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QUINORIC 200MG FILM COATED TABLETS

Active substance: HYDROXYCHLOROQUINE SULPHATE

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24 mm

Quinoric 200mg Film-coated Tablets
Hydroxychloroquine Sulphate
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet:
1. What Quinoric® Tablets are and what they are used for
2. What you need to know before you take Quinoric® Tablets
3. How to take Quinoric® Tablets
4. Possible side effects
5. How to store Quinoric® Tablets
6 Contents of the pack and other information

1. What Quinoric® Tablets are and what they are used for
Quinoric ® Tablets contain a medicine called hydroxychloroquine
sulphate. Quinoric® Tablets work 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. What you need to know before you take Quinoric® Tablets
Do not take Quinoric® Tablets and tell your doctor if:
• You are allergic (hypersensitive) to:
- hydroxychloroquine
- other similar medicines such as quinolones and quinine

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- any of the other ingredients of this medicine (listed in section 6)
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
• You are pregnant, might become pregnant or think you may be
pregnant or breast-feeding (see ‘Pregnancy and Breast-feeding’
below)
Do not take Quinoric® Tablets if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before taking
Quinoric ®.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine if:
• You have liver, kidney or heart 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
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported with the use of hydroxychloroquine, appearing initially as reddish target-like spots or circular
patches often with central blisters on the trunk.
- Additional signs to look for include ulcers in the mouth, throat,
nose, genitals and conjunctivitis (red and swollen eyes).
- These potentially life-threatening skin rashes are often accompanied
by flu-like symptoms. The rash may progress to widespread
blistering or peeling of the skin
- The highest risk for occurrence of serious skin reactions is within
the first weeks of treatment.
If you have developed Stevens-Johnson syndrome or toxic epidermal
necrolysis with the use of hydroxychloroquine, you must not be
re-started on this medicine at any time.

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If you develop a rash or these skin symptoms, seek immediate advice
from a doctor and tell him that you are taking this medicine.
Before treatment with Quinoric® Tablets:
• Before you take this medicine you should have your eyes examined
• This testing should be repeated at least every 12 months whilst taking
Quinoric® Tablets
• 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
• Quinoric® Tablets 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
Other medicines and Quinoric® Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
The following medicines may increase the chance of you getting
side effects when taken with Quinoric® Tablets:
• Some antibiotics used for infections (such as gentamicin, neomycin or
tobramycin)
• Cimetidine - used for stomach ulcers
• Neostigmine and pyridostigmine - used for muscle weakness
• Medicines that may affect the kidney or liver
• Medicines that affect 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 Quinoric® Tablets
work or Quinoric ® Tablets 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 Quinoric®
Tablets
• 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 Quinoric® Tablets if you are:
• pregnant, might become pregnant or think you may be pregnant.
• breast-feeding or planning to breast-feed. This is because small
amounts may pass into mother’s milk.
Ask your doctor or pharmacist for advice before taking any medicine if
you are pregnant or breast-feeding.
Driving or 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.

3. How to take Quinoric® Tablets
Always take Quinoric® Tablets exactly as your doctor has told you.
Please check with your doctor or pharmacist if you are not sure.
The recommended dose is
Adults, including the elderly
• One or two tablets each day
Use in 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 Quinoric® Tablets.
Route and method of administration
• Take this medicine by mouth.
• Swallow the tablets whole with a meal or a glass of milk. Do not crush
or chew your tablets.
Duration of treatment
• If you are taking this medicine for skin problems that are sensitive to
sunlight, only take Quinoric® Tablets 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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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If


If




4. Possible side effects
Like all medicines, Quinoric® Tablets can cause side effects, although not
everybody gets them.
Stop taking Quinoric® Tablets and see a doctor or go to hospital
straight away if:
Not known (frequency cannot be estimated from the available data)

• 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
• 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 Quinoric® Tablets and see a doctor straight away if
you notice any of the following serious side effects - you may
need urgent medical treatment:

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• Changes in mood with uncontrollable laughing or crying
Uncommon (may affect up to 1 in 100 people)
• 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

Not known (frequency cannot be estimated from the available data)

• 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at www.mhra.gov.uk/
yellowcard. By reporting side effects, you can help provide more
information on the safety of this medicine.

• 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 (may affect more than 1 in 10 people)
• Stomach pain
• Feeling sick
Common (may affect up to 1 in 10 people)
• Skin rashes, itching
• Being sick, diarrhoea
• Loss of appetite (anorexia)
• Headache

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Not known (frequency cannot be estimated from the available data)

5. How to store Quinoric® Tablets

6. Contents of the pack and other information
What Quinoric® Tablets contain
Each tablet contains 200mg Hydroxychloroquine Sulphate as the
active ingredient.
Quinoric ® Tablets also contain maize starch, calcium hydrogen
phosphate dihydrate, colloidal anhydrous silica, polysorbate 80,
purified talc, magnesium stearate, hypromellose, titanium dioxide and
macrogol 6000.
What Quinoric® Tablets look like and content of the pack
Quinoric ® Tablets are white, circular, biconvex, film-coated tablets
embossed with ‘BL’ on one side and ‘200’ on the other.
Quinoric® Tablets are supplied in blister packs of 60 tablets or HDPE
containers of 100, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted,Hertfordshire,
HP4 1EG, United Kingdom.
Telephone:
0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
Email:
info@bristol-labs.co.uk
®
Quinoric 200mg Film-coated Tablets; PL 17907/0017
This leaflet was last revised in February 2015
To request a copy of this leaflet in Braille, large print or audio format,
please contact the licence holder at the address (or telephone, fax,
email) above.

• Keep out of the sight and reach of children.
• Do not use Quinoric® Tablets after the expiry date which is stated on
the pack. The expiry date refers to the last day of that month.
• Blisters: Store in the original package.
• Containers: Store in the original container. Keep the container tightly
closed.
• Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.
V7 10-02-15 D1

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Common (may affect up to 1 in 10 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 (may affect up to 1 in 100 people)
• 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

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If


you, see your doctor. This is because the treatment may need to be
stopped.
you take more Quinoric® Tablets than you should
If you take more Quinoric® 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 these tablets. Take the child to a hospital straight away.
you forget to take Quinoric® Tablets
If you forget a dose, take it as soon as you remember. 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.
you stop taking Quinoric® Tablets
Keep taking Quinoric® Tablets until your doctor tells you to stop. Do
not stop taking Quinoric® Tablets 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 medicine, ask
your doctor or pharmacist.

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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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