Zentel

Patient Information Leaflet: User Information

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

Zentel, 400 mg/20 ml, Oral Suspension

Albendazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have 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, 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 using Zentel
• 3. How to use 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 roundworm (strongyloidiasis);
• infection with human roundworm (ascariasis);
• infection with whipworm (trichuriasis);
• infection with tapeworm (taeniasis).

For additional information on parasitic diseases, see section 7 of the leaflet.

2. Important information before using Zentel

When not to use 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 pregnantor thinks she may be pregnant (see Pregnancy and breastfeeding). →

The patient should inform their doctor if they are affected by the above circumstances.

Warnings and precautions

Before starting to use 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 affected by the above circumstances.

If the patient experiences at least two of the following symptomsduring the use of Zentel:

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• visual 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, called neurocysticercosis, may occur at the same time. The patient may not be aware that they have this infection, and the use of 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.

Using Zentel with food and drink

Zentel can be taken with or without food.

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 using this medicine.
If a woman is pregnant or thinks she may be pregnant, the use of Zentel is contraindicated. Zentel may cause harm to 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 result. This is to avoid using Zentel in early pregnancy.
Women who are breastfeeding should not use Zentel unless the potential benefits outweigh the risks associated with treatment.
Women who are breastfeeding should consult their doctor before using 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.
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Zentel contains:

Benzonic acid
Zentel contains 46 mg of benzonic 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 use Zentel

Zentel should always be used as directed by the doctor.
→
If the patient has any doubts, they 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

Infection with pinworm, hookworm, roundworm, or whipworm

Adults and children over 2 years: 20 ml of suspension taken once.

Infection with tapeworm or roundworm

Adults and children over 2 years: 20 ml of suspension once a 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

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 preparation.

Using a higher dose of Zentel than recommended

If the patient has taken a higher dose of Zentel than recommended, 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 the use of Zentel

The patient should not stop using Zentel without consulting their doctor.
→
If the patient has any further doubts about using 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):
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• 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 contact their doctor as soon as possible.

Other symptoms that may occur during the use of Zentel

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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.
Store in a temperature below 25°C.
Do not use this medicine 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 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: aluminum magnesium silicate, sodium carmellose, glycerol, polysorbate 80, sorbitan monolaurate, potassium sorbate, benzonic acid, ascorbic acid, antifoam emulsion 1510, sodium saccharin (E 954), orange flavor, vanilla flavor, passion fruit flavor, purified water.

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What Zentel looks like and what the pack contains

Zentel is an oral suspension.
Zentel is packaged in a white, opaque PVC bottle with a capacity of 20 ml, with an aluminum cap, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Portugal, the country of export:

Perrigo Portugal, Lda.
Lagoas Park, Edifício 15 – 3° Piso
2740-262 - Porto Salvo
Portugal

Manufacturer:

Farmaclair
440, Avenue du Général de Gaulle
F-14200 Hérouville Saint-Clair
France

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
Portuguese marketing authorization number: 8644906

Parallel import authorization number: 908/12 Date of approval of the leaflet: 20.12.2022

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.
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.

Prevention of parasitic infections is necessary.

It is crucial to take measures to prevent re-infection, infection of others, and self-reinfection during the use of 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.

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[Information about the trademark]
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