ESKAZOLE 400 mg TABLETS

2. What you need to know before starting to take Eskazole 400 mg tablets

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 up to one month after treatment has ended.

Warnings and Precautions

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

• Your doctor will perform liver function tests before starting each treatment cycle and at least every 2 weeks during treatment. If the enzymes increase significantly, treatment should be discontinued. 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 treatment to monitor blood count. Treatment with albendazole should be suspended if there are clinically significant decreases in blood count.
• If you are a woman of childbearing age. To avoid administering Eskazole during the first months of pregnancy, treatment should only be started after a negative pregnancy test 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 has ended.
• Before starting treatment with Eskazole, in rare cases of neurocysticercosis in the retina, your doctor will monitor for any lesions in the retina. If such lesions are visualized, the benefit of therapy will be weighed against 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 you may not be aware of it. When the parasites die, a reaction occurs in the brain. Symptoms include seizures, headache, and vision problems.

Taking Eskazole 400 mg tablets with other medications

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

It has been observed that cimetidine (for the treatment of stomach ulcers), praziquantel (for the treatment of parasitic infections), and dexamethasone (for the treatment of inflammation or allergy) increase plasma levels of the active metabolite of albendazole.

It has been observed that ritonavir (for the treatment of HIV infections), phenytoin, carbamazepine, and phenobarbital (for the treatment of seizures and epilepsy) may reduce plasma levels of the active metabolite of albendazole.

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 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 up to one month after treatment has ended. Treatment should only be started after a negative pregnancy test result.

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

Driving and Using Machines

Eskazole may cause dizziness. Therefore, caution is recommended when driving or using machinery.

Eskazole 400 mg tablets contain lactose

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

Eskazole 400 mg tablets contain orange yellow S

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

Eskazole 400 mg tablets contain sodium

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

Eskazole 400 mg tablets contain benzyl alcohol

This medication contains 0.98 mg 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 can 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 can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of adverse effects, including respiratory problems ("gasping syndrome") in children.

3. How to take Eskazole 400 mg tablets

Follow your doctor's or pharmacist's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

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

Eskazole should be taken with food to facilitate absorption. Swallow the tablets with water. For people who have difficulty swallowing whole tablets, especially young children, the tablets can be crushed or chewed with a little water.

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Patients weighing over 60kg:total daily dose of 800 mg, divided into two doses of 400 mg for a total of 28 days.

Patients weighing under 60kg:total daily dose of 15 mg/kg, administered in two equal divided doses (maximum dose of 800 mg/day), for a total of 28 days.

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

1. Multilocular and inoperable cysts:

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

1. Before surgery:

Two 28-day cycles should be administered before surgery. In cases where surgical intervention is necessary 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 postoperatively for 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 percutaneous drainage of cysts: Treatment is similar to that after surgery.

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Patients weighing over 60kg:total daily dose of 800 mg, divided into two doses of 400 mg for cycles of 28 days with 14-day rest periods between cycles.

Patients weighing under 60kg:total daily dose of 15 mg/kg, administered in two equal divided doses (maximum dose of 800 mg/day), for cycles of 28 days with 14-day rest periods between cycles.

Treatment is administered in cycles of 28 days. It can 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 shown that continuous treatment in a limited number of patients can lead to apparent cure.

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Patients weighing over 60kg:total daily dose of 800 mg, divided into two doses of 400 mg for 7 to 30 days, depending on the response.

Patients weighing under 60kg:total daily dose of 15 mg/kg, administered in two equal divided doses (maximum dose of 800 mg/day), for 7 to 30 days, depending on the response.

A second cycle can be administered after a 14-day rest period between cycles.

The duration of treatment for neurocysticercosis varies according to the type of cyst:

1. Parenchymal cysts / granulomas:

Treatment is administered for a minimum of 7 days and up to a maximum of 28 days.

1. Arachnoid and ventricular cysts:

Treatment usually lasts 28 days for non-parenchymal cysts.

1. Cysts in clusters:

A minimum treatment duration 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, oral or intravenous corticosteroids should be administered to prevent episodes of increased intracranial pressure.

Use in Children and Adolescents

The use of Eskazole is not recommended in children under 6 years of age.

The posological recommendations in children over 6 years of age are the same as those for adults.

Use in Elderly Patients

Experience in patients over 65 years of age is limited. Reports indicate that no dose adjustments are required.

Use in Patients with Renal Impairment

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

Use in Patients with Hepatic Impairment

Patients with abnormal liver function test results before starting treatment with albendazole should be evaluated with caution, and treatment should be discontinued if liver enzymes increase significantly or if there is a decrease in total blood count.

If you take more Eskazole 400 mg tablets than you should

There is no experience with overdose of Eskazole. 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 medication and the amount used.

If you forget to take Eskazole 400 mg tablets

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

If you stop treatment with Eskazole 400 mg tablets

Do not stop taking Eskazole so that the result of your treatment is not compromised. Therefore, follow your doctor's instructions carefully.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

By convention, the frequencies are classified into the following categories:

Very common (at least 1 in 10 patients)

Common (at least 1 in 100 patients)

Uncommon (at least 1 in 1,000 patients)

Rare (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: leukopenia.

Very rare: pancytopenia, aplastic anemia, agranulocytosis.

Leukopenia has been associated with albendazole treatment when treating patients with echinococcosis.

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 disorders (abdominal pain, nausea, and vomiting).

Gastrointestinal disorders have been associated with albendazole when treating patients with echinococcosis.

Hepatobiliary Disorders

Very common: mild to moderate increase in liver enzymes.

Uncommon: hepatitis.

Skin and Subcutaneous Tissue Disorders

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

Very rare: erythema multiforme, Stevens-Johnson syndrome.

General Disorders and Administration Site Conditions

Common: fever.

If you consider any of the adverse effects you are experiencing to be serious, or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus.

You can also report them directly through the Spanish Medication Surveillance System for Human Use, www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Eskazole 400 mg tablets

Do not store above 30 °C.

Keep this medication out of sight and reach of children.

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

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

6. Package Contents and Additional Information

Composition of Eskazole 400 mg tablets

• The active ingredient is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: cornstarch, povidone, sodium lauryl sulfate, sodium croscarmellose, microcrystalline cellulose, orange yellow 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 Package Contents

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

The package contains 60 tablets. The package is a plastic bottle (polypropylene) with a plastic cap (polyethylene).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Spain

Tel: +34 900 202 700

[email protected]

Manufacturer

GlaxoSmithKline Trading Services Limited

12 Riverwalk,

Citywest Business Campus

Dublin 24,

Ireland

Date of the Last Revision of this Prospectus:May 2024

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