INFORMATION FOR CONSUMERS
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This leaflet answers some common questions about Plaquenil Tablets. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. In deciding to give you Plaquenil, your doctor has weighed the risks of taking Plaquenil against the benefits it will have for you.
Keep this information with the tablets. You may wish to read it again later.
Plaquenil may be used for any of the following conditions:
Rheumatoid arthritis is a form of arthritis with inflammation of the joints,
characterised by stiffness, swelling and pain. Plaquenil may be used for short
or long-term rheumatoid arthritis treatment.
In treating rheumatoid arthritis, Plaquenil may slow down the substances which
harm the joints.
SLE is a disease in which a person's normal immunity is upset. The body
produces an excess of blood proteins called antibodies and these antibodies may
cause problems in any organ of the body.
These antibodies may end up, for example, in the skin causing a variety of skin
rashes or deposit in the kidney, brain, lung and joints causing injury.
DLE is similar to SLE except it only affects the skin and is characterised by a scaling, red rash.
Malaria is an infectious disease caused by the presence of parasites in red
blood cells.
The disease is characterised by chills, fever and sweats.
In malaria, Plaquenil destroys the harmful parasite which causes the illness.
Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why Plaquenil has been prescribed for you.
Plaquenil is not addictive. This medicine is available only with a doctor's prescription.
Do not take Plaquenil if you have ever had an allergic reaction to hydroxychloroquine, chloroquine, or related products or any of the ingredients listed under "Product Description".
If you are uncertain whether you have had an allergic reaction to a
related product ask your doctor or pharmacist.
The symptoms of an allergic reaction may include an asthma attack, facial
swelling, skin rash or hay fever.
Ask your doctor about the risks and benefits of taking Plaquenil while you
are pregnant.
When Plaquenil is taken for long periods of time, there is an increased risk to
the unborn child. It may cause problems with brain function, hearing, balance
and vision.
Ask your doctor about the risks and benefits of taking Plaquenil while you are breastfeeding.
Do not take Plaquenil if you have previously experienced changes in your eyesight when taking medicines for rheumatoid arthritis or malaria.
Plaquenil should not be used in children under 6 years.
Plaquenil should not be used in children over 6 years for long periods.
Do not take Plaquenil after the expiry date printed on the bottle.
It may have no effect at all, or worse, an entirely unexpected effect if you
take it after the expiry date.
Do not take Plaquenil if the bottle is damaged or shows signs of tampering.
Do not take Plaquenil to treat any other complaint unless your doctor says it is safe. Do not give this medicine to anyone else.
You must tell your doctor if:
If you have not told your doctor about any of these things, tell him/her before you take any Plaquenil.
Tell your doctor 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 may interfere with Plaquenil. These include:
These medicines may be affected by Plaquenil or affect the way Plaquenil works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
Swallow tablets whole with a little water or other liquid.
It is best to take Plaquenil at meal times.
The dosage will depend on why you are being treated with Plaquenil.
The usual doses are:
2-3 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.
2-4 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.
2 tablets once a week. The tablets should be taken on exactly the same day of each week.
For example, if your first dose is taken on a Monday, then each weekly dose should be taken on a Monday.
The starting dose is 4 tablets. Take another 2 tablets six to eight hours later and two further tablets on each of the next 2 days.
Always follow the instructions given to you by your doctor.
Dosages for children are calculated according to the child's body weight.
Your doctor will work out the correct dose for you.
Plaquenil should not be used in children for long periods.
Your doctor may ask you to take a different dose. You should follow the
instructions on the label.
If you are unsure what dose to take ask your pharmacist or doctor.
If you are being given Plaquenil for rheumatoid arthritis or SLE or DLE, do not take a double dose to make up for the dose missed. Just continue with the appropriate dose on the next day.
If you are being given Plaquenil for suppression or treatment of malaria, you should take your tablets as soon as you remember, and go back to taking it as you would normally.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
Immediately telephone your doctor, or the Poisons Information Centre (in Australia telephone 13 11 26 and in New Zealand telephone 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Plaquenil.
Do this even if there are no signs of discomfort or poisoning. You may
need urgent medical attention.
If you take too many tablets you may experience headaches, drowsiness, visual
disturbances or fits.
These symptoms may occur within 30 minutes of overdose.
Your doctor will need to perform the following tests during treatment with Plaquenil:
Your doctor will need to perform some eye tests every few months to check that your eyesight is not changing.
In extremely rare cases, Plaquenil has been associated with blindness.
This can be avoided by having regular eye tests.
It is recommended you wear sunglasses when out in the sun.
Your doctor will need to perform occasional blood tests to check for any blood reactions.
Be careful driving or operating machinery until you know how Plaquenil
affects you.
Plaquenil may cause problems with the eyesight of some people. Make sure you
know how you react to Plaquenil before you drive a car, operate machinery, or do
anything else that could be dangerous with blurred vision.
Tell your doctor or pharmacist as soon as possible if you do not feel well
while taking Plaquenil.
Plaquenil helps most people with rheumatoid arthritis, SLE, DLE, treatment of
malaria and the control of malaria symptoms, but it may have unwanted side
effects in a few people.
All medicines can have side effects. Some times 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 to answer any questions.
Tell your doctor if you notice any of the following and they worry you:
Stomach problems such as:
Other problems such as:
If you already have psoriasis, you are more likely to experience skin reactions than other people when taking Plaquenil.
Tell your doctor if you notice any of the following:
These are serious side effects. You may need urgent medical attention.
Serious side effects are rare.
Tell your doctor if you notice anything else that is making you feel
unwell.
Some people may get other side effects while taking Plaquenil.
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they will not keep well.
Keep it in a cool dry place where the temperature stays below 25°C.
Heat and dampness can destroy some medicines. Do not leave Plaquenil in the car
on hot days.
Do not store Plaquenil or any other medicine in the bathroom or near a sink.
Keep Plaquenil where young children cannot reach it.
Children are particularly sensitive to the unwanted effects of Plaquenil.
A locked cupboard at least one and a half metres above the ground is a good
place to store medicines.
If your doctor tells you to stop taking the tablets, ask your pharmacist what to do with any tablets that are left over.
Plaquenil comes as white to off-white peanut shaped tablets marked "PLAQUENIL" with black ink. A bottle contains 100 tablets.
Each Plaquenil tablet contains 200 mg hydroxychloroquine sulfate.
AUST R 50055
Plaquenil is supplied by in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Plaquenil is supplied in New Zealand by:
sanofi-aventis new zealand ltd
56 Cawley St
Ellerslie, Auckland, New Zealand
Phone: (09) 580 1810
This leaflet was prepared in October 2006