Zentel

PATIENT INFORMATION LEAFLET: USER INFORMATION

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

ZENTEL, 400 mg

chewable tablets
Albendazole

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

• The leaflet should be kept so that it can be read 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 inform 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 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:

• infection with human pinworm (enterobiasis);
• infection with hookworm (ancylostomiasis);
• infection with American hookworm (necatoriasis);
• infection with roundworm (toxocariasis);
• infection with human roundworm (ascariasis);
• infection with whipworm (trichuriasis);
• infection with tapeworm (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 an allergy to albendazole or any of the other ingredients of the medicine (listed in section 6).
• If the patient is pregnantor suspects that they may be pregnant (see "Pregnancy and breastfeeding"). →

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

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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 affected by the above circumstances.

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

• headache (which can 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 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 currently 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, with a glass of water.

Pregnancy and breastfeeding

→
If the patient is pregnant or breastfeeding, 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 that they are 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.
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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 (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

Lactose

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.

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 recommendations.
→
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 roundworm 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.
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, 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.

Taking a higher dose of Zentel than recommended

In case of taking a higher dose of Zentel than recommended, the patient should consult their doctor. If possible, they should show the doctor the packaging of the medicine.

Missing a dose of Zentel

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The patient should not take extra tablets 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 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, 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 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 any side effects not listed in the leaflet, they should inform their doctor, 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, 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.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
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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, orange yellow S, sodium saccharin (E 954), magnesium stearate, vanilla flavor, passion fruit flavor, orange flavor.

What Zentel looks like and what the pack contains

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

Marketing authorization holder in Portugal, the country of export:

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

Manufacturer:

Omega Pharma International
Venecoweg 26
9810 Nazareth
Belgium
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany

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: 8644815

Parallel import authorization number: 841/12 Date of approval of the leaflet: 18.11.2022

7. Additional information on parasitic diseases

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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.
Treating 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, 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.

[Information about the trademark]
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