PLAQUENIL 200MG FILM-COATED TABLETS

Active substance: HYDROXYCHLOROQUINE SULPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Tell your doctor or pharmacist if any of
the following side effects get serious or
lasts longer than a few days:
• Skin rashes, itching, changes in the
colour of your skin or the inside of your
nose or mouth
• Psoriasis (red scaly patches on the skin
usually affecting the knees, elbows and
scalp)
• Hair loss or loss of hair colour
• Feeling or being sick, diarrhoea, loss of
appetite (anorexia) or stomach pain
• Feeling nervous, ringing in the ear
(tinnitus), hearing loss, headache, fits,
balance problems (vertigo) or feeling
dizzy, mental problems (such as
delusions, hallucinations or changes in
mood)
• Weakening of the heart muscle
(cardiomyopathy) resulting in difficulty
in breathing, coughing, high blood
pressure, swelling, increased heart rate,
low amount of urine
• You may get infections more easily
than usual. This could be due to bone
marrow depression
• Symptoms of a condition called
‘porphyria’ which may include stomach
pain, being sick, fits, blisters, itching
Blood Tests
• A blood test may show changes in the
way the liver is working and
occasionally the liver may stop working
Talk to your doctor or pharmacist if any of
the side effects get serious or lasts longer
than a few days or if you notice any side
effects not listed in this leaflet.
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: 01483 505515
Fax: 01483 535432
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 12/2012
© Sanofi, 2001 - 2012

31612305
4

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Plaquenil 200mg
Film-coated Tablets
hydroxychloroquine sulphate

Is this leaflet hard to see or
read?
Phone 01483 505515 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 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
Turn
Over
1

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
 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
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
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

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.
2

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.
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:
• 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
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:
• 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
• 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
• Severe skin reactions such as blistering,
widespread scaly skin, pus-filled spots
together with a high temperature
• 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
• You may get infections more easily
than usual. This could be due to bone
marrow depression or a blood disorder
called ‘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’
• Liver problems that may cause the eyes
or skin to go yellow (jaundice)
Turn
Over
3

Expand view ⇕

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.

Got questions about Rheumatoid Arthritis? Get answers from our expert Dr. Carteron. Click Here

Close
Hide
(web5)