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PLAQUENIL 200MG FILM-COATED TABLETS

Active substance: HYDROXYCHLOROQUINE SULPHATE

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Common (affects 1 to 10 people in a 100 people)
• Skin rashes, itching
• Being sick, diarrhoea
• Loss of appetite (anorexia)
• Headache
• Changes in mood with uncontrollable laughing
or crying
Uncommon (affects 1 to 10 people in a 1,000)
• Changes in the colour of your skin or the inside
of your nose or mouth
• Hair loss or loss of hair colour
• Feeling nervous
• Ringing in the ear (tinnitus)
• Balance problems (vertigo) or feeling dizzy
• Liver problems shown by blood tests
Frequency unknown
• Psoriasis (red scaly patches on the skin usually
affecting the knees, elbows and scalp)
• Hearing loss
• Mental problems (such as delusions,
hallucinations or changes in mood)
• Symptoms of a condition called ‘porphyria’
which may include stomach pain, being sick,
fits, blisters, itching
Heart and blood tests
• Your doctor may look at your heart’s electrical
activity using an ECG (electrocardiogram) machine.
• A blood test may show changes in the way the
liver is working and occasionally the liver may
stop working
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue
D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Plaquenil
Keep out of the reach and sight of children. Store
below 25°C.
Do not use Plaquenil after the expiry date which
is stated on the carton. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Further information
What Plaquenil contains
• Each tablet contains 200mg of the active
substance, hydroxychloroquine sulphate
• The other ingredients are lactose monohydrate,
maize starch, magnesium stearate,
polypovidone, hypromellose, macrogol and
titanium dioxide (E171)
What Plaquenil looks like and contents of the pack
Plaquenil 200mg Film-coated Tablets are round
white film coated tablets with HCQ on one side
and 200 on the other. They are supplied in boxes
of 60 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Fawdon Manufacturing Centre,
Edgefield Avenue, Fawdon, Newcastle-upon-Tyne,
Tyne & Wear, NE3 3TT, UK
This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor or
pharmacist.
This leaflet was last revised in 11/2014
© Sanofi, 2001 - 2014
31612307
4

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Plaquenil 200mg
Film-coated Tablets
hydroxychloroquine sulphate

Is this leaflet hard to see or
read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you
start taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Plaquenil is and what it is used for
2. Before you take Plaquenil
3. How to take Plaquenil
4. Possible side effects
5. How to store Plaquenil
6. Further information
1. What Plaquenil is and what it is
used for
Plaquenil contains a medicine called
hydroxychloroquine sulphate.
Plaquenil works by reducing inflammation in people
with autoimmune diseases (this is where the body’s
immune system attacks itself by mistake).
It can be used for:
• Rheumatoid arthritis (inflammation of the joints)
• Juvenile idiopathic arthritis (in children)
• Discoid and systemic lupus erythematosus
(a disease of the skin or the internal organs)
• Skin problems which are sensitive to sunlight

2. Before you take Plaquenil
Do not take this medicine and tell your
doctor if:
 You are allergic (hypersensitive) to:
- hydroxychloroquine
- other similar medicines such as quinolones
and quinine
- any of the other ingredients of Plaquenil
(listed in Section 6 below)
Signs of an allergic reaction include:
a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
 You have an eye problem which affects the retina,
the inside of the eye (maculopathy) or you get a
change in eye colour or any other eye problem
 You are pregnant, might become pregnant or
think you may be pregnant (see ‘Pregnancy
and breast-feeding’ below)
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before taking Plaquenil.
Take special care with Plaquenil
Check with your doctor or pharmacist before
taking your medicine if:
You have liver or kidney problems
You have serious stomach or gut problems
You have heart problems
You have any problems with your blood. You
may have blood tests to check this
You have any problems with your nervous
system or brain
You have psoriasis (red scaly patches on the skin
usually affecting the knees, elbows and scalp)
You have had a bad reaction to quinine in the past
You have a genetic condition known as
‘glucose-6-dehydrogenase deficiency’
You have a rare illness called ‘porphyria’ which
affects your metabolism
Before treatment with Plaquenil
Before you take this medicine you should have
your eyes examined
This testing should be repeated at least
every 12 months whilst taking Plaquenil Turn
Over
1

If you are over 65, need to take a high dose
(2 tablets a day) or have kidney problems then this
examination should be performed more often
Hydroxychloroquine can cause lowering of the
blood glucose level. Please ask your doctor to
inform you of signs and symptoms of low
blood glucose levels. A check of the blood
glucose level may be necessary
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking Plaquenil.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
This includes medicines you buy without a
prescription, including herbal medicines. This is
because Plaquenil can affect the way some other
medicines work. Also some medicines can affect
the way Plaquenil works.
In particular, tell your doctor if you are taking any
of the following:
The following medicines may increase the
chance of you getting side effects when
taken with Plaquenil:
• Some antibiotics used for infections (such as
gentamicin, neomycin or tobramycin)
• Cimetidine - used for stomach ulcers
• Neostigmine and pyridostigmine - used for
muscle weakness (myasthenia gravis)
• Medicines that may affect the kidney or liver
• Medicines that affect the skin or the eyes
• Halofantrine, mefloquine - used for malaria
• Amiodarone - used for heart problems
• Moxifloxacin - used to treat infections
• Medicines used for epilepsy
The following medicines can change the way
Plaquenil works or Plaquenil may affect the
way some of these medicines work:
• Digoxin - used for heart problems
• Medicines for diabetes (such as insulin or
metformin)
• Antacids - used for heartburn or indigestion.
You should leave a gap of at least 4 hours
between taking these medicines and Plaquenil
• Rabies vaccine
• Ciclosporin - used after an organ
transplantation to help prevent rejection
• Praziquantel - used to treat worm infections
• Agalsidase - used to treat a rare condition
called Fabry's disease

