Consumer medicine information

Zentel tablets

Albendazole

BRAND INFORMATION

Brand name

Zentel

Active ingredient

Albendazole

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zentel tablets.

WHAT IS IN THIS LEAFLET

This leaflet answers some of the common questions about ZENTEL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the possible risks of taking ZENTEL against the expected benefits.

If you have any concerns about taking this medicine talk to your doctor or pharmacist.

Keep this leaflet with this medicine. You may need to read it again.

WHAT ZENTEL IS USED FOR

ZENTEL contains albendazole as the active ingredient.

ZENTEL is used to clear worms or parasites from the gut and other tissues. ZENTEL is effective against threadworm or pinworm, roundworm, whipworm, tapeworm and hookworm among others.

ZENTEL is thought to kill these worms by causing them to starve. The eggs, larvae and adult worms are affected.

Your doctor may have prescribed ZENTEL for another reason. Ask your doctor if you have any questions about why ZENTEL has been prescribed for you.

There is no evidence that ZENTEL is addictive.

BEFORE TAKING IT

Do not take ZENTEL if:

  • you have had an allergic reaction to albendazole or any of the other ingredients contained in this medicine. Albendazole is also contained in Eskazole. The ingredients are listed at the end of this leaflet. Signs of an allergic reaction may include an itchy skin rash, shortness of breath and swelling of the face or tongue.
  • if you have taken albendazole before and became unwell, tell your doctor or pharmacist before taking the first dose.
  • you are allergic to medicines similar to albendazole such as mebendazole (Sqworm, Vermox) or thiabendazole (Mintezol).
  • YOU KNOW OR SUSPECT YOU ARE PREGNANT.
    Pregnancy must be avoided (ie use effective contraceptive measures) during treatment, and for one month after stopping ZENTEL.
    In order to avoid taking ZENTEL during early pregnancy, treatment with ZENTEL should only be started during the first week of having your period or after a negative pregnancy test.
  • you are breast feeding.
    Your baby can absorb albendazole from breast milk if you are breast feeding. Breast feeding should be stopped while taking ZENTEL, and for at least 5 days after finishing treatment.
  • the expiry date printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

ZENTEL is not recommended for children under 2 years of age.

Do not give this medicine to anyone else; your doctor has prescribed it specifically for you and your condition.

Before you start taking ZENTEL tell your doctor if:

  • you are or think you may be pregnant or if you intend to become pregnant.
    Pregnancy must be avoided (ie use effective contraceptive measures) during treatment, and for one month after stopping ZENTEL. In order to avoid taking ZENTEL during early pregnancy, treatment with ZENTEL should only be started during the first week of having your period or after a negative pregnancy test.
  • you are breast feeding.
    Breast feeding should be stopped while taking ZENTEL, and for at least 5 days after finishing treatment.
  • you have any liver problems.

Taking other medicines with ZENTEL:

The effects of some medicines may be affected if other medicines are used at the same time. You should therefore tell your doctor if you use other medicines regularly, have used other medicines until recently or wish to use other medicines at the same time as ZENTEL. This includes those medicines that you buy without a prescription. Your doctor will be able to tell you if any problems could occur when taking ZENTEL with other medicines.

HOW TO TAKE IT

Follow your doctors' instructions about how and when to use ZENTEL. Read the direction label carefully. If you have any concerns about how to take this medicine talk to your doctor or pharmacist.

How much to take

Your doctor will advise how many doses are needed each day, and for how long you will need to take ZENTEL. The usual dose for adults and children older than 2 years of age, is two ZENTEL tablets as a single dose.

For other conditions the dose prescribed by your doctor may be different. You should take the full course of tablets, and not just stop when you feel better.

Your doctor may need to see you two to four weeks after taking the dose or course. This is to make sure that ZENTEL has worked. A second dose or course of ZENTEL is sometimes needed.

How to take

You will be told whether to take the tablets with food or on an empty stomach, and it is important you follow these instructions. ZENTEL tablets are usually taken on an empty stomach. In some conditions the tablets may need to be taken after food.

ZENTEL tablets may be taken crushed or chewed or swallowed whole. No special laxative or fasting is needed.

If you forget to take

Take the missed tablets as soon as you remember. If you have been prescribed more than a single dose, do not try to make up for missed doses by taking more than two tablets at a time.

Taking more than the prescribed dose can increase the chance of unwanted side effects.

