APO-ALLOPURINOL

Main information

  • Trade name:
  • APO-ALLOPURINOL allopurinol 300 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-ALLOPURINOL allopurinol 300 mg tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218875
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218875

APO-ALLOPURINOL allopurinol 300 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Arrow Pharma Pty Ltd

Postal Address

15 - 17 Chapel Street,Cremorne, VIC, 3121

Australia

ARTG Start Date

25/07/2014

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"

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. APO-ALLOPURINOL allopurinol 300 mg tablets blister pack

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

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 phosphoribosyltransferase including Lesch-Nyhan syndrome, glucose

6-phosphatase including glycogen storage disease, phosphoribosylpyrophosphate synthetase, phosphoribosylpyrophosphate

amidotransferase.,APO-ALLOPURINOL is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of

adenine phosphoribosyl transferase.,APO-ALLOPURINOL is indicated for the management of recurrent 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

Blister Pack

PVC/Al

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APO-ALLOPURINOL allopurinol 300 mg tablets blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:15:42 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

Visual Identification

White, biconvex, round tablets, coded "C9B" and scored on upper face,

bottom face plain

Active Ingredients

Allopurinol

300 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 04:15:42 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

APO-ALLOPURINOL™ Tablets

APO-ALLOPURINOL™

Tablets

Contains the active ingredient allopurinol

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

This leaflet answers some common

questions about APO-

ALLOPURINOL (Allopurinol

tablets).

It does not contain all of the available

information about APO-

ALLOPURINOL tablets.

It does not replace talking to your

doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you or your child taking

APO-ALLOPURINOL against the

benefits he or she expects it will

have.

Ask your doctor or pharmacist if

you have any concerns about

taking this medicine.

Keep this leaflet with the medicine.

You may need to read it again.

What this medicine is

used for

The name of your medicine is APO-

ALLOPURINOL and is available in

tablets of two different strengths.

The active ingredient is called

allopurinol.

Allopurinol belongs to a group of

medicines called anti-uricaemic

agents and is used to reduce the

amount of uric acid in the body. Most

commonly, high levels of uric acid in

the body are related to gout.

APO-ALLOPURINOL is available

as a 100 mg and 300 mg tablet.

APO-ALLOPURINOL is used to

treat high levels of uric acid in the

blood (hyperuricaemia) associated

with gout or some other conditions.

Your doctor will identify these other

conditions if necessary, as they are

very uncommon (e.g. Lesch-Nyhan

Syndrome).

Your doctor however, may have

prescribed APO-ALLOPURINOL

for another purpose not listed above.

Ask your doctor if you have any

questions about why APO-

ALLOPURINOL has been

prescribed for you.

If you have any concerns, you should

discuss this with your doctor.

This medicine is only available with

a doctor’s prescription.

Before you take this

medicine

When you must not take it

Do not take APO-ALLOPURINOL if

you are allergic to:

Allopurinol or any of the

ingredients listed at the end of

this leaflet including lactose.

Some of the symptoms of an allergic

reaction to APO-ALLOPURINOL

may include hives and other skin

rashes, difficulty breathing, hay

fever, swelling of the face or throat

or faintness.

Do not take APO-ALLOPURINOL

after the expiry date (EXP.)

printed on the pack.

If you take it after the expiry date has

passed, it may have no effect at all,

or worse, there may be an entirely

unexpected effect.

Do not purchase or take APO-

ALLOPURINOL if the packaging

is torn or shows signs of

tampering.

Do not take the tablets if they do

not look quite right.

If you are not sure whether you

should start taking APO-

ALLOPURINOL, contact your

doctor or pharmacist.

Do not give your medicine to

children unless your doctor has

prescribed it.

Before you start to take it

You must tell your doctor if you are:

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

APO-ALLOPURINOL™ Tablets

Some of the symptoms of an allergic

reaction to APO-ALLOPURINOL

may include shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or

other parts of the body; rash, itching

or hives on the skin.

You have or have had any

medical conditions, especially the

following:

kidney disease

liver disease

high blood pressure

diabetes

epilepsy

heart disease

haemochromatosis (a disease

involving excessive deposits of

iron in the body).

3. You are currently pregnant or

you plan to become pregnant.

APO-ALLOPURINOL like all

medicines should not be used during

pregnancy, unless your doctor tells

you to.

4.You are currently breastfeeding

or you plan to breast-feed.

