QUINORIC 200MG FILM COATED TABLETS

Active substance: HYDROXYCHLOROQUINE SULPHATE

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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 get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What QuinoricTM Tablets are and what they are used for
2. Before you take QuinoricTM Tablets
3. How to take QuinoricTM Tablets
4. Possible side effects
5. How to store QuinoricTM Tablets
6 Further information

1. What QuinoricTM Tablets are and
what they are used for
Quinoric TM Tablets contain a medicine called hydroxychloroquine
sulphate. QuinoricTM 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

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Do not take QuinoricTM Tablets 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 hydroxychloroquine (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 QuinoricTM Tablets if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking QuinoricTM.
Take special care with QuinoricTM and check with your doctor or
pharmacist before taking your medicines 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
Although the occurrence of retinopathy (dysfunction of the retina, an
important layer of the eye for image formation) is very uncommon, ensure
that the recommended daily dose is not exceeded
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

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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.

• Medicines that affect skin or the eyes.

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.
If you develop a rash or these skin symptoms, seek immediate advice
from a doctor and tell him that you are taking this medicine.

Pregnancy and breast-feeding
Do not take QuinoricTM if you are:
• pregnant, might become pregnant or think you may be pregnant.
• are 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.

Before treatment with QuinoricTM Tablets:
• Before you take this medicine you should have your eyes examined
• This testing should be repeated at least every 12 months while taking
QuinoricTM Tablets.
• Your eye examination may need to be more frequent or adapted if
you are 65 years of age, need to take a high dose (2 tablets a day),
have kidney problems or if you already have decreased vision.
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 QuinoricTM tablets
can affect the way some other medicines work. Also some medicines can
affect the way QuinoricTM tablets works.
The following medicines may increase the chance of you getting
side effects when taken with QuinoricTM 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

The following medicines can change the way QuinoricTM tablets
work or Quinoric TM 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 QuinoricTM
tablets.
• Rabies vaccine

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 QuinoricTM Tablets
Always take QuinoricTM Tablets exactly as your doctor has advised you.
Please check with your doctor or pharmacist if you are unsure.
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 QuinoricTM 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

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QuinoricTM 200mg Film-coated Tablets
Hydroxychloroquine Sulphate

2. Before you take QuinoricTM Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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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 QuinoricTM.
If you take more QuinoricTM Tablets than you should
• If you take more QuinoricTM 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.
If you forget to take QuinoricTM 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.
If you stop taking QuinoricTM Tablets:
• Keep taking QuinoricTM until your doctor tells you to stop. Do not stop
taking QuinoricTM 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, QuinoricTM Tablets can cause side effects, although
not everybody gets them.

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Stop taking QuinoricTM Tablets and see a doctor straight away if
you notice any of the following serious side effects - you may
need urgent medical treatment:
• Very rarely, potentially life-threatening skin rashes like Stevens
Johnson syndrome (blistering or peeling of the skin around lips,
eyes, mouth, nose, genitals, flu like symptoms and fever) and toxic
epidermal necrolysis (blistering, widespread scaly skin, pus filled
spots together with high temperature) have been reported (see
section 2).
• You have any eye problems. This includes changes in the colour of
your eye and problems with your eye sight 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
• 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 ‘anaemia’
• You may feel weak, short of breath, bruise more easily than usual
and get infections more easily than usual. These could be symptoms
of ‘aplastic anaemia’
• Liver problems that may cause the eyes or skin to go yellow
(Jaundice)
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

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• 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
• Lowering of blood glucose level
Blood tests:
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.

5. How to store QuinoricTM Tablets
• Keep out of the sight and reach of children.
• Do not use QuinoricTM Tablets after the expiry date which is stated on
the pack. The expiry date refers to the last day of that month.
• Blisters: No special storage precautions. Store in the original
package.
• Containers: No special storage precautions. Store in the original
container, tightly closed.
• 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 QuinoricTM Tablets contains
Each tablet contains 200mg Hydroxychloroquine Sulphate as the
active ingredient.
Quinoric TM 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 QuinoricTM Tablets look like and content of the pack
QuinoricTM Tablets are white, circular, biconvex, film-coated tablets
embossed with ‘BL’ on one side and ‘200’ on the other.
QuinoricTM 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

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How much to take
Adults, including the elderly
• One or two tablets each day

Stop taking QuinoricTM Tablets and see a doctor or go to 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

QuinoricTM 200mg Film-coated Tablets; PL 17907/0017
This leaflet was last revised in November 2013
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.

V2 14-11-13 D0

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• 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.

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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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