Glucantime 1500 mg/5 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucantime 1,500 mg/5 ml injectable solution

Meglumine antimoniate

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

Package leaflet contents:

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

1. What Glucantime is and what it is used for

Glucantime belongs to a group of medicines called Leishmanicidal agents.

Glucantime is indicated for the treatment of:

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

Leishmaniasis is a parasitic disease transmitted through the bite of a type of sandfly.

2. What you need to know before using Glucantime

Do not use Glucantime

• if you are allergic to meglumine antimoniate or to any of the other ingredients of this medicine listed in section 6.
• if you have renal, cardiac, or hepatic impairment (poor functioning of the kidneys, heart, or liver).

Warnings and precautions

Talk to 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 reactions).

• 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 without delay.

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

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

• nausea or vomiting, fever, feeling tired, loss of appetite, dark-colored urine, pale-colored stools, yellowing of the skin or the whites of the eyes, itching, rash, or pain in the upper stomach area.

These symptoms may be signs of liver problems.

• Since meglumine antimoniate may cause cardiac disturbances such as QT interval prolongation and serious arrhythmias, ECG monitoring is recommended during treatment. Your doctor should exercise caution when using this medicine if you have known risk factors for a heart condition called QT prolongation, such as, for example:

• uncorrected electrolyte imbalance (e.g., low levels of potassium or magnesium)

• congenital long QT syndrome (a hereditary heart condition)

• heart disease (e.g., myocardial infarction, reduced heart rate (bradycardia))

• if you are taking other medicines known to prolong the QT interval (e.g., Class IA and III antiarrhythmic drugs, certain tricyclic antidepressants, certain macrolide antibiotics, certain antipsychotics, other antiparasitic agents).

• This medicine is not recommended in patients with L. aethiopica, due to the possibility of resistance.

• If the desired response is not achieved with this treatment, a change to other leishmanicidal agents is recommended.

Other medicines and Glucantime

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

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

It is recommended to avoid concomitant 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Animal studies have shown reproductive toxicity.

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

Driving and using machines

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

Glucantime contains sulfites, sodium, and potassium

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

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

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

3. How to use Glucantime

Follow exactly the administration instructions for Glucantime provided by your doctor. If in doubt, consult your doctor again.

Glucantime is administered only by intramuscular route.

Local pain may occur; therefore, it is recommended 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 determine the duration of treatment. Do not stop treatment prematurely.

If the disease persists or recurs after completion of treatment, your doctor should refer you to a specialized service for follow-up. In such cases, repeating the treatment cycle may be necessary.

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, contact your doctor immediately or go to the nearest hospital.

In case of overdose, gastrointestinal disorders (vomiting, diarrhea) of varying severity, skin reactions such as urticaria, liver disorders such as jaundice (yellowing of the skin), heart disorders (reduced heart rate, electrocardiogram abnormalities), kidney disorders such as renal failure (impaired kidney function), blood disorders, and nervous system disorders (nerve inflammation) may occur. In very rare cases, these may be life-threatening.

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

If you forget to use Glucantime

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

4. Possible adverse effects

Like all medicines, Glucantime can cause adverse effects, although not everyone experiences them.

Adverse 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 the available data

The following adverse effects have been reported:

Immune system disorders

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

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

Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency department without delay.

Metabolism and nutrition disorders

Common: loss of appetite (anorexia).

Nervous system disorders

Very common: headache.

Cardiac disorders

Common: electrocardiogram (ECG) changes are dose-dependent and are generally reversible. In most cases, certain ECG abnormalities (T-wave inversion and QT interval prolongation) precede the onset of serious 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: difficulty breathing (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: laboratory tests show increased levels of liver enzymes, sometimes accompanied by impaired 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: abnormalities in kidney function tests, kidney function problems (acute renal failure).

General disorders and administration site conditions

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

Uncommon: general malaise.

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

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

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 Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glucantime

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

Nature of the product and contents of the pack

Glucantime is a clear solution. Rarely, small particles may appear in the solution. In such cases, shake well before use. If particles persist, the solution must not be used.

Glucantime is supplied in boxes of 10 vials 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 most recent revision of this package leaflet: October 2022

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