5. Having an attack of gout

If you are having an attack of gout

before starting APO-

ALLOPURINOL, you should tell

your doctor and wait for the attack to

subside before starting APO-

ALLOPURINOL. If an acute attack

of gout does occur when you are

already taking APO-

ALLOPURINOL, it should be

continued. Do not stop taking this

medicine during an attack of gout

unless advised by your doctor.

When you first start taking APO-

ALLOPURINOL, it may make the

symptoms of gout attack temporarily

worse. During an acute gout attack,

it is important to continue taking the

medicines prescribed for gout attack

relief while you are taking APO-

ALLOPURINOL.

If you have not told your doctor

about any of the above, tell him or

her before you start to take APO-

ALLOPURINOL.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may interfere with

APO-ALLOPURINOL.

These include:

Aspirin (a drug which is used to

treat headache, pain,

inflammation, clotting or high

temperatures). Other salicylate

type drugs are also included. Ask

your pharmacist.

Coumarin type anticoagulant

drugs, medicine used to prevent

blood clots (e.g. warfarin)

Other medicines used to treat

gout or hyperuricaemia such as

probenecid (Benemid)

Some medicines used to suppress

the immune system such as

azothioprine (Imuran), 6-

mercaptopurine and cyclosporin

Some medicines used to treat

epilepsy such as phenytoin

(Dilantin)

Theophylline (a drug used to treat

asthma)

Ampicillin or amoxycillin, which

are two commonly used

antibiotics used to treat bacterial

infections

Chlorpropamide (Diabinese) used

to treat diabetes

Medicines containing thiazide

diuretics, used to decrease blood

pressure and fluid retention (e.g.

Chlorothiazide,

hydrochlorothiaide,

bendrofluazide)

The above medicines may reduce the

effectiveness of APO-

ALLOPURINOL, reduce its own

effectiveness and/or react with APO-

ALLOPURINOL resulting in

untoward or sometimes dangerous

side effects.

This list is not exhaustive. Your

doctor or pharmacist has more

information on medicines to be

careful with or avoid while taking

APO-ALLOPURINOL.

How to take this

medicine

How to take it

Swallow the tablets with plenty of

water and after food to reduce the

possibility of gastric upset.

When to take it

Take APO-ALLOPURINOL

immediately after meals at the

frequency directed by your doctor.

For example, morning and night,

after breakfast and dinner for a twice

daily dosage.

If you forget to take it

If your dosing schedule is one dose

a day, take the missed dose as soon

as possible, but not later than 4

hours before your next dose.

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking it as you would normally.

Do not take a double dose to make

up for the dose that you missed.

Speak to your doctor or

pharmacist if you are unsure about

whether to take your next dose.

Do not try to make up for missed

doses by taking more than one dose

at a time. This may increase the

chance of you getting an unwanted

side effect.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

APO-ALLOPURINOL™ Tablets

If you take too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

your nearest hospital, if you think

that you or anyone else may have

taken too much APO-

ALLOPURINOL. Do this even if

there are no signs of discomfort or

poisoning. Also, report any other

medicines or alcohol which has

been taken. You may need urgent

medical attention.

Keep telephone numbers for these

places handy.

If you take too much APO-

ALLOPURINOL you may have the

following symptoms: nausea,

vomiting, diarrhoea and dizziness.

While you are taking

this medicine

Things you must do

Immediately stop taking APO-

ALLOPURINOL and check with

your doctor if a skin rash or other

allergic reaction occurs.

Take your medicine exactly as your

doctor has prescribed.

It is important to drink at least 2 litres

of fluid per day. This will help

prevent kidney stones.

APO-ALLOPURINOL helps

prevent, but does not relieve gout

attacks. It is important that you

continue taking APO-

ALLOPURINOL with the

medication prescribed for gout

attacks.

Tell all doctors, dentists and

pharmacists who are treating you that

you are taking this medicine.

Tell your doctor (immediately) if you

become pregnant while you are

taking it.

Visit your doctor regularly. Your

doctor needs to check your progress

and see whether you need to keep

taking APO-ALLOPURINOL.

Always discuss with your doctor any

problems or difficulties during or

after taking APO-ALLOPURINOL.

Tell your doctor if for any reason,

you have not taken your medicine

exactly as prescribed. Otherwise your

doctor may think that it was not

effective and change your treatment

unnecessarily.

Keep enough APO-ALLOPURINOL

to last weekends and holidays.

