Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Plaquenil?
Plaquenil contains the active ingredient hydroxychloroquine sulfate. Plaquenil is
used to treat rheumatoid arthritis and may slow down the process of joint damage and
relieve the symptoms of the disease. For more information, see Section
1. Why am I using Plaquenil? in the full CMI.
2. What should I know before I use Plaquenil?
Do not use if you have ever had an allergic reaction to hydroxychloroquine sulfate
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use Plaquenil? in the full CMI.
3. What if I am taking other medicines?
4. How do I use Plaquenil?
Swallow tablets whole with a little water or other liquid at mealtimes. The dosage
will depend on why you are being treated with Plaquenil. More instructions can be
found in Section
4. How do I use Plaquenil? in the full CMI.
5. What should I know while using Plaquenil?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Plaquenil.
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Things you should not do
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Plaquenil should not be used in children under 6 years.
Plaquenil should not be used in children over 6 years for long periods.
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Driving or using machines
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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.
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Looking after your medicine
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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.
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6. Are there any side effects?
Speak to your doctor if you have any of these less serious side effects and they worry
you: nausea, vomiting, diarrhoea, abdominal cramps, loss of appetite, muscle weakness,
dizziness, ringing in the ears, headache, nervousness, skin rash and itching, hair
loss. Call your doctor straight away or go to the Emergency Department at your nearest
hospital if you have any of these serious side effects: visual disturbances, hearing
loss, suicidal behavior, frequent fevers, severe chills, bruising, sore throat or
mouth ulcers (these may be signs of blood reactions), changes in the way your heart
beats. Having thoughts of self-harm or suicide, feeling depressed, feeling nervous
or anxious, feeling confused, agitated, difficulty sleeping, delusions, hallucinations,
changes in mood, feeling elated or overexcited. Liver problems. Symptoms may include
a general feeling of being unwell, with or without jaundice (yellowing of the skin
and eyes), dark urine, nausea, vomiting and/or abdominal pain. Rare cases of liver
failure (including fatal cases) have been observed. Kidney problems due to accumulation
of phospholipids. More severe symptoms of low blood sugar levels including disorientation,
seizures, fits or convulsions and loss of consciousness. Rash with a fever and flu-like
symptoms and enlarged lymph nodes. Blistering, scaly skin, pus-filled spots with fever.
Blistering or peeling of the skin with flu-like symptoms and fever. Skin lesions,
skin itching, joint aches, fever and a general ill feeling. Reddish-purple coloured
painful sores with or without a fever. For more information, including what to do
if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
hydroxychloroquine sulfate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Plaquenil. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Plaquenil.
Where to find information in this leaflet:
1. Why am I using Plaquenil?
Plaquenil contains the active ingredient hydroxychloroquine sulfate.
Plaquenil is 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.
2. What should I know before I use Plaquenil?
Warnings
Do not use Plaquenil if:
you are allergic to hydroxychloroquine, chloroquine or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
You have previously experienced changes in your eyesight when taking medicines for
rheumatoid arthritis or malaria.
You have a heart rhythm disorder.
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.
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.
Check with your doctor if you:
are taking any other medicines for any medical condition.
are allergic to quinine.
have allergies to any ingredients listed under "Product Description" at the end of
this leaflet.
have any pre-existing eye disorders.
have experienced low blood sugar levels (hypoglycaemia - a "hypo"). Plaquenil may
increase the risk of you having a hypo.
have an inactive chronic infection such as hepatitis B, chickenpox/shingles (a painful
blistering rash) or tuberculosis as they may flare up.
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
Porphyria Cutanea Tarda (PCT), which is a rare disorder of painful, blisters on the
skin
Myasthenia (a disease with general muscle weakness including in some cases muscles
used for breathing). You may notice aggravation of symptoms such as muscle weakness,
difficulty in swallowing, double vision, etc.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Plaquenil should be avoided in pregnancy except when, in the judgement of the physician,
the potential benefits outweigh the potential hazards.
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.
There is very limited data on the safety in the breastfed infant during long-term
treatment with Plaquenil. The active ingredient (hydroxychloroquine) is excreted in
breast milk and it is known that infants are extremely sensitive to the toxic effects.
Plaquenil should not be used during breast-feeding unless your doctor considers the
benefits outweigh the risks.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant
or think you may be pregnant or planning to have a baby or breast-feeding. Your doctor
will discuss with you whether Plaquenil is suitable for you.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Plaquenil and affect how it works, these include:
Any medicine to treat depression, including fluoxetine, paroxetine, and the herbal
product St John’s wort
Digoxin, Flecainide, Propafenone, Quinidine - medicine used to treat heart disease
Medicines to treat diabetes
Medicines used to suppress the immune system such as ciclosporin
Antiarrythmic drugs such as amiodarone and moxifloxacin
Other antimalarial drugs
Medicines to treat epilepsy, such as carbamazepine and phenobarbital
Tamoxifen (a medicine used to treat breast cancer)
Anti-infective medicines
Some antibiotics used for bacterial infections (such as moxifloxacin, azithromycin,
clarithromycin, erythromycin, roxithromycin). Taking these antibiotics at the same
time as hydroxychloroquine may increase the chance of you getting side effects that
affect your heart which could be life-threatening.
