Zentel

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zentel, 400 mg, Chewable Tablets

Albendazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Zentel and what is it 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 is Zentel and what is it used for

Zentel contains albendazole, an active substance with anthelmintic (anti-parasitic) action.
Albendazole acts on parasites (worms) and their larvae, preventing them from absorbing sugars (glucose), which causes them to lose energy and die. It also acts on the eggs of parasites.
Zentel is a medicine used to treat diseases caused by parasites (worms), such as:

• infection with human pinworm (enterobiasis);
• infection with hookworm (ancylostomiasis);
• infection with American hookworm (necatoriasis);
• infection with roundworm (strongyloidiasis);
• infection with human roundworm (ascariasis);
• infection with whipworm (trichuriasis);
• infection with tapeworm (taeniasis).

For additional information about parasitic diseases, see section 7 of the leaflet.

2. Important information before taking Zentel

When not to take Zentel

• If the patient has been found to be hypersensitive to albendazole or any of the other ingredients of the medicine (listed in section 6).
• If the patient is pregnant or thinks she may be pregnant (see "Pregnancy and breastfeeding").
• The patient should inform their doctor if they are in any of the above situations.

Warnings and precautions

Before starting to take Zentel, the patient should discuss it with their doctor:

• if the patient is breastfeeding (see "Pregnancy and breastfeeding"),
• if the patient has kidney or liver function disorders,
• if the patient is elderly.
• The patient should inform their doctor if they are in any of the above situations.

If the patient experiences at least two of the following symptoms while taking Zentel:

• headache (which can be severe),
• seizures,
• nausea,
• vomiting,
• vision disturbances,
• the patient should immediately consult a doctor.These symptoms may be caused by the death of parasites in the brain. In some people being treated for parasitic infections, a rare but serious brain infection caused by tapeworms, called neurocysticercosis, may occur. The patient may not be aware that they have this infection, and taking Zentel may reveal it.

Zentel and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the action of Zentel or increase the risk of side effects. These medicines 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, they should inform their doctor.

Taking Zentel with food and drink

Zentel can be taken with or without food, with a glass of water.

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.

If the woman is pregnant or thinks she may be pregnant, taking Zentel is contraindicated. Zentel may cause harm to the fetus.
In women of childbearing age, it is recommended to take Zentel during the first 7 days of menstruation or after a negative pregnancy test. This is to avoid taking Zentel in early pregnancy.
Breastfeeding women should not take Zentel unless the potential benefits outweigh the risks associated with treatment.
Breastfeeding women should consult a doctor before taking Zentel, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (such as metabolic acidosis).

Driving and using machines

Zentel may cause dizziness. If dizziness occurs, the patient should not drive or operate machinery.

What Zentel contains

Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of the vanilla flavor) per tablet. Benzyl alcohol may cause allergic reactions.
Administering benzyl alcohol to small children is associated with a risk of serious side effects, including respiratory disorders (such as "gasping syndrome").
Patients with liver or kidney disease should consult a doctor before taking Zentel, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (such as metabolic acidosis).
Lactose monohydrate
Zentel contains a sugar called lactose monohydrate. If the patient has previously been found to have an intolerance to some sugars, they should consult a doctor before taking Zentel.
Orange yellow S (E 110)
Zentel contains orange yellow S - a dye that may cause allergic reactions.
Maltodextrin (contains glucose)
If the patient has previously been found to have an intolerance to some sugars, they should consult a doctor before taking Zentel.
Sodium
Zentel contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Zentel

Zentel should always be taken according to the doctor's recommendations.

• In case of doubts, the patient should consult a doctor or pharmacist.

If it is necessary to take more than one dose, it should be taken daily at the same time.

Dosage

Infection with pinworm, hookworm, roundworm, or whipworm

One 400 mg tablet, taken once.

Infection with tapeworm or roundworm

One 400 mg tablet per day, for three consecutive days.
If the patient has not been cured, the doctor may decide to repeat the treatment after three weeks.
If the patient feels that the effect of Zentel is too strong or too weak, they should consult a doctor.

Method of administration

Zentel can be taken with or without food.
The tablets can be swallowed whole, with a glass of water. If the patient has difficulty swallowing whole tablets, they can be crushed, chewed, or crushed, with a small amount of water.
For children and patients who have difficulty swallowing tablets, it is possible to use the medicine in a different form (Zentel is also available as a suspension).
It is not necessary to take the medicine on an empty stomach or after bowel movements.

Overdose

In case of taking a higher dose of Zentel than recommended, the patient should consult a doctor. If possible, they should show the packaging of the medicine.

Missed dose

The patient should not take extra tablets or a double dose to make up for a missed dose. They should take the next dose at the usual time.

Stopping treatment

The patient should not stop taking Zentel without consulting a doctor.

• In case of any further doubts about taking the medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zentel can cause side effects, although not everybody gets them.
Uncommon side effects(may affect up to 1 in 100 people):

• headache, dizziness,
• nausea, vomiting, abdominal pain, diarrhea.

Rare side effects(may affect up to 1 in 1,000 people):

• hypersensitivity reactions (e.g., rash, urticaria, itching).

Rare side effects that may appear in blood tests:

• increased liver enzyme activity.

Very rare side effects

(may affect less than 1 in 1,000 people):
severe skin reactions

• erythema multiforme, characterized by a rash that may be blistering and looks like small targets (dark spots in the center, surrounded by a lighter area with a dark ring around),
• Stevens-Johnson syndrome - a severe, widespread rash with blisters and peeling skin, occurring especially around the mouth, nose, eyes, and genitals.
• If the patient experiences any of the above symptoms, they should consult a doctor as soon as possible.

Other side effects that may occur while taking Zentel

See section 2 of the leaflet (subsection "If the patient experiences at least two of the following symptoms while taking Zentel").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects can help gather more information on the safety of the medicine.

5. How to store Zentel

The medicine should be stored 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 month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Zentel contains

• The active substance of Zentel is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, corn starch, sodium croscarmellose, povidone, sodium lauryl sulfate, orange yellow S (E 110), sodium saccharin, magnesium stearate, vanilla flavor (contains maltodextrin, benzyl alcohol, anise oil, and Peruvian balsam), passion fruit flavor, orange flavor.

What Zentel looks like and contents of the pack

Zentel tablets are pale orange, elongated, rounded, and biconvex, with a score line on one side and the inscription "ALB 400" on the other side. They have a characteristic fruity odor.
A cardboard box contains an aluminum/PVDC/PVC blister pack with 1 tablet, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Italy, the country of export:027096041

Parallel import authorization number: 368/24

Date of leaflet approval: 22.10.2024

[Information about the trademark]

7. Additional information about parasitic diseases

Parasitic infections occur when water or food containing parasite eggs or larvae is ingested, which then develop in the intestines. Since the disease may not cause any symptoms in the early stages, the infected person may not be aware of the infection.
The symptoms of the disease depend on the type of worm. Abdominal pain, nausea, diarrhea, anemia, and fatigue may occur. Some parasitic infections can cause symptoms related to other parts of the body, such as the liver, lungs, or brain.
Treating infections limited to the intestines is usually easy. Since some worms can migrate to other parts of the body, it is essential to start treatment as soon as possible. This can help prevent the development of the disease and permanent damage. Some untreated parasitic infections can be life-threatening.

Prevention of parasitic infections

It is crucial to take measures to prevent re-infection, infection of others, and self-reinfection while taking Zentel.
Hands should be washed with soap and water after using the toilet, contacting animals, and before each meal.
It should be ensured that meat intended for consumption has been prepared at a sufficiently high temperature, and fruits and vegetables have been washed in clean water before eating.