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HYDROXYCHLOROQUINE SULFATE 200 MG FILM-COATED TABLETS

Active substance(s): HYDROXYCHLOROQUINE SULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Hydroxychloroquine Sulfate 200 mg film-coated tablets
(referred to as Hydroxychloroquine Sulfate Tablets in the remainder of the leaflet)
Hydroxychloroquine Sulfate
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, please 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.
In this leaflet:
1. What Hydroxychloroquine Sulfate Tablets are and what
they are used for
2. What you need to know before you take Hydroxychloroquine
Sulfate Tablets
3. How to take Hydroxychloroquine Sulfate Tablets
4. Possible side effects
5. How to store Hydroxychloroquine Sulfate Tablets
6. Contents of the pack and other information
1. What Hydroxychloroquine Sulfate Tablets
are and what they are used for
The name of your medicine is Hydroxychloroquine Sulfate
Tablets; the active ingredient is hydroxychloroquine sulfate.
These tablets are used in the treatment of inflammatory diseases
such as rheumatoid arthritis and juvenile idiopathic arthritis.
They are also used to treat discoid and systemic lupus
erythematosus (a disease where the immune system attacks the
body causing tissue damage and inflammation) and also in
problems with the skin that are triggered or worsened by sunlight.
2. What you need to know before you take
Hydroxychloroquine Sulfate Tablets
Do not take Hydroxychloroquine Sulfate Tablets if you:
• are allergic (hypersensitive) to hydroxychloroquine sulfate
or to any of the other ingredients in Hydroxychloroquine
Sulfate Tablets (listed in section 6, Contents of the pack
and other information)
• are allergic (hypersensitive) to 4-aminoquinolone compounds
(e.g. chloroquine, amodiaquine)
• suffer from maculopathy (a disease of the eye)
• are pregnant.
Before starting this medicine your doctor should arrange
for you to have a thorough eye test.



this should be repeated at least once every year while you
are taking this medicine
the elderly, those with kidney or previous eye problems and
those taking more than one tablet per day may need more
frequent eye tests.

Warnings and precautions
Talk to your doctor before taking Hydroxychloroquine
Sulfate Tablets if you:









suffer from liver or kidney disease
suffer from severe problems with your gastrointestinal system
or nervous system
suffer from severe problems with your blood or bone marrow
suffer from porphyria (a disease of blood proteins that can
affect the skin, gut and nervous system)
have the inherited condition glucose-6-phosphate
dehydrogenase (G6PD) deficiency (an enzyme deficiency
which increases the risk of developing anaemia)
suffer from psoriasis (a skin condition causing scaly skin
patches over the body)
have eye or eyesight problems
are allergic to quinine (a medicine used to treat malaria).

Other medicines and Hydroxychloroquine Sulfate Tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. In particular, tell your doctor if you are
taking any of the following medicines:
The following medicines may increase the chance of you
getting side effects when taken with Hydroxychloroquine
Sulfate Tablets:






medicines used to treat myasthenia gravis – a disease of
the muscles and nerves (e.g. neostigmine and
pyridostigmine)
aminoglycoside antibiotics (used to treat bacterial infections)
cimetidine (used to treat heartburn and stomach ulcers)
medicines that affect the skin or the eyes
medicines that may affect the kidney or liver.

The following medicines can change the way
Hydroxychloroquine Sulfate Tablets work or
Hydroxychloroquine Sulfate Tablets may affect
the way some of these medicines work:





medicines used to treat diabetes (e.g. insulin and antidiabetic
tablets)
digoxin (used to treat abnormal heart rhythms and heart failure)
rabies vaccine
antacids (medicines used to treat indigestion) – you should wait
at least four hours between taking antacids and Hydroxychloroquine
Sulfate Tablets.

Taking Hydroxychloroquine Sulfate Tablets with food and drink
Hydroxychloroquine Sulfate Tablets should be taken with a meal
or a glass of milk.
Pregnancy and breast-feeding
Do not take this medicine If you are pregnant.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
When you first start treatment with Hydroxychloroquine Sulfate
Tablets you may get blurred vision. If this happens do not drive a
car or operate machinery. If this continues or you get other visual
problems see your doctor immediately. There is more information
on this in section 4.
Hydroxychloroquine Sulfate Tablets contain lactose
This medicine contains lactose, if you have been told by your
doctor that you have an intolerance to some sugars contact your
doctor before taking this medicine.
3. How to take Hydroxychloroquine Sulfate Tablets
Always take Hydroxychloroquine Sulfate Tablets exactly as your
doctor has told you. Check with your doctor or pharmacist if you
are not sure. Your doctor will decide the right dose for you; this
will be on the pharmacist’s label. Check this carefully, it will tell
you how many tablets to take and how often to take them.







swallow the tablets whole with a meal or a glass of milk
the doctor will work out the dose depending on your body weight
if you are being treated for a skin disease that is sensitive to
sunlight light, then you should use this medicine during periods of
high exposure to light
while you are taking this medicine your doctor may arrange for
blood tests to monitor your response to treatment
if you have been taking this medicine for more than 6 months for
the treatment of rheumatoid arthritis and you do not feel that it is
helping you, speak to your doctor as it may be decided to stop
treatment with this medicine.

