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QUININE BISULFATE 300 MG TABLETS

Active substance(s): QUININE BISULFATE

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ZINC Ref:

Version:

EAS1954a LEA QUININE BISULFATE 300mg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

Colours Used:

11 December 2017

BLACK
PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

Quinine Bisulfate 300 mg
Tablets
PACKAGE LEAFLET: INFORMATION
FOR THE USER

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.
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:

Pharma code 677

1. What Quinine Bisulfate is and what it is used
for
2. What you need to know before you take
Quinine Bisulfate
3. How to take Quinine Bisulfate
4. Possible side effects
5. How to store Quinine Bisulfate
6. Contents of the pack and other information

1

What Quinine Bisulfate is and what it
is used for

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

2

What you need to know before you
take Quinine Bisulfate

Do not take Quinine Bisulfate :
• if you are allergic to quinine bisulfate or any
of the other ingredients of this medicine
(listed in section 6).
• if you have kidney problems resulting in the
presence of blood in your urine
• if you have inflammation of the optic nerve
causing problems with your eye sight
• if you suffer from tinnitus (ringing in the ears)
• if you have myasthenia gravis (a disorder in
which the muscles are weak and tire easily)
• if you problems with your eyes or difficulty
seeing.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Quinine bisulfate.
Tell your doctor before you start to take this
medicine:
• if you suffer from heart, kidney or liver
problems
• if you have irregular heart beats or other
heart disease
• if you have had malaria for a long time
• if you 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.
Tell your doctor if you were born with or have
any condition that causes an abnormal heart
rhythm.
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.
Other medicines and Quinine bisulfate
Tell your doctor if you are taking or have
recently taken or might take any other
medicines.

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Version 5.2

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)
• amiodarone, quinidine or flecainide (used to
treat an irregular heartbeat)
• pimozide or thioridazine (used in the
treatment of mental illness)
• terfenadine (used in the treatment of allergies)
• moxifloxacin or rifampicin (antibiotics)
• antifungals (to treat infections)
• ciclosporin (used to prevent transplant
rejection)
• halofantrine, chloroquine, mefloquine or
artemether with lumefantrine or primaquine
(also to treat malaria)
• cimetidine (to treat stomach ulcers or acid
reflux and indigestion)
• amantadine (to treat Parkinsons Disease or
some viral infections)
• suxamethonium (a muscle relaxant)
• carbamazepine or phenytoin
(anticonvulsants)
• antifungal medicines, e.g. fluconazole,
itraconazole, ketoconazole
• barbiturates, e.g. phenobarbital (medicines
to treat epilepsy)
• medicines to prevent blood clots forming,
e.g. warfarin
• medicines to treat diabetes e.g. metformin,
tolbutamide, glimepiride
• medicines used in the treatment of HIV e.g.
ritonavir, indinavir, nelfinavir
• medicines which are known to cause
disturbances in heart rhythm.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy, breast-feeding and fertility
You should not take Quinine Bisulfate tablets if
you are pregnant, planning to become
pregnant or breast-feeding unless advised to
by your doctor.
Quinine Bisulfate is not recommended for use
during pregnancy for the prevention of night
cramps.
Driving and using machines
Quinine Bisulfate may affect your vision or
cause vertigo (a feeling of dizziness or
“spinning”). If you are affected, DO NOT drive
or operate machinery.
Quinine Bisulfate contains sucrose
Patients who are intolerant to sucrose should
note that Quinine Bisulfate 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 Bisulfate

Always take this medicine exactly as your
doctor has told you. 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 300 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.
• Treatment of malaria (you may be given
another medicine for malaria with or after
this course of quinine):

Approved

Page 1 of 3

Top of page cut-off to middle of registration mark: 44 mm.