Medicines that may affect your blood
Medicines that may affect your eyes
Antacids containing magnesium or kaolin or cimetidine, used to neutralise stomach
acid
Itraconazole, an antifungal medication
Rifampicin (antibiotics)
Grapefruit juice
Anticoagulant drugs such as dabigatran and clopidogrel
Medicines to treat high cholesterol, such as gemfibrozil, statins
Ritonavir (a medicine used to treat HIV)
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Plaquenil.
4. How do I use Plaquenil?
How much to take
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 or your child.
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.
When 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.
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 it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you take too much Plaquenil
If you think that you have taken too much Plaquenil, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia or 0800 764 766 in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too many tablets you may experience headaches, drowsiness, visual disturbances
or fits.
These symptoms may occur within 30 minutes of overdose.
5. What should I know while using Plaquenil?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Plaquenil.
Call your doctor straight away if you:
Are about to start taking any new medicines, tell your doctor and pharmacist that
you are taking Plaquenil.
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.
Serious skin reactions
Serious skin reactions have been reported with the use of Plaquenil.
Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These serious skin rashes are often preceded by flu-like symptoms
such as fever, headache and body ache. The rash may progress to widespread blistering
and peeling of the skin.
If you develop these skin symptoms, stop taking hydroxychloroquine and contact your
doctor immediately.
Mental health problems
Some people being treated with Plaquenil can experience mental health problems such
as irrational thoughts, anxiety, hallucinations, feeling confused or feeling depressed,
including thoughts of self-harm or suicide, even those who have never had similar
problems before. If you or others around you notice any of these side effects (see
section Side effects) seek medical advice straight away, and stop your treatment if
you have thoughts of self-harm or suicide.
Talk to your doctor if you have a rare illness called porphyria which affects your
metabolism.
Muscle and Nerve disorders
Hydroxychloroquine may cause muscle and nerve disorders. Caution should be taken when
you take this medicine for a long time, your doctor will occasionally check for muscle
weakness, numbness and pain.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Plaquenil
affects you.
Plaquenil may cause dizziness in some people.
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.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
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.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Children are particularly sensitive to the unwanted effects of Plaquenil.
When to discard your medicine
If your doctor tells you to stop taking the tablets, ask your pharmacist what to do
with any tablets that are left over.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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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.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Visual disturbances
Any hearing loss
Suicidal behaviour
Having thoughts of self-harm or suicide
Feeling depressed, feeling nervous or anxious, feeling confused, agitated, difficulty
sleeping, delusions, hallucinations, changes in mood, feeling elated or overexcited
Frequent fevers, severe chills, bruising, sore throat or mouth ulcers (these may be
signs of blood reactions)
Changes in the way your heart beats
Liver problems. Symptoms may include a general feeling of being unwell, with or without
jaundice (yellowing of the skin and eyes), dark urine, nausea, vomiting and/or abdominal
pain.
Rare cases of liver failure (including fatal cases) have been observed.
Kidney problems due to accumulation of phospholipids
More severe symptoms of hypoglycaemia, including:
disorientation
seizures, fits or convulsions
loss of consciousness
Rash with a fever and flu-like symptoms and enlarged lymph nodes. This could be a
condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Blistering, widespread scaly skin, pus-filled spots together with fever. This could
be a condition called Acute Generalized Exanthematous Pustulosis (AGEP).
Blistering or peeling of the skin around the lips, eyes, mouth, nose, genitals, hands
or feet, flu-like symptoms and fever. This could be a condition called Stevens-Johnson
syndrome (SJS).
Multiple skin lesions, itching of the skin, joint aches, fever and a general ill feeling.
This could be a condition called Toxic Epidermal Necrolysis (TEN).
Skin reaction including reddish-purple color, raised, painful sores, particularly
on your arms, hands, fingers, face and neck, which may also be accompanied by fever.
This could be a condition called Sweet’s syndrome.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Serious side effects are rare.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Plaquenil contains
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Active ingredient
(main ingredient)
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hydroxychloroquine sulfate
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Other ingredients
(inactive ingredients)
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Calcium Hydrogen Phosphate Dihydrate
Maize starch
Magnesium Stearate
Hypromellose
Macrogol 400
Titanium dioxide
Polysorbate 80
Carnauba Wax
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Potential allergens
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Not Applicable
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Do not take this medicine if you are allergic to any of these ingredients.
What Plaquenil looks like
Plaquenil comes as white to off-white peanut shaped tablets. A bottle contains 100
tablets. AUST R 50055
Who distributes Plaquenil
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in October 2024
plaquenil-ccdsv21-cmiv20-28oct24