Zentel

PATIENT INFORMATION LEAFLET: USER INFORMATION

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

ZENTEL, 400 mg

chewable tablets
Albendazole

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same. → If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, 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 threadworm (strongyloidiasis);
• infection with human roundworm (ascariasis);
• infection with human whipworm (trichuriasis);
• infection with tapeworm (taeniasis). For more 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 found to be allergic to albendazole or any of the other ingredients of the medicine (listed in section 6).
• If the patient is pregnantor suspects that she may be pregnant (see Pregnancy and breastfeeding). →

The doctor should be informed if the patient has any of the above conditions.

Warnings and precautions

Before starting to take Zentel, the doctor should be consulted:

• if the patient is breastfeeding (see Pregnancy and breastfeeding),
• if the patient has kidney or liver function disorders,
• if the patient is elderly.

→

The doctor should be informed if the patient has any of the above conditions.

If the patient experiences at least two of the following symptoms:

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances, → the doctor should be consulted immediately.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 that they have this infection, and taking Zentel may reveal it.

Zentel and other medicines

The doctor or pharmacist should be told about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans 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 anticonvulsant, sedative, and sleeping pill). →

If the patient is taking or has recently taken any of these medicines, the doctor should be informed.

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 her doctor or pharmacist before taking this medicine.
If a woman is pregnant or suspects that she is pregnant, Zentel should not be taken. Zentel may harm the fetus.
In women of childbearing age, it is recommended to take Zentel during the first 7 days of menstruation or after a negative pregnancy test. 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 their doctor before taking Zentel, 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 0.98 mg of benzyl alcohol (a component of the vanilla flavor) per 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 their doctor before taking Zentel, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Lactose

Zentel contains a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Zentel.

Yellow azo dye

Zentel contains the yellow azo dye, which may cause allergic reactions.

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 instructions.
→
In case of doubts, the doctor or pharmacist should be consulted.
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 threadworm 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 their 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, Zentel is also available in a suspension form.
It is not necessary to take the medicine on an empty stomach or after bowel preparation.

Taking a higher dose of Zentel than recommended

In case of taking a higher dose of Zentel than recommended, the doctor should be consulted. If possible, the packaging of the medicine should be shown.

Missing a dose of Zentel

No additional tablets or double dose should be taken to make up for a missed dose. The next dose should be taken at the usual time.

Stopping treatment with Zentel

Treatment with Zentel should not be stopped without the doctor's advice.
→
In case of any further doubts about taking the medicine, the doctor or pharmacist should be consulted.

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 consult their doctor as soon as possible.

Other symptoms that may occur during treatment with Zentel

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

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. HOW TO STORE ZENTEL

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Zentel contains

• The active substance of Zentel is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: lactose, microcrystalline cellulose, corn starch, sodium croscarmellose, povidone, sodium lauryl sulfate, yellow azo dye FD&C yellow no. 6 aluminum lake 20-24% FDA, sodium saccharin, magnesium stearate, vanilla flavor (contains benzyl alcohol and propylene glycol), passion fruit flavor, orange flavor.

What Zentel looks like and what the pack contains

Zentel tablets are pale orange, elongated, rounded, and biconvex, with a dividing line on one side and the inscription "ALB 400" on the other side. They have a characteristic fruity odor.
A cardboard box contains a blister pack of PVC/PVDC/Aluminum foil with 1 tablet.
For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in Bulgaria, the country of export:

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

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20110176

Parallel import authorization number: 260/15

Date of leaflet approval:08.05.2025

7. ADDITIONAL INFORMATION ON PARASITIC DISEASES

Parasitic infections occur when water or food containing parasite eggs or larvae is ingested, which then develop in the intestines. Since the disease may not cause any symptoms at an early stage, the infected person may not be aware of the infection.
The 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 intestinal infections 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 measures to prevent re-infection, infecting others, and re-infecting oneself during treatment with 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.

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