Zentel

Package leaflet: Information for the patient

Zentel 400 mg tablets

Albendazole
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Zentel is and what it is used for

Zentel contains the active substance albendazole, which is used to treat infections caused by a variety of parasites or worms that usually infect the intestine, such as Ascariasis, Enterobiasis, Ancylostomiasis, Necatoriasis, Trichuriasis, Strongyloidiasis, Taeniasis, Hymenolepiasis, Opisthorchiasis, Clonorchiasis, and Giardiasis in children. These parasites may also cause problems in other parts of the body, such as Cystic and Alveolar Echinococcosis, in cases where surgical intervention cannot be performed, as well as in treatments before and after surgery or following cyst drainage (percutaneous drainage for diagnostic or therapeutic reasons).
Zentel acts against worms, parasites, larvae, and their eggs.

2. What you need to know before taking Zentel

Do not take Zentel

• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, think you may be pregnant, are trying to become pregnant, or are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions
Take special care with Zentel tablets

• if you have seizures or other neurological symptoms: patients being treated for parasitic infections may rarely have an undiagnosed serious brain infection called neurocysticercosis. When the parasites are killed, a reaction in the brain may occur, causing seizures, headache, and vision problems;
• if your liver enzyme levels are elevated: Zentel may cause an increase in liver enzyme values, which usually return to normal after stopping treatment. Your doctor may carry out liver function tests before starting treatment and during treatment;
• if your white blood cell counts are low, especially if you have liver disease: Zentel may reduce the number of white blood cells in the blood. Your doctor should monitor these values regularly and may need to discontinue treatment with Zentel.

With prolonged treatment, hair loss and impaired liver function or liver enzyme levels may occur. Before starting each treatment cycle and at least every two weeks during treatment, laboratory tests should be performed, and treatment should be discontinued if a significant increase in liver enzymes is observed (more than double the upper normal limit).

Other medicines and Zentel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may reduce the effectiveness of Zentel or increase the likelihood of side effects. These include:

• cimetidine (for stomach ulcers)
• praziquantel (for worm infections)
• dexamethasone (for inflammation or allergies)
• ritonavir (for HIV infections)
• phenytoin, carbamazepine, or phenobarbital (for seizures and epilepsy)

Tell your doctor or pharmacist if you are taking any of these medicines.

Zentel with food and drink
For systemic parasitic infections, take the medicine during meals.
For intestinal infections, the medicine may be taken during meals, after meals, or on an empty stomach.

Pregnancy and breastfeeding
Do not take Zentel if you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding.
Zentel contains benzyl alcohol. Large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
If you become pregnant during treatment with Zentel, inform your doctor immediately.
To avoid taking Zentel during early pregnancy, it is recommended to:

• start taking Zentel only after a negative pregnancy test. Another test should be performed before starting a new course of Zentel treatment;
• use a reliable method of contraception to prevent pregnancy during treatment with Zentel and for one month after stopping the medicine.

Zentel must not be used by women who are breastfeeding, as there are insufficient data on its use during lactation.

Driving and using machines
Zentel may cause dizziness; therefore, caution is advised when driving or operating machinery.

Zentel contains lactose, sodium, sunset yellow (E110), and benzyl alcohol
Zentel contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
Zentel contains a colouring agent called sunset yellow (E110). It may cause allergic reactions.
Zentel contains 0.98 mg of benzyl alcohol per tablet (contained in the vanilla flavouring). Benzyl alcohol may cause allergic reactions.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
This medicine contains less than 1 mg of propylene glycol per tablet (contained in the vanilla flavouring).

3. How to take Zentel

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Zentel tablets you should take each day and for how long. The dose
depends on your body weight or age, and on the type and severity of the infection.
Your doctor may consider it necessary to carry out tests after you have taken the prescribed dose or at the end
of the treatment course, to ensure that Zentel is working effectively. Sometimes, a second single dose or a
second treatment course may be required.
Always follow your doctor's instructions regarding dosage, method, timing, and duration of treatment; otherwise, the medicine may not be effective.

Recommended doses

For the treatment of intestinal infections
In adults and children over 2 years of age:
The recommended dose is 1 tablet of ZENTEL 400 mg.

• For infections due to Strongyloides stercoralis, Taenia spp., or Hymenolepis nana, treatment should be repeated for three consecutive days;
• For infections due to Hymenolepis nana, repeating the treatment after 10–21 days is recommended;
• For mixed infections involving Opisthorchis viverrini and Clonorchis sinensis, the recommended dose of ZENTEL is 400 mg (1 tablet) twice daily for three consecutive days. If infection persists three weeks after administration, a second treatment course is advisable;
• For giardiasis (only in children aged 2 to 12 years), administer a single daily dose of 400 mg for 5 days.

In elderly patients
Experience in patients aged 65 years or older is limited. No dose adjustment is required; however, albendazole should be used with caution in patients with liver problems.

Patients with kidney or liver problems
If you have kidney or liver problems, Zentel should be used under strict medical supervision and continuous monitoring.

For the treatment of systemic infections
Do not use in children under six years of age.
Dosages depend on the parasite involved, body weight, and severity of infection:

• Cystic echinococcosis
  Patients weighing over 60 kg: 1 tablet of 400 mg twice daily for a total of 28 days.

Patients weighing less than 60 kg
Total daily dose: 15 mg/kg administered in two equally divided doses (maximum dose 800 mg per day) for a total of 28 days. This 28-day treatment course may be repeated, after a 14-day treatment-free interval, for a total of three cycles.
If surgery is required due to the disease, two 28-day treatment courses must be completed before surgery. If surgery must be performed before completion of the two treatment cycles, Zentel should be administered for as long as possible prior to surgery.
If surgery is performed less than 14 days after starting treatment, Zentel should be continued after surgery for two 28-day cycles, with a 14-day treatment-free interval between cycles.

