Zentel

Warning! Keep the package leaflet! Information on the 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, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine 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 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 about parasitic diseases

1. What Zentel is and what it is used for

Zentel contains albendazole – an active substance with anthelmintic (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 is also effective against parasite eggs.
Zentel is a medicine used to treat diseases caused by parasitic worms, such as:

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

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 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 should 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 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 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, known as 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 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 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 a doctor or pharmacist before using this medicine.

Zentel must not be used if the patient is pregnant or suspects she may be pregnant. 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 period or after a negative pregnancy test to avoid administration of 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 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, do not drive or operate machinery.

Zentel contains:

Benzyl alcohol
Zentel contains 0.98 mg of benzyl alcohol (a component of the vanilla flavouring) in each tablet. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of serious adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before taking Zentel, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

Lactose monohydrate
Zentel contains a sugar called lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Orange-yellow lake
Zentel contains orange-yellow lake – a dye which may cause allergic reactions.

Maltodextrin (contains glucose)
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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 your doctor.

• If you have any doubts, contact 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 taken once.

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 you have difficulty swallowing whole tablets, 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 another 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.

Taking more Zentel than recommended
If you take more than the recommended dose of Zentel, contact your doctor immediately. If possible, show the doctor the medicine packaging.

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.

Stopping Zentel treatment
Do not stop taking Zentel without consulting your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may occur in 1 to 10 out of 1,000 patients):

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

Rare side effects (may occur in 1 to 10 out of 10,000 patients):

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

Rare side effects which may be observed in blood tests:

• increased liver enzyme activity.

Very rare side effects
(may occur in less than 1 out of 10,000 patients):
severe skin reactions

• erythema multiforme, characterized by a rash which may be blistering and appear as small target-like 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 experiences any of the above symptoms, medical advice should be sought 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 side effects

If any side effects occur, including any not listed in this leaflet, they should be reported to a doctor, pharmacist or nurse. Side effects can also be reported directly to the Department for 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, website: https://smz.ezdrowie.gov.pl .

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Zentel medicine

Keep this medicine out of the 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 are 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 pack and other information

What Zentel contains

• The active substance is albendazole. Each tablet contains 400 mg of albendazole.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, sodium lauryl sulfate, sunset yellow lake (E 110), sodium saccharin, magnesium stearate, vanilla flavour (containing maltodextrin, benzyl alcohol, anise alcohol and Peruvian balsam), passionflower flavour, orange flavour.

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
imprinted "ALB 400" on the other side. They have a characteristic fruity odour.
The cardboard box contains one aluminium/PVDC/PVC blister with 1 tablet, inside a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Italy, the country of export: 027096041
Parallel Import Licence Number: 368/24

7. Additional information about parasitic diseases

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 worm. Abdominal pain, nausea, diarrhea, anemia, and fatigue may occur. Some parasitic infections may 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 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.
You should protect yourself against worm infection.
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 your 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 appropriate high temperature, and wash fruits and vegetables in clean water before eating.