Zentel

Patient Information Leaflet: User Information

Warning! Keep the leaflet! 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 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 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 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 taking Zentel

When not to take Zentel

• If the patient has been found to be allergic 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 are in any of the above situations.

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 in any of the above situations.

If during the use of Zentel at least two of the following symptoms occur:

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances,
• the patient should immediately consult a 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 (neurocysticercosis) may occur simultaneously. 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 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 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.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

If a woman is pregnant or thinks she may be pregnant, the use of 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 result. 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.
Breastfeeding women should consult a 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

Benzoic acid (E 210)
Zentel contains 2.3 mg of benzoic acid in each 1 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 per maximum recommended daily dose, which means that the medicine is considered "sodium-free".
Glycerol
The medicine may cause headache, stomach upset, and diarrhea.
Potassium
The medicine contains potassium. This information should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take Zentel

Zentel should always be taken according to the doctor's recommendations.

• In case of doubts, the patient should consult a 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

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

Overdose of Zentel

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

Missing a dose of Zentel

The patient should not take extra doses 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 a doctor.

• In case of any further doubts about taking the medicine, the patient should consult a 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, stomach 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 contact their doctor as soon as possible.

Other symptoms that may occur during treatment with Zentel

See section 2 of the leaflet (subsection "If during the use of Zentel at least two of the following symptoms occur").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
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.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
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 of the medicine are: aluminum magnesium silicate, sodium carmellose, glycerol, polysorbate 80, sorbitan monolaurate, potassium sorbate, benzoic acid (E 210), ascorbic acid, antifoam emulsion 1510, sodium saccharin (E 954), orange flavor, vanilla flavor, passion fruit flavor, purified water.

What Zentel looks like and what the pack contains

Zentel is an oral suspension.
The medicine is packaged in a white, opaque PVC bottle with an aluminum cap, with a capacity of 20 ml, 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
3º piso, 2740-262 Porto Salvo
Portugal

Manufacturer:

Farmaclair
440 Avenue du General de Gaulle
14200 Hérouville Saint Clair
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Portuguese marketing authorization number:8644906
Parallel import authorization number:262/13
Date of leaflet approval: 18.05.2023

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.
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 during treatment with 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.

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