Zentel

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Zentel

400 mg, chewable tablets

Albendazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 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 works on parasites (worms) and their larvae, preventing them from absorbing sugars (glucose), which causes them to lose energy and die. It also works on the eggs of parasites. Zentel is used to treat diseases caused by parasites (worms), such as: human pinworm infection (enterobiasis); hookworm infection (ancylostomiasis); American hookworm infection (necatoriasis); intestinal strongyloidiasis; human roundworm infection (ascariasis); human whipworm infection (trichuriasis); tapeworm infection (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 is 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).

Inform your doctor if you have any of the above conditions.

Warnings and precautions

Before taking Zentel, discuss with your doctor:

• if you are breastfeeding (see Pregnancy and breastfeeding),
• if you have kidney or liver problems,
• if you are elderly. Inform your doctor if you have any of the above conditions.

If you experience at least two of the following symptoms while taking Zentel:

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances, you should contact your doctor 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 called neurocysticercosis may occur. The patient may not know they have this infection, and taking Zentel may reveal it.

Zentel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Some medicines may affect the action of Zentel or increase the risk of side effects. These 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 you are taking or have recently taken any of these medicines, inform your doctor.

Taking Zentel with food and drink

Zentel can be taken with or without food, with a glass of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant or think you may be pregnant, do not take Zentel. Zentel may harm the unborn baby. 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 during early pregnancy. Breastfeeding women should not take Zentel unless the potential benefits outweigh the risks. Breastfeeding women should contact their doctor before taking Zentel, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Driving and using machines

Zentel may cause dizziness. If you experience dizziness, do not drive or operate machinery.

What Zentel contains

Benzyl alcohol Zentel contains benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions. Administration of benzyl alcohol to small children is associated with a risk of serious side effects, including respiratory distress (gasping syndrome). Patients with liver or kidney disease should contact their doctor before taking Zentel, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis). Lactose monohydrate Zentel contains lactose monohydrate, a sugar. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking Zentel. Orange yellow S Zentel contains orange yellow S, which may cause allergic reactions. Maltodextrin (contains glucose) If you have been diagnosed with intolerance to some sugars, contact your doctor before taking Zentel. Sodium Zentel contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Zentel

Always take Zentel exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist. If more than one dose is required, take it at the same time every day.

Dosage Pinworm, hookworm, roundworm, or whipworm infection

One 400 mg tablet, taken once. Tapeworm or intestinal strongyloidiasis infectionOne 400 mg tablet per day, for three consecutive days. If the patient is not 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, contact your doctor.

Method of administration

Zentel can be taken with or without food. Zentel tablets can be swallowed whole, with a glass of water. If you have difficulty swallowing whole tablets, they can be crushed, chewed, or crushed, with a small amount of water. For children and patients with 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.

Overdose

If you have taken more than the recommended dose of Zentel, contact your doctor. If possible, show the doctor the packaging of the medicine.

Missed dose

Do not take extra tablets or a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping treatment

Do not stop taking Zentel without consulting your doctor. If you have any further questions about taking Zentel, ask your 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 targets (dark spots in the center, surrounded by a pale area with a dark ring around it)
• Stevens-Johnson syndrome - a severe, widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals. If you experience any of these symptoms, contact your doctor immediately.

Other side effects that may occur while taking Zentel

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. 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.: +48 22 49-21-301 Fax: +48 22 49-21-309 Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zentel

Keep the medicine out of the 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 stated. There are no special storage precautions. Medicines should 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 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 monohydrate, microcrystalline cellulose, corn starch, sodium croscarmellose, povidone K 30, sodium lauryl sulfate, orange yellow S, 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, and biconvex, with a score line on one side and the imprint "ALB 400" on the other. They have a characteristic fruity odor. Cardboard boxes containing blisters of 1, 60, or 100 tablets. For more information, contact the marketing authorization holder or the 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:

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

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Marketing authorization number in Bulgaria, the country of export: 20110176 Parallel import authorization number: 205/25 Date of leaflet approval: 13.06.2025

[Information about the trademark]

7. Additional information on parasitic diseases

Parasitic infections occur when parasites or their eggs are ingested through contaminated food or water. Since the early stages of the disease may not cause symptoms, the infected person may not be aware of the infection. The symptoms of the disease depend on the type of parasite. Abdominal pain, nausea, diarrhea, anemia, and fatigue may occur. Some parasitic infections can cause symptoms in other parts of the body, such as the liver, lungs, or brain. Treatment of intestinal infections is usually easy. Since some parasites can migrate to other parts of the body, it is essential to start treatment as soon as possible to prevent the development of the disease and permanent damage. Some untreated parasitic infections can be life-threatening. Protect yourself from parasitic infections.It is crucial to take measures to prevent reinfection, infecting others, and re-infecting yourself while taking Zentel. Wash your hands with soap and water after using the toilet, contacting animals, and before each meal. Ensure that meat is cooked at a sufficiently high temperature, and fruits and vegetables are washed in clean water before eating.