OVERDOSE

Immediately telephone your doctor or Poisons Information Centre (In Australia telephone 131126. In New Zealand telephone 0800 POISON) or go to the emergency department at your nearest hospital if you or anyone else has taken a large amount of ZENTEL. Do this even if there are no signs of discomfort or poisoning. Be sure to show the doctor the ZENTEL packet. There are unlikely to be any serious problems following an overdose of ZENTEL.

WHILE YOU ARE TAKING IT

Things you must do:

Take ZENTEL exactly as your doctor has prescribed.

Tell your doctor if you become pregnant while taking ZENTEL.

Tell your doctor or pharmacist you are taking ZENTEL, before starting any other medicines.

Some medicines may affect the way other medicines work.

You may require monitoring of your liver function or white blood cell counts. Patients with liver disease may be monitored more closely.

If you are having a blood test done, tell your doctor you are taking ZENTEL.

Keep any follow up appointments with your doctor. It may be necessary to check that ZENTEL has worked. A second dose or course of ZENTEL is sometimes needed.

Things to be careful of:

Be careful driving or operating machinery until you know how you react to ZENTEL.

ZENTEL may cause dizziness in some people.

SIDE EFFECTS

Besides their main effect, medicines may have some unwanted effects. Unwanted effects do not always occur in every person.

Most unwanted effects following ZENTEL are mild, and may disappear without stopping ZENTEL. However, some side effects may need medical treatment.

Tell the doctor about any effect which is troublesome or ongoing.

Mild Effects

Tell your doctor if you notice any of the following that are troublesome or ongoing:

  • headache or dizziness
  • vomiting or feeling sick, stomach pains or diarrhoea
  • mild skin rash or itchiness

More Serious Effects

Tell your doctor immediately if you notice any of the following:

  • fever
  • bone pain
  • headache
  • tiredness, shortness of breath, looking pale.
  • frequent infections
  • unusual bleeding or bruising.
  • yellowing of the skin and eyes, also called jaundice, dark coloured urine and/or light coloured stools.
  • infections of the throat, mouth, skin or nasal passage.
  • Seizures
  • Blurred or abnormal vision
  • Unusual behaviour
  • Unusual numbness or weakness
  • Unusual taste, smell or hearing

Stop taking ZENTEL and contact a doctor immediately or go to the emergency department of your nearest hospital if any of the following happens:

  • swelling of limbs, face, mouth or throat
  • shortness of breath or breathing difficulties
  • hives or severe skin reactions

These are signs of a severe allergic reaction to ZENTEL. Allergy to ZENTEL is rare.

You should tell the doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur during or after treatment with ZENTEL.

Other side effects not listed above may also occur in some people.

AFTER TAKING IT

Storage

Keep your tablets in the original pack until it is time to take them.

Keep the pack in a cool dry place. Store below 30°C.

Do not leave it in the car on a hot day. Do not store medicine in the bathroom or near a sink.

Heat and dampness can destroy some medicines.

Keep all medicines out of the reach of children, such as in a locked cupboard.

If your doctor tells you to stop taking ZENTEL ask your pharmacist what to do with any tablets that are left over.

PRODUCT DESCRIPTION

What it looks like

ZENTEL is available as a white to off-white, circular, biconvex, bevel edged film coated tablet, debossed Z on one face and plain on the other. Each tablet contains 200mg of albendazole.

ZENTEL tablets do not contain sucrose, gluten or tartrazine.

ZENTEL tablets are available in blisters* or bottles of 6, 60 and 100 tablets. *Currently not marketed (Not all pack sizes may be marketed).

Ingredients

Active ingredient:

Each tablet contains 200mg of the active ingredient albendazole

Inactive ingredients:

lactose monohydrate
maize starch
microcrystalline cellulose
magnesium stearate
sodium lauryl sulphate
povidone
hypromellose, macrogols
propylene glycol
sodium starch glycollate
saccharin sodium

SPONSOR

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia.

Australian registration numbers

AUST R 50815

AUST R 43928.

This leaflet was revised in November 2021.

Published by MIMS February 2022

BRAND INFORMATION

Brand name

Zentel

Active ingredient

Albendazole

Schedule

S4

 

1 Name of Medicine

Albendazole.

