Zentel

Caution! Keep the leaflet! Information on the immediate packaging in a foreign language.
Zentel
400 mg/20 ml, oral suspension
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 give it to others. This medicine may harm someone else, even if their symptoms are similar.
• If any adverse reactions occur in the patient, 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 on parasitic diseases

1. What Zentel is and what it is used for

Zentel contains albendazole – an active substance with antihelminthic (antiparasitic) properties.
Albendazole acts on parasites (worms) and their larvae by preventing them from absorbing sugars (glucose), causing them to lose energy and die. It also acts on parasite eggs.
Zentel is a medicine used in the treatment of diseases caused by parasites (worms), such as:

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

Inform your doctor if any of the above apply to you.

Warnings and precautions
Before taking 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.

Inform your doctor if any of the above apply to you. If, during treatment with Zentel, at least two of the following symptoms occur:

• headache (which may be severe),
• seizures,
• nausea,
• vomiting,
• visual disturbances,

seek immediate medical advice. These symptoms may result from the death of parasites located 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 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, she should inform her 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 to become pregnant, 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, Zentel should be administered during the first 7 days of the menstrual cycle or only after a negative pregnancy test result, in order to avoid inadvertent use of Zentel in early pregnancy.
Breastfeeding women should not use Zentel unless the potential benefits outweigh the risks associated with treatment.
Breastfeeding women 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).

Driving and operating machinery
Zentel may cause dizziness. If dizziness occurs, do not drive or operate machinery.

Zentel contains:

Benzyl alcohol (vanilla flavouring component)
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 small children is associated with a risk of severe adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Patients with liver or kidney disease should consult their doctor before using this medicine, as high levels of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

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

Glycerol
This medicine may cause headache, gastrointestinal disturbances, and diarrhoea.

Benzoic acid
Zentel contains 46 mg of benzoic acid in each 20 ml of oral suspension. Benzoic acid may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

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 use Zentel

Zentel should always be used exactly as directed by the doctor.

• If in doubt, 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, hookworm, roundworm, or whipworm
Adults and children over 2 years of age: a single dose of 20 ml of suspension.

Infection with tapeworm or Hymenolepis nana (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.

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’s packaging.

Missing a 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 Zentel treatment

Do not stop taking Zentel without consulting your doctor.

• If you have any further doubts about using 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 symptoms (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, characterized by 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 peeling skin, particularly affecting the area around the mouth, nose, eyes and genital organs.

If any of the above symptoms occur in a patient, medical advice should be sought 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 not listed in this leaflet, they should be reported to your 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
Adverse reactions can also be reported to the Marketing Authorisation Holder or a parallel importer.
Reporting adverse reactions helps to provide more information on the safety of this 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 pack and other information

What Zentel contains

• The active substance is albendazole. 20 ml of suspension contains 400 mg of albendazole.
• The other ingredients are: magnesium aluminium silicate, sodium carboxymethylcellulose, glycerol, polysorbate 80, monolaurin sorbitan, potassium sorbate, benzoic acid (E 210), ascorbic acid, antifoaming emulsion 1510, sodium saccharin (E 954), orange flavour, vanilla flavour (contains propylene glycol and benzyl alcohol), passionflower flavour, 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 marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Perrigo Portugal, Lda.
World Trade Center Lisboa
Av. Vítor Figueiredo, no 4-J, piso 1B
2790-255 Carnaxide
Portugal

Manufacturer:
Farmaclair
440 Avenue du General de Gaulle
14200 Hérouville Saint Clair
France

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. k.
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation Number in Portugal, country of export: 8644906
Parallel Import Licence Number: 387/25

ADDITIONAL INFORMATION ON PARASITIC DISEASES
Parasitic infections occur 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, diarrhoea, anaemia, and fatigue may occur. Some parasitic infections may cause symptoms affecting other parts of the body, such as the liver, lungs, or brain.
Intestinal-limited infections are usually easy to treat. However, since some worms 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.
Protect yourself from 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 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 is cooked at sufficiently high temperatures, and wash fruits and vegetables thoroughly with clean water before eating.