Zentel

Warning! Keep the package 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, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. 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 antihelminthic (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 also acts on parasite eggs.
Zentel is a medicine used to treat diseases caused by parasites (worms), 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 tapeworm (taeniasis).

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 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 with other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan 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 affective disorder);
• phenobarbital (used as an anticonvulsant, sedative, and hypnotic). If you are taking or have recently taken any of these medicines, you should inform your doctor.

Taking Zentel with food and drink
Zentel may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Zentel must not be used if you are pregnant or suspect you may be pregnant. Zentel may harm the unborn baby.
In women of childbearing potential, it is recommended to take Zentel within the first 7 days of the menstrual cycle or only after a negative pregnancy test, to avoid inadvertent use 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, do 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 severe adverse reactions, including respiratory distress (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 the 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 use Zentel

Zentel should always be used as directed by the physician.
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, hookworms, roundworm or whipworm
Adults and children over 2 years of age: a single dose of 20 ml of suspension.

Infection with tapeworm or intestinal threadworm
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.

Administration instructions
Shake well before use.
Zentel may be taken with or without food.
It is not necessary to administer the medicine on an empty stomach or following bowel cleansing.

Use of a higher than recommended dose of Zentel
If an overdose is taken, seek medical advice immediately. If possible, show the medicine package to the doctor.

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

Stopping Zentel treatment
Do not discontinue treatment with 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 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 reactions (e.g. rash, urticaria, pruritus).

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 the patient develops 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 adverse reactions
If any adverse reactions occur, including any 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, 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.
The expiry date refers to the last day of the specified month.
Store below 25°C. Keep in the original packaging to protect from light.
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 package 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 85%, polysorbate 80, sorbitan laurate, potassium sorbate, benzoic acid, ascorbic acid, antifoaming emulsion (containing simethicone) Q7-2587, sodium saccharin, orange flavour, vanilla flavour (contains benzyl alcohol, propylene glycol, anise alcohol and Peru balsam), passion fruit flavour, purified water.

What Zentel looks like and contents of the pack
Zentel is an oral suspension.
The medicine is packed in a white, opaque bottle (HDPE) with a polypropylene cap, containing 20 ml of oral suspension, in a cardboard box.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Slovakia, country of export:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Slovakia, country of export: 10/0173/85-C/S
Parallel Import Number: 386/25

7. Additional information about parasitic infections

Infection with parasites occurs as a result of consuming 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 worm. Abdominal pain, nausea, diarrhea, anemia, and fatigue may occur. Some parasitic infections can cause symptoms affecting other parts of the body, for example the liver, lungs, or brain.
Treatment of infections limited to the intestines is usually straightforward. However, since certain 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 can be life-threatening.
It is essential to protect yourself from worm infections.
It is very important to take preventive measures to avoid re-infection, transmission 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.