Zentel

Patient Information Leaflet: User Information

Warning! Keep the leaflet, the 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 medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Zentel and what is it used for
• 2. Important information 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 on parasitic diseases

1. What is Zentel and what is it used for

Zentel contains albendazole, an active substance with antiparasitic action. Albendazole acts on parasites (worms) and their larvae, preventing them from absorbing sugars (glucose), which causes them to lose energy and die. It also acts on the eggs of parasites.
Zentel is a medicine used to treat diseases caused by parasites (worms), such as:

• infection with human pinworm (enterobiasis);
• infection with hookworm (ancylostomiasis);
• infection with American hookworm (necatoriasis);
• infection with intestinal strongyloidosis (strongyloidiasis);
• infection with human roundworm (ascariasis);
• infection with human whipworm (trichuriasis);
• infection with tapeworm (taeniasis).

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

2. Important information before taking Zentel

When not to take Zentel

• If the patient has been diagnosed with an allergy to albendazole or any of the other ingredients of the medicine (listed in section 6).
• If the patient is pregnant or thinks she may be pregnant (see Pregnancy and breastfeeding).
• The patient should inform their doctor if they are in any of the above situations.

Warnings and precautions

Before starting to take Zentel, the patient should discuss it with their doctor:

• if the patient is breastfeeding (see Pregnancy and breastfeeding),
• if the patient has kidney or liver function disorders,
• if the patient is elderly.
• The patient should inform their doctor if they are in any of the above situations.

If the patient experiences at least two of the following symptoms while taking Zentel:

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances
• the patient should immediately consult a doctor.These symptoms may be caused by the death of parasites in the brain. In some people being treated for parasitic infections, a rare but serious brain infection caused by tapeworms may occur: so-called neurocysticercosis. The patient may not know they have this infection, and taking Zentel may reveal it.

Zentel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of Zentel or increase the risk of side effects. These medicines include:

• cimetidine (used to treat stomach ulcers);
• praziquantel (used to treat worm infections);
• dexamethasone (used to treat inflammatory and allergic conditions);
• ritonavir (used to treat HIV infection);
• phenytoin (used to treat epilepsy);
• carbamazepine (used to treat epilepsy and bipolar disorder);
• phenobarbital (used as an antiepileptic, 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 can be taken with or without food, with a glass of water.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine .

If the woman is pregnant or thinks she may be pregnant, taking Zentel is contraindicated. Zentel may cause fetal harm.
In women of childbearing age, it is recommended to take Zentel during the first 7 days of menstruation or after a negative pregnancy test result. This is to avoid taking Zentel in early pregnancy.
Breastfeeding women should not take Zentel unless the potential benefits outweigh the risks associated with treatment.
Breastfeeding women should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Driving and using machines

Zentel may cause dizziness. If dizziness occurs, the patient should not drive or operate machinery.

What Zentel contains

Benzyl alcohol
Zentel contains benzyl alcohol (a component of the vanilla flavoring) in each tablet. Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to small children is associated with a risk of serious side effects, including respiratory disorders (so-called "gasping syndrome").
Patients with liver or kidney disease should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Lactose monohydrate
Zentel contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
Orange yellow
Zentel contains orange yellow –a dye, as a component of Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA, which may cause allergic reactions.
Maltodextrin (contains glucose)
If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.
Sodium
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Zentel

Zentel should always be taken according to the doctor's recommendations.

• In case of doubts, the patient should consult a doctor or pharmacist.

If it is necessary to take more than one dose, it should be taken every day at the same time.

Dosage Pinworm, hookworm, roundworm, or whipworm infection

One 400 mg tablet, taken once.
Tapeworm or intestinal strongyloidosis infection
One 400 mg tablet per day, for three consecutive days.
If the patient has not been cured, the doctor may decide to repeat the treatment after three weeks.
If the patient feels that the effect of Zentel is too strong or too weak, they should consult a doctor.

Method of administration

Zentel can be taken with or without food.
Zentel tablets can be swallowed whole, with a glass of water. If the patient has difficulty swallowing whole tablets, they can be crushed, chewed, or sucked, with a small amount of water.
For children and patients who have difficulty swallowing tablets, it is possible to use the medicine in a different form (Zentel is also available as a suspension).
It is not necessary to take the medicine on an empty stomach or after bowel movements.

Overdose of Zentel

In case of taking a higher dose of the medicine than recommended, the patient should consult a doctor. If possible, they should show the packaging of the medicine.

Missed dose of Zentel

The patient should not take extra tablets or a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping Zentel treatment

The patient should not stop taking Zentel without their doctor's advice.

• In case of any further doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zentel can cause side effects, although not everybody gets them.
Uncommon side effects(may affect up to 1 in 100 people):

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

Rare side effects(may affect up to 1 in 1,000 people):

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

Rare side effects that may appear in blood tests:

• increased liver enzyme activity.

Very rare side effects(may affect less than 1 in 1,000 people):
severe skin reactions

• erythema multiforme, characterized by a rash that may be blistering and looks like small targets (dark spots in the center, surrounded by a lighter area with a dark ring around)
• Stevens-Johnson syndrome - a severe, widespread rash with blisters and peeling skin, occurring especially around the mouth, nose, eyes, and genitals.
• If the patient experiences any of the above symptoms, they should contact their doctor as soon as possible.

Other symptoms that may occur while taking Zentel

See section 2 of the leaflet (subsection If the patient experiences at least two of the following symptoms while taking Zentel).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zentel

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zentel contains

• The active substance of the medicine is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: lactose, microcrystalline cellulose, corn starch, sodium croscarmellose, povidone K 29/30, sodium lauryl sulfate, orange yellow (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E110), sodium saccharin, magnesium stearate, vanilla flavor (contains maltodextrin, benzyl alcohol, anise oil, and Peruvian balsam), passion fruit flavor, orange flavor.

What Zentel looks like and contents of the pack

Zentel tablets are pale orange, elongated, rounded, biconvex, with a dividing line on one side and the imprint "ALB 400" on the other side. They have a characteristic fruity smell.
Cardboard boxes containing 1, 60, or 100 tablets in blisters.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Romania, the country of export: 9938/2017/01
9938/2017/02
Parallel import authorization number: 173/23

Date of approval of the leaflet: 29.05.2024

[Information about the trademark]

7. Additional information on parasitic diseases

Parasitic infections occur as a result of consuming water or food containing parasite eggs or larvae, which then develop in the intestines. Since the disease may not cause any symptoms in the early stages, the infected person may not be aware of the infection.
Symptoms of the disease depend on the type of worm. Abdominal pain, nausea, diarrhea, anemia, and fatigue may occur. Some parasitic infections can cause symptoms related to other parts of the body, such as the liver, lungs, or brain.
Treating infections limited to the intestines is usually easy. Since some worms can migrate to other parts of the body, it is essential to start treatment as soon as possible. This can prevent the development of the disease and permanent damage. Some untreated parasitic infections can be life-threatening.
Protection against worm infections is necessary.
It is crucial to take actions to prevent re-infections, infecting others, and re-infecting oneself while taking Zentel.

• Hands should be washed with soap and water after using the toilet, contacting animals, and before each meal.
• It should be ensured that meat intended for consumption has been prepared at a sufficiently high temperature, and fruits and vegetables have been washed in clean water before eating.