Zentel

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Zentel
400 mg, chewable tablets
Albendazole
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

1. What Zentel is and what it is 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 Zentel is and what it is used for

Zentel contains albendazole – an active substance with anthelmintic (anti-parasitic) properties. Albendazole acts against parasites (worms) and their larvae by preventing them from absorbing sugars (glucose), causing them to lose energy and die. It is also effective against parasite eggs.
Zentel is a medicine used to treat diseases caused by parasitic worms (helminths), such as:

• Infection with Enterobius vermicularis (pinworm infection, enterobiasis);
• Infection with Ancylostoma duodenale (ancylostomiasis);
• Infection with Necator americanus (necatoriasis);
• Infection with Strongyloides stercoralis (strongyloidiasis);
• Infection with Ascaris lumbricoides (ascariasis);
• Infection with Trichuris trichiura (trichuriasis);
• Infection with tapeworm (taeniasis).

For additional information about parasitic diseases, see section 7 of this leaflet.

2. Important information before using Zentel

When not to use Zentel

• If the patient has a known allergy to albendazole or any of the other ingredients of the medicine (listed in section 6).
• If the patient is pregnant or suspects she may be pregnant (see Pregnancy and breastfeeding).
• You should inform your doctor if any of the above apply to you.

Warnings and precautions
Before taking Zentel, discuss with your doctor:

• if the patient is breastfeeding (see Pregnancy and breastfeeding),
• if the patient has impaired kidney or liver function,
• if the patient is elderly.
• You should inform your doctor if any of the above apply to you.

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

• headache (which may be severe),
• seizures,
• nausea,
• vomiting,
• visual disturbances,
• seek immediate medical advice. These symptoms may be caused by dying parasites in the brain. Some individuals being treated for parasitic infections may also have a rare but serious infection of the central nervous system caused by tapeworms, known as neurocysticercosis. The patient may not be aware of this infection, and treatment with Zentel may reveal it.

Zentel with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may affect the action of Zentel or increase the risk of adverse effects. These include:

• cimetidine (used in the treatment of stomach ulcers);
• praziquantel (used in the treatment of worm infections);
• dexamethasone (used in the treatment of inflammatory and allergic conditions);
• ritonavir (used in the treatment of HIV infection);
• phenytoin (used in the treatment of epilepsy);
• carbamazepine (used in the treatment of 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 may be taken with or without food, swallowed with water.
Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Zentel must not be used during pregnancy. Zentel may cause harm to the unborn baby.
In women of childbearing potential, Zentel should be taken only during the first 7 days of the menstrual cycle or after a negative pregnancy test result. This is to avoid administering Zentel during early pregnancy.
Breastfeeding women should not use Zentel unless the potential benefits outweigh the risks.
Breastfeeding women should consult their doctor before taking Zentel, as significant amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Driving and operating machinery
Zentel may cause dizziness. If dizziness occurs, do not drive or operate machinery.
Zentel contains:

Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of the vanilla flavouring) in each tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of serious adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before taking Zentel, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Lactose
Zentel contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tartrazine (in the form of a coating)
Zentel contains tartrazine, a dye which may cause allergic reactions.
Maltodextrin (contains glucose)
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Sodium
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Zentel

Zentel should always be taken exactly as directed by the doctor.

• If in doubt, consult your doctor or pharmacist.

If more than a single dose is required, it should be taken daily at the same time.

Dosage

Infection with pinworms, hookworms, roundworms, or whipworms
One 400 mg tablet taken once.

Infection with tapeworm or dwarf tapeworm
One 400 mg tablet once daily for three consecutive days.
If the patient has not been cured, the doctor may decide to repeat treatment after three weeks.

If you feel that the effect of Zentel is too strong or too weak, consult your doctor.

Method of administration

Zentel may be taken with or without food.
Zentel tablets may be swallowed whole with water. If you have difficulty swallowing the tablets whole, they may be crushed, chewed, or chewed thoroughly, and taken with a small amount of water.
Alternatively, the medicine may be administered in another form (Zentel is also available as a suspension).
It is not necessary to take the medicine on an empty stomach or following bowel cleansing.

Taking more Zentel than recommended

If you take more Zentel than recommended, consult your doctor immediately. If possible, show the medicine’s packaging.

Missed dose of Zentel

Do not take an extra tablet or double the dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Zentel treatment

Do not stop taking Zentel unless instructed by your doctor.

• If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):

• headache, dizziness
• nausea, vomiting, abdominal pain, diarrhoea.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):

• hypersensitivity reactions (e.g. rash, urticaria, itching).

Rare adverse reactions which may be observed in blood tests:

• increased liver enzyme activity.

Very rare adverse reactions (may occur in less than 1 out of 10,000 patients):
severe skin reactions

• erythema multiforme, characterized by a rash which may be blistering and resemble target lesions (dark spots in the center, surrounded by a paler area with a dark ring around it)

• Stevens-Johnson syndrome – a severe widespread rash with blisters and skin peeling, particularly affecting the area around the mouth, nose, eyes and genital organs.

• If any of the above symptoms occur in the patient, contact a doctor immediately.

Other symptoms which may occur during treatment with Zentel
See section 2 of the leaflet (subsection: If at least two of the following symptoms occur during treatment with Zentel).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder or the parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zentel

Keep this medicine out of the 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 stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Zentel contains

• The active substance is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: lactose, microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, sodium lauryl sulfate, orange yellow lake, sodium saccharin, magnesium stearate, vanilla flavour (containing propylene glycol and benzyl alcohol), passionflower flavour, orange flavour.

What Zentel looks like and contents of the pack
Zentel tablets are pale orange, oblong, rounded, biconvex tablets, with a score line on one side and
the imprint "ALB 400" on the other side. They have a characteristic fruity odour.
Carton boxes containing 1 tablet in a blister pack.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Portugal, country of export:
Perrigo Portugal, Lda.
World Trade Center Lisboa
Avenida Vitor Figueiredo No. 4 - J, Piso 1B
2790-255 - Carnaxide
Portugal

Manufacturer:
Omega Pharma Internacional
Venecoweg 26
9810 Nazareth
Belgium
Aspen Bad Oldesloe GmbH
Industriestrasse, 32-36
23843 Bad Oldesloe
Germany

Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing authorisation number in Portugal, country of export: 8644815
Parallel import authorisation number: 393/25

Additional information about parasitic diseases
Infection with parasites occurs through ingestion of water or food contaminated with parasite eggs or larvae, which then develop in the intestines. Since the disease may not cause any symptoms in the early stages, an infected person may be unaware of the infection.
Symptoms depend on the type of parasite. Abdominal pain, nausea, diarrhoea, anaemia, and fatigue may occur. Some parasitic infections may cause symptoms affecting other parts of the body, such as the liver, lungs, or brain.
Treatment of intestinal infections is usually straightforward. However, since some worms may migrate to other parts of the body, it is important to start treatment as soon as possible. This helps prevent disease progression and permanent damage. Some untreated parasitic infections may be life-threatening.

Protect yourself from worm infections.
It is very important to take preventive measures to avoid re-infection, transmission to others, and self-reinfection during treatment with Zentel.

• Wash hands thoroughly with soap and water after using the toilet, after contact with animals, and before every meal.
• Ensure that meat intended for consumption is cooked at sufficiently high temperatures, and wash fruits and vegetables in clean water before eating.