ZENTEL™

Albendazole
Read all of this leaflet carefully before you start taking this medicine.

WHAT IS IN THIS MEDICINE

Tablet containing 200 mg or 400 mg albendazole.

4 % w/v suspension to be taken orally; 4 g albendazole per 100 ml.

WHAT ZENTEL IS AND WHAT IT IS USED FOR

ZENTEL is a benzimidazole carbamate with anthelmintic and antiprotozoal activity against the
intestinal and tissue worm infections.

ZENTEL is used for the treatment of common worm infections of the gut, such as the following
conditions caused by sensitive intestinal helminths/protozoa:

- Pinworm infection (enterobiasis)

- Hookworm disease (ancylostomiasis and necatoriasis)
- Dwarf tapeworm infection (hymenolepsiasis)
- Pork/beef tapeworm infections (taeniasis)
- Threadworm infection (strongyloidiasis)
- Roundworm infection (ascariasis)
- Whipworm infection (trichuriasis)
- Liver fluke infections (clonorchiasis and opisthorchiasis)
- Hookworm (animal origin) causing skin disease (cutaneous larva migrans)
- Giardia infection (giardiasis in children)

HOW TO TAKE ZENTEL

The recommended dose of ZENTEL is as follows:

Adults and children over 2 years of age 400 mg as a single dose.

Children 1-2 years of age 200 mg as a single dose.
ZENTEL should not to be used in children aged under 1 year.

No special procedures, such as fasting or purging, are required.

If the patient is still symptomatic after a single course of treatment, they must consult a Healthcare
Professional for further treatment.

The maximum duration of treatment will vary according to your condition. Please refer to the table
below for information on maximum doses for each condition. Do not exceed the maximum daily doses
and treatment durations recommended.

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 the tablets may be crushed. The
suspension can also be administered as an alternative.

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 Indications Age Dose Period Maximum Dose
Recommended

Pinworm infection * adults and 400 mg [two 200 single dose (to be Single dose, 400
children over 2 mg tablet(s) or 10 taken on an empty mg
Hookworm disease years of age ml 4% stomach)
suspension]#
Roundworm
infection children 1-2 years 200 mg (one 200 single dose (to be Single dose, 200
of age mg tablet or 5 ml taken on an empty mg
Whipworm 4% suspension) stomach)
infection

Threadworm adults and 400 mg (#see one dose per day 400 mg per day
infection children over 2 above) for 3 days (to be (1200 mg for 3
years of age taken on an empty consecutive days)
Pork/beef tapeworm stomach)
infection

Dwarf tapeworm
infection **

Liver fluke adults and 400 mg (#see two doses per day 800 mg per day
infections *** children over 2 above) for 3 days (to be (2400 mg over a 3
years of age taken with food) day period)

Cutaneous larva adults and 400 mg Once daily for 1 400 mg per day
migrans children over 2 to 3 days (to be (Up to 1200 mg
years of age taken with food) over a 3 day
period)

Giardia infection children 2 - 12 400 mg (#see one dose per day 400 mg per day
years of age only above) for 5 days (to be (2000 mg over a 5
taken on an empty day period)
stomach)
*
In order to obtain a complete cure in the case of pin-worm infestation, measures should be taken to
maintain strict hygiene. Relatives and individuals sharing the same housing should also take a course of
treatment.
**
In cases of proven dwarf tapeworm infection (Hymenolepiasis), a repeat course of the medicine in 10-
21 days is recommended.

***Advice should be sought from your Healthcare Professional 1 month after treatment to confirm fluke
eradication.

• Elderly

Elderly patients with hepatic impairment (liver problems) must seek advice from a Healthcare
Professional before taking this medicine.

• Renal Impairment (Kidney problems)

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If you have been diagnosed with renal impairment (kidney problems), seek advice from a Healthcare
Professional before taking this medicine.