Package leaflet: Information
for the user

ZINC Ref:

Version:

EAS1954a LEA QUININE BISULFATE 300mg TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

1

Colours Used:

11 December 2017

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Use in children and adolescents
Adults (including elderly) and children over
12 years – 600 mg every eight hours for
5-7 days.
Children under 12 years – 10 mg per kg of
body weight every eight hours for 7 days.
Children
The dosage depends on the weight of the
child. Your doctor will calculate the appropriate
dose for your child. This dose should be given
every 8 hours for 7 days.
Patients with kidney or liver problems
A lower dose than the usual adult dose or
increased time between doses should be used
if you have kidney or liver problems.
If you take more Quinine Bisulfate than you
should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
accidentally swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose of Quinine Bisulfate may cause
‘cinchonism’. Early symptoms are:
• tinnitus (ringing in the ears), impaired
hearing and vision, headache, feeling sick,
being sick, fits
• rashes, confusion, hot and flushed skin.
More severe symptoms include:
• nervous system disorders, stomach
problems, shallow breathing, loss of
consciousness
• severe eyesight problems including blindness
• effects on the heart, kidney and brain
• shock, low blood sugar.
Large doses can also 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 Bisulfate
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

5

Version 5.2

How to store Quinine Bisulfate

Keep this medicine out of the sight and reach
of children.
The tablets should be stored below 25oC in the
package or container supplied. Do not transfer
them to another container.
Do not use this medicine after the expiry date
which is stated on the outer packaging. The
expiry date refers to the last day of that month.
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.

6

Possible side effects

Like all medicines, this medicine 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.
Contact your doctor at once if the following
effects occur:
• cinchonism – abdominal pain, diarrhoea,
disturbed vision (blurred vision, changes
in colour perception or field of vision, total
blindness), headache, feeling or being sick,
ringing in the ears or impaired hearing,
rashes, loss of consciousness, fits, shock
due to heart problems, irregular heart
beats, death. If these occur while taking
Quinine Bisulfate tablets for leg cramps,
treatment should be stopped and a doctor
contacted straight away.
• changes to blood cells, if you notice that
you are bruising or bleeding easily, have
frequent nose bleeds, or you have more
sore throats and infections than usual tell
your doctor who may want to give you a
blood test.
• a serious illness with blistering of the skin,
mouth eyes and genitals
(Stevens-Johnson Syndrome).

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If you feel unwell whilst taking Quinine
Bisulfate for night cramps, stop taking the
tablets and talk to your doctor immediately.
The following side effects have also been
reported:
• diarrhoea, feeling or being sick, abdominal
pain, low blood sugar
• muscle weakness, excitement, agitation,
‘spinning’ sensation’, confusion, loss of
consciousness, coma, death
• headache, changes in vision, ‘ringing’ in
the ears, loss of hearing
• swollen, itchy, flaky, red or raised patches
of skin, rashes, sensitivity to light
• kidney damage, water retention, slowed
heart rate, changes in heart rhythm and
the way the heart beats, eczema,
miscarriages (at very high concentrations),
difficulty breathing
• problems with blood clotting
• aggravation of myasthenia gravis
• asthma, fever.
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 or
search for MHRA Yellow Card in the Google
Play or Apple App Store.
By reporting side effects you can help provide
more information on the safety of this medicine.

Contents of the pack and other
information

What Quinine Bisulfate Tablets contain:
• The active substance is quinine bisulfate
• The other ingredients are gelatin, calcium
stearate, crospovidone, maize starch, stearic
acid, talc (E553), sucrose and titanium
dioxide (E171). The printing ink contains
shellac, black iron oxide (E172) and
propylene glycol (E1520). The tablets are
polished with shellac (E904), carnauba wax
(E903) and white beeswax (E901).
What Quinine Bisulfate Tablets look like and
contents of the pack:
• The Quinine Bisulfate 300 mg Tablets are
white, biconvex, sugar-coated tablets. They
are plain on one side and marked 300 over
1202 on the reverse.
• The product is available in pack sizes of 7, 10,
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
120, 150, 160, 168 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture is TEVA
UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in November 2017
PL 00289/5245R

Approved

EAS1954a
70395-ZE
160 x 323

Page 2 of 3

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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