Prospecto:Information for the User

Glucantime 1.500 mg/5 ml Injectable Solution

Meglumine Antimoniate

Read this prospect carefully 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 you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the Prospect:

1. What isGlucantimeand for what it is used

2. What you need to know before starting to useGlucantime

3. How to useGlucantime

4. Possible adverse effects

5. Storage ofGlucantime

6. Contents of the package and additional information

Glucantimebelongs to a group of medications known asLeishmanicidas.

Glucantime is indicated for the treatment of:

• Visceral leishmaniasis (Kala azar)
• Cutaneous leishmaniasis (Oriental sore) and mucocutaneous leishmaniasis.

Leishmaniasis is a parasitic disease transmitted by the bite of a variety of mosquito.

Do not use Glucantime

• If you are allergic to meglumine antimoniate or any of the other components of this medication listed in section 6.
• If you have renal, cardiac, or hepatic insufficiency (kidney, heart, or liver malfunction).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glucantime.

• If you are allergic, because Glucantime contains sulfites, which may induce or worsen severe allergic reactions (anaphylactic type).

• If you experience an allergic reaction (see section “Possible side effects”). Contact your doctor or a healthcare professional immediately or go to the nearest hospital emergency room immediately.

• You will be asked to undergo liver and kidney function tests during treatment, due to the risk of antimony intolerance, which is the component of Glucantime.

Stop using Glucantime and contact a doctor immediately if you experience any of the following symptoms:

• Nausea or vomiting, fever, feeling tired, loss of appetite, dark urine, light-colored stools, yellow discoloration of the skin or the white part of the eyes, itching, hives, or stomach pain.

These symptoms may be signs of liver problems.

• Since meglumine antimoniate can cause cardiac alterations such as QT interval prolongation and severe arrhythmia, it is recommended to perform ECG controls during treatment. Your doctor should be cautious when using this medication if you have known risk factors for a heart condition called QT interval prolongation, such as:

• Presenting an uncorrected electrolyte imbalance (e.g. low potassium or magnesium levels)
• Having a congenital long QT syndrome (hereditary heart disease)
• Having a heart disease (e.g. myocardial infarction, bradycardia)
• Being treated with other medications known to prolong the QT interval (e.g. Class IA and III antiarrhythmic medications, some tricyclic antidepressants, some macrolide antibiotics, some antipsychotics, other antiparasitic medications)

• This medication is not recommended for patients withL. aethiopica,due to the possibility of resistance.

• If you do not obtain the desired response with this treatment, it is recommended to change it and use other leishmanicidal medications.

Other medications and Glucantime

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

Medications known to prolong the QT interval: Use meglumine antimoniate with caution in patients being treated with medications known to prolong the QT interval (e.g. Class IA and III antiarrhythmic medications, some tricyclic antidepressants, some macrolides, some antipsychotics, other antiparasitic medications) (see section “Warnings and precautions”).

It is recommended to avoid simultaneous administration of Glucantime with medications that have toxic effects on the heart, liver, pancreas, or nervous system.

Pregnancy and breastfeeding

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

Since the safety of Glucantime in pregnancy has not been demonstrated, it should not be administered during pregnancy, except that your doctor considers that the benefit of administering this medication is greater than the possible risk for you and the fetus.

Animal studies have shown reproductive toxicity.

The elimination of Glucantime in breast milk is unknown. For this reason, breastfeeding is not recommended during treatment with Glucantime.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Glucantime contains sulfites, sodium, and potassium

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sulfites.

This medication contains less than23 mg of sodium (1 mmol) per 1 ml of injectable solution; it is essentially “sodium-free”.

This medication contains less than 39 mg (1 mmol) of potassium per 1 ml of injectable solution, so it is considered essentially “potassium-free”.

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

Glucantime is administered only by intramuscular injection.

Local pain may occur, so it is suggested to alternate the injection site, preferably in the gluteal area.

The recommended dose is 20 mg/kg/day of antimony (75 mg/kg/day of meglumine antimoniate)

- for 20 days in the case of cutaneous leishmaniasis

- for 28 days in the case of visceral and mucocutaneous leishmaniasis.

