INFORMATION FOR CONSUMERS

Home  |  Consumers  |  Health Professionals  |  Regulatory  |  Other  |  Hot Topics  |  Search

Consumer Medicine Information

PROGOUT

Allopurinol 100 mg & 300 mg Tablets

What is in this leaflet

This leaflet answers some common questions about PROGOUT. It does not contain all the information available on this medicine. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PROGOUT against the benefits they expected it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may want to read it again.

What PROGOUT is used for and how it works

Your PROGOUT tablets contain the active ingredient allopurinol. PROGOUT belongs to a group of medicines called anti-uricaemics. These medicines work by reducing the formation and accumulation of uric acid in the body. Excess amounts of uric acid in the blood may lead to the development of crystals which deposit in the joints, causing pain, swelling and tenderness.

PROGOUT is used in the treatment of

• gout or gouty arthritis (a condition of painful swollen joints caused by uric acid crystals)
• kidney stones (uric acid crystals in the kidney)
• skin tophi (uric acid crystals beneath the skin)
• other rare conditions where high levels of uric acid occur in the blood (eg. Lesch-Nyhan syndrome)

PROGOUT helps to treat the symptoms of these conditions but will not cure them. It will not help treat the pain that occurs in an acute attack of gout.

Your doctor may have prescribed PROGOUT for another reason. Ask your doctor if you have any questions about why PROGOUT has been prescribed for you.

There is no evidence that PROGOUT is addictive.

PROGOUT is available only with a prescription from your doctor.

Before you take PROGOUT

When you must not take it

Do not take PROGOUT if you are allergic to medicines containing allopurinol, or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.

Do not take PROGOUT if:

• you or a member of your immediate family have haemochromatosis, a condition where there is too much iron in the body, and you are also taking iron salts at the same time
• you are having an acute attack of gout.

Before you start taking it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.
Your doctor will discuss the risks and benefits of taking PROGOUT during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed.
PROGOUT passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of taking PROGOUT when breastfeeding.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

• liver problems
• kidney problems
• high blood pressure
• heart failure or other heart problems
• diabetes mellitus
• cancer or tumours.

Your doctor may want to take special care of you if you have any of these conditions.

Tell your doctor if you plan to have surgery.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any you get without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may be affected by PROGOUT, or may affect how well it works. These include:

• mercaptopurine (Puri-Nethol), a medicine used to treat some cancers
• azathioprine (Thioprine, Imuran) and cyclosporin (Neoral, Sandimmun), medicines used to prevent organ transplant rejection or to treat certain immune system problems
• aspirin and other salicylates
• probenecid, a medicine used to treat gout
• warfarin (Coumadin, Marevan), a medicine used to prevent blood clots
• phenytoin (Dilantin), a medicine for epilepsy
• theophylline (Nuelin), a medicine for asthma
• antibiotics called amoxycillin (Amoxil, Apo-Amoxi, Ospamox, Augmentin) and ampicillin
• thiazide diuretics or fluid tablets (eg. Amizide, Navidrex)
• chlorpropamide, a medicine for diabetes

Your doctor can tell you what to do if you are taking any of these medicines. If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking PROGOUT.

How to take PROGOUT properly

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.

How much to take

The dose varies from person to person. Your doctor will tell you how many tablets you need to take each day.

In adults, the usual dose is 100 mg to 200 mg daily for mild conditions, 300 mg to 600 mg daily for moderately severe conditions and 700 mg to 900 mg daily for severe conditions.

Elderly people over 65 years of age and those with kidney or liver problems may need smaller doses.

For children under 15 years of age the dose is calculated according to body weight. The maximum dose used in children is usually 400 mg daily.

Your doctor may advise you to take a different dose. This depends on your condition and whether or not you are taking any other medicines.

How to take it

Swallow the tablets with a glass of water.

It is important to drink at least 2 litres of fluid each day when you have high levels of uric acid in the blood.

When to take it

Take PROGOUT during or immediately after a meal. This will lessen the chance of a stomach upset.

PROGOUT is usually taken once a day. However, if your dose is higher than 300 mg a day, your doctor may advise you to take it morning and night.

How long to take it

To properly control your condition, PROGOUT must be taken every day. PROGOUT will not cure your condition but will help control pain, stiffness and other symptoms.

Keep taking PROGOUT for as long as your doctor recommends.

If you forget to take it

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 the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

Taking your medicine at the same time each day may help you to remember to take it regularly. If you have trouble remembering to take your medicine, ask you pharmacist for some hints.

