Zentel

Warning! Keep the package leaflet. Information on immediate packaging in a foreign language.
ZENTEL, 400 mg
chewable tablets
Albendazole
Please read the entire 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. It may harm someone else even if their symptoms are the same. → If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse immediately. 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 package 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 (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 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 tapeworms (tapeworm infection, 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 to 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 must inform your doctor if any of the above apply to you.

Warnings and precautions
Before taking Zentel, consult 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 must 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 patients being treated for parasitic infections may also have a rare but serious infection of the brain caused by tapeworms, known as 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 you are currently taking, have recently taken, or plan 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 you are taking or have recently taken any of these medicines, you must inform your doctor.

Taking Zentel with food and drink
Zentel may be taken with or without food, swallowed with water.

Pregnancy and breastfeeding
→ If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Zentel must not be used if you are pregnant or suspect you may be pregnant. Zentel may harm the unborn baby.
In women of childbearing age, 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 using Zentel during early pregnancy.
Breastfeeding women should not use Zentel unless the potential benefit outweighs the risk.
Breastfeeding women should consult their doctor before using Zentel, as significant amounts 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
Zentel contains 0.98 mg of benzyl alcohol (flavouring component with vanilla taste) in each tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of severe adverse reactions, including breathing disorders (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before using 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 you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Azo dye yellow
Zentel contains azo yellow dye, 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 must always be used exactly 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, hookworm, roundworm, or whipworm
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 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, followed by 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 administer the drug on an empty stomach or after bowel cleansing.

Overdose of Zentel
In case of taking more than the recommended dose, 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.

Interrupting treatment with 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 1000 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, 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 reaction involving large areas of skin with blisters and peeling skin, particularly affecting the area around the mouth, nose, eyes and genital organs. → If any of the above symptoms occur in a 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 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
Phone: +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 MEDICINE

Keep this medicine out of the sight and reach of children.
No special storage instructions are required.
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.
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, corn 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 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, elongated, rounded, biconvex, with a dividing line on one side and
"ALB 400" embossed on the other side. They have a characteristic fruity odour.
The cardboard box contains 1 tablet in a blister made of PVC/PVDC/Aluminum foil.
For further information, please contact the Marketing Authorisation Holder or 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Bulgaria, the country of export: 20110176
Parallel Import Licence Number: 260/15

7. ADDITIONAL INFORMATION ON PARASITIC INFECTIONS

Infection with parasites occurs through ingestion of water or food containing 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 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 may be life-threatening.
Protection against worm infection is essential.
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 to an adequately high temperature, and wash fruits and vegetables in clean water before eating.