Your doctor will indicate the duration of treatment..Do not stop treatment before.

If the disease persists or reappears after completing treatment, your doctor should refer you to a specialized service for follow-up. In these cases, it may be necessary to repeat the treatment cycle.

Children:

The same doses as those used for adults should be followed: 20 mg/kg/day of antimony (75 mg/kg/day of meglumine antimoniate).

• 20 days in the case of cutaneous leishmaniasis
• 28 days in the case of visceral and mucocutaneous leishmaniasis.

If you use more Glucantime than you should

If you receive more Glucantime than you should, consult your doctor immediately or go to the nearest hospital.

In case of overdose, gastrointestinal disturbances (vomiting, diarrhea) of varying severity, skin disorders (urticaria), liver disorders (jaundice), heart disorders (decreased heart rate, electrocardiogram alterations), kidney disorders (renal insufficiency), blood disorders, and nervous system disorders (inflammation of the nerves) may occur. In rare cases, it may be life-threatening.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount used or ingested.

If you forgot to use Glucantime

Do not administer a double dose to compensate for the missed dose.

Like all medications, Glucantimemay cause side effects, although not everyone will experience them.

Side effects are classified by their frequency, using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known: cannot be estimated from available data

The following side effects have been reported:

Immune system disorders

Frequency not known: allergic reactions (which may occur immediately or within several days after administration of the medication), which may be life-threatening.

Symptoms may include skin rash, itching, difficulty breathing, shortness of breath, facial swelling, lip, throat, or tongue swelling, cold, moist skin, palpitations, dizziness, weakness, or fainting.

Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room immediately.

Metabolism and nutrition disorders

Common: loss of appetite (anorexia).

Nervous system disorders

Very common: headache.

Cardiac disorders

Common: los changes in the electrocardiogram are dose-dependent and are generally reversible. In most cases, some alterations in the electrocardiogram (T wave inversion and QT interval prolongation) precede the onset of severe arrhythmias.

Uncommon: severe arrhythmias(irregular heartbeats) (Torsade de Pointes, ventricular fibrillation), and in individual cases may have a fatal outcome.

Respiratory, thoracic, and mediastinal disorders

Uncommon: shortness of breath (dyspnea).

Gastrointestinal disorders

Common: nausea and vomiting associated with antimony may occur at the beginning of treatment: abdominal pain.

Frequency not known: inflammation of the pancreas (pancreatitis).

Hepatobiliary disorders

Uncommon: abnormal liver enzyme levels (increase in liver enzymes: transaminases and alkaline phosphatase).

Frequency not known: an increase in liver enzyme levels is observed in laboratory tests, and sometimes, along with alterationof the renal function tests (increase in blood urea and serum creatinine).

Skin and subcutaneous tissue disorders

Uncommon: skin rash.

Musculoskeletal and connective tissue disorders

Very common: joint pain (arthralgia), muscle pain (myalgia).

Renal and urinary disorders

Frequency not known: alterations in kidney function tests, kidney function problems (acute renal insufficiency).

General disorders and administration site conditions

Common: a transient febrile reaction accompanied by chills or a sensation of fainting with sweating, antimony-associated cough may appear at the beginning of treatment.

Uncommon: general malaise.

Frequency not known: facial edema; phlebitis when not administered correctly.

A decrease in white blood cell count (leucopenia) and anemia may also occur.

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 theSpanish 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 medication.

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

No special storage conditions are required.

Do not use Glucantime after the expiration date that appears on the box 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. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Glucantime

• The active principle is antimoniato of meglumina. Each ampoule contains 1,500 mg (equivalent to 405 mg of antimony).
• The other components are: potassium metabisulphite (E-224), anhydrous sodium sulphite (E-221) and water for injectable preparations.

Appearance of the product and contents of the packaging

Glucantime is a clear solution. In rare cases, small particles may appear in the solution. In this case,shake well before use.If the particles persist, it should not be used.

Glucantime is presented in boxes of 10 ampoules of 5 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: October 2022

The detailed information of this medicine is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/