Zentel

Warning! Keep the package leaflet! Information on the immediate packaging is in a foreign language.
Zentel (Zentel)
400 mg, chewable tablets
Albendazole
Zentel and Зентел are trade names of the same medicinal product written in Polish and Bulgarian, respectively.
Please read the leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 others, even if their symptoms are the same.
• If you experience any adverse reactions, including those 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. What you need to know 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, such as:

• infection with pinworm (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 is allergic 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 situations 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 situations 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 attention. These symptoms may result from 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 be unaware 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 planned for future use.
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 affective 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 if the patient is pregnant or suspects she may be pregnant. Zentel may harm 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, in order to avoid administration during early pregnancy.
Breastfeeding women should not use Zentel unless the potential benefits outweigh the risks associated with treatment.
Breastfeeding women should consult their doctor before using Zentel, as a large 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, the patient should not drive or operate machinery.

Zentel contains benzyl alcohol, lactose, azo dye FD&C Yellow No. 6 aluminum lake 20-24% FDA, and sodium

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 effects, including respiratory disturbances (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before taking this medicine, 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.

Azo dye FD&C Yellow No. 6 aluminum lake 20-24% FDA
Zentel contains the azo dye FD&C Yellow No. 6 aluminum lake 20-24% FDA, which may cause allergic reactions.

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 used as directed by the physician.

• If in doubt, consult a doctor or pharmacist.

If more than one dose is required, it should be taken daily at the same time.
Dosage
Infection with pinworms, hookworm, roundworm, or whipworm
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 physician may decide to repeat the treatment after three weeks.
If the effect of Zentel appears too strong or too weak, consult the physician.
Method of administration
Zentel may be taken with or without food.
Zentel tablets may be swallowed whole with water. If difficulty swallowing whole tablets occurs, they may be crushed, chewed, or chewed and taken with a small amount of water.
For children and patients who have difficulty swallowing tablets, the medicine may be administered in another form (Zentel is also available as an oral suspension).
It is not necessary to administer the medicine on an empty stomach or following bowel cleansing.
Overdose of Zentel
If an overdose is taken, consult a doctor immediately. If possible, show the medicine packaging to the doctor.
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.
Discontinuation of Zentel
Do not stop using Zentel without consulting your doctor.

• If you have any further doubts regarding 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, pruritus).

Rare adverse effects that may be observed in blood tests:

• increased liver enzyme activity.

Very rare adverse reactions (may occur in fewer 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 rash involving large areas of the body, 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 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 not listed in this leaflet, inform a doctor or pharmacist. 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.: 22 49 21 301, fax: 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.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, azo dye FD&C Yellow No. 6 aluminum lake 20-24% FDA, sodium saccharin, magnesium stearate, vanilla flavour and aroma composition (containing, among others, benzyl alcohol and propylene glycol), passionflower flavour and aroma composition, orange flavour and aroma composition.

What Zentel looks like and contents of the pack
Zentel tablets are pale orange, oblong, rounded, biconvex, with a score line on one side and the imprint “ALB 400” on the other side. They have a characteristic fruity odour.
The cardboard box contains one PVC/PVDC/Al blister pack with 1 chewable tablet.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Parallel Importer:
InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorisation Number in Bulgaria, the country of export: 20110176
Parallel Import Licence Number: 156/20

7. Additional information about parasitic diseases

Infection with parasites occurs as a result of consuming water or food contaminated with parasite eggs or larvae, which then develop in the intestines. Since in the early stage 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, for example the liver, lungs, or brain.
Treatment of infections limited to the intestines 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.
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 has been cooked to an appropriately high temperature, and wash fruits and vegetables with clean water before eating.