Zentel

Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Zentel (Eskazole)
400 mg, chewable tablets
Albendazole
Zentel and Eskazole are different trade names for the same medicinal product.
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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
7. Additional information about parasitic diseases

1. What Zentel is and what it is used for

Zentel contains the active substance albendazole, which has anthelmintic (anti-parasitic) properties.
Albendazole acts against parasites (worms) and their larvae by preventing them from absorbing sugars (glucose), causing them to lose energy and die. It is also effective against parasite eggs.
Zentel is a medicine used in the treatment of diseases caused by parasitic worms, such as:

• infection with Enterobius vermicularis (pinworm infection, enterobiasis);
• infection with Ancylostoma duodenale (hookworm infection, ancylostomiasis);
• infection with Necator americanus (necatoriasis);
• infection with Strongyloides stercoralis (strongyloidiasis);
• infection with Ascaris lumbricoides (ascariasis);
• infection with Trichuris trichiura (whipworm infection, trichuriasis);
• infection with tapeworm (taeniasis).

For additional information about parasitic diseases, see section 7 of the leaflet.

2. Important information before using Zentel

When not to use Zentel

• If the patient has a known allergy to albendazole or to any of the other ingredients of the medicine (listed in section 6).
• If the patient is pregnant or suspects she may be pregnant (see "Pregnancy and breastfeeding").
• Inform your doctor if any of the above apply to you.

Warnings and precautions
Before taking Zentel, discuss with your doctor:

• if the patient is breastfeeding (see "Pregnancy and breastfeeding"),
• if the patient has impaired kidney or liver function,
• if the patient is elderly.
• Inform your doctor if any of the above apply to you.

If at least two of the following symptoms occur during treatment with Zentel:

• headache (which may be severe),
• seizures,
• nausea,
• vomiting,
• visual disturbances,
• seek immediate medical advice. These symptoms may result from the death of parasites located in the brain. Some individuals being treated for parasitic infections may also have a rare but serious infection of the central nervous system caused by tapeworms, known as neurocysticercosis. The patient may be unaware of this infection, and administration of Zentel may unmask it.

Zentel with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may affect the action of Zentel or increase the risk of adverse effects. These include:

• cimetidine (used in the treatment of stomach ulcers);
• praziquantel (used to treat worm infections);
• dexamethasone (used to treat inflammatory and allergic conditions);
• ritonavir (used in the treatment of HIV infection);
• phenytoin (used to treat epilepsy);
• carbamazepine (used to treat epilepsy and bipolar affective disorder);
• phenobarbital (used as an anticonvulsant, sedative, and hypnotic);
• If the patient is taking or has recently taken any of these medicines, they should inform their doctor.

Taking Zentel with food and drink
Zentel may be taken with or without food, swallowed with water.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Zentel must not be used if the patient is pregnant or suspects she may be pregnant. Zentel may harm the unborn baby.
In women of childbearing age, Zentel should be taken only during the first 7 days of the menstrual cycle or after a negative pregnancy test result. This is to avoid administering Zentel during early pregnancy.
Breastfeeding women should not use Zentel unless the potential benefits outweigh the risks.
Breastfeeding women should consult their doctor before using Zentel, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

Driving and using machines
Zentel may cause dizziness. If dizziness occurs, do not drive or operate machinery.

Zentel contains:

Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of the vanilla flavouring) in each tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of severe adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before using Zentel, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

Lactose monohydrate
Zentel contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

Tartrazine (Orange Yellow)
Zentel contains tartrazine, a dye which may cause allergic reactions.

Maltodextrin (contains glucose)
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

Sodium
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Zentel

Zentel should always be taken exactly as directed by your doctor.

• If you have any doubts, consult your doctor or pharmacist.

If more than one dose is required, it should be taken at the same time each day.
Dosage
Infection with pinworms, roundworms, hookworms, or whipworms
One 400 mg tablet taken once.
Infection with tapeworm or intestinal threadworm
One 400 mg tablet once daily for three consecutive days.
If the patient has not been cured, the doctor may decide to repeat the treatment after three weeks.
If you feel that the effect of Zentel is too strong or too weak, consult your doctor.
Method of administration
Zentel may be taken with or without food.
Zentel tablets may be swallowed whole with water. If you have difficulty swallowing the tablets whole, they may be crushed, chewed, or chewed thoroughly and taken with a small amount of water.
For children and patients who have difficulty swallowing tablets, an alternative formulation of the medicine is available (Zentel is also available as an oral suspension).
It is not necessary to take the medicine on an empty stomach or after bowel cleansing.
Taking more Zentel than recommended
If you take more than the recommended dose, contact your doctor immediately. If possible, show the doctor the medicine’s packaging.
Missed dose of Zentel
Do not take extra tablets or double the dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Zentel treatment
Do not stop taking Zentel without consulting your doctor.

• If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):

• headache, dizziness,
• nausea, vomiting, abdominal pain, diarrhoea.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):

• hypersensitivity symptoms (e.g. rash, urticaria, itching).

Rare adverse reactions which may be observed in blood tests:

• increased liver enzyme activity.

Very rare adverse reactions (may occur in less than 1 out of 10,000 patients):
severe skin reactions

• erythema multiforme, presenting as a rash which may be blistering and resembling target lesions (dark spots in the center, surrounded by a paler area with a dark ring around it),
• Stevens-Johnson syndrome – a severe widespread rash with blisters and skin peeling, particularly affecting the area around the mouth, nose, eyes and genital organs.
• If any of the above symptoms occur in the patient, contact a doctor immediately.

Other symptoms which may occur during treatment with Zentel
See section 2 of the leaflet (subsection “If at least two of the following symptoms occur during treatment with Zentel”).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zentel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Zentel contains

• The active substance is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: lactose, microcrystalline cellulose, maize starch, sodium croscarmellose, povidone K 29/30, sodium lauryl sulfate, orange yellow dye in the form of a lake (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E 110), sodium saccharin, magnesium stearate, vanilla flavouring composition, passionflower flavouring composition, orange flavouring composition.

What Zentel looks like and contents of the pack
Zentel tablets are pale orange, oblong, rounded, biconvex, with a score line on one side and
the imprint “ALB 400” on the other side. They have a characteristic fruity odour.
The cardboard box contains a PVC-PVDC/Al blister pack with 1 tablet.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Romania, the country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus
Dublin 24, Ireland
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin 24, Ireland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Romania, the country of export: 9938/2017/01
9938/2017/02
Parallel Import Authorisation Number: 180/19

7. Additional information on parasitic infections

Infection with parasites occurs as a result of ingesting water or food contaminated with parasite eggs or larvae, which then develop in the intestines. Since in the early stages the disease may not cause any symptoms, an infected person may be unaware of the infection.
Symptoms depend on the type of worm. Abdominal pain, nausea, diarrhea, anemia, and fatigue may occur. Some parasitic infections can cause symptoms affecting other parts of the body, such as the liver, lungs, or brain.
Treatment of intestinal infections is usually straightforward. However, since certain worms can migrate to other parts of the body, it is important to start treatment as soon as possible. This helps prevent disease progression and permanent damage. Some untreated parasitic infections may be life-threatening.
Protection against worm infection is essential.
It is very important to take preventive measures to avoid reinfection, spreading the infection to others, and self-reinfection during treatment with Zentel.

• Wash hands with soap and water after using the toilet, after contact with animals, and before every meal.
• Ensure that meat intended for consumption is cooked to an appropriately high temperature, and wash fruits and vegetables thoroughly with clean water before eating.