SUMMARY CMI

ESKAZOLE

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using ESKAZOLE?

ESKAZOLE contains the active ingredient albendazole. ESKAZOLE is used to clear worms or parasites from the gut and other tissues. ESKAZOLE is effective in a number of different conditions caused by parasites including hydatid disease and neurocysticercosis.

For more information, see Section 1. Why am I using ESKAZOLE? in the full CMI.

2. What should I know before I use ESKAZOLE?

Do not use if you have ever had an allergic reaction to ESKAZOLE or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ESKAZOLE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ESKAZOLE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ESKAZOLE?

• Your doctor will advise how many doses are needed each day, and for how long you will need to take ESKAZOLE.
• Follow your doctors' instructions about how and when to use ESKAZOLE.

More instructions can be found in Section 4. How do I use ESKAZOLE? in the full CMI.

5. What should I know while using ESKAZOLE?

For more information, see Section 5. What should I know while using ESKAZOLE? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

ESKAZOLE

Active ingredient: albendazole

Consumer Medicine Information (CMI)

This leaflet provides important information about using ESKAZOLE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ESKAZOLE.

Where to find information in this leaflet:

1. Why am I using ESKAZOLE?
2. What should I know before I use ESKAZOLE?
3. What if I am taking other medicines?
4. How do I use ESKAZOLE?
5. What should I know while using ESKAZOLE?
6. Are there any side effects?
7. Product details

1. Why am I using ESKAZOLE?

ESKAZOLE contains the active ingredient albendazole.

ESKAZOLE is used to clear worms or parasites from the gut and other tissues. ESKAZOLE is effective in a number of different conditions caused by parasites including hydatid disease and neurocysticercosis.

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

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

There is no evidence that ESKAZOLE is addictive.

2. What should I know before I use ESKAZOLE?

Warnings

Do not use ESKAZOLE if:

• you are allergic to albendazole, or any of the ingredients listed at the end of this leaflet. Albendazole is also contained in ZENTEL. Signs of an allergic reaction may include an itchy skin rash, shortness of breath and swelling of the face or tongue.
• Always check the ingredients to make sure you can use this medicine.
• 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 (Emverm or Vermox) or thiabendazole (Mintezol).
• you know or suspect you are pregnant.
  Pregnancy must be avoided (i.e. use effective contraceptive measures) during treatment, and for one month after stopping ESKAZOLE.
• you are breastfeeding.
  Your baby can absorb albendazole from breast milk if you are breastfeeding. Breastfeeding should be stopped while taking ESKAZOLE, and for at least 1 month after finishing treatment.
• The expiry date printed on the pack has passed.
• The packaging is torn or shows signs of tampering.

ESKAZOLE should not be given to children unless instructed by a doctor.

ESKAZOLE can:

• reduce the number of blood cells produced in the body.
• increase the levels of enzymes (chemicals found in the blood) that are produced by the liver.

Your doctor may arrange to take blood samples to check the number of blood cells and your liver enzymes before and during treatment. Depending on the results you may have to stop or interrupt your treatment.

There is only a small amount of information available about the use of ESKAZOLE in children. Use in children under 6 years of age is not recommended.

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

Check with your doctor if you have any liver problems.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

• Tell your doctor if you are or think you may be pregnant or if you intended to become pregnant.
  Pregnancy must be avoided (i.e. use effective contraceptive measures) during treatment, and for one month after stopping ESKAZOLE.
• Tell your doctor if you are breastfeeding or intend to breastfeed.
  Breastfeeding should be stopped while taking ESKAZOLE, and for at least 1 month after finishing treatment.

Look out for important symptoms:

Fits (seizures) and other symptoms:

People being treated for parasite infections can also have a rare and serious brain infection called neurocysticercosis but they don't always know that they have it. A reaction happens in the brain when the parasites are killed. The symptoms include fits (seizures), headache and problems with your vision.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ESKAZOLE.

4. How do I use ESKAZOLE?

Follow your doctors' instructions about how and when to use ESKAZOLE. 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 ESKAZOLE. The usual daily dose for adults is one ESKAZOLE tablet taken twice daily with meals.

