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Package Leaflet: Information for the User

Eskazole® Tablets 400 mg albendazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, or pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

In this leaflet:

1    What Eskazole is and what it is used for

2    What you need to know before you take Eskazole

3    How to take Eskazole

4    Possible side effects

5    How to store Eskazole

6    Contents of the pack and other information

1 What Eskazole is and what it is used for

What Eskazole is

Eskazole Tablets 400 mg (called Eskazole in this leaflet) belongs to a group of medicines known anthelmintics, which are effective against certain worms which are parasitic in humans.

What Eskazole is used for

Eskazole is used to treat hydatid disease which is caused by a worm living inside your body. The inactive worms (larvae) form cysts in the body which slowly grow bigger. Your medicine kills the larvae, and therefore stops any more cysts growing.

2 What you need to know before you take Eskazole

Do not take Eskazole:

•    if you are pregnant, think you may be pregnant, or are trying to become pregnant

•    if you are are allergic (hypersensitive) to albendazole or any of the other ingredients of Eskazole (listed in section 6).

Do not take Eskazole if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking Eskazole.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine:

•    if you have kidney or liver problems

•    if you have had any problems relating to your blood or blood cells

•    if you weigh less than 60 kg

•    if you are 65 years of age or above

Your doctor will probably carry out regular tests on your liver and blood at the start and during treatment with your medicine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Eskazole.

Children and adolescents

Eskazole is not recommended for children and adolescents weighing less than 60 kg.

In children aged under 6 as there has been limited clinical experience with the use of this medicine in this age group. Although there is clinical experience of older childen and adolescents under 60 kg using this medicine, it is not possible to give the correct dose with the 400 mg tablet.

Other medicines and Eskazole

Please tell your doctor, or pharmacist or nurse if you are taking, using or have recently taken or might take/use any other medicines. This is because Eskazole can affect the way some other medicines work. Also some other medicines can affect the way Eskazole works.

You must tell your doctor if you are taking the following before taking Eskazole:

•    medicines to treat fits (seizures) and epilepsy, for example phenytoin, fospheytoin, carbamazepine, phenobarbital or primidone

•    medicines used to treat worms, for example praziquantel and levamisole

•    ritonavir (a medicine used to treat HIV infection)

•    cimetidine (a medicine used to treat heartburn and stomach ulcers)

•    dexamethazone (a medicine used to reduce inflammation and reduce the effectiveness of your immune system)

•    oral contraceptives ("The Pill”)

•    medicines to thin the blood (anticoagulants)

•    medicines to treat diabetes (oral hypoglycaemics)

•    theophylline (a medicine used to treat respiratory diseases)

Eskazole with food and drink

You should avoid drinking grapefruit juice whilst taking Eskazole.

Pregnancy and breast-feeding

Do not take Eskazole if you are pregnant, think you are pregnant, or are trying to become pregnant. For women of child-bearing age, treatment will only be started after a negative pregnancy text. These tests will be repeated before starting a further course of treatment.

If you are a woman of child-bearing age, you should take precautions against becoming pregnant whilst taking your medicine and for one month after completing the course. You should use a non-hormonal method of contraception, for example condom (sheath), diaphragm or cap with spermicide. "The Pill” should not be used because Eskazole may affect the way that it works.

It is not known whether the ingredients of Eskazole can pass into breast-milk. Talk to your doctor about breast-feeding while you are taking Eskazole. The doctor will weigh-up the benefit to you against any risk to your baby of taking Eskazole while you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Eskazole can have side effects and the symptoms may make you unfit to drive or operate machinery.

Don’t drive or operate machinery unless you are feeling well.

Eskazole contains:

•    Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

•    Sunset yellow (E110), may cause allergic reactions.

•    1.9 mg of sodium per 400 mg tablet. This should be considered if you are on a controlled sodium diet.

3 How to take Eskazole

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children weighing more than 60 kg

One 400 mg tablet taken twice a day for 28 days.Your doctor may tell you to repeat this treatment after 14 days, usually up to three times.