2 Qualitative and Quantitative Composition

Each Zentel tablet contains albendazole 200 mg as the active ingredient.
List of excipients with known effect include lactose monohydrate and saccharin sodium. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Zentel 200 mg chewable tablets are a white to off-white, circular, biconvex, bevel edged film coated tablet, debossed Z on one face and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Single dose or short-term courses of Zentel are indicated in the treatment of single or mixed infestations of intestinal and tissue parasites, in adults and children over 2 years of age.
Clinical studies have shown Zentel to be effective in the treatment of infections caused by: Enterobius vermicularis (pinworm/threadworm), Ascaris lumbricoides (roundworm), Ancylostoma duodenale and Necator americanus (hookworms), Trichuris trichiura (whipworm), Strongyloides stercoralis, animal hookworm larvae causing cutaneous larva migrans, and the liver flukes Opisthorchis viverrini and Clonorchis sinensis.
Zentel is also indicated for the treatment of Hymenolepis nana and Taenia spp. (tapeworm) infections when other susceptible helminth species are present. Treatment courses should be extended to 3 days (see Section 4.4 Special Warnings and Precautions for Use).

4.2 Dose and Method of Administration

Zentel 200 mg chewable tablets may be crushed, chewed or swallowed whole.

Adults and children (over two years).

Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus and Trichuris trichiura.

400 mg (two Zentel 200 mg tablets) as a single dose, taken on an empty stomach.

Suspected or confirmed Strongyloides stercoralis infestation.

Zentel 400 mg once daily taken on an empty stomach for three consecutive days. Patients should then be appropriately followed for at least 2 weeks to confirm cure.

Cutaneous larva migrans.

400 mg once daily taken with food for one to three days has been reported to be effective.

Suspected or confirmed Taenia spp. or Hymenolepis nana infestation when other susceptible helminth species are present.

Zentel 400 mg once daily taken on an empty stomach for three consecutive days. If the patient is not cured after three weeks, a second course of Zentel treatment is indicated. In cases of proven H. nana infestation, retreatment in 10-21 days is recommended (see Section 4.4 Special Warnings and Precautions for Use).

Mixed worm infestations including Opisthorchis viverrini and Clonorchis sinensis.

400 mg twice a day taken, with food for three days is effective. Patients should be re-examined 1 month after treatment to confirm fluke eradication.

4.3 Contraindications

Zentel should not be administered during pregnancy or in women thought to be pregnant. Zentel has been shown to be teratogenic and embryotoxic in rats and rabbits. Women of childbearing age should be advised to take effective precautions against conception during and within one month of completion of treatment with Zentel (see Section 4.6 Fertility, Pregnancy and Lactation).
Zentel is contraindicated in persons who are known to be hypersensitive to albendazole, other benzimidazole derivatives, or any component of the tablets.

4.4 Special Warnings and Precautions for Use

Use in intestinal infections and cutaneous larva migrans (short duration treatment at lower dose).

Treatment with albendazole may uncover pre-existing neurocysticercosis, particularly in areas with high taenosis infection. Patients may experience neurological symptoms, e.g. seizures, increased intracranial pressure and focal signs as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should be started immediately.

Use in systemic helminth infections (longer duration of treatment at higher doses).

Mild to moderate elevations of liver enzymes have been reported with albendazole. In prolonged higher dose albendazole therapy for hydatid disease there have been rare reports of severe hepatic abnormalities associated with jaundice and histological hepatocellular damage, which may be irreversible. Enzyme abnormalities usually normalise on discontinuation of treatment.
Patients with abnormal liver function test results (transaminases) prior to commencing albendazole therapy should be carefully evaluated and therapy should be discontinued if liver enzymes are significantly increased (greater than twice the upper limit of normal) or full blood count decreased by a clinically significant level (see Section 4.8 Adverse Effects (Undesirable Effects)). Albendazole treatment may be restarted when liver enzymes have returned to normal limits, but patients should be carefully monitored for a recurrence.
Case reports of hepatitis have also been received (see Section 4.8 Adverse Effects (Undesirable Effects)). Liver function tests should be obtained before the start of each treatment cycle and at least every two weeks during treatment.
Albendazole has been shown to cause bone marrow suppression and therefore blood counts should be performed at the start and every two weeks during each 28 day cycle. Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anaemia, agranulocytosis and leukopenia and therefore warrant closer monitoring of blood counts. Albendazole should be discontinued if clinically significant decreases in blood cell counts occur.
Symptoms associated with an inflammatory reaction following death of the parasite may occur in patients receiving albendazole treatment for neurocysticercosis (e.g. seizures, raised intracranial pressure, focal signs). These should be treated with appropriate steroid and anticonvulsant therapy. Oral or intravenous corticosteroids are recommended to prevent cerebral hypertensive episodes during the first week of treatment.
Pre-existing neurocysticercosis may also be uncovered in patients treated with albendazole for other conditions, particularly in areas with high taenosis infection. Patients may experience neurological symptoms, e.g. seizures, increased intracranial pressure and focal signs as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should be started immediately.
There is a risk that treatment of Taenia solium infections may be complicated by cysticercosis, and appropriate measures should be taken to minimise this possibility.
Confirmation of eradication of many intestinal and tissue parasites is necessary after treatment (see Section 4.2 Dose and Method of Administration).

