered intravenously. This dose may be repeated every 4–6 hours, up to a maximum of 3–4 doses. The maximum single dose is 2 grams of magnesium sulfate.

Maintenance dose: 30–60 mg/kg/24 hours of magnesium sulfate administered intravenously (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 administer 30–60 mg/kg/24 hours of magnesium sulfate intravenously (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 simple than you should

If the recommended doses are exceeded, symptoms such as the following may occur:

• nervous system disturbances including paralysis of limbs, muscles involved in speaking and swallowing, and potentially leading to paralysis of respiratory muscles.
• cardiovascular manifestations consisting primarily of a marked decrease in blood pressure, accompanied by an increased heart rate (tachycardia) or decreased heart rate (bradycardia).

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

Symptoms may include loss of deep tendon reflexes, somnolence, confusion, lethargy, etc. Inform your doctor if you experience any of these symptoms.

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

In the event of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91.562.04.20, stating the medicine and the amount ingested.

If you forget to use Sulmetin simple

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

This medicine will be administered to you in the hospital according to the dosing schedule prescribed by your doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

General disorders and administration site conditions:

pain at the injection site, decreased body temperature below normal limits (hypothermia), vasodilation with sensation of warmth

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

Nervous system disorders:

loss of reflex movement of muscle in response to a minor contusion or impact stimulus (loss of tendon reflex), headache, dizziness, coma, somnolence, confusion, central nervous system depression which 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 if you have a serious problem with kidney function (severe renal failure) or if Sulmetin simple is injected too rapidly.

Post-marketing experience

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the container and on the ampoule after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Sulmetin simple

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

• The other component is: water for injections.

Nature of the product and contents of the container

Sulmetin simple is a clear, colourless and odourless injectable solution.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent revision of this leaflet: June 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Information intended for healthcare professionals

Preparation of intravenous solution

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

For intravenous infusion, Sulmetin Simple solution may also be diluted in 5% glucose solution.

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

Management of overdose:

Treatment consists of:

• Rehydration, forced diuresis.
• Intravenous administration of calcium salts: 1 g of calcium gluconate administered intravenously slowly to reverse cardiac blockade or respiratory depression. Artificial respiration may be required.
• In case of renal failure, hemodialysis or peritoneal dialysis must be performed.

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