Patient Information

Eskazole 400mg Tablets

albendazole

Read this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Eskazole is a medication with anthelmintic and antiprotozoal activity against intestinal and tissue parasites.

Eskazole is indicated for the treatment of the following systemic helminthic infections:echinococcosis or hydatid disease and neurocysticercosis.

Do not take Eskazole 400mg tablets

• If you are allergic to albendazole or any of the other components of this medication (listed in section 6).
• If you are pregnant or think you may be pregnant. It is recommended that women of childbearing age use an effective contraceptive method during treatment and for at least one month after it has ended.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Eskazole 400mg tablets.

• Your doctor will perform liver function tests before starting each treatment cycle and at least every 2 weeks during the treatment. If the enzymes increase significantly, the treatment should be interrupted.Your doctor will assess whether you can continue treatment with Eskazole when liver enzymes have returned to normal.
• Your doctor will perform blood counts at the start of treatment and every 2 weeks during the treatment to monitor blood counts. Treatment with albendazole should be suspended if clinically significant decreases in blood counts occur.
• If you are a woman of childbearing age. To avoid administering Eskazole during the first months of pregnancy, treatment should only be initiated after a pregnancy test with a negative result. This test should be repeated at least once before starting the next cycle. Pregnancy should be avoided during and for at least one month after treatment is discontinued.
• Before starting treatment with Eskazole, in rare cases of neurocysticercosis in the retina, your doctor will monitor for retinal lesions. If these lesions are visualized, the benefit of therapy will be weighed against the potential retinal damage.
• If you are being treated for a parasitic infection, you may also have a rare and serious brain infection called neurocysticercosis and may not know it. When the parasites die, a reaction occurs in the brain. Symptoms include seizures, headaches, and vision problems.

Taking Eskazole 400mg tablets with other medications

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

Cimetidine (for the treatment of stomach ulcers), praziquantel (for the treatment of parasitic infections), and dexamethasone (for the treatment of inflammation or allergy) have been observed to increase plasma levels of the albendazole active metabolite.

Ritonavir (for the treatment of HIV infections), phenytoin, carbamazepine, and phenobarbital (for the treatment of seizures and epilepsy) have been observed to reduce plasma levels of the albendazole active metabolite.

Pregnancy and breastfeeding

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

Eskazole should not be administered during pregnancy or to women who think they may be pregnant. It is recommended that women of childbearing age use an effective contraceptive method during treatment and for at least one month after it has ended. Treatment should only be initiated after a pregnancy test with a negative result. This test should be repeated at least once before starting the next cycle.

There is not enough information available about the excretion of albendazole in breast milk. Therefore, Eskazole should not be used during breastfeeding.

Driving and operating machinery

Eskazole may cause dizziness. Therefore, caution should be exercised when driving or operating machinery.

Eskazole 400mg tablets contain lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Eskazole 400mg tablets contain yellow orange S

This medication may cause allergic reactions because it contains yellow orange S. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Eskazole 400mg tablets contain sodium

This medication contains less than 23mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.

Eskazole 400mg tablets contain benzyl alcohol

This medication contains 0.98mg of benzyl alcohol in each tablet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of adverse effects that include respiratory problems (“breathing difficulty”) in children.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.again.

The doses are dependent on the parasites involved, the patient's weight, and the severity of theinfection.

Eskazole should be taken with food to facilitate its absorption.Swallow the tablets with water. For those who find difficulty in swallowing the whole tablets, especially small children, the tablets can be crushed or chewed with a little water.

?Cystic Echinococcosis

Patients with a weight of 60kg or more:daily total dose of 800mg, divided into two doses of 400mg over a total of 28 days.

Patients with a weight of less than 60kg:daily total dose of 15mg/kg administered in two equal fractions(maximum daily dose of 800mg), over a total of 28 days.

These 28-day treatment cycles can be repeated with 14-day periods of rest between the cycles depending on the therapeutic indication, for a total of 3 cycles.

1. Multiple inoperable cysts:

Up to three 28-day treatment cycles of Eskazole can be administered for the treatment ofhepatic, pulmonary, and peritoneal cysts. In bone or cerebral locations, a longer treatment may be required.

1. Before surgery:

Two 28-day cycles should be administered before surgery. In cases where the surgical intervention is precise before completing the two cycles, Eskazole should be administered for as long as possible.

1. After surgery:

In cases where only a short preoperative cycle (less than 14 days) has been administered and in those where emergency surgery is required, Eskazole should be administered postoperativelyfor two 28-day cycles, separated by a 14-day rest period. Additionally, in cases where the cysts are viable after preoperative treatment, or if there has been a rupture, a complete treatment of two cycles should be administered.

1. After a percutaneous drainage of the cysts:Treatment similar to that after surgery.

?Alveolar Echinococcosis

Patients with a weight of 60kg or more:daily total dose of 800mg, divided into two doses of 400mg over 28-day cycles with 14-day periods of no treatment between the cycles.