• Hepatic Impairment (Liver problems)

If you have been diagnosed with hepatic impairment (liver problems), seek advice from a Healthcare
Professional before taking this medicine.

DON’T TAKE ZENTEL

If you are pregnant, if you think you could be pregnant, or if you are planning to become pregnant (see
PREGNANCY AND BREAST FEEDING).

If you are allergic (hypersensitive) to ZENTEL or any other ingredients of ZENTEL (see section on
WHAT ZENTEL CONTAINS).

WHAT YOU NEED TO KNOW BEFORE TAKING ZENTEL

In order to avoid administering ZENTEL during early pregnancy, women of childbearing age should
initiate treatment within the first week of menstruation or after a negative pregnancy test.

If you develop severe headache, nausea and vomiting, fits and/or problems with your vision after taking
this medicine, consult a Healthcare Professional immediately.

ZENTEL may cause liver problems. Please consult a Healthcare Professional if you experience
yellowing of the skin or eyes, dark coloured urine and/or light coloured stools. Patients diagnosed with
hepatic or renal impairment (liver or kidney problems) must seek advice from a Healthcare Professional
before taking this medicine.

Keep out of the sight and reach of children.

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/HCP if you use other medicines regularly, have used other medicines
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.

PREGNANCY AND BREAST FEEDING

ZENTEL should not be administered during pregnancy or in women thought to be pregnant (see
WHAT YOU NEED TO KNOW BEFORE TAKING ZENTEL).

Patients who are breast feeding must seek advice from a Healthcare Professional prior to taking this
medicine.

DRIVING AND USING MACHINES

When driving vehicles or operating machinery it should be taken into account that dizziness has been
reported after using ZENTEL (see Side Effects).

SIDE EFFECTS

Uncommon side effects (up to 1 in 100 people) are headache, dizziness, stomach pain, nausea,
vomiting and diarrhoea.

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Rare side effects (up to 1 in 1000 people) are hypersensitivity reactions including rash, pruritus and
urticaria, and changes in liver blood test. Please consult a Healthcare Professional if you experience
yellowing of the skin or eyes, dark coloured urine and/or light coloured stools.

Very rare side effects (up to 1 in 10,000 people) are serious blistering skin rashes with swelling and
peeling (erythema multiforme, Stevens-Johnsons syndrome). Please contact a Healthcare Professional
if you notice any of these symptoms.

OVERDOSE

Please consult a Healthcare Professional for advice in the event of overdose.

HOW TO STORE ZENTEL

Do not use ZENTEL after the expiry date shown on the pack.

Tablets: Store below 30°C.

Suspensions: Store below 30°C and protect from direct sunlight.

INSTRUCTIONS FOR USE/HANDLING

Suspensions: Shake well before use.

WHAT ZENTEL CONTAINS

ZENTEL Tablet 200mg

Lactose
Maize starch
Polyvidone
Sodium lauryl sulphate
Sodium starch glycollate
Microcrystalline cellulose
Sodium saccharin
Magnesium stearate
Purified water

Film coating
Methylhydroxypropyl cellulose 15
Methylhydroxylpropyl 5
Propylene glycol
Purified water

ZENTEL Tablet 400mg

Lactose
Microcrystalline cellulose
Maize starch
Croscarmellose sodium
Povidone
Sodium lauryl sulphate
Sunset yellow lake
Sodium saccharin
Magnesium stearate
Orange flavour
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Vanilla favour
Passion fruit flavour

ZENTEL Suspension 400mg/10ml

Sodium Lauryl Sulfate

Glycerin
Methylparaben
Propylparaben
Sodium Carboxymethylcellulose 7MF
Sodium Carboxymethylcellulose 7HF
Saccharin sodium
Orange flavour
Vanilla favour
Passion fruit flavour

VERSION NUMBER: cGDS v1.0 (SI)

DATE OF ISSUE: 15 May 2014

ZENTEL is a trademark of the GlaxoSmithKline group of companies

[GSK logo]

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