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QUININE BISULFATE 300MG TABLETS BP

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TEVA UK Ref:

Version:

231-30-70395-ZB LEA QUININE BISULPHATE 300mg TAB TUK

1

22 January 2016

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 231 (1101000)
First bar is 105mm from the top edge of the leaflet.

• pimozide or thioridazine (used in the
treatment of mental illness)
• terfenadine (used in the treatment of
PACKAGE LEAFLET:
allergies)
INFORMATION FOR THE USER
• moxifloxacin or rifampicin (antibiotics)
• antifungals (to treat infections)
Read all of this leaflet carefully before you
• ciclosporin (used to prevent transplant
start taking this medicine.
rejection)
• Keep this leaflet. You may need to read it
• halofantine, chloroquine, mefloquine or
again.
artemether with lumefantrine or
• If you have any further questions, ask your
primaquine (also to treat malaria)
doctor or pharmacist.
• cimetidine (to treat stomach ulcers or acid
• This medicine has been prescribed for
reflux and indigestion)
you. Do not pass it on to others. It may
• amantadine (to treat Parkinsons Disease
harm them, even if their symptoms are
or some viral infections)
the same as yours.
• suxamethonium (a muscle relaxant)
• If you get any side effects, talk to your
• carbamazepine or phenytoin
doctor or pharmacist. This includes any
(anticonvulsants)
possible side effects not listed in this
• antifungal medicines, e.g. fluconazole,
leaflet. See section 4.
itraconazole, ketoconazole
IN THIS LEAFLET:
• barbiturates, e.g. phenobarbital
• medicines to prevent blood clots forming,
1. What Quinine Bisulfate is and what it is
e.g. warfarin
used for
• medicines to treat diabetes e.g.
2. Before you take Quinine Bisulfate
metformin, tolbutamide, glimepiride
3. How to take Quinine Bisulfate
• medicines used in the treatment of HIV
4. Possible side effects
e.g. ritonavir, indinavir, nelfinavir.
5. How to store Quinine Bisulfate
6. Further information
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
WHAT
QUININE
BISULFATE
IS
AND
1 WHAT IT IS USED FOR
medicines, including medicines obtained
without a prescription.
Quinine Bisulfate is an antimalarial drug
Pregnancy and breast-feeding
also used for muscle disorders.
You should not take Quinine Bisulfate
tablets if you are pregnant, planning to
Quinine Bisulfate is used:
become pregnant or breast-feeding unless
• to prevent night cramps
• for the treatment of chloroquine-resistant advised to by your doctor.
Quinine Bisulfate is not recommended for
malaria.
use during pregnancy for the prevention of
night cramps.
2 BEFORE YOU TAKE QUININE

BISULFATE

Do NOT take Quinine Bisulfate if you:
• are allergic (hypersensitive) to quinine
bisulfate 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)
• problems with your eyes or difficulty
seeing.
Take special care with Quinine Bisulfate
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)
• amiodarone, quinidine or flecainide (used
to treat an irregular heartbeat)

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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.
Important information about some of the
ingredients of Quinine Bisulfate
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 Quinine Bisulfate 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):

Approved

Adults (including elderly) and children
over 12 years – 600 mg every eight hours
for 5-7 days.

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

QUININE BISULFATE 300 mg
TABLETS

TEVA UK Ref:

Version:

231-30-70395-ZB LEA QUININE BISULPHATE 300mg TAB TUK

1

PAGE 2: REAR FACE (OUTSIDE OF REEL)

your doctor who may want to give you a
blood test.

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.

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
Patients with kidney or liver problems
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 Bisulfate than you
• headache, changes in vision, ‘ringing’ in
should
the ears, loss of hearing
If you (or someone else) swallow a lot of the
• swollen, itchy, flaky, red or raised patches
tablets all together, or if you think a child
of skin, rashes, sensitivity to light
has accidentally swallowed any of the
• kidney damage, water retention, slowed
tablets, contact your nearest hospital
heart rate, changes in heart rhythm and
casualty department or your doctor
the way the heart beats, eczema,
immediately.
miscarriages (at very high concentrations),
An overdose of Quinine Bisulfate may cause
difficulty breathing
‘cinchonism’. Early symptoms are:
• problems with blood clotting
• tinnitus (ringing in the ears), impaired
• aggravation of myasthenia gravis.
hearing and vision, headache, feeling sick,
Reporting of side effects
being sick, fits
If you get any side effects, talk to your
• rashes, confusion, hot and flushed skin..
doctor or pharmacist. This includes any
More severe symptoms include:
possible side effects not listed in this leaflet.
• nervous system disorders, stomach
You can also report side effects directly via
problems, shallow breathing, loss of
the Yellow Card Scheme at:
consciousness
www.mhra.gov.uk/yellowcard
• severe eyesight problems including
By reporting side effects you can help
blindness
provide more information on the safety of
• effects on the heart, kidney and brain
this medicine.
• shock, low blood sugar.

5

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.

HOW TO STORE QUININE
BISULFATE

Keep out of the reach and sight of children.
The tablets should be stored below 25oC in
the package or container supplied. Do not
transfer them to another container. Do not
If you forget to take Quinine Bisulfate
use Quinine Bisulfate after the expiry date
If you forget to take a tablet, take one as
that is stated on the outer packaging. The
soon as you remember, unless it is nearly
expiry date refers to the last day of that
time to take the next one. Do not take a
month. Medicines should not be disposed of
double dose to make up for a forgotten
via wastewater or household waste. Ask
dose. Take the remaining doses at the
your pharmacist how to dispose of
correct time.
medicines no longer required. These
If you have any further questions on the use measures will help to protect the
environment.
of this product, ask your doctor or
pharmacist.
FURTHER INFORMATION

4

6

POSSIBLE SIDE EFFECTS

Like all medicines, Quinine Bisulfate 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.

What Quinine Bisulfate Tablets contain:
• The active ingredient 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 January 2016
PL 00289/5245R

• 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

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22 January 2016

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-5245R-quinine-bisulphate-300mg-tablets

APPROVALS
Signed by
Darryl Hill

REG0068235

Meaning of Signature
Regulatory Affairs Approval

Version 2.3

Approved

Server Date
18-Mar-2016 11:01:29 AM

Page 3 of 3

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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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