ZENTEL

Warning! Keep the 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, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• 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 you experience any adverse effects, including any 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 the active substance albendazole, which has 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 in the treatment of diseases caused by parasitic worms (helminths), 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, cestodiasis).

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 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 starting treatment with 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 patients 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 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 during pregnancy or if pregnancy is suspected. Zentel may harm the unborn baby.
In women of childbearing potential, Zentel should be taken only 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 large 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 severe adverse effects, including respiratory disturbances (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 monohydrate
Zentel contains a sugar called lactose. If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Tartrazine (E102)
Zentel contains tartrazine, a 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 should always be taken exactly as directed by your doctor.
→ If you have any doubts, consult your doctor or pharmacist.
If more than a single dose is required, it should be taken at the same time each day.

Dosage

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

Infection with tapeworm or intestinal fluke
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 the tablets whole, they may be crushed, chewed, or chewed thoroughly, and taken with a small amount of water.
Alternatively, the medicine may be administered in another formulation (Zentel is also available as an oral suspension).
It is not necessary to take the medicine on an empty stomach or following bowel cleansing.

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

If you forget to take Zentel
Do not take a double dose or extra tablets to make up for a missed dose. Take the next dose at your usual time.

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

→ 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 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 reactions 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 resemble target lesions (dark spots in the centre, 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 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 be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
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: lactose monohydrate, microcrystalline cellulose, maize starch, sodium croscarmellose, povidone, sodium lauryl sulfate, orange yellow lake, 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, with a dividing line on one side and
imprinted "ALB 400" on the other side. They have a characteristic fruity odour.
Carton boxes contain blisters of 1, 60 or 100 tablets.
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Italy, the country of export: 027096041
Parallel import licence number: 88/26

7. Additional information on parasitic infections

Infection with parasites occurs as a result of ingesting 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 parasite. 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 infections limited to the intestines is usually straightforward. However, because certain parasites 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.
It is essential to protect against worm 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 is cooked to an adequately high temperature, and wash fruits and vegetables with clean water before eating.