GLUCANTIME 1500 MG/5 ML INJECTABLE SOLUTION

1. What Glucantime is and what it is used for

Glucantime belongs to a group of medicines called Leishmanicides.

Glucantime is indicated for the treatment of:

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

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

2. What you need to know before taking Glucantime

Do not use Glucantime

• if you are allergic to meglumine antimoniate or any of the other components of this medicine listed in section 6.
• if you have kidney, heart, or liver failure (malfunction of the kidneys, heart, or liver).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glucantime.

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

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

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

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

• nausea or vomiting, fever, feeling of tiredness, loss of appetite, dark-colored urine, light-colored stools, yellowish discoloration of the skin or the white part of the eyes, itching, rash, or pain in the upper abdomen.

These symptoms may be signs of liver problems.

• Since meglumine antimoniate can cause cardiac disorders such as QT interval prolongation and severe arrhythmia, it is recommended to perform ECG controls during treatment. Your doctor should exercise caution when using this medicine if you have known risk factors for a cardiac disease called QT interval prolongation, such as:

• you have an uncorrected electrolyte imbalance (e.g., low potassium or magnesium levels)
• you have congenital long QT syndrome (inherited heart disease)
• you have heart disease (e.g., myocardial infarction, decreased heart rate (bradycardia))
• you are being treated with other medicines known to prolong the QT interval (e.g., Class IA and III antiarrhythmic drugs, some tricyclic antidepressants, some macrolide antibiotics, some antipsychotics, other antiparasitic drugs).

• This medicine is not recommended for patients with L. aethiopicadue to the possibility of resistance.

• In case of no response to this treatment, it is recommended to change it and use other leishmanicidal medicines.

Other medicines and Glucantime

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

Medicines known to prolong the QT interval: meglumine antimoniate should be used with caution in patients being treated with medicines known to prolong the QT interval (e.g., Class IA and III antiarrhythmic drugs, some tricyclic antidepressants, some macrolides, some antipsychotics, other antiparasitic drugs) (see section "Warnings and precautions").

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

Pregnancy and breastfeeding

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

Since the safety of Glucantime in pregnancy has not been demonstrated, it should not be administered during pregnancy, unless your doctor considers that the benefit of administering this medicine outweighs the possible risk to you and the fetus.

Animal studies have shown reproductive toxicity.

It is not known whether Glucantime is excreted in breast milk. For this reason, breastfeeding is not recommended during treatment with Glucantime.

Driving and using machines

No studies have been conducted on the ability to drive and use machines.

Glucantime contains sulfites, sodium, and potassium

This medicine can cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfites.

This medicine contains less than 23 mg of sodium (1 mmol) per 1 ml of injectable solution; it is essentially "sodium-free".

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

3. How to take Glucantime

Follow your doctor's instructions for administering Glucantime exactly. If in doubt, consult your doctor again.

Glucantime is administered only by intramuscular injection.

Local pain may occur, so it is recommended to alternate the application area, 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 case of cutaneous leishmaniasis
• for 28 days in case of visceral and mucocutaneous leishmaniasis.

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

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

Children:

Follow the same doses used for adults: 20 mg/kg/day of antimony (75 mg/kg/day of meglumine antimoniate).

• 20 days in case of cutaneous leishmaniasis
• 28 days in 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 or go to the nearest hospital immediately.

In case of overdose, gastrointestinal disorders (vomiting, diarrhea) of varying severity, skin disorders such as urticaria, liver disorders such as jaundice (yellowing of the skin), heart disorders (decreased heart rate, electrocardiogram changes), kidney disorders such as renal failure (malfunction of the kidneys), blood disorders, and nervous system disorders (nerve inflammation) may occur. In very rare cases, they can be life-threatening.

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 used or ingested.

If you forget to use Glucantime

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

4. Possible side effects

Like all medicines, Glucantime can cause side effects, although not everyone gets them.

Side effects are classified according to 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 can occur immediately or within several days after administration of the medicine), which can be life-threatening.

Symptoms may include skin rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold, clammy skin, palpitations, dizziness, weakness, or fainting.

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

Metabolism and nutrition disorders

Common: loss of appetite (anorexia).

Nervous system disorders

Very common: headache.

Cardiac disorders

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

Uncommon: severe arrhythmias (Torsade de Pointes, ventricular fibrillation), and in individual cases, they can be fatal.

Respiratory, thoracic, and mediastinal disorders

Uncommon: difficulty breathing (dyspnea).

Gastrointestinal disorders

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

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

Hepatobiliary disorders

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

Frequency not known: an increase in liver enzyme levels is observed in laboratory tests, and sometimes, along with changes in kidney function tests (increased 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: changes in kidney function tests, kidney problems (acute renal failure).

General disorders and administration site conditions

Common: at the start of treatment, a transient febrile reaction may occur, accompanied by chills or a feeling of fainting with sweating, cough associated with antimony.

Uncommon: general malaise.

Frequency not known: facial swelling (facial edema); vein inflammation (thrombophlebitis) when not administered correctly.

It can also cause a decrease in white blood cell count (leukopenia) and anemia.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 Glucantime

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

No special storage conditions are required.

Do not use Glucantime after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Glucantime

• The active ingredient is meglumine antimoniate. Each ampoule contains 1,500 mg (equivalent to 405 mg of antimony).
• The other ingredients are: potassium metabisulfite (E-224), sodium sulfite anhydrous (E-221), and water for injectable preparations.

Appearance of the product and package contents

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

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

Marketing authorization holder and manufacturer

Marketing authorization holder

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

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

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this leaflet: October 2022

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