Use in hepatic or renal impairment.

The use of Zentel in patients with impaired renal or hepatic function has not been studied. However, caution should be used in patients with pre-existing liver disease, since Zentel is metabolised by the liver and has been associated with idiosyncratic hepatotoxicity.

Use in the elderly.

No data available.

Paediatric use.

There is limited experience with Zentel in children under 2 years of age, therefore use in this age group is not recommended.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Cimetidine, praziquantel and dexamethasone have been reported to increase the plasma levels of the albendazole active metabolite.
Ritonavir, phenytoin, carbamazepine and phenobarbital may have the potential to reduce plasma concentrations of the active metabolite of albendazole; albendazole sulfoxide. The clinical relevance of this is unknown, but may result in decreased efficacy, especially in the treatment of systemic helminth infections. Patients should be monitored for efficacy and may require alternative dose regimens or therapies.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
See Section 4.3 Contraindications. Zentel is contraindicated during pregnancy and for one month prior to conception. In order to avoid administering albendazole during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.
The use of Zentel in human pregnancy has not been studied, but in animal studies it is teratogenic in more than one species. In animal studies, oral treatment with maternotoxic doses of albendazole (30 mg/kg/day) during the period of organogenesis was associated with multiple malformations in rats and ectrodactyly in rabbits. In one study in rats, an oral dose (10 mg/kg/day) similar to the human therapeutic dose was not maternotoxic, but was associated with microphthalmia and microfetalis. The latter occurred alone and together with multiple malformations including cranioschisis, talipes and renal agenesis. There is no information on the possible effect of albendazole on the human foetus.
 Adequate human and animal data on use during lactation are not available. Therefore breastfeeding should be discontinued during and for a minimum of 5 days after treatment.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse events were observed during clinical studies and postmarketing surveillance (marked with asterisks (*)). It should however be noted that causality has not necessarily been established for these events.
During prolonged higher dose albendazole therapy of hydatid disease there have also been reports of severe hepatic abnormalities, including jaundice and hepatocellular damage which may be irreversible.
The following convention has been used for the classification of frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000).
Use in intestinal infections and cutaneous larva migrans (short duration treatment at lower dose).

Blood and the lymphatic system disorders.

Rare: low red cell count.

Immune system disorder.

Rare: hypersensitivity reactions including rash, pruritus and urticarial.

Nervous system disorder.

Uncommon: headache*, dizziness.

Gastrointestinal disorder.

Common: upper gastrointestinal symptoms (e.g. epigastric or abdominal pain, nausea, vomiting). Uncommon: diarrhoea.

Hepatobiliary disorders.

Rare: elevations of hepatic enzymes.

Skin and subcutaneous tissue disorders.

Uncommon: itchiness and/or skin rashes. Very rare: erythema multiforme*, Stevens-Johnson syndrome*.

Musculoskeletal and connective tissue disorder.

Rare: bone pain.

Renal and urinary disorders.

Rare: proteinuria.
Use in systemic helminth infections (longer duration of treatment at higher dose).

Blood and the lymphatic system disorders.

Uncommon: leucopenia. Rare: low red cell count. Very rare: pancytopenia*, aplastic anaemia*, agranulocytosis*.

Immune system disorders.

Uncommon: hypersensitivity reactions including rash, pruritus and urticarial.

Nervous system disorder.

Very common: headache*. Common: dizziness.

Gastrointestinal disorder.

Common: gastrointestinal disturbances (abdominal pain, nausea, vomiting).

Hepatobiliary disorder.

Very common: mild to moderate elevations of hepatic enzymes. Uncommon: hepatitis*.
During prolonged higher dose albendazole therapy of hydatid disease there have also been reports of severe hepatic abnormalities, including jaundice and hepatocellular damage which may be irreversible.

