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QUININE SULPHATE 200MG TABLETS BP

Active substance: QUININE SULPHATE

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TEVA UK Ref:

Version:

231-30-12087-ZA LEA QUININE SULPHATE A/S TAB TUK

4

29 May 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 156

• amiodarone, quinidine or flecainide (used
to treat an irregular heartbeat)
• pimozide or thioridazine (used in the
PACKAGE LEAFLET: INFORMATION
treatment of mental illness)
FOR THE USER
• terfenadine (used in the treatment of
allergies)
Read all of this leaflet carefully before you
• moxifloxacin or rifampicin (antibiotics)
start taking this medicine.
• antifungals (to treat infections)
• Keep this leaflet. You may need to read it
• ciclosporin (used to prevent transplant
again.
rejection)
• If you have any further questions, ask your
• halofantine, chloroquine, mefloquine or
doctor or pharmacist.
artemether with lumefantrine or
• This medicine has been prescribed for
primaquine (also to treat malaria)
you. Do not pass it on to others. It may
• cimetidine (to treat stomach ulcers or acid
harm them, even if their symptoms are
reflux and indigestion)
the same as yours.
• amantadine (to treat Parkinsons Disease
• If you get any side effects, talk to your
or some viral infections)
doctor or pharmacist. This includes any
• suxamethonium (a muscle relaxant)
possible side effects not listed in this
• carbamazepine or phenytoin
leaflet. See section 4.
(anticonvulsants)
IN THIS LEAFLET:
• antifungal medicines, e.g. fluconazole,
itraconazole, ketoconazole
1. What Quinine Sulphate is and what it is
• barbiturates, e.g. phenobarbital
used for
• medicines to prevent blood clots forming,
2. Before you take Quinine Sulphate
e.g. warfarin
3. How to take Quinine Sulphate
• medicines to treat diabetes e.g.
4. Possible side effects
metformin, tolbutamide, glimepiride
5. How to store Quinine Sulphate
• medicines used in the treatment of HIV
6. Further information
e.g. ritonavir, indinavir, nelfinavir.

1

WHAT QUININE SULPHATE IS AND
WHAT IT IS USED FOR

Quinine Sulphate is an antimalarial drug
also used for muscle disorders.
Quinine Sulphate is used:
• to prevent night cramps
• for the treatment of chloroquine-resistant
malaria.

2

BEFORE YOU TAKE QUININE
SULPHATE

Do NOT take Quinine Sulphate if you:
• are allergic (hypersensitive) to quinine
sulphate or any of the other ingredients of
this medicine (see section 6)
• have kidney problems resulting in the
presence of blood in your urine
• have inflammation of the optic nerve
causing problems with your eye sight
• suffer from tinnitus (ringing in the ears)
• have myasthenia gravis (a disorder in
which the muscles are weak and tire easily)
• have problems with your eyes or difficulty
seeing.
Take special care with Quinine Sulphate
Tell your doctor before you start to take this
medicine if you:
• suffer from heart, kidney or liver problems
• have irregular heart beats or other heart
disease
• have had malaria for a long time
• suffer from glucose 6-phosphate
dehydrogenase (G6PD) deficiency, a rare
hereditary disease. This can cause episodes
of anaemia after eating certain foods such
as fava beans (favism) or certain drugs
including drugs to prevent malaria and
dapsone.
You should not take more than the
prescribed dose as a condition called
‘cinchonism’ may occur even with normal
doses. Please see section 4 ‘Possible side
effects’ for symptoms of cinchonism and tell
your doctor if you experience any of them.
Taking other medicines
Talk to your doctor if you are taking any of
the following:
• anticoagulants (to stop your blood from
clotting)
• cardiac glycosides (for your heart such as
digoxin)

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Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
You should not take Quinine Sulphate
tablets if you are pregnant, planning to
become pregnant or breast-feeding unless
advised by your doctor.
Quinine Sulphate is not recommended for
use during pregnancy for the prevention of
night cramps.
Driving and using machines
Quinine Sulphate may affect your vision or
cause vertigo (a feeling of dizziness or
“spinning”). If you are affected, DO NOT
drive or operate machinery.
Important information about some of the
ingredients of Quinine Sulphate
Patients who are intolerant to sucrose
should note that Quinine Sulphate tablets
contain a small amount of sucrose. If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3

HOW TO TAKE QUININE SULPHATE

Always take Quinine Sulphate exactly as
your doctor has told you. You should check
with your doctor or pharmacist if you are
not sure. Do not take more than your doctor
has recommended.
If you see another doctor or go into hospital,
let them or the staff know what medicines
you are taking.
The tablets should be swallowed preferably
with a drink of water.
The usual dose is:
Adults (including the elderly)
• Prevention of night cramp:
One 200 mg tablet before going to bed.
Do not take more than the prescribed dose.
It may take up to 4 weeks before you see a
reduction in the frequency of night time
cramps.
Your doctor will monitor the effects of
your treatment and adjust it accordingly.
Maximum dose - 300 mg at bedtime.
• Treatment of malaria (you may be given
another medicine for malaria with or after
this course of quinine):

