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Plaquenil

hydroxychloroquine sulfate
Consumer Medicine Information (CMI)
Please read this leaflet before you start to take this medicine.
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Plaquenil. It does not contain all the information that is known about Plaquenil. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

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 process of joint damage and relieve the symptoms of the disease.

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 experienced low blood sugar levels (hypoglycaemia - a "hypo"). Plaquenil may increase the risk of you having a hypo.
You have or have had any of these medical conditions:
Chloroquine-resistant malaria
Liver or kidney problems
Diabetes
Stomach, brain or blood disorders
Disease of the heart muscle
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
Medicines used to suppress the immune system such as cyclosporin
Antiarrythmic drugs such as amiodarone
Other antimalarial drugs
Medicines to treat epilepsy
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, 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 764766), 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

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Plaquenil.
Tell all doctors, dentists and pharmacists who are treating you that you are taking Plaquenil.
Tell your doctor if you experience any of the following symptoms including; weakness, trembling or shaking, sweating, light-headedness, headache, dizziness, lack of concentration, tearfulness or crying, irritability, hunger and numbness around the lips and fingers.
These symptoms may be associated with hypoglycaemia.
If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose urgently. You can do this by taking one of the following:
5-7 jelly beans
3 teaspoons of sugar or honey
1/2 can of ordinary (non-diet) soft drink
2-3 concentrated glucose tablets
unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates e.g. plain biscuits, fruit or milk - when over the initial symptoms. Taking this extra carbohydrate will prevent a second drop in your blood glucose level.
Make sure you, your friends, family and work colleagues can recognise the symptoms of hypoglycaemia and know how to treat them.
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 Tests

Your doctor will need to perform occasional blood tests to check for any blood reactions.
Your doctor may monitor your blood sugar levels if you have experienced hypoglycaemia while taking Plaquenil.

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. 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 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:
Loss of appetite
Muscle weakness
Dizziness
Ringing in the ears
Headache
Nervousness
Skin rash and itching
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
Suicidal behaviour
Frequent fevers, severe chills, bruising, sore throat or mouth ulcers (these may be signs of blood reactions)
More severe symptoms of hypoglycaemia, including:
disorientation
seizures, fits or convulsions
loss of consciousness
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 200mg hydroxychloroquine sulfate.
Other ingredients
Calcium Hydrogen Phosphate
Starch-Maize
Magnesium Stearate
Water-Purified
hypromellose
Macrogol 400
Titanium dioxide
Polysorbate 80
Carnauba Wax
Black Ink

Australian Registration Number

AUST R 50055

Supplier

Plaquenil is supplied 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 limited
56 Cawley St
Ellerslie, Auckland, New Zealand
Phone: (09) 580 1810
This leaflet was prepared in April 2014.
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