Zentel

Patient Information Leaflet: User Information

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 give it 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. 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 parasite eggs. Zentel is a medicine 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 has been diagnosed with hypersensitivity 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 have any of the above conditions.

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 have any of the above conditions.

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

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances, they should see a 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 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, have recently taken, or 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 her doctor or pharmacist before taking this medicine. If the patient is pregnant or thinks she may be pregnant, taking Zentel is contraindicated. Zentel may harm the fetus. In women of childbearing age, it is recommended to take Zentel during the first 7 days of the menstrual period 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. 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.

What Zentel contains

Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of the vanilla flavoring) 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 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 been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Orange yellow S
Zentel contains orange yellow S, a dye that may cause allergic reactions. Maltodextrin (contains glucose)
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Sodium
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Zentel

Zentel should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist. If more than one dose is required, it should be taken at the same time every day.

Dosing Pinworm, hookworm, roundworm, or whipworm infection

One 400 mg tablet, taken once.
Tapeworm or intestinal strongyloidiasis infection
One 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 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, an alternative form of the medicine may be used (Zentel is also available as a suspension). It is not necessary to take the medicine on an empty stomach or after bowel evacuation.

Taking a higher dose of Zentel than recommended

If the patient has taken more than the recommended dose of Zentel, they should see a doctor. If possible, they should show the doctor the packaging of the medicine.

Missing a dose of Zentel

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

Stopping treatment with Zentel

The patient should not stop taking Zentel without consulting their doctor. If the patient has any further questions about taking the medicine, they 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 it)
• 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 see a 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 not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, more information can be collected 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 after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storing Zentel. 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 monohydrate, microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, sodium lauryl sulfate, orange yellow S lake, 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 inscription "ALB 400" on the other. They have a characteristic fruity smell. Cardboard boxes containing blisters of 1 or 100 tablets or plastic containers of 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Manufacturer

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. For more information, the patient should contact the representative of the marketing authorization holder: GSK Services Sp. z o.o., Warsaw Office, ul. Rzymowskiego 53, 02-697 Warsaw, Tel.: 22 576 9000. Date of last revision of the leaflet:January 2025

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 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. Treatment of 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, infection of others, and self-reinfection during treatment with Zentel. The patient should wash their hands with soap and water after using the toilet, contacting animals, and before each meal. The patient should ensure that meat intended for consumption has been prepared at a sufficiently high temperature and that fruits and vegetables have been washed in clean water before eating.