Zentel

Patient Information Leaflet: User Information

Zentel, 400 mg/20 ml, Oral Suspension

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 those not listed in this leaflet, they should inform 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 parasite eggs.
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 diagnosed with hypersensitivity to albendazole or any other component of the medicine (listed in section 6).
• If the patient is pregnant or suspects they may be pregnant (see Pregnancy and breastfeeding). ➔ The patient should inform their doctor if they are pregnant or suspect they may be pregnant.

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 during treatment with Zentel:

• severe headaches,
• 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: neurocysticercosis. The patient may not be aware that 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 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.

Pregnancy and breastfeeding

➔ If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
If the patient is pregnant or suspects they may be pregnant, they should not take Zentel. Zentel may harm the fetus.
In women of childbearing age, it is recommended to take Zentel during the first 7 days of the menstrual cycle 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 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 (such as metabolic acidosis).

Driving and using machines

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

What Zentel contains

Zentel contains benzyl alcohol (a component of the vanilla flavor)
This medicine contains about 4 mg of benzyl alcohol in each 20 ml of oral suspension. Benzyl alcohol may cause allergic reactions.
Administration of 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 (such as metabolic acidosis).
Propylene glycol (a component of the vanilla flavor)
This medicine contains about 8 mg of propylene glycol in each 20 ml of oral suspension.
Benzoic acid
Zentel contains 40 mg of benzoic acid in each 20 ml of oral suspension, which is a moderate skin, eye, and mucous membrane irritant.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium in each 20 ml of oral suspension, which means that the medicine is considered "sodium-free".

3. How to take Zentel

Zentel should always be taken as directed by the doctor.
➔ If the patient has any doubts, they should consult their doctor or pharmacist.
If more than one dose is required, it should be taken daily at the same time.

Dosage Pinworm, hookworm, roundworm, or whipworm infection

Adults and children over 2 years: 20 ml of suspension taken once.
Tapeworm or threadworm infection
Adults and children over 2 years: 20 ml of suspension taken once daily 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

Shake before use.
Zentel can be taken with or without food.
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 consult their 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 doubts about taking Zentel, 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 be seen 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, especially around the mouth, nose, eyes, and genitals. ➔ If the patient experiences any of these symptoms, they should consult their doctor immediately.

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 during treatment with Zentel).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or their representative.
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 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.
The batch number is indicated by "Lot".
Store in a temperature not exceeding 25°C. Protect from light.
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. 20 ml of suspension contains 400 mg of albendazole.
• The other ingredients are: magnesium-aluminum silicate, sodium carboxymethylcellulose, glycerol, polysorbate 80, sorbitan monolaurate, potassium sorbate, benzoic acid, sorbic acid, antifoam emulsion Q7-2587, sodium saccharin, orange flavor, vanilla flavor (contains benzyl alcohol, anise oil, and Peruvian balsam), passion fruit flavor, purified water.

What Zentel looks like and contents of the pack

Zentel is an oral suspension.
Zentel is packaged in a high-density polyethylene (HDPE) bottle with a polypropylene (PP) cap with a tamper-evident ring, containing 20 ml of oral suspension, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Phone: 0 22 576 9000
Date of last revision of the leaflet:January 2025

7. ADDITIONAL INFORMATION ABOUT 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 in the early stages, 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 affecting 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 to 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.
Hands should be washed with soap and water after using the toilet, contact with 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.