Prospect: information for the user

Magnesium Sulfate Altan 150 mg/ml injectable solution and for infusion EFG

Magnesium Sulfate heptahydrate

Read this prospect thoroughly before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What is Magnesium Sulfate Altan and how it is used

2. What you need to know before starting to use Magnesium Sulfate Altan

3. How to use Magnesium Sulfate Altan

4. Possible adverse effects

5. Storage of Magnesium Sulfate Altan

6. Contents of the package and additional information

Magnesium Sulfate Altanis an anticonvulsant medication.

This medication is a solution that will be administered through a vein via injection or by infusion with a drip. It is indicated for:

• treatment oftorsade de pointes(a heart rhythm disorder).
• providing magnesium 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)

• providing magnesium in parenteral nutrition.
• eclampsia.

No use Sulfato de Magnesio Altan:

• If you are allergic to magnesium sulfate or any of the other components of this medication (listed in section 6).
• If you have a kidney function disorder (severe renal insufficiency).
• If you are being treated with a quinidine-derived medication (see section “Use of Sulfato de Magnesio Altan with other medications”).
• 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 have a liver function disorder.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medication if:

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

Patients with mild to moderate magnesium deficiency may be treated with diet or oral magnesium supplements. Intravenous administration of Sulfato de Magnesio Altan 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.

- Deep tendon reflexes disappear.

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 Sulfato de Magnesio Altan”), the dose should be reduced and closer monitoring of renal function, blood pressure, and magnesemia should be performed.
• Sulfato de Magnesio Altan should not be administered with calcium salts (due to the antagonistic effect, see section “Use of Sulfato de Magnesio Altan with other medications”).

Use of Sulfato de Magnesio Altan with other medications

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

Certain medications may interact with Sulfato de Magnesio Altan. In these cases, it may be necessary to change the dose or discontinue 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): magnesium sulfate should be administered with extreme caution in 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, lactation, and fertility

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

Pregnancy

Treatment with Sulfato de Magnesio Altan 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 by intravenous infusion (not to be administered during the 2 hours prior to delivery) in cases of preeclampsia, the newborn may show signs of toxicity due to magnesium, including neuromuscular depression or respiratory depression.

Lactation

Magnesium sulfate is eliminated through breast milk during treatment. It is recommended to discontinue treatment during lactation.

Driving and operating machinery

Not applicable

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, making it essentially “sodium-free”.

Magnesium Sulfate Altanmay be administered:

- via slow intravenous injection

- in venous perfusion, diluted in a glucose or saline solution.

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

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

In adults:

Ventricular tachycardia withtorsades de pointes:

It is recommended to administer an initial dose of 2 g of magnesium sulfate intravenously (IV), in 1 - 2 minutes, followed by a perfusion of 2 - 4 mg / minute, or the initial dose may be repeated up to a total of 6 g, with intervals of 5 - 15 minutes between doses

Hypomagnesemia:

It is recommended to administer 8 - 12 g of magnesium sulfate intravenously 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 may be administered for 3 - 6 hours, decreasing to 0.5 - 1 g/h, as maintenance.

The maximum perfusion should generally 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, in 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.

Magnesium Sulfate Altan should be used under strict 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, it is recommended to administer a dose of 25 - 50 mg of magnesium sulfate/kg of body weight IV in a slow bolus.

With pulse, the same dose may be administered in 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, IV. The 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.

Daily maintenance dose: 30 - 60 mg/kg/24 hours of magnesium sulfate IV (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 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 moreMagnesium Sulfate Altanthan you should

If the recommended doses are exceeded, symptoms such as:

- nervous disorders consisting of paralysis of limbs, muscles thatallow 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 that may 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.

If you forgot to use Magnesium Sulfate Altan

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 can 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 a 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 can be potentially fatal in the case of severe kidney function impairment (severe renal insufficiency) or if magnesium sulfate is administered 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the National System for Pharmacovigilance of Medicines for Human Use: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.

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

Once opened:the product must be used immediately.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Magnesium Sulfate Altan Composition

• The active ingredient is:

Heptahydrated magnesium sulfate: 150 mg/ml

One 10 ml vial contains 1.5 g of heptahydrated magnesium sulfate.

1 ml of injection/infusion solution contains 150 mg of heptahydrated magnesium sulfate.

• Magnesium: 6.09 mmol (148.02 mg) / vial

• Sulfate: 6.09 mmol (585.02 mg) / vial

• The other components are: sodium hydroxide and water for injection preparations.

Product Appearance and Packaging Content

Magnesium Sulfate Altan is a clear and colorless solution for injection/infusion.

Magnesium Sulfate Altan is supplied in containers containing 10 and 100 vials of 10 ml. Some package sizes may only be marketed.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/Colquide, Nº 6, Portal 2, 1st floor, Office F.

Edificio Prisma - Las Rozas (Madrid) -28230 – Spain

Responsible for Manufacturing

Altan Pharmaceuticals, S.A.

Avda. Constitución 198-199. Pol. Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Last Review Date of this Brochure: August 2021

The detailed and updated information of 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

Magnesium Sulfate Altan is a hypertonic injection solution, administration will be performed at an infusion rate that does not exceed 150 mg/minute of heptahydrated magnesium sulfate.

Preparation of the Intravenous Solution

In the case of administration by intravenous injection or intravenous perfusion, the solution ofMagnesium Sulfate Altanmay be diluted in sodium chloride injectable at 0.9%.

In the case of intravenous perfusion, the solution ofMagnesium Sulfate Altanmay also be diluted in 5% glucose.

To prepare for intravenous perfusion, dilute 4-5 grams in 250 ml of physiological saline 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. Artificial respiration may be necessary.

- in case of renal insufficiency, hemodialysis or peritoneal dialysis will be performed.

Newborn hypermagnesemia may require resuscitation and assisted ventilation by endotracheal intubation or intermittent positive pressure ventilation, as well as intravenous calcium.

The chemical and physical stability has been demonstrated in use for 24 hours at 20-25 ° C and at 5 ° C after dilution to 2% in physiological saline or 5% glucose and sodium chloride injectable at 0.9%.

From a microbiological point of view, unless the opening method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the storage times and conditions in use are the responsibility of the user.