Things you must not do

Do not take any other medicine while

you are taking APO-

ALLOPURINOL without first telling

your doctor.

Do not drive, operate machinery,

or participate in any dangerous

activities where alertness is

required, until you know how

APO-ALLOPURINOL affects you.

APO-ALLOPURINOL may cause

dizziness and affect co-ordination in

some people. Therefore, it may affect

alertness or concentration. it can also

affect your eyesight.

Make sure you know how you react

to this medicine before you drive a

car, operate machinery or do

anything else that could be dangerous

if you are dizzy or have affected

vision.

Do not take APO-ALLOPURINOL

for a longer time than your doctor

has prescribed.

Do not change your dose without

first checking with your doctor.

Do not stop taking it or lower the

dose without checking first with your

doctor.

Stopping this medicine suddenly on

your own accord may cause some

unwanted and dangerous effects, or

your condition may reappear.

Your doctor will advise you when

you can stop taking APO-

ALLOPURINOL completely.

Do not take this medicine to treat any

other complaints unless your doctor

tells you to.

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking APO-

ALLOPURINOL.

APO-ALLOPURINOL helps most

people with the medical conditions

listed in the beginning of this leaflet,

but it may have unwanted side effects

in some people.

All medicines have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Ask your doctor or pharmacist any

questions you may have.

Common side effects:

The most common side effect is

skin rash. Stop treatment with

APO-ALLOPURINOL

immediately and contact your

doctor if a rash does occur.

Tell your doctor if you notice any

of the following:

nausea (feeling sick)

oedema (swelling)

high blood pressure

abdominal pain

headache

dizziness

skin rash

vomiting

blurred vision

unexplained nosebleeds

There are other side effects that

occur less often.

If any of the following happen, stop

taking APO-ALLOPURINOL and

tell your doctor immediately or go

APO-ALLOPURINOL™ Tablets

to Accident and Emergency at

your nearest hospital:

fatty stools

going to the toilet often

blood in the urine

hair loss

general malaise or depression

sleepiness

confusion or vision problems

numbness in the limbs

angina (chest pain involving the

heart)

severe palpitations

rash, itching or hives on the skin

swelling of the face, lips, tongue

or other parts of the body

wheezing, shortness of breath, or

trouble breathing

pain or tightness in the chest

if chills, fever, joint pain or

swollen glands occur, especially

if they occur together with or

shortly after a skin rash

These are serious side effects.

You may need urgent medical

attention.

Serious side effects are rare.

Some people may get other side

effects when taking APO-

ALLOPURINOL.

Your doctor may lower the dose to

help control any serious side effects

and decide on the necessary tests to

monitor any of the above

problems.

Check with your doctor as soon as

possible if you have any problems

while taking APO-

ALLOPURINOL, even if you do

not think the problems are

connected with the medicine or are

not listed in this leaflet.

Storage and disposal

Storage

Keep it where children cannot

reach it.

A locked cupboard at least one and a

half metres above the floor is a good

place to store medicines.

Keep APO-ALLOPURINOL in a

cool dry place where the

temperature stays below 30

°C and

protect from light. Do not store it

or any other medicines in a

bathroom or near a sink.

Do not leave it in the car or on

windowsills.

Heat and dampness can destroy some

medicines.

Keep your tablets in the packs or

bottles they were provided in until

it is time to take them.

Disposal

If your doctor tells you to stop

taking this medication OR it has

passed the expiry date, ask your

pharmacist what to do with any

left over.

Product description

What it looks like

APO-ALLOPURINOL 100 mg

tablets are white to off-white,

biconvex, round tablets coded with

“U4A” and scored on the upper face,

bottom face plain; in bottles of 200.

APO-ALLOPURINOL 300 mg

tablets are white, biconvex, round

tablets coded with “C9B” and scored

on the upper face, bottom face plain;

in blister packs of 60.

Ingredients

Each APO-ALLOPURINOL 100 mg

and 300 mg tablet contains the active

ingredient allopurinol.

The non-active ingredients in each

APO-ALLOPURINOL tablet are:

povidone

maize starch

lactose monohydrate

magnesium stearate

APO-ALLOPURINOL tablets

contain lactose but do not contain

gluten or sucrose.

Sponsor or Supplier

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

Australian Registration

Numbers

APO-ALLOPURINOL 100 mg

AUST R 218874

APO-ALLOPURINOL 300 mg

AUST R 218875

This leaflet was last updated in:

February 2017

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