ZENTEL 400 mg Tablets

Зміст інструкції

1. Zentel 400 mg tablets
   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. Package contents and other information

Zentel 400 mg tablets

Albendazole

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 ingredient albendazole which is used to treat infections caused by a number of
parasites or worms that usually infect the intestine such as Ascariasis, Enterobiasis, Hookworm infection,
Necatoriasis, Trichuriasis, Strongyloidiasis, Taeniasis, Hymenolepiasis, Opisthorchiasis, Clonorchiasis, Giardiasis in
children but can also cause problems in other parts of the body such as cystic and alveolar Echinococcosis
in cases where surgery cannot be performed, in therapies before and after surgery or after cyst drainage
(percutaneous drainage for diagnostic or therapeutic purposes).
Zentel acts on 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 ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant, think you may be pregnant, or are trying to become pregnant, or while breastfeeding(see the Pregnancy and breastfeeding section).

Warnings and precautions
Take particular care with Zentel tablets

• if you have seizures or other neurological symptoms: people being treated for parasitic infections may unknowingly have a serious brain infection called neurocysticercosis. When the parasites are killed, a reaction occurs in the brain that causes seizures, headache and vision problems;
• if your liver enzyme levels are elevated:Zentel can lead to an increase in liver enzyme levels, which however return to normal after stopping treatment. Your doctor may perform liver function tests before starting treatment and during it.
• if your white blood cell count is low, especially if you suffer from liver disease: Zentel causes a reduction in the number of white blood cells in the blood; the doctor must monitor these values frequently and possibly suspend treatment with Zentel.

In case of prolonged treatments, the following may occur: hair loss, alteration of the functionality and of the
liver enzymes. Before starting each treatment cycle and at least every two weeks during the
treatment, you must undergo laboratory tests and interrupt the treatment if a significant increase in liver enzymes is observed (more than twice 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 medicine.
Some medicines can reduce the functioning of Zentel, or make the onset of certain
side effects more likely. These include:

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

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

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

Pregnancy and breastfeeding
Do not take Zentelif you are pregnant, think you may be pregnant, are planning a pregnancy or are
breastfeeding.
Zentel contains benzyl alcohol. Large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).

If you become pregnantduring therapy with Zentel, inform your doctor immediately.
To avoid taking Zentel during the beginning of pregnancy, it is recommended to:

• start taking Zentel only after a negative pregnancy test. Another test should be performed before starting a new treatment of Zentel.
• use a reliable contraceptive method to avoid pregnancyduring therapy with Zentel and for one month after stopping taking it. Zentel should not be used by breastfeeding women, as there is insufficient data on use during breastfeeding.

Driving and using machines
Zentel can cause dizziness, so caution is recommended when driving vehicles and
using machines.

Zentel contains lactose, sodium, sunset yellow (E110), benzyl alcohol
Zentel contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him
before taking this medicine.
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

Zentel contains a coloring agent called sunset yellow(E110). It may cause allergic reactions.
Zentel contains 0.98 mg of benzyl alcoholper tablet (contained in the vanilla flavour). Benzyl alcohol can
cause allergic reactions.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended
by your doctor or pharmacist.
Ask your doctor or pharmacist if you have a liver or kidney disease. This is because large amounts
of benzyl alcohol can 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 flavour).

3. How to take Zentel

Always take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.
Your doctor will tell you how many Zentel tablets you will need to take each day and for how long. The dose
depends on your weight or age, and on the type and severity of the infection.
Your doctor may deem it necessary to subject you to tests after taking the prescribed dose or once
the treatment cycle is completed, to ensure that Zentel is working. Sometimes it may be necessary
to administer a second single dose or to carry out a second treatment cycle.
Always follow your doctor's instructions regarding the dose, how, when and for how long to use the
medicine, otherwise it will not be beneficial.

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

• for infestations with Strongyloides stercoralis, Taeniaspp. or Hymenolepis nana, this treatment should be repeated for three consecutive days;
• for infestations with Hymenolepis nana, it is recommended to repeat the treatment after 10-21 days;
• for mixed infestations including Opistorchis viverriniand Chlonorchis sinensis, the recommended dose of ZENTEL is 400 mg (1 tablet) twice a day for three consecutive days, if the infestation is still present three weeks after administration, a second course of therapy is advisable;
• for giardiasis (only in children between 2 and 12 years of age) administer a single dose of 400 mg per day for 5 days.

In the elderly
Experience in patients aged 65 years or over is limited. No dosage adjustment is required, however, albendazole must be used with caution in case of liver problems.
Patients with kidney or liver problems
If you have kidney or liver problems, the use of Zentel must be done under strict control and continuous monitoring
by your doctor.

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

• Cystic echinococcosisPatients weighing more than 60 kg1 tablet of 400 mg twice a day for a total of 28 days.