While you are taking PROGOUT

Things you must do

Drink at least 2 litres (8 to 10 glasses) of fluid each day.
This will help to reduce the levels of uric acid in your body and prevent the formation of kidney stones.

Stop taking PROGOUT immediately if you develop a skin rash or any other sign of an allergic reaction.

Before starting any new medicine, tell your doctor or pharmacist that you are taking PROGOUT.

Tell all doctors, dentists and pharmacists who are treating you that you are taking PROGOUT.

If you become pregnant while taking PROGOUT, tell your doctor immediately.

Visit your doctor regularly so they can check on your progress.
You may need to have blood or urine tests.

Tell your doctor if you feel PROGOUT is not helping your condition. If you continue to have painful attacks of gout your doctor may need to adjust your treatment.

Tell your doctor if, for any reason, you have not taken PROGOUT exactly as prescribed. Otherwise, your doctor may adjust your treatment unnecessarily.

Things you must not do

Do not take PROGOUT to treat an acute attack of gout.
Your doctor will prescribe another medicine such as colchicine or a non-steroidal anti-inflammatory drug (NSAID) to relieve an acute attack of gout.

Do not use PROGOUT to treat any other conditions unless your doctor tells you to.

Do not give PROGOUT to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how PROGOUT affects you.
PROGOUT may cause drowsiness, dizziness or lack of co-ordination in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Avoid drinking alcohol while taking PROGOUT.
Combining PROGOUT and alcohol can make you more sleepy, dizzy or lightheaded. Alcohol may also increase the formation of uric acid.

Certain foods are best avoided when you have gout.
Food such as organ meats, anchovies and yeast extracts can increase the levels of uric acid in your body. Ask your doctor or pharmacist for more advice about which foods to avoid

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking PROGOUT.

PROGOUT helps most people with gouty arthritis and kidney stones, but it may have unwanted side effects in some people.

Side effects only occur rarely in people taking PROGOUT. Most of the time they are minor. You may need medical treatment if you get some of the side effects.

People with liver and kidney problems have an increased chance of experiencing side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

• nausea, vomiting
• headache
• drowsiness, dizziness, unsteadiness when walking
• change in taste sensation
• change in bowel habits
• hair loss or discolouration

These reactions are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

• signs of liver problems such as yellowing of the skin and eyes, dark coloured urine and generally feeling unwell
• tingling or numbness of the hands or feet
• visual disturbances
• excessive thirst, going to the toilet more often, a burning feeling when passing urine
• blood in the urine
• frequent infections such as fever, severe chills, sore throat or mouth ulcers
• bleeding or bruising more easily than normal
• swelling of the hands, feet or ankles
• general feeling of being unwell or depression

These side effects can be serious and you may need medical attention.

If any of the following happen, stop taking PROGOUT and tell your doctor immediately, or go to the Accident and Emergency Department at the nearest hospital:

• severe itching, skin flaking, skin rash or hives
• swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
• wheezing or shortness of breath
• pain or tightness in the chest
• fits or seizures.

These are very serious yet rare side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor of you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some patients. Some of these side effects (eg. high blood pressure) can only be found when your doctor does tests from time to time to check your progress.

In case of overdose

You should only take the number of tablets that you have been told.

Immediately contact your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) or go to the Emergency department at your nearest hospital, if you think that you may have taken too much, or if anyone else has taken any PROGOUT by mistake. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Take the container of PROGOUT with you if you can.

Keep telephone numbers for these places handy.

Storage conditions

Keep PROGOUT 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.

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store PROGOUT, or any other medicine, in the bathroom or near a sink. Do not leave it in the car or on windowsills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking PROGOUT, or if the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

PROGOUT tablets are available in 2 strengths:
PROGOUT 100 - round, white tablet marked "AL" above "100" on one side.
PROGOUT 300 - round, white tablet marked "AL" above "300" on one side

Ingredients

The active ingredient in PROGOUT is allopurinol.

Each PROGOUT 100 tablet contains 100 mg of allopurinol. Each PROGOUT 300 tablet contains 300 mg of allopurinol.

Each PROGOUT tablet also contains lactose monohydrate, maize starch, povidone, sodium starch glycollate and magnesium stearate.

If you want to know more

Should you have any questions regarding this product, please contact your doctor or pharmacist.

Who supplies this medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,
P O Box 11183,
Ellerslie,
Auckland.

Telephone: (09) 579 2792

Date of information

2 February 2009
(Based on datasheet dated 2 February 2009)