The dose in children aged 6 years and over depends on their body-weight.

When to take ESKAZOLE

Take ESKAZOLE in the morning with breakfast and at night with the evening meal.

Take ESKAZOLE at the same time each day.

Taking your medicine at the same time each day will give the best effect. It will also help you to remember when to take your medicine.

How to take ESKAZOLE

ESKAZOLE should be taken with a meal.

Swallow the tablets with water. For people, particularly young children, who may find it difficult to swallow the tablets whole, they can be crushed or chewed with a little water.

How long to take ESKAZOLE

Keep taking ESKAZOLE for as long as your doctor tells you. Do not stop taking ESKAZOLE just because you feel better. ESKAZOLE is usually taken for a 28 day course. You may need to take more than one course. Usually you will need to wait for fourteen days before starting a second, or third course of tablets.

If you forget to take ESKAZOLE

Take the missed tablets as soon as you remember. Then take the next dose at the time it is normally due. Do not take two doses within an hour of each other.

Do not try to make up for missed doses by taking more than one dose at a time.

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

If you use too much ESKAZOLE

If you think that you have used too much ESKAZOLE, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using ESKAZOLE?

Things you should do

Take ESKAZOLE exactly as your doctor has prescribed.

Tell your doctor if you become pregnant while taking ESKAZOLE.

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

Some medicines may affect the way other medicines work.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ESKAZOLE affects you.

ESKAZOLE may cause dizziness in some people.

Looking after your medicine

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

Store below 30°C.

Keep the pack in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

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

Fits (seizures) and other symptoms:

People being treated for parasite infections may also have a rare and serious condition called neurocysticercosis meaning that they have parasites in the brain. By taking ESKAZOLE a reaction happens in the brain when the parasites are killed.

Look for the following combination of symptoms:

• Headache, which can be severe
• Nausea and vomiting
• Fits (seizures)
• Problems with your vision.

Contact a doctor immediately if you get these.

Most unwanted effects following ESKAZOLE are mild, and may disappear without stopping ESKAZOLE. However, some side effects may need medical treatment. Tell the doctor about any effect which is troublesome or ongoing.

Less serious side effects

More serious side effects

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

If you are receiving ESKAZOLE for neurocysticercosis you may experience a worsening of your symptoms (such as headache and high temperature) when you first start to take ESKAZOLE.

Other rare events that have been reported with ESKAZOLE include:

• inflammation of the pancreas
• severe liver effects
• effects on the eyes
• blood disorders
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome).

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What ESKAZOLE contains

ESKAZOLE tablets do not contain sucrose, gluten or tartrazine.

Do not take this medicine if you are allergic to any of these ingredients.

What ESKAZOLE looks like

ESKAZOLE 400 mg chewable tablets are a mottled pale orange rounded oblong biconvex tablets with a score line on one side and embossed “ALB 400” on the reverse, with a characteristic fruity odour.

The tablets can be broken in half.

ESKAZOLE tablets are available in blisters packs of 56* (AUST R 97504) and bottles of 60 tablets (AUST R 97505).

*Currently not marketed

Who distributes ESKAZOLE

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

This leaflet was prepared in August 2022.

Published by MIMS October 2022

1 Name of Medicine

Albendazole.

2 Qualitative and Quantitative Composition

Each Eskazole tablet contains albendazole 400 mg as the active ingredient.
Excipients with known effect: saccharin and sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eskazole 400 mg chewable tablets are a mottled pale orange rounded oblong biconvex tablets with a score line on one side and embossed "ALB 400" on the reverse, with a characteristic fruity odour.

4 Clinical Particulars

4.1 Therapeutic Indications

Hydatid disease.

Larval taeniasis (neurocysticercosis).

Other indications.

4.2 Dose and Method of Administration

Eskazole 400 mg chewable tablets may be crushed, chewed, or swallowed whole.
Some people, particularly young children, may experience difficulties swallowing the tablets whole and should be encouraged to chew the tablets with a little water, alternatively tablets may be crushed and taken with a little water.
To increase the systemic bioavailability of albendazole in the treatment of tissue helminth infections, Eskazole tablets should be taken with a meal (see Section 5.2 Pharmacokinetic Properties).