Skin and subcutaneous tissue disorders.

Common: reversible alopecia (thinning of hair, and moderate hair loss)*. Very rare: erythema multiforme*, Stevens-Johnson syndrome*.

Musculoskeletal and connective tissue disorder.

Rare: bone pain.

Renal and urinary disorder.

Rare: proteinuria.

General disorders and administrative site conditions.

Common: fever*.

Postmarketing data.

During postmarketing surveillance, the following reactions have been reported additionally in temporal association with Zentel.
Use in intestinal infections and cutaneous larva migrans (short duration treatment at lower dose).

Nervous system disorder.

Headache.

Skin and subcutaneous tissue disorders.

Erythema multiforme and Stevens-Johnson syndrome.
Use in systemic helminth infections (longer duration of treatment at higher doses).

Nervous system disorder.

Headache.

Skin and subcutaneous tissue disorders.

Reversible alopecia (thinning of hair, and moderate hair loss), erythema multiforme and Stevens-Johnson syndrome.

Hepatobiliary disorder.

Hepatitis.

Blood and the lymphatic system disorders.

Pancytopenia, aplastic anaemia and agranulocytosis.
Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression (see Section 4.4 Special Warnings and Precautions for Use).

General disorders and administrative site conditions.

Fever.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Zentel (albendazole) is a broad spectrum antihelminthic which is highly effective against a wide range of intestinal helminths. Zentel is also effective against tissue helminth infections, such as cutaneous larva migrans (see Section 4.1 Therapeutic Indications).
Albendazole therapy has also been used in the high dose, long-term treatment of tissue helminth infections including hydatid cysts and cysticercosis.
The antihelminthic action of albendazole is thought to be mainly intraintestinal. However, at higher albendazole doses, sufficient is absorbed and metabolised to the active sulphoxide metabolite to have a therapeutic effect against tissue parasites.
Albendazole exhibits larvicidal, ovicidal and vermicidal activity, and is thought to act via inhibition of tubulin polymerization. This causes a cascade of metabolic disruption, including energy depletion, which immobilizes and then kills the susceptible helminth.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

In man, the full extent of albendazole absorption following oral administration has not been established. However, it is known that albendazole is poorly absorbed, with most of an oral dose remaining in the gastrointestinal tract. The poor absorption is believed to be due to the low aqueous solubility of albendazole. Absorption is significantly enhanced (approximately 5-fold) if albendazole is administered with a fatty meal.

Metabolism and excretion.

Albendazole rapidly undergoes extensive first-pass metabolism in the liver and is generally not detected in plasma. Albendazole sulphoxide is the primary metabolite, which is thought to be the active moiety in effectiveness against systemic tissue infections. The plasma half-life of albendazole sulphoxide is 8½ hours. Albendazole sulphoxide and its metabolites appear to be principally eliminated in bile, with only a small proportion appearing in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

Mutagenicity tests with bacterial cells and an assay of chromosomal damage in vivo have shown no clear evidence that albendazole has genotoxic activity. A cell transformation assay showed a slight dose related increase in the transformation rate of cultured mouse cells in the presence of metabolic activation.

Carcinogenicity.

No evidence of carcinogenic activity was observed in mice given albendazole in the diet at doses up to 400 mg/kg/day for 25 months. In rats, dietary administration of doses of 3.5, 7 and 20 mg/kg/day did not affect the total incidence of adrenocortical tumours (adenoma plus carcinoma), however in females there was an increased incidence of adrenocortical carcinomas.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Zentel tablet contains the following inactive ingredients: microcrystalline cellulose, hypromellose, lactose monohydrate, magnesium stearate, povidone, propylene glycol, saccharin sodium, sodium lauryl sulphate, sodium starch glycollate and maize starch.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Zentel tablets should be stored below 30°C.

6.5 Nature and Contents of Container

Zentel tablets are available in blisters* or bottles of 6, 60 and 100 tablets.
*Currently not marketed.
(Not all pack sizes may be marketed).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Albendazole is a white to off-white, odourless or almost odourless powder, which is practically insoluble in water and slightly soluble in methanol, chloroform, ethyl acetate and acetonitrile. Its molecular weight is 265.33.
Zentel contains albendazole, which is methyl [5-(propylthio)-1H-benzimidazol-2-yl] carbamate. It is a member of the benzimidazole group of anthelmintic agents.

Chemical structure.


CAS number.

54965-21-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes