CHEMMART

Main information

  • Trade name:
  • CHEMMART ALLOPURINOL allopurinol 100mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHEMMART ALLOPURINOL allopurinol 100mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219912
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219912

CHEMMART ALLOPURINOL allopurinol 100mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

27/03/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods

Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 February 1992, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 February 1992, other than condition No. 11.

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No. 8 and condition No. 9.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995, other than condition No.11

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

The therapeutic goods grouped in this registration/listing as export only goods under the following names are included in the Australian Register of

Therapeutic Goods and may not be supplied in Australia. Export Name(s) to be added:

Products

1. CHEMMART ALLOPURINOL allopurinol 100mg tablet bottle

Product Type

Single Medicine Product

Effective date

7/02/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

INDICATIONS AS AT 6 February 2003: Main clinical manifestations of urate/uric acid deposition. These are gouty arthritis, skin tophi and/or renal

involvement through crystal deposition or stone formation. Such clinical manifestations may occur in: idiopathic gout; uric acid lithiasis; acute uric acid

nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously or

after cytotoxic therapy, certain enzyme disorders which lead to overproduction of urate and involve: hypoxanthine guanine phosphoriboslytransferase

including Lesch-Nyhan syndrome, glucose 6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase,

phosphoribosylpyrophosphate amidotransferase. ALLOSIG is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to

deficient activity of adenine phosphoribosyl transferase. ALLOSIG is indicated for the management of recurred mixed calcium oxalate renal stones in the

presence of hyperuricosuria, when fluid, dietary and similar measures have failed.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass

4 Years

Store below 30

degrees Celsius

Not recorded

Store in a Dry Place

Pack Size/Poison information

Pack Size

Poison Schedule

200 tablets in 75ml glass bottle - tamper proof

(S4) Prescription Only Medicine

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:15:53 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Components

1. Medicine Component

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Off-white biconvex round scored tablet marked "U4A".

Active Ingredients

Allopurinol

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 26.11.2017 at 03:15:53 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Chemmart Allopurinol

contains the active ingredient, allopurinol (al-oe-PUR-in-ol)

Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

Ask your doctor or pharmacist if

you do not understand anything or

are worried about taking your

medicine.

This leaflet answers some common

questions about allopurinol.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. Some more recent

information on your medicine may

be available. Speak to your

pharmacist or doctor to obtain the

most up-to-date information.

All medicines have risks and

benefits. Your doctor or pharmacist

has weighed the risks of you taking

this medicine against the benefits

they expect it will have for you.

Keep this leaflet with your

medicine.

You may need to read it again.

What allopurinol is

used for

The name of your medicine is

Chemmart Allopurinol. It contains

the active ingredient, allopurinol.

Allopurinol is used to treat:

• gouty arthritis or gout

• kidney stones

rare conditions where high levels

of uric acid occur in the blood

(for example, Lesch-Nyhan

syndrome).

Allopurinol is used to treat the

symptoms of these conditions, but it

will not cure them. Also, it will not

help treat the pain that occurs in an

acute attack of gout.

How it works

Allopurinol belongs to a group of

medicines called anti-uricaemic

agents. These medicines work by

reducing high levels of uric acid in

the body, which are usually due to

gout. Excess amounts of uric acid in

the blood may lead to uric acid

crystals being made and deposited in

the joints, thereby causing pain,

swelling and tenderness.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed

allopurinol for another reason.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Use in children

There is very little information to

recommend the use of this medicine

in children. Allopurinol should only

be taken by children if a doctor has

prescribed it.

Before you take

allopurinol

When you must not take it

Do not take this medicine if you

have had an allergic reaction to

allopurinol or any of the

ingredients listed at the end of this

leaflet.

Symptoms of an allergic reaction

may include: shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue,

throat or other parts of the body;

muscle pain or tenderness or joint

pain; or rash, itching or hives on the

skin.

Do not take allopurinol if you or a

member of your immediate family

has been diagnosed with

haemochromatosis (a disease

involving too much iron in the

body) and you are taking iron

salts.

Do not take this medicine after the

expiry date (EXP) printed on the

pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not take this medicine if the

packaging is torn, shows signs of

tampering or if the tablets do not

seem quite right.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you:

1. have allergies to:

• any other medicines

any other substances, such as

foods, preservatives or dyes.

2. have or have had any medical

conditions, especially the

following:

kidney problems, including

kidney stones

• liver problems

• high blood pressure

• heart problems

conditions where the levels of

uric acid are abnormally high

• cancer or tumours.

3. are having an attack of gout.

Treatment with allopurinol should

not be started until the attack has

stopped, otherwise more attacks

may occur.

(However, if an attack of gout

occurs when a person is already

taking allopurinol, it can be

continued).

4. are pregnant or intend to

become pregnant.

Your doctor will discuss with you

the risks and benefits of taking

allopurinol during pregnancy.

5. are breast-feeding or plan to

breast-feed.

Allopurinol passes into breast

milk and may affect your baby.

Your doctor will discuss with you

the risks and benefits of taking

allopurinol when breast-feeding.

If you have not told your doctor

about any of the above, tell them

before you start taking this

medicine.

Taking other medicines

Tell your doctor or pharmacist if you

are taking any other medicines,

including any that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and allopurinol may

interfere with each other. These

include:

some medicines used to treat high

blood pressure or heart problems

thiazide diuretics (a certain type

of water tablet)

mercaptopurine, azathioprine or

cyclosporin - medicines used to

suppress the immune system

aspirin and other medicines

known as salicylates

probenicid, a medicine used to

treat gout

warfarin, used to help prevent

blood clots

chlorpropamide, a medicine used

to treat diabetes

phenytoin, a medicine used to

treat epilepsy

certain antibiotics such as

ampicillin and amoxycillin

theophylline, a medicine used to

treat asthma

vidarabine, an anti-viral

medicine.

These medicines may be affected by

allopurinol or may affect how well it

works. You may need different

amounts of your medicine, or you

may need to take different medicines.

Your doctor and pharmacist can tell

you if you are taking any of these

medicines. They may also have more

information on medicines to be

careful with or avoid while taking

allopurinol.

Other interactions not listed above

may also occur.

How to take this

medicine

Follow all directions given to you by

your doctor or pharmacist carefully.

They may be different to the

information in this leaflet.

If you do not understand any written

instructions, ask your doctor or

pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how many tablets you need to

take. This depends on your condition

and whether or not you are taking

any other medicines.

The usual adult dose range is:

100 - 200 mg per day for mild

conditions

300 - 600mg per day for

moderately severe conditions

700 - 900mg per day for severe

conditions.

People over 65 years of age, and

those with kidney and/or liver

problems should be started on the

lowest dose possible to control uric

acid production.

Children under 15 years of age

usually take 100 - 400 mg per day.

How to take it

Swallow the tablets with a glass of

water.

When to take it

Take your medicine immediately

after food, as this will lessen the

chance of a stomach upset.

Take your medicine at the same time

each day.

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take it.

Allopurinol is usually taken once

daily. However, if your dose is more

than 300 mg, your doctor may advise

you to take your medicine twice a

day. Then, it should be taken

morning and night, after breakfast

and dinner.

How long to take it

Continue taking your medicine for as

long as your doctor tells you.

Allopurinol helps to control the

symptoms of your condition but does

not cure it. It is important to keep

taking your medicine, even if you

feel well.

If you forget to take it

If you miss a dose, and it is more

than 4 hours until your next dose is

due, take the missed dose as soon as

you remember.

If it is less than 4 hours to your next

dose, do not take the dose you missed

and take your next dose when you

are meant to.

Then go back to taking your

medicine as you would normally.

Do not take a double dose to make

up for the dose that you missed.

of an allergic reaction occur -

immediately tell your doctor.

The signs of an allergic reaction were

listed earlier in this leaflet.

You should drink at least two litres

(8 - 10 glasses) of fluid each day.

This will assist in reducing the uric

acid levels in your body and prevent

kidney stones from forming.

Tell your doctor if you have an

acute attack of gout while you are

taking allopurinol.

Your doctor may prescribe a

Things to be careful of

Make sure you know how allopurinol

affects you before you drive a car,

operate machinery or do anything

else that could be dangerous if you

are drowsy.

As with other medicines, allopurinol

may cause drowsiness, dizziness or

lack of co-ordination in some people.

Side effects of

allopurinol

This may increase the chance of you

medicine to relieve the acute attack.