Patients with a weight of less than 60kg:daily total dose of 15mg/kg administered in two equal fractions(maximum daily dose of 800mg), over 28-day cycles with 14-day periods of notreatment between the cycles.

The treatment is administered in 28-day cycles. It may be continued for months or even years.

Continuous treatment at the same dose has been used for periods of up to 20 months.

Current follow-up suggests that survival times are substantially improved after prolonged treatment. It has been demonstrated that continuous treatment in a limited number of patients can lead to apparent cure.

?Neurocysticercosis

Patients with a weight of 60kg or more:Daily total dose of 800mg, divided into two doses of 400mg from 7 to30 days depending on the response.

Patients with a weight of less than 60kg:Daily total dose of 15mg/kg administered in two equal fractions(maximum daily dose of 800mg), from 7 to 30 days depending on the response.

A second cycle can be administered after a 14-day period of no treatment between the cycles.

The duration of treatment for neurocysticercosis varies depending on the type of cysts:

1. Cystic/Granulomatous cysts:

Treatment is performed for a minimum of 7 days and a maximum of 28 days.

1. Arachnoid and ventricular cysts:

Normally, treatment lasts 28 days in non-cystic cysts.

1. Cluster cysts:

A minimum treatment of 28 days is required. The duration is determined by the radiological and clinical response, and treatment is administered as continuous treatment.

Patients treated for neurocysticercosis should receive the required anticonvulsant and steroid treatment. During the first week of treatment, corticosteroids should be administered orally or intravenously to prevent episodes of cerebral hypertension.

Use in children and adolescents

Eskazole is not recommended for use in children under 6 years old.

Posological recommendations in children 6 years old or more are the same as those for adults.

Use in the elderly

Experience in patients 65 years old or more is limited. Reports indicate that no dose adjustments are required.

Use in patients with renal insufficiency

No dose adjustments are required, however, patients with evidence of renal insufficiency should be monitored with caution.

Use in patients with liver insufficiency

Patients with abnormal liver function test results (transaminases) before starting albendazole treatment should be evaluated with caution and treatment should be suspended if liver enzymes significantly increase or total blood count decreases.

If you take more Eskazole 400mg tablets than you should

There is no experience of overdosing with Eskazole. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call theToxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forget to take Eskazole 400mg tablets

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Eskazole 400mg tablets

Do not stop taking Eskazole to prevent the treatment outcome from being compromised. Therefore, follow your doctor's instructions carefully.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

By agreement (or consensus) the frequencies are classified in the following categories:

Very common (in at least 1 in 10 patients)

Common (in at least 1 in 100 patients)

Uncommon (in at least 1 in 1,000 patients)

Rare (in at least 1 in 10,000 patients)

Very rare (less than 1 in 10,000 patients)

Use in systemic helminthic infections:

Blood and lymphatic system disorders

Uncommon:leucopenia.

Very rare:pancytopenia, aplastic anemia, agranulocytosis.

Leucopenia has been associated with albendazole treatment when patients with echinococcosis are treated.

Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression.

Immune system disorders

Uncommon:hypersensitivity reactions including rash, pruritus, and urticaria.

Nervous system disorders

Very common:headache.

Common:dizziness.

Gastrointestinal disorders

Common:gastrointestinal disturbances (abdominal pain, nausea, and vomiting).

When treating patients with echinococcosis, gastrointestinal disturbances have been associated with albendazole.

Hepatobiliary disorders

Very common:mild to moderate increase in liver enzymes.

Uncommon:hepatitis.

Skin and subcutaneous tissue disorders

Common:reversible alopecia (hair loss and moderate hair thinning).

Very rare:erythema multiforme, Stevens-Johnson syndrome.

General disorders and administration site conditions

Common:fever.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 not mentioned in this leaflet.

You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store at a temperature above 30°C.

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

Do not use this medication after the expiration date that appears on the label of the package. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and the

medicines that you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so,you will help protect the environment.

Composition of Eskazole 400 mg tablets

• The active ingredient is albendazole. Each tablet contains 400 mg of albendazole.
• The other components are: cornstarch, povidone, sodium lauryl sulfate, croscarmellose sodium, microcrystalline cellulose, yellow-orange S (E-110) , magnesium stearate, vanilla flavor (contains benzyl alcohol and propylene glycol (E-1520) ) , passion fruit flavor, orange flavor, lactose monohydrate, sodium saccharin.

Appearance of the product and content of the packaging

The Eskazole tablets are speckled, pale orange, oval, biconvex, with a groove on one side and engraved with "ALB 400" on the other. The tablets have a characteristic fruity odor.

The packaging contains 60 tablets. The packaging is a plastic bottle (polypropylene) with a plastic lid (polyethylene).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

GlaxoSmithKline , S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Spain

Tel: +34 900 202 700

es-ci@gsk.com

Responsible for manufacturing

GlaxoSmithKline Trading Services Limited

12 Riverwalk,

Citywest Business Campus

Dublin 24,

Ireland

Last review date of this leaflet: May 2024

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