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QUININE BISULFATE 300 MG TABLETS

Active substance(s): QUININE BISULFATE

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Length:
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Colours Used:
323 mm
160 mm

PAGE 1: FRONT FACE (INSIDE OF REEL)

Quinine Bisulfate
300 mg Tablets

Pharma code 231 (1101000)

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
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.

Version

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 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):

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

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
PACKAGE LEAFLET:
digoxin)
INFORMATION FOR THE USER
• amiodarone, quinidine or flecainide (used
Read all of this leaflet carefully before you
to treat an irregular heartbeat)
start taking this medicine because it
• pimozide or thioridazine (used in the
contains important information for you.
treatment of mental illness)
• Keep this leaflet. You may need to read it
• terfenadine (used in the treatment of
again.
allergies)
• If you have any further questions, ask your • moxifloxacin or rifampicin (antibiotics)
doctor or pharmacist.
• antifungals (to treat infections)
• This medicine has been prescribed for
• ciclosporin (used to prevent transplant
you. Do not pass it on to others. It may
rejection)
harm them, even if their signs of illness
• halofantine, chloroquine, mefloquine or
are the same as yours.
artemether with lumefantrine or
• If you get any side effects, talk to your
primaquine (also to treat malaria)
doctor or pharmacist. This includes any
• cimetidine (to treat stomach ulcers or acid
possible side effects not listed in this
reflux and indigestion)
leaflet. See section 4.
• amantadine (to treat Parkinsons Disease
or some viral infections)
What is in this leaflet:
• suxamethonium (a muscle relaxant)
1. What Quinine Bisulfate is and what it is

carbamazepine or phenytoin
used for
(anticonvulsants)
2. What you need to know before you take
• antifungal medicines, e.g. fluconazole,
Quinine Bisulfate
itraconazole, ketoconazole
3. How to take Quinine Bisulfate
• barbiturates, e.g. phenobarbital
4. Possible side effects
• medicines to prevent blood clots forming,
5. How to store Quinine Bisulfate
e.g. warfarin
6. Contents of the pack and other information
• medicines to treat diabetes e.g.
Quinine Bisulfate is and
metformin, tolbutamide, glimepiride
1 What
what it is used for
• medicines used in the treatment of HIV
e.g. ritonavir, indinavir, nelfinavir.
Quinine Bisulfate is an antimalarial drug
Please tell your doctor or pharmacist if you
also used for muscle disorders.
are taking or have recently taken any other
Quinine Bisulfate is used:
medicines, including medicines obtained
• to prevent night cramps
without a prescription.
• for the treatment of chloroquine-resistant
Pregnancy, breast-feeding and fertility
malaria.
You should not take Quinine Bisulfate
What
you
need
to
know
before
tablets if you are pregnant, planning to
2 you take Quinine Bisulfate
become pregnant or breast-feeding unless
advised to by your doctor.
Do not take Quinine Bisulfate :
Quinine Bisulfate is not recommended for
• if you are allergic to quinine bisulfate or
use during pregnancy for the prevention of
any of the other ingredients of this
night cramps.
medicine (listed in section 6).
• if you have kidney problems resulting in Driving and using machines
Quinine Bisulfate may affect your vision or
the presence of blood in your urine
• if you have inflammation of the optic nerve cause vertigo (a feeling of dizziness or
“spinning”). If you are affected, DO NOT
causing problems with your eye sight
drive or operate machinery.
• if you suffer from tinnitus (ringing in the
ears)
Quinine Bisulfate contains sucrose
• if you have myasthenia gravis (a disorder Patients who are intolerant to sucrose
in which the muscles are weak and tire
should note that Quinine Bisulfate tablets
easily)
contain a small amount of sucrose. If you
• if you problems with your eyes or
have been told by your doctor that you have
difficulty seeing.
an intolerance to some sugars, contact your
doctor before taking this medicinal product.
Warnings and precautions
Package leaflet: Information for the user

Dimensions:
Length:
Width:

Colours Used:
323 mm
160 mm

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

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)
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.
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 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

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 April 2016
PL 00289/5245R

70395-ZC
160 x 323

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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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