• Alveolar echinococcosis
  Patients weighing over 60 kg: 1 tablet of 400 mg twice daily for 28-day cycles, with a 14-day treatment-free interval between cycles.
  Patients weighing less than 60 kg: Total daily dose: 15 mg/kg administered in two equally divided doses (maximum dose 800 mg per day) for 28-day cycles, with a 14-day treatment-free interval between cycles. Treatment may need to be prolonged for months or even years. Continuous treatment with the same dosage has been administered for periods up to 20 months.

In elderly patients
Experience in patients aged 65 years or older is limited. No dose adjustment is required; however, albendazole should be used with caution in patients with liver problems.

Patients with kidney or liver problems
If you have kidney or liver problems, the use of Zentel must be under strict medical supervision and continuous monitoring.
Treatment with Zentel should be discontinued in case of a significant increase in liver enzymes or a clinically significant reduction in blood cell counts.

Use in children
Children under 6 years of age
Administration of albendazole for the treatment of systemic helminthic infections is not recommended in children under 6 years of age.

Method of administration
The tablets may be swallowed whole, chewed, or crushed and mixed with food.
If you have difficulty swallowing the tablets whole—particularly young children—it is recommended to mix the crushed tablet with a small amount of water or to break it.

If you take more Zentel than you should
If you take more Zentel than prescribed, contact your doctor, pharmacist, or emergency services immediately and show them the medicine packaging. You may be given gastric lavage or other treatments as recommended by poison control centers.

If you forget to take Zentel
Do not take a double dose to make up for the missed dose.

If you stop taking Zentel
Take Zentel as prescribed and according to the doses indicated by your doctor. Do not stop using the medicine unless otherwise instructed by your doctor.
It is very important to complete the full course of treatment with Zentel.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

In case of treatment for intestinal infections (shorter treatment duration and lower doses)

Uncommon side effects
May occur in less than 1 in 100 people:

• headache, dizziness
• vomiting or nausea, stomach ache, diarrhoea

Rare side effects
May occur in 1 in 10,000 people:

• allergic reactions including skin rash, itching, and urticaria
• increased liver enzyme levels

Very rare side effects
May occur in less than 1 in 10,000 people:

• skin rashes, which may appear as pustules or with a target-like appearance, or skin peeling, particularly around the mouth, nose, eyes, and genital organs (erythema multiforme, Stevens-Johnson syndrome)
  If you notice any of these symptoms, contact your doctor urgently.

In case of treatment for systemic helminthic infections (longer treatment duration and higher doses)

Very common side effects
May occur in more than 1 in 10 people:

• headache
• increased liver enzyme levels

Common side effects
May occur in 1 in 10 people:

• dizziness
• vomiting or nausea, stomach ache
• fever
• thinning and moderate hair loss (reversible alopecia)

Uncommon side effects
May occur in less than 1 in 100 people:

• inflammation of the liver (hepatitis). Symptoms may include: abdominal pain, yellowing of the skin and eyes, dark-coloured urine and/or pale stools
• allergic reactions including skin rash, itching, and urticaria
• reduced number of white blood cells in the blood (leucopenia)

Very rare side effects
May occur in less than 1 in 10,000 people:

• skin rashes, which may appear as pustules or with a target-like appearance, or skin peeling, particularly around the mouth, nose, eyes, and genital organs (erythema multiforme, Stevens-Johnson syndrome)
• reduced number of blood cells involved in clotting (thrombocytopenia) or of all types of blood cells (pancytopenia). Symptoms caused by these changes include: fatigue, shallow breathing, pallor, frequent infections, bleeding or increased tendency to bruise more easily than normal
• inability of the bone marrow to produce new red or white blood cells (aplastic anaemia)
• reduced number of blood cells called granulocytes (agranulocytosis). Symptoms caused by these changes include: infections of the throat, mouth, skin, and nasal passages

If you notice any of these symptoms, contact your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zentel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zentel contains

• The active substance is albendazole. One tablet contains 400 mg of albendazole.

The other ingredients are lactose, maize starch, croscarmellose sodium, microcrystalline cellulose, povidone, vanillin, orange flavor, magnesium stearate, passion fruit flavor, sodium lauryl sulfate, sodium saccharin, sunset yellow lake (E110).

Description of the appearance of Zentel and pack sizes

Pack containing 1 or 3 tablets of 400 mg.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Laboratoire GlaxoSmithKline 23, Rue François Jacob - 92500 RUEIL-MALMAISON, France
Local representative: GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - Verona, Italy

Manufacturer
GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Behavioral hygiene

How worm and parasite infections occur

Infection usually occurs by drinking water or eating food contaminated with worm eggs or larvae. These develop in the intestine. Since there may be few or no symptoms in the early stages of infection, infected individuals may not be aware they are infected.

Signs and symptoms depend on the type of worm, but may include abdominal pain, nausea, diarrhea, anemia, and fatigue. Some infections can cause problems in other parts of the body, such as the liver, lungs, or brain.

Worms and parasites confined to the intestine can be easily treated. However, because some parasites may migrate to other parts of the body, it is important to start treatment as early as possible. This will help prevent permanent damage. Some infections, if left untreated, can be life-threatening.

How to protect yourself from worm and parasite infections

It is important to follow these recommendations to avoid becoming infected in the future, to prevent spreading infections to others, and to avoid re-infection during treatment with Zentel:

• Always wash hands with soap and water after using the toilet, after touching animals, and before eating.
• Make sure meat is thoroughly cooked and that fruits and vegetables are washed with potable water before consumption.