Hydatid disease (echinococcosis).

Inoperable and multiple cysts.

Preoperatively.

Peri and postsurgery.

Larval taeniasis (neurocysticercosis).

Capillaria philippinensis.

4.3 Contraindications

Eskazole should not be administered during pregnancy or in women thought to be pregnant. Eskazole 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 Eskazole (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).
Eskazole is contraindicated in persons who are known to be hypersensitive to albendazole, other benzimidazole derivatives, or any component of the tablets.
There is limited experience with the use of Eskazole in children under six years of age, therefore use in this age group is not recommended.

4.4 Special Warnings and Precautions for Use

In clinical trials involving patients with hydatid disease, approximately 16% of subjects experienced mild to moderate elevations of liver enzymes during the treatment cycle. Rare severe cases were associated with histological hepatocellular damage, which may be irreversible, and jaundice. Enzyme abnormalities have usually normalised on discontinuation of treatment. In patients with hydatid disease, liver function tests should be obtained before the start of each treatment cycle and at least every two weeks during treatment. Patients with disturbed liver function tests prior to commencing albendazole therapy should be carefully evaluated, since the drug is metabolised by the liver and has been associated with idiosyncratic hepatotoxicity. In patients with hepatic hydatidosis, it should be determined whether the underlying disease or another process is affecting liver function. If enzymes are significantly increased (greater than twice the upper limit of normal) during treatment, Eskazole should be discontinued. Eskazole treatment may be reinstituted when levels have returned to normal limits, but liver function should be monitored frequently during repeat therapy.
Eskazole 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. Eskazole should be discontinued if clinically significant decreases in blood cell counts occur (see Section 4.2 Dose and Method of Administration; Section 4.8 Adverse Effects (Undesirable Effects)).
In patients treated with Eskazole for hydatid disease, appropriate long-term monitoring should be considered, since approximately 14% of patients followed for 2 years developed recurrent cysts.
The therapeutic action of albendazole in the treatment of neurocysticercosis, may exacerbate presenting symptoms or precipitate new neurological disturbances (e.g. headache, nausea, convulsions, visual changes). These symptoms should be anticipated and patients treated accordingly (see Section 4.8 Adverse Effects (Undesirable Effects)).
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 taeniasis 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 renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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.

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)

In clinical trials, Eskazole was associated with new adverse events in approximately 15% of patients treated for hydatid disease. Drug related withdrawals were predominantly due to either hepatic abnormalities (3.8%) or leucopenia (0.7%).
Data from large clinical studies were used to determine the frequency of very common to rare undesirable reactions. The frequencies assigned to all other undesirable reactions (i.e. those occurring at < 1/1000) were mainly determined using postmarketing data and refer to a reporting rate rather than a true frequency.
The following convention has been used for the classification of frequency. Very common: ≥ 1/10. Common: ≥ 1/100 and < 1/10. Uncommon: ≥ 1/1000 and < 1/100. Rare: ≥ 1/10,000 and < 1/1000. Very rare: < 1/10,000.

Blood and the lymphatic system disorders.

Immune system disorders.

Nervous system disorders.

Eye disorders.

Gastrointestinal disorders.

Hepatobiliary disorders.

Skin and subcutaneous tissue disorders.

General disorders and administrative site conditions.

Reporting suspected adverse effects.

4.9 Overdose

There is no experience of overdosage. No specific antidote is known. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
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.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Eskazole tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, povidone sodium lauryl sulfate, sunset yellow FCF aluminium lake, saccharin sodium, magnesium stearate, vanilla flavour 54286 BP 0551 (ARTG PI No: 1633), passion fruit flavour 54442 AP0551 (ARTG PI No: 1629) and orange flavour 55588 AP 0551 (ARTG PI No: 1631).

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

Eskazole tablets should be stored below 30°C.

6.5 Nature and Contents of Container

Eskazole tablets are available in PVC/PVDC/Al blisters packs of 56* and in polypropylene bottles of 60 tablets.
*Currently not 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.
Eskazole 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.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only medicine.

Summary Table of Changes