Zentel

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zentel (Зентел)

400 mg, chewable tablets
Albendazole
Zentel and Зентел are the same trade names for the same medicine written in Polish and Bulgarian.

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 necessary.
• In case of 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. 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 about parasitic diseases

1. What is Zentel and what is it used for

Zentel contains albendazole, an active substance with anthelmintic (anti-parasitic) 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 additional information about 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 hypersensitive 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 may be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances,
• The patient should immediately consult their 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 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 can be taken with or without food, washed down with 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 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. 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 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.

Zentel contains benzyl alcohol, lactose, azo dye FD&C yellow no. 6 aluminum lake 20-24% FDA, and sodium

Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of the vanilla flavor) in each tablet. Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to small children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their 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
Zentel contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Azo dye FD&C yellow no. 6 aluminum lake 20-24% FDA
Zentel contains the azo dye FD&C yellow no. 6 aluminum lake 20-24% FDA, 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 patient should consult their doctor or pharmacist.

If it is necessary to take more than one dose, it should be taken daily 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.
The tablets can be swallowed whole, washed down with water. If the patient has difficulty swallowing whole tablets, they can be crushed, chewed, or sucked, washed down 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 preparation.

Overdose of Zentel

In case of overdose, the patient should consult their doctor. If possible, they should show the doctor the packaging of the medicine.

Missed dose of Zentel

The patient should not take an additional tablet or 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 their 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, 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. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl .
By reporting side effects, it is possible to 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.
Do not use this medicine after the expiry date stated on the packaging. 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 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, 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 contents of the pack

Zentel tablets are pale orange, elongated, rounded, and biconvex, with a score line on one side and the inscription "ALB 400" on the other. They have a characteristic fruity smell.
A cardboard box contains a PVC/PVDC/Al blister pack with 1 chewable tablet.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20110176
Parallel import authorization number: 156/20

Date of leaflet approval: 25.06.2025

7. Additional information about 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 at an early stage, 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 intestinal infections is usually easy. Since some worms can penetrate 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 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.

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