Zentel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Zentel
400 mg/20 ml (20 mg/ml), oral suspension
Albendazolum
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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents:

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 on parasitic diseases

1. What Zentel is and what it is used for

Zentel contains albendazole – an active substance with antihelminthic
(antiparasitic) action.
Albendazole acts against parasites (worms) and their larvae by preventing them from absorbing sugars (glucose), thereby depriving them of energy and causing their death. It also acts on 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 tapeworms (taeniasis).

For 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 is allergic 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).
• The patient must inform their doctor if any of the above conditions apply.

Warnings and precautions
Before starting treatment with Zentel, discuss the following 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.
• The patient must inform their doctor if any of the above conditions apply.

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, 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 the patient is currently taking, has recently taken, or 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.
Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult a doctor or pharmacist before using this medicine.

Zentel must not be used during pregnancy. Zentel may harm the unborn baby.
In women of childbearing potential, treatment with Zentel is recommended during the first 7 days of the menstrual cycle or after a negative pregnancy test to avoid using 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 significant amounts 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 (vanilla flavouring ingredient)
This medicine contains approximately 4 mg of benzyl alcohol in each 20 ml of oral suspension. 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 using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

Propylene glycol (vanilla flavouring ingredient)
This medicine contains approximately 8 mg of propylene glycol in each 20 ml of oral suspension.

Benzoic acid
Zentel contains 40 mg of benzoic acid in each 20 ml of oral suspension, which is a moderately irritating substance for skin, eyes, and mucous membranes.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium in each 20 ml of oral suspension, meaning the medicine is considered "sodium-free".

3. How to take Zentel

Zentel must always be taken exactly as directed by your doctor.

• If you have any doubts, 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, roundworms, hookworms or whipworms
Adults and children over 2 years of age: a single dose of 20 ml of suspension.
Infection with tapeworm or dwarf tapeworm
Adults and children over 2 years of age: 20 ml of suspension 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
Shake well before use.
Zentel may be taken with or without food.
It is not necessary to take the medicine on an empty stomach or after bowel cleansing.

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

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

Stopping treatment with Zentel
Do not stop taking Zentel without your doctor's advice.

• If you have any further doubts 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 experiences 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 symptoms (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 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 in the patient, 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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 the medicine.

5. How to store Zentel

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.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Zentel contains

• The active substance is albendazole. 20 ml of suspension contains 400 mg of albendazole.
• The other components are: magnesium aluminium silicate, sodium carboxymethylcellulose, glycerol, polysorbate 80, sorbitan monolaurate, potassium sorbate, benzoic acid, ascorbic acid, antifoaming emulsion 1510, sodium saccharin, orange flavour, vanilla flavour, fruit flavour with passionflower, purified water.

What Zentel looks like and contents of the pack
Zentel is a suspension.
The medicine is packed in a white HDPE bottle with an aluminium cap, placed in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible entity in Portugal, country of export:
Perrigo Portugal Lda.
Lagoas Park, Edificio 15 - 3° Piso
2740-262 Porto Salvo
Portugal
Manufacturer:
Farmaclair
440 Avenue du General de Gaulle
14200 Hérouville Saint Clair
France
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 Portugal, country of export: 8644906
Parallel import authorisation number: 221/20

7. ADDITIONAL INFORMATION ON PARASITIC INFECTIONS

Infection with parasites occurs as a result of ingesting 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, such as the liver, lungs, or brain.
Treatment of infections limited to the intestines is usually straightforward. However, since 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 yourself from parasite infection.
It is very important to take preventive measures to avoid re-infection, spreading 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.