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QUININE SULPHATE 200 mg
AND 300 mg TABLETS BP

TEVA UK Ref:

Version:

231-30-12087-Z LEA QUININE SULPHATE A/S TAB TUK

4

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you feel unwell whilst taking Quinine
Sulphate for night cramps, stop taking the
tablets and talk to your doctor immediately.
The following side effects have also been
Children under 12 years - 10 mg per kg
reported:
of body weight every eight hours for 7 days.
• diarrhoea, feeling or being sick,
Patients with kidney or liver problems
abdominal pain, low blood sugar
A lower dose than the usual adult dose or
• muscle weakness, excitement, agitation,
increased time between doses should be
‘spinning’ sensation’, confusion, loss of
used if you have kidney or liver problems.
consciousness, coma, death
If you take more Quinine Sulphate than you • headache, changes in vision, ‘ringing’ in
the ears, loss of hearing
should
If you (or someone else) swallow a lot of the • swollen, itchy, flaky, red or raised patches
of skin, rashes, sensitivity to light
tablets all together, or if you think a child has
• kidney damage, water retention, slowed
accidentally swallowed any of the tablets,
heart rate, changes in heart rhythm and
contact your nearest hospital casualty
the way the heart beats, eczema,
department or your doctor immediately.
miscarriages (at very high concentrations),
An overdose of Quinine Sulphate may cause
difficulty breathing
‘cinchonism’. Early symptoms are:
• problems with blood clotting
• tinnitus (ringing in the ears), impaired
hearing and vision, headache, feeling sick, • aggravation of myasthenia gravis.
being sick, fits
Reporting of side effects
• rashes, confusion, hot and flushed skin.
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
More severe symptoms include:
side effects not listed in this leaflet. You can
• nervous system disorders, stomach
also report side effects directly via the Yellow
problems, shallow breathing, loss of
Card Scheme at: www.mhra.gov.uk/yellowcard
consciousness
By reporting side effects you can help
• severe eyesight problems including
provide more information on the safety of
blindness
this medicine.
• effects on the heart, kidney and brain
• shock, low blood sugar.
HOW TO STORE QUININE SULPHATE
Adults (including elderly) and
children over 12 years - 600 mg every
eight hours for 5-7 days.

5

Large doses can cause abortion.
Please take this leaflet, any remaining
tablets, and the container with you to the
hospital or doctor so that they know which
tablets were consumed.
If you forget to take Quinine Sulphate
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. Do not take a
double dose to make up for a forgotten
dose. Take the remaining doses at the
correct time.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Quinine Sulphate can
cause side effects, although not everybody
gets them.
If any of the following happen, stop taking
the tablets and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives)
• unexplained bruising or bleeding.
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.

Keep out of the reach and sight of children.
The tablets should be stored below 25°C in
the package or container supplied. Do not
transfer them to another container. Do not
use Quinine Sulphate after the expiry date
that is stated on the outer packaging. 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 Quinine Sulphate Tablets contain:
• The active ingredient is quinine sulphate
• The other ingredients are alginic acid
(E400), magnesium stearate (E572), maize
starch, sucrose, talc (E553), gelatin and
titanium dioxide (E171). The printing ink
contains shellac (E904), black iron oxide
(E172) and propylene glycol (E1520). The
tablet polish contains shellac (E904),
carnauba wax (E903) and white beeswax
(E901).

What Quinine Sulphate Tablets look like and
contents of the pack:
• The Quinine Sulphate 200 mg Tablets are
white, biconvex, sugar-coated tablets.
They are plain on one side, marked 200
over 1205 on the reverse.
Contact your doctor at once if the following • The Quinine Sulphate 300 mg Tablets are
white, biconvex, sugar-coated tablets.
effects occur:
They are plain on one side, marked 300
• cinchonism – abdominal pain, diarrhoea,
over 1206 on the reverse.
disturbed vision (blurred vision, changes
in colour perception or field of vision, total • The product is available in pack sizes of 7,
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110,
blindness), headache, feeling or being
112, 120, 150, 160, 168, and 500 tablets.
sick, ringing in the ears or impaired
The Quinine Sulphate 300 mg Tablets are
hearing, rashes, loss of consciousness,
also available in pack sizes of 25 and 50.
fits, shock due to heart problems, irregular
Not all pack sizes may be marketed.
heartbeats, death. If these occur while
Marketing Authorisation Holder and
taking Quinine Sulphate tablets for leg
cramps, treatment should be stopped and Manufacturer
The Marketing Authorisation holder and
a doctor contacted straight away
company responsible for manufacture is
• changes to blood cells, if you notice that
TEVA UK Limited, Eastbourne, BN22 9AG.
you are bruising or bleeding easily, have
frequent nose bleeds, or you have more
This leaflet was last revised: May 2015.
sore throats and infections than usual tell PL 00289/5242R-5243R
your doctor who may want to give you a
blood test.
12087-ZA
160 x 323

REG0068157

Version 1.4

Approved

Page 2 of 3

29 May 2015

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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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