Zentel

Warning! Keep the leaflet. Information on the immediate packaging is 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 share it with others. This medicine may harm others, even if their symptoms are similar. → If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse.

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 (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 (hookworm infection, 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 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). → You must inform your doctor if any of the above apply to you.

Warnings and precautions
Before taking Zentel, discuss 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 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 individuals being treated for parasitic infections may also have a rare but serious infection of the brain caused by tapeworms—so-called 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 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 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 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.
If a woman is pregnant or suspects she may be pregnant, Zentel must not be used. Zentel may harm the unborn child.
In women of childbearing age, it is recommended to take Zentel within 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 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, the patient should not drive or operate machinery.
Zentel contains:
Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of vanilla flavor) 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 using Zentel, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Lactose monohydrate
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.
Orange yellow (E 110) as a coating pigment
Zentel contains orange yellow (E 110), a dye 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 a doctor or pharmacist.
If more than one dose is required, it should be taken daily at the same time.

Dosage
Infection with pinworms, whipworm, roundworm, or hookworm
One 400 mg tablet as a single dose.

Infection with tapeworm or beef 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 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 Zentel on an empty stomach or after bowel cleansing.

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

Missed dose of Zentel
Do not take additional tablets or a double dose to make up for a missed dose. Take the next dose at the usual time.

Stopping Zentel treatment
Do not discontinue treatment with Zentel without medical advice.
→ 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 they do not occur in everyone.
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 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 resembles bullseye targets (dark spots in the center, surrounded by a paler area with a dark ring around it),
• Stevens-Johnson syndrome – severe widespread rash with blisters and skin peeling, particularly affecting the area around the mouth, nose, eyes and genital organs. → If any of the above symptoms occur, contact a doctor immediately.

Other symptoms which 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 your 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
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 this medicine.

5. HOW TO STORE ZENTEL MEDICINE

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 you no longer use. 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.
• Other ingredients are: monohydrate lactose, microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, sodium lauryl sulfate, sunset yellow FCF as a lake (E 110), sodium saccharin, magnesium stearate, vanilla flavour (containing benzyl alcohol, anise alcohol and Peru balsam), passionflower flavour, orange flavour.

What Zentel looks like and contents of the pack
Zentel tablets are pale orange, elongated, rounded, biconvex tablets, 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 one aluminium/PVdC/PVC blister with 1 tablet.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Italy, the country of export:
Laboratoire GlaxoSmithKline
23, Rue François Jacob
92500 Rueil-Malmaison
France
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
Italian Marketing Authorisation Number in the country of export: 027096066
Parallel Import Licence Number: 226/25

7. ADDITIONAL INFORMATION ABOUT PARASITIC INFECTIONS

Infection with parasites occurs as a result of consuming 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 parasite. 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 parasites can migrate to other parts of the body, it is important to start treatment as quickly as possible. This helps prevent disease progression and permanent damage. Some untreated parasitic infections may be life-threatening.
You should protect yourself against parasitic infections.
It is very important to take preventive measures to avoid re-infection, spreading the 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.