Your doctor may prescribe Eskazole before or after an operation for removal of a hyatid cyst. In some cases your doctor may tell you to continue the tablets in 28 day courses for months or even years. It is important that you follow your doctor’s advice.

Adults and children weighing less than 60 kg

Eskazole is not recommended for children and adolescents weighing less than 60 kg. Ask your doctor or pharmacist for advice.

How to take

Eskazole should be taken with meals. Take your tablets evenly and spread through the day, for example take one in the morning and one in the evening.

Some people may experience difficulties swallowing the tablets whole. If this happens, encourage them to chew the tablets with a little water. The tablets may also be crushed to make it easier for them to swallow.

If you take more Eskazole than you should

You should only take the dose that your doctor or pharmacist has told you to. If you take too many tablets, tell your doctor or hospital casualty department straight away. Show them your pack or container of tablets.

If you forget to take Eskazole

If you miss a dose, take the next one with your next meal, then take your next dose at the normal time and carry on as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Eskazole and see a doctor straight away, if you notice any of the serious side effects - you may need urgent medical treatment:

The following are very rare (affects less than 1 in 10,000 people)

•    a skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and private parts. You may have a fever and be very tired

•    other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches.

Look out for serious symptoms

People being treated for parasite infections may also have a rare and serious condition called neurocysticerosis meaning that they have parasites in the brain. They may not know they have this. By taking Eskazole a reaction happens in the brain when the parasites are killed. Tell your doctor immediately if you get any of the following symptoms:

•    headache, which can be severe

•    nausea and vomiting

•    fits (seizures)

•    problems with your vision

Eskazole can cause uncommon and serious side effects. You should tell your doctor as soon as possible if you get any of the symptoms when taking these tablets:

•    darker urine or paler stools

•    yellowing of the skin or whites of the eyes

The other possible side effects are:

Very common (may affect more than 1 in 10 people)

•    headache

•    changes to blood test results, so tell your doctor that you are taking Eskazole before a blood test.

Common (may affect up to 1 in 10 people)

•    fever

•    dizziness

•    upset stomach including feeling sick (nausea), being sick (vomiting) or stomach pain

•    Thinning of the hair or hair loss, which may happen whilst taking the tablets but returns to normal after.

Uncommon (may affect up to 1 in 100 people)

•    liver disease

•    blood reaction that causes an increase in infections (like fever, chills, sore throats or mouth ulcers

•    allergic skin reaction causing a rash, itching or hives and rarely it can be severe including flaking, peeling or blistering.

Very rare (may affect up to 1 in 10,000 people)

•    blood reactions that cause tiredness, shortness of breath, bruising or bleeding (like nose bleeds) more than normal.

If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Eskazole

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of the month.

•    Do not store above 30°C

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

What Eskazole contains

•    The active substance is albendazole. Each tablet contains 400 mg of albendazole.

•    The other ingredients are lactose, maize starch, sunset yellow lake (E110), sodium lauryl sulphate, poyvinylpyrrolidone, microcrystalline cellulose (E460), sodium saccharin, sodium starch glycolate, vanilla flavour, orange flavour, passion fruit flavour, magnesium stearate, hydroxypropylmethylcellulose (E464), propylene glycol and purified water.

•    See section 2 for further important information about some of the ingredients of Eskazole.

What Eskazole looks like and contents of the pack

Eskazole 400 mg tablets are mottled orange, rounded oblong, with a score line on one side and marked "ALB 400” on the other side. They also have a fruity odour. Each pack contains 60 tablets.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder: SmithKline & French Laboratories Ltd. 980 Great West Road, Brentford, Middlesex TW8 9GS Manufacturer: SmithKline Beecham Laboratories Pharmaceutiques, Rue Joseph Cugnot, 53100 Mayenne, France.

This leaflet was last revised in: September 2014

Eskazole is a registered trade mark of the GSK group of companies

© 2014 GSK group of companies

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