Zentel

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Zentel (Eskazole)
400 mg, chewable tablets
Albendazole
Zentel and Eskazole are different trade names of the same medicine.
Please read this leaflet carefully before using the 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Zentel is and what it is used for
2. Important information before using Zentel
3. How to use 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 Zentel is and what it is used for

Zentel contains albendazole – an active substance with antihelminthic (antiparasitic) properties. 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 parasitic worms (helminths), such as:

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

For additional information on 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 might be pregnant (see Pregnancy and breastfeeding). → The patient should inform her doctor if any of the above circumstances apply.

Warnings and precautions
Before taking 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 her 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 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—so-called neurocysticercosis. The patient may be unaware of this infection, and treatment with Zentel may unmask it.

Zentel with other medicines
Tell the doctor or pharmacist about all medicines currently or 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 disorder);
• phenobarbital (used as an anticonvulsant, sedative, and hypnotic). → If the patient is currently taking or has recently taken any of these medicines, she should inform her 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 might be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Zentel must not be used during pregnancy. Zentel may harm the unborn child.
In women of childbearing potential, it is recommended to take Zentel within the first 7 days of the menstrual cycle or only after a negative pregnancy test result, in order to avoid administering Zentel 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
Zentel contains benzyl alcohol (a component of the vanilla-flavored composition) in each tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to neonates and low-birth-weight infants is associated with a risk of serious adverse reactions, including respiratory disorders (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before taking Zentel, as high levels 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 been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

Tartrazine (FD&C Yellow No. 6)
Zentel contains tartrazine – a colouring agent, as part of Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA, which may cause allergic reactions.

Maltodextrin (contains glucose)
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her 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 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 as a single dose.

Infection with tapeworm or intestinal fluke
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 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 difficulty swallowing whole tablets occurs, 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, the medicine may be administered in an alternative form (Zentel is also available as an oral suspension).
It is not necessary to take the medicine on an empty stomach or after bowel cleansing.

Overdose of Zentel
In case of ingestion of more than the recommended dose of Zentel, consult a doctor immediately. If possible, show the medicine package to the doctor.

Missed dose of Zentel
Do not take extra tablets or a double 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 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 effects 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 centre, surrounded by a paler area with a dark ring around it)
• Stevens-Johnson syndrome – a severe widespread rash with blisters and peeling skin, particularly affecting the areas around the mouth, nose, eyes and genitals. → If the patient develops any of the above symptoms, 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 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 authorisation holder or parallel importer.

Reporting adverse reactions helps to provide more information on the safety of this 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 instructions apply.
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, corn starch, sodium croscarmellose, povidone K 29/30, sodium lauryl sulfate, sunset yellow FCF as a lake (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E 110), sodium saccharin, magnesium stearate, vanilla flavouring mixture (containing, among others, maltodextrin, benzyl alcohol, anise alcohol and Peru balsam), passionflower flavouring mixture, orange flavouring mixture.

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 box containing one blister with 1 tablet.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, the country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37
02-234 Warsaw 87-100 Toruń
Marketing authorisation number in Romania, the country of export: 9938/2017/01
9938/2017/02
Parallel import authorisation number: 293/23

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 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, diarrhoea, anaemia, 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 intestinal infections is usually straightforward. However, since some 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.
It is essential to protect against 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 has been cooked to an adequately high temperature, and wash fruits and vegetables with clean water before eating.