Pregnancy and breast-feeding
Do not take Plaquenil if:
• You are pregnant, might become pregnant or
think you may be pregnant
• You are breast-feeding or planning to
breast-feed. This is because small amounts may
pass into mothers’ milk
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may get eye problems while taking this medicine.
If this happens, do not drive or use any tools or
machines, and tell your doctor straight away.
Important information about some of the
ingredients of Plaquenil
This medicine contains lactose. If you have been
told by your doctor that you can not tolerate some
sugars, talk to your doctor before taking Plaquenil.
3. How to take Plaquenil
Always take Plaquenil exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a meal or a
glass of milk. Do not crush or chew your tablets
• If you are taking this medicine for skin problems
that are sensitive to sunlight, only take Plaquenil
during periods of high exposure to light
• The doctor will work out the dose depending
on your body weight
If you feel the effect of your medicine is too
weak or too strong, do not change the dose
yourself, but ask your doctor
• If you have been taking this medicine for
rheumatoid arthritis for a long time (more than
6 months) and you do not feel that it is helping
you, see your doctor. This is because the
treatment may need to be stopped.
How much to take
Adults, including the elderly
• One or two tablets each day
Children and Adolescents
• One tablet each day
• This medicine is only suitable for children
who weigh more than 31kg (around 5 stones)
It may take several weeks before you notice the
benefit of taking Plaquenil.
2

If you take more Plaquenil than you should
• If you take more Plaquenil than you should, tell
a doctor or go to a hospital casualty department
straight away. Take the medicine pack with you.
This is so the doctor knows what you have taken.
The following effects may happen: headache,
problems with your eyesight, fall in blood
pressure, convulsions (fits), heart problems,
followed by sudden severe breathing problems
and possibly heart attack
• Young children and babies are particularly at
risk if they accidentally take Plaquenil. Take
the child to a hospital straight away
If you forget to take Plaquenil
If you forget a dose, take it as soon as you
remember it. However, if it is nearly time for the
next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Plaquenil
Keep taking Plaquenil until your doctor tells you
to stop. Do not stop taking Plaquenil just because
you feel better. If you stop, your illness may get
worse again.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Plaquenil can cause side
effects, although not everybody gets them.
Stop taking Plaquenil and see a doctor or go
to a hospital straight away if:
Frequency unknown
• You have an allergic reaction. The signs may
include: a red or lumpy rash, swallowing or
breathing problems, swelling of your eyelids,
lips, face, throat or tongue
• Severe skin reactions such as blistering,
widespread scaly skin, pus-filled spots together
with a high temperature, reddening and being
more sensitive to the sun
• Blistering or peeling of the skin around the
lips, eyes, mouth, nose and genitals, flu-like
symptoms and fever. This could be a condition
called Stevens-Johnson syndrome

Stop taking Plaquenil and see a doctor straight
away if you notice any of the following serious
side effects - you may need urgent medical
treatment:
Common (affects 1 to 10 people in a 100 people)
• You have any eye problems. This includes
changes in the colour of your eye and
problems with your eyesight such as blurring,
sensitivity to light or the way you see colour
Uncommon (affects 1 to 10 people in a 1,000)
• You have any muscle weakness, cramps,
stiffness or spasms or changes in sensation
such as tingling. If you take this medicine for
a long time, your doctor will occasionally check
your muscles and tendons to make sure they
are working properly
Frequency unknown
• You have frequent infections such as fever,
severe chills, sore throat or mouth ulcers.
These could be signs of a blood problem called
‘leucopenia’ or ‘agranulocytosis’
• You may bruise more easily than usual. This
could be due to a blood problem called
‘thrombocytopenia’
• You feel tired, faint or dizzy and have pale skin.
These could be symptoms of something called
‘anaemia’
• You feel weak, short of breath, bruise more
easily than usual and get infections more easily
than usual. These could be symptoms of
something called ‘aplastic anaemia’
• Weakening of the heart muscle (cardiomyopathy)
resulting in difficulty in breathing, coughing,
high blood pressure, swelling, increased heart rate,
low amount of urine
• low blood sugar levels (hypoglycaemia). You
may feel a sense of nervousness, shaky or
sweaty
• You notice yellowing or your skin or eyes and
your urine becomes darker in colour. This could
be a liver problem, such as jaundice or hepatitis
• Fits
Tell your doctor or pharmacist if any of the
following side effects get serious or lasts
longer than a few days:
Very common (affects more than 1 in 10 people)
• Stomach pain
Turn
• Feeling sick
Over
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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