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.
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
- heart disease
- haemochromatosis (a disease involving excessive deposits of iron in the body).
- 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.
- You are currently breastfeeding or you plan to breast-feed.
- 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.
- 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.
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
- skin rash
- 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 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
- 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
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.
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.
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.
Each APO-ALLOPURINOL 100 mg and 300 mg tablet contains the active ingredient allopurinol.
The non-active ingredients in each APO-ALLOPURINOL tablet are:
- 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
Published by MIMS August 2017