How much to take
Adults (including older people)



the usual dose is one tablet taken daily or one tablet taken
morning and night
your doctor may alter your dose depending on your response
to treatment.

Children and Adolescents
• one tablet each day
• this medicine is only suitable for children who weigh more
than 31kg.
It may be several weeks before you notice an improvement in your
condition with this medicine.
The score line is not intended for breaking the tablet.
If you take more Hydroxychloroquine Sulfate Tablets than you
should
If you (or anybody else), takes more Hydroxychloroquine Sulfate
Tablets than you should contact your nearest hospital casualty
department or doctor immediately. Always take the blister pack of
tablets and this leaflet with you.
Young children and babies are particularly at risk if they accidentally take Hydroxychloroquine Sulfate Tablets. Take the child to
hospital straight away.
Symptoms that could indicate someone has taken too much are
headache, visual disturbances, breathing difficulties, problems
with your heart, low blood pressure and fits.
If you forget to take Hydroxychloroquine Sulfate Tablets
If you forget a dose, take another as soon as you remember. If it is
almost time for your next dose, then do not take the missed dose
at all. NEVER take a double dose to make up for the one missed.
4. Possible side effects
Like all medicines, Hydroxychloroquine Sulfate Tablets can
cause side effects, although not everybody gets them.
As can happen with any medicine, a few people may
develop an allergic reaction. If you experience any of the
following, seek medical help immediately:
• rash, itching and/or difficulty breathing
• rapid swelling of the skin around the face, particularly the mouth
If you experience any of the following symptoms then stop
taking the medicine and seek medical help immediately:
• 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
• any visual disturbance including persistent blurring of vision,
changes to your colour vision, or sensitivity to light
• any muscle weakness, particularly of the upper arms or legs,
muscle spasms or cramps, or changes in sensation of your
skin. If you take this medicine over a long time your doctor
will occasionally check your muscles and tendons to ensure
they are not affected
• blistering of the skin, particularly the mouth, face, nose and
genitals, fever and flu-like symptoms. This could be a serious
reaction called Stevens - Johnson syndrome
• other skin changes including the formation of numerous small
pustules or itchy pink-red blotches or generalised scaling of
the skin

You should tell your doctor or pharmacist if you have any of
the following side effects, or if you think Hydroxychloroquine
Sulfate Tablets are making you feel unwell in any other way.
Side effects reported with this medicine include:


















• diarrhoea
feeling or being sick
• stomach pains
loss of appetite
• Visual disturbances
dizziness
• vertigo
ringing in the ears
• hearing loss
headache
• nervousness
mood swings
• psychosis
fits
• liver failure
spasm of airways
• itchy, raised rash
muscle weakness
• muscle wasting
decreased reflexes
• anaemia
low platelets
• low white blood cells
bone marrow depression
abnormal nerve conduction • general tissue swelling
• problems with heart
abnormal liver function
conduction system
seen on blood tests
• bleaching of hair / hair loss
lowering of the blood
glucose level
symptoms of a condition called Porphyria, which may include
stomach pain, being sick, constipation, fits, rashes or
blisters, itching, pain or weakness in back, arms and legs
weakening of the heart muscle (cardiomyopathy) resulting
in difficulty breathing, chest pain, an irregular or abnormal
heartbeat, feeling dizzy or tired, swelling of feet, ankles and
legs.

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 report side effects directly via
http://yellowcard.mhra.gov.uk/. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Hydroxychloroquine Sulfate Tablets
Keep this medicine out of the sight and reach of children.
• Do not store above 25°C. Store in the original packaging; do
not transfer your tablets to another container
• Do not take after the expiry date on the label; the expiry date
refers to the last day of the month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines no
longer required. These measures will help protect the
environment.
6. Contents of the pack and other information
What Hydroxychloroquine Sulfate Tablets contain
The active ingredient is: 200 mg hydroxychloroquine sulfate.
The other ingredients are: lactose monohydrate, maize starch,
hypromellose, croscarmellose sodium, magnesium stearate,
talc, titanium dioxide, macrogol 6000, iron oxide yellow E172
and polysorbate 80.
What Hydroxychloroquine Sulfate Tablets look like and
contents of the pack
Hydroxychloroquine Sulfate Tablets are round, light yellow
tablets with a score line on one side and Incepta inscribed on the
reverse. They are supplied in blister pack of 10 tablets, with an
outer cardboard carton, and are available in pack size of 28, 30
or 60 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Abbey Place
24-28 Easton Street
High Wycombe
HP11 1NT, UK
33271/0001

Leaflet Prepared: June 2014

V.N.03

Taking this medicine

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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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