Patients weighing less than 60 kg
Total daily dose: 15 mg/kg administered in two equal divided doses (maximum dose 800 mg per
day) for a total of 28 days. This 28-day treatment cycle may be
repeated, after a 14-day period without any treatment, for a total of three cycles.
If you are to be operated on due to the disease, two 28-day treatments should be performed before
surgery. If surgery is to be performed before the end of the two cycles of
treatment, Zentel should be administered for as long as possible.
If surgery is performed less than 14 days after the start of treatment, Zentel should be taken after
surgery for two 28-day cycles with a 14-day rest period.

• Alveolar echinococcosisPatients weighing more than 60 kg1 tablet of 400 mg twice a day for cycles of 28 days, with an interval of 14 days without treatment between cycles. Patients weighing less than 60 kgTotal daily dose: 15 mg/kg administered in two equal divided doses (maximum dose 800 mg per day) for cycles of 28 days, with an interval of 14 days without treatment between cycles. It may be necessary to prolong the treatment for months or years. Continuous treatment with the same dosage has been carried out for periods of up to 20 months.

In the elderly
Experience in patients aged 65 years or over is limited. No dosage adjustment is required, however, albendazole must be used with caution in case of liver problems.
Patients with kidney or liver problems
If you have kidney or liver problems, the use of Zentel must be done under strict control and continuous monitoring
by your doctor.
Therapy with Zentel must be discontinued in case of a significant increase in liver enzymes or a
clinically significant reduction in blood count.

Use in children
Children under 6 years of age
The 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 can be swallowed, chewed or broken and mixed with food.
If you have difficulty swallowing whole tablets, especially young children, it is therefore recommended
to mix the tablets with a little water or break them.

If you take more Zentel than you should
If you take more Zentel than you should, contact your doctor, pharmacist or emergency department immediately
and show them the medicine packaging. Gastric lavage or other treatments may be performed
according to the recommendations of poison control centers.

If you forget to take Zentel
Do not take a double dose to make up for a 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 indicated by your doctor.
It is very important to follow the complete treatment with Zentel.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In case of treatment for intestinal infections (shorter treatment duration and lower doses)
Uncommon side effects
May affect less than 1 in 100 people:

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

Rare side effects
May affect up to 1 in 10,000 people:

• allergic reactions including skin rash, itching and hives
• increased liver enzyme values

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

• skin rashes, which may appear as blisters or with a target-like appearance, or peeling of the skin, particularly around the mouth, nose, eyes and genitals (erythema multiforme, Stevens-Johnson syndrome)If you notice any of these symptoms, seek medical attention urgently.

In case of treatment for systemic helminthic infections (longer treatment duration and higher doses)
Very common side effects
May affect more than 1 in 10 people:

• headache
• increased liver enzyme values

Common side effects
May affect up to 1 in 10 people:

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

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

• liver inflammation (hepatitis). Symptoms may include: abdominal pain, yellowing of the skin and eyes, dark urine and/or discolored stools
• allergic reactions including skin rash, itching and hives
• reduction in the number of white blood cells in the blood (leukopenia)

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

• skin rashes, which may appear as blisters or with a target-like appearance, or peeling of the skin, particularly around the mouth, nose, eyes and genitals (erythema multiforme, Stevens-Johnson syndrome)
• reduction in the number of blood cells involved in coagulation (thrombocytopenia) or of all types of cells present in the blood (pancytopenia). Symptoms caused by these alterations include: fatigue, shortness of breath, paleness, frequent infections, bleeding or a tendency to bruise more easily than normal
• inability of the bone marrow to produce new red or white blood cells (aplastic anaemia)
• reduction in the number of blood cells called granulocytes (agranulocytosis). Symptoms caused by these alterations include: infections of the throat, mouth, skin and nasal passages

If you notice any of these symptoms, seek medical attention immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the pack after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature .
Do not dispose of any medicine in 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 ingredient is albendazole. One tablet contains 400 mg of albendazole

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

Description of Zentel and package contents
Pack of 3 or 1 tablet(s) of 400 mg
Not all pack sizes may be marketed

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Laboratoire GlaxoSmithKline 23, Rue François Jacob - 92500 RUEIL-MALMAISON, France
Local representative :GlaxoSmithKline S.p.A. – Viale dell’Agricoltura, 7 - Verona

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

Behavioural hygiene
How worm and parasite infections occur
Infection usually occurs by drinking water or eating food containing worm eggs or larvae. These
grow in the intestine. Because in the early stages of infection there may be few or no symptoms, the
infected person may not notice it.
Signs and symptoms depend on the type of worm, but can include abdominal pain, nausea, diarrhoea,
anaemia and fatigue. Some infections can cause problems in other parts of the body, such as the liver,
lungs or brain.
Worms and parasites that remain in the intestine can be treated easily. However, due to the
movement to other parts of the body, it is important to start treatment as soon as possible. This will help
to avoid 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 tips to avoid getting infections in the future, to avoid transmitting
infections to others, and to avoid re-infection during therapy with Zentel:

• always wash your hands with water and soap after using the toilet, after touching animals and before eating
• make sure that meat is well cooked and that fruit and vegetables have been washed in drinking water before eating.