Zentel

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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
(antiparasitic) action.
Albendazole acts against parasites (worms) and their larvae by preventing them from absorbing sugars (glucose), causing 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 Enterobius vermicularis (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).

Additional information about parasitic diseases, see section 7 of the 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).
• The patient should inform their doctor if any of the above circumstances apply.

Warnings and precautions
Before starting treatment with Zentel, discuss with a doctor:

• if the patient is breastfeeding (see Pregnancy and breastfeeding),
• if the patient has impaired kidney or liver function,
• if the patient is elderly.
• The patient should inform their doctor if any of the above circumstances apply.

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 located in the brain. In some individuals being treated for parasitic infections, a rare but serious infection of the brain caused by tapeworms—so-called neurocysticercosis—may also be present. The patient may not be aware of this infection, and treatment with Zentel may unmask it.

Zentel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 to treat worm infections);
• dexamethasone (used to treat inflammatory and allergic conditions);
• ritonavir (used in the treatment of 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 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 have a child, she should consult a doctor or pharmacist before using this medicine.

Zentel must not be used if the patient is pregnant or suspects she may be pregnant. Zentel may harm the unborn baby.
In women of childbearing potential, it is recommended to take Zentel during the first 7 days of the menstrual period or only after a negative pregnancy test result. This is to avoid using Zentel during early pregnancy.
Breastfeeding women should not use Zentel unless the potential benefits outweigh the risks.
Breastfeeding women should consult their doctor before using Zentel, as a significant amount 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 carries a risk of serious adverse effects, including breathing disorders (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before using 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 (Orange Yellow S)
Zentel contains tartrazine (Orange Yellow S), 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 your doctor.

• If you have any doubts, consult your doctor or pharmacist.

If more than one dose is required, it should be taken daily at the same time.
Dosage
Infection with pinworms, hookworms, roundworms, or whipworms
One 400 mg tablet as a single dose.
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 the 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 can be taken with or without food.
Zentel tablets can 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.
For children and patients who have difficulty swallowing tablets, an alternative formulation of the medicine is available (Zentel is also available as an oral suspension).
It is not necessary to take the medicine on an empty stomach or after bowel cleansing.
Taking more Zentel than recommended
If you take more than the recommended dose, contact your doctor immediately. If possible, show the doctor the medicine package.
Missed dose of Zentel
Do not take extra tablets 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 without consulting 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 that 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, presenting as 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 the patient experiences any of the above symptoms, medical advice should be sought immediately.

Other symptoms that 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 also 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zentel

Keep this medicine 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 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 required. This will help protect the environment.

6. Contents of the packaging 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 flavouring composition, passionflower flavouring composition, orange flavouring composition.

What Zentel looks like and contents of the pack
Zentel tablets are pale orange, oblong, rounded, biconvex, with a dividing line on one side and
the imprint “ALB 400” on the other side. They have a characteristic fruity odour.
Cardboard boxes containing blisters with 1 tablet (1, 60 or 100 blisters).
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.
Lagoas Park, Edifício 15 - 3º Piso
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation Number in Portugal, country of export: 8644815
Parallel Import Licence Number: 340/19

7. Additional information about parasitic infections

Infection with parasites occurs through ingestion of water or food containing parasite eggs or larvae, which then develop in the intestines. Since in the early stages the disease may not cause any symptoms, an infected person may be unaware of the infection.
Symptoms 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 straightforward. However, since certain worms can 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 can be life-threatening.
You should protect yourself against worm infections.
It is very important to take preventive measures to avoid re-infection, spreading infection 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 to an adequately high temperature, and wash fruits and vegetables in clean water before eating.