Zentel

Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Zentel (Eskazole), 400 mg, chewable tablets
Albendazole
Zentel and Eskazole are different brand names of the same medicine.
Please read the leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If any adverse reactions occur in the patient, including any adverse reactions 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 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 Zentel is and what it is used for

Zentel contains albendazole – an active substance with anthelmintic
(antiparasitic) properties.
Albendazole acts on 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 (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).

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 may be pregnant (see "Pregnancy and breastfeeding").
• You should inform your doctor if any of the above apply to you.

Warnings and precautions
Before starting treatment with Zentel, discuss the following 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 located 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 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 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 anticonvulsant, sedative, and hypnotic).
• If the patient is 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 may 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 or if pregnancy is suspected. 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. 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 this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

Driving and using machines
Zentel may cause dizziness. If dizziness occurs, do not drive or operate machinery.

Zentel contains benzyl alcohol, lactose, sunset yellow FCF in lake form (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E 110), maltodextrin, and sodium

Benzyl alcohol
Zentel contains benzyl alcohol (a component of the vanilla flavouring). Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to newborns and 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 a large amount 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, she should consult her doctor before taking this medicine.

Sunset yellow FCF in lake form (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E 110)
Zentel contains sunset yellow FCF in lake form (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E 110), which may cause allergic reactions.

Maltodextrin (contains glucose)
If the patient has previously been 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 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 intestinal threadworm
One 400 mg tablet once daily for three consecutive days.
If the patient has not been cured, the physician 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 whole tablets, they may be crushed, chewed, or chewed thoroughly, followed by 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 a suspension).
It is not necessary to take the medicine on an empty stomach or after bowel cleansing.

Use of a higher than recommended dose of Zentel
If you take more than the recommended dose, consult your doctor immediately. If possible, show the doctor the medicine packaging.

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 treatment with Zentel
Do not stop taking Zentel without your doctor's advice.

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

4. Possible adverse reactions

Like any medicine, 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 resembles 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 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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, 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. This will help protect the environment.

6. Contents of the package 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 K 29/30, sodium lauryl sulfate, orange yellow lake (Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA) (E 110), sodium saccharin, magnesium stearate, vanilla flavouring and aroma composition (containing, among others, maltodextrin, benzyl alcohol, anise alcohol and Peru balsam), passionflower flavouring and aroma composition, orange flavouring and aroma 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.
The cardboard box contains a blister with 1 chewable tablet.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Romania, country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
GlaxoSmithKline Trading Services Limited
12 Riverwalk, Citywest Business Campus
Dublin 24, Ireland
Parallel importer:
Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Czesky Tesin, Czech Republic
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Manufacturing site: Euceryn Pharmaceutical Laboratory COEL S.J. E.Z.M. Konstanty
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
Marketing Authorisation number in Romania, country of export: 9938/2017/01
Parallel import authorisation number: 235/20

7. Additional information about parasitic infections

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, 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 intestinal infections is usually straightforward. However, since certain 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.
It is essential to protect 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 adequately high temperature, and wash fruits and vegetables with clean water before eating.