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or pharmacist or the Poisons

Information Centre (telephone 13

11 26), or go to Accident and

Emergency Department at your

nearest hospital, if you think that

you or anyone else may have taken

too many allopurinol.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much allopurinol, you

may feel some or all of the

following:

• nausea

• vomiting

• diarrhoea

• dizziness.

While you are taking

allopurinol

Things you must do

You must immediately stop taking

allopurinol if a skin rash or signs

You can continue taking allopurinol.

Tell any other doctors, dentists or

pharmacists who are treating you that

you are taking allopurinol.

Tell your doctor immediately if you

become pregnant while you are

taking this medicine.

If you are about to have any surgery,

tell the surgeon, dentist or doctor that

you are taking this medicine.

If you are about to be started on any

new medicine, tell your doctor,

dentist or pharmacist that you are

taking this medicine.

If you are about to have any blood

tests, tell your doctor that you are

taking this medicine.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do

tests to make sure this medicine is

working and to prevent side effects.

Things you must not do

Do not take this medicine to treat

an acute attack of gout.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do not take this medicine to treat any

other complaints unless your doctor

tells you to.

Do not stop taking your medicine, or

change the dosage, without checking

with your doctor

All medicines may have some

unwanted side effects. Sometimes

they are serious, but most of the time

they are not.

If you are over 65 years of age, have

kidney and/or liver problems, you

may have an increased chance of

getting side effects.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking allopurinol.

Ask your doctor or pharmacist to

answer any questions you may have.

Following is a list of possible side

effects. Do not be alarmed by this

list. You may not experience any of

them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

stomach upsets, including nausea,

vomiting or diarrhoea

dizziness, drowsiness or

unsteadiness when walking

• change in bowel habits

• headache

• change in taste sensation

• sleeplessness

• hair loss or change in hair colour.

These are the more common side

effects of allopurinol. Mostly these

are mild and short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

• changes in vision

tingling or numbness of the hands

or feet

fever, chills, sore throat or mouth

ulcers

a change in the amount of urine

passed, going to the toilet more

often or a burning feeling while

passing urine

• blood in your urine

• yellowing of the skin and eyes

(jaundice)

generally feeling of being unwell

or depressed

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

• bleeding or bruising more easily

• angina or palpitations

swelling of the hands, ankles or

legs.

These may be serious side effects.

You may need medical attention.

Most of these side effects are rare.

If any of the following happen, stop

taking your medicine and tell your

doctor immediately or go to

Accident and Emergency of your

nearest hospital:

asthma, wheezing or shortness of

breath

swelling of the face, lips, tongue

or throat which may cause

difficulty in breathing

• sudden or severe itching, skin

rash or hives, other skin problems

• fainting, seizures or fits

• pain or tightness in the chest.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are rare.

Other side effects not listed above

may occur in some patients.

Tell your doctor or pharmacist if you

notice anything that is making you

feel unwell.

After taking this

medicine

Storage

Keep your medicine in its original

packaging until it is time to take

them.

If you take the tablets out of their

original packaging they may not keep

well.

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink.

Do not leave it on a window sill or

in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells you

to stop taking this medicine or it has

passed its expiry date, ask your

pharmacist what to do with any

medicine that is left over.

Where to go for further

information

Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice on

the treatment of your condition.

Product description

What Chemmart Allopurinol

looks like

100 mg tablets:

White, to off-white, round, biconvex

tablets coded with “U4A” and scored

on the upper face and bottom face

plain.

They are packed in a bottle of

200 tablets.

300 mg tablets:

White, round, biconvex tablets coded

with “C9B” and scored on the upper

face and bottom face plain.

They are packed in a blister pack of

60 tablets.

Ingredients

Each tablet contains 100 mg or

300 mg of allopurinol as the active

ingredient.

It also contains the following inactive

ingredients:

povidone

maize starch

lactose monohydrate

magnesium stearate

This medicine contains lactose but is

gluten-free,

sucrose-free,

tartrazine-

free and free of other azo dyes.

Australian Registration

Numbers

Chemmart Allopurinol 100mg:

AUST R 219912

Chemmart Allopurinol 300mg:

AUST R 219913

Sponsor

Arrow Pharma Pty Ltd

15 – 17 Chapel Street

Cremorne VIC 3121

Chemmart is a registered trade mark

of Symbion Pty Ltd.

Date of last update

February 2017

22-8-2018

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