Plaquenil Tablets

Hydroxychloroquine Sulfate

What is in this leaflet

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.

What is Plaquenil used for

Plaquenil may be used for any of the following conditions:

Rheumatoid arthritis

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.

Systemic Lupus Erythematous (SLE)

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.

Discoid Lupus Erythematous (DLE)

DLE is similar to SLE except it only affects the skin and is characterised by
a scaling, red rash.

Malaria (treatment and control of symptoms)

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.

Before you take Plaquenil

When you must not take Plaquenil

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.

Before you start to take Plaquenil

You must tell your doctor if:

• You are allergic to quinine.
• You have allergies to any ingredients listed under "Product Description"
  at the end of this leaflet.
• You have any pre-existing eye disorders.
• You have any of these medical conditions:
  • Chloroquine-resistant malaria
  • Liver or kidney problems
  • Stomach, brain or blood disorders
  • Skin diseases, in particular psoriasis which is a kind of itchy rash.
  • Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency which is a lack of
    a chemical substance which causes the breakdown of sugar in the body.
  • Porphyria, which is a rare disease of blood pigments.

If you have not told your doctor about any of these things, tell him/her
before you take any Plaquenil.

Taking Plaquenil with other medicines

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:

• Any medicine to treat depression
• Digoxin - a medicine used to treat heart disease
• Medicines to treat diabetes.

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.

How to take Plaquenil

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:

Rheumatoid arthritis

Adults

2-3 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.

SLE and DLE

Adults

2-4 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.

Control of Malaria Symptoms

Adults

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.

Treatment of malaria

Adults

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 forget to take Plaquenil

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.

If you take too much Plaquenil (Overdose)

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.

While you are taking Plaquenil

Your doctor will need to perform the following tests during treatment with
Plaquenil:

Eye Tests

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.

Blood Reactions

Your doctor will need to perform occasional blood tests to check for any
blood reactions.

Driving/Operating Machinery

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.

Side Effects

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:

Less serious side effects

Stomach problems such as:

• Nausea
• Vomiting
• Diarrhoea
• Abdominal cramps

Other problems such as:

• Muscle weakness
• Dizziness
• Ringing in the ears
• Headache
• Nervousness
• Skin rash
• Hair loss

If you already have psoriasis, you are more likely to experience skin
reactions than other people when taking Plaquenil.

More serious side effects

Tell your doctor if you notice any of the following:

• Visual disturbances
• Any hearing loss
• Frequent fevers, severe chills, bruising, sore throat or mouth ulcers
  (these may be signs of blood reactions)

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.

After taking Plaquenil

Storage

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.

Disposal

If your doctor tells you to stop taking the tablets, ask your pharmacist
what to do with any tablets that are left over.

Product Description

What Plaquenil looks like

Plaquenil comes as white to off-white peanut shaped tablets marked
"PLAQUENIL" with black ink. A bottle contains 100 tablets.

Ingredients

Active Ingredient

Each Plaquenil tablet contains 200 mg hydroxychloroquine sulfate.

Other ingredients

• Calcium Hydrogen Phosphate
• Starch-Maize
• Magnesium Stearate
• Water-Purified
• Opadry, White (YS-1-7443)
• Macrogol
• Carnauba Wax
• Black Ink