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QUININE BISULPHATE TABLETS BP 300MG

Active substance(s): QUININE BISULPHATE

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Patient Information Leaflet

QUININE BISULPHATE 300MG TABLETS

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 other questions, or if there is
something you do not understand, please ask
your doctor or pharmacist.
• This medicine has been prescribed for you
only. Never give it to someone else. It may
not be the right medicine for 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 Quinine Bisulphate is and what it is
used for
2. What you need to know before you take
Quinine Bisulphate
3. How to take Quinine Bisulphate
4. Possible side effects
5. How to store Quinine Bisulphate
6. Contents of the pack and other information

1. What Quinine Bisulphate is and what
it is used for

Quinine Bisulphate belongs to a group of
medicines called anti-protozoal agents and they
are used to treat:
• malaria
• and prevent night cramps in adults and the
elderly when sleep is regularly disrupted

2. What you need to know before you
take Quinine Bisulphate

Do NOT take quinine bisulphate if you:
• are allergic (hypersensitive) to quinine or
any of the other ingredients of this medicine
(listed in section 6)
• have haemolytic anaemia (tiredness caused
by the destruction of red blood cells)
• have blood in your urine
• have tinnitus (ringing sound in the ears)
• have optic neuritis (loss of vision or
difficulty seeing)
• have haemoglobinuria (high concentration
of haemoglobin in urine)
• have myasthenia gravis (suffer from muscle
weakness)

Warnings and precautions
Talk to your doctor or pharmacist before taking
these tablets if you:
• have irregular heartbeats or other heart
problems
• suffer from kidney or liver problems
• have had malaria for a long time
• suffer from glucose-6-phosphate
dehydrogenase deficiency (G6PD), this can
increase the risk of the destruction of red
blood cells during quinine therapy
• consume excessive amounts of beverages that
contain quinine such as tonic water
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 bisulphate
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Tell your doctor if you are taking any of the
following medicines, as special care may be
required:
• warfarin (to prevent blood clots)
• chloroquine (for rheumatoid arthritis,
malaria)
• cimetidine (to treat stomach ulcer)
• digoxin (for heart problems)
• amantadine (to treat Parkinsons Disease or
some viral infections)
• halofantrine, mefloquine or artemether with
lumefantrine or primaquine (also to treat
malaria)
• flecainide, quinidine or amiodarone (to treat
irregular heartbeats)
• terfenadine (for allergic reactions)
• ciclosporin (to prevent transplant rejection)
• pimozide or thioridazine (to treat some
mental disorders)
• moxifloxacin or rifampicin (to treat
infections)
• metformin (medicines to treat diabetes)
• suxamethonium (a muscle relaxant)
• ritonavir, indinavir (HIV medicines)
• barbiturates, phenytoin or carbamazepine
(anticonvulsants)

Pregnancy and breast feeding
You should not take quinine bisulphate tablets if
you are pregnant, planning to become pregnant
or breast-feeding unless advised by your doctor.
Quinine bisulphate tablets should not be used
for night cramps during pregnancy.

Driving and using machines
Quinine bisulphate tablets may affect your
vision or cause vertigo (a feeling of dizziness or
spinning). Make sure you are not affected before
you drive or operate machinery.
Quinine bisulphate contains sucrose
These tablets contain sucrose. If you have been
told by you doctor that you have an intolerance
to some sugars, contact your doctor before
taking this medicinal product.

3. How to take Quinine Bisulphate

Always take this medicine exactly as described
in this leaflet or as your doctor has told you.
Check with your doctor or pharmacist if you are
not sure. Swallow the tablets with water.

For uncomplicated malaria (you may be given
another medicine for malaria with or after this
course of quinine):
• Adults, the elderly and children over 12
years - Two tablets every eight hours for 7
days.
• Children under 12 years - Equivalent of
10mg/kg of body weight every eight 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.
For the relief of nocturnal cramps:
• Adults and the elderly
300mg at bedtime.
It may take up to 4 weeks before you notice any
reduction in the frequency of leg cramps.
Do not take more than the recommended dose

If you take more quinine bisulphate than you
should
If you or anyone else has taken too many tablets,
or you think a child may have swallowed any,
contact your nearest hospital casualty
department or tell your doctor immediately.
Take any remaining tablets with you to show the
doctor.
Symptoms of overdose include loss of
consciousness, difficulty breathing, changes in
heart beat, fits, ‘ringing’ in the ears, loss of
hearing, headache, feeling or being sick, kidney
failure and changes in vision. Severe poisoning
can produce convulsions, coma, permanent loss
of vision, respiratory depression and death.
If you forget to take quinine bisulphate
Do not take a double dose to make up for a
forgotten dose. If you forget to take a dose take
it as soon as you remember it and then take the
next dose at the right 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 bisulphate tablets
can cause side effects, although not everybody
gets them.

Contact your doctor at once if the following
serious side effects occur:
• allergic reactions –itchy skin rash, swelling
of the lips, face, throat or tongue, flushing,
fever, asthma or sensitivity to light
• 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 heartbeats, death. If these
occur while taking these 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
Talk to your doctor if you notice any of the
following side effects or notice any other
effects not listed:
• 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

• aggravation of myasthenia gravis
• 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

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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 Bisulphate

Keep all medicines out of the sight and reach
of children.
• Do not take this medicine after the expiry
date printed after abbreviation ‘EXP’ on the
carton, blister pack or bottle.
• Do not store above 25˚C.
• Protect from light and moisture.
• Store in the original package (for blister
packs and bottles).
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 to protect
the environment.

6. Contents of the pack and other
information

What quinine bisulphate tablets contain
• The active substance is quinine bisulphate.
Each tablet contains 300mg quinine
bisulphate.
• The other ingredients are: maize starch,
polyvinylpyrrolidone, talc, stearic acid,
sodium starch glycollate, opaglos, sucrose and
titanium dioxide.
See end of section 2 for further information on
sucrose.
What quinine bisulphate tablets look like and
contents of the pack:
Quinine bisulphate tablets are white, round,
biconvex sugar coated tablets.
Pack sizes for quinine bisulphate are “25, 28,
30, 50, 56, 100, 250, 500 and 1000 tablets. Not
all pack sizes may be marketed.

Marketing Authorisation Holder
and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433

To request a copy of this leaflet in large print
or audio format or additional copies, please
contact the licence holder at the address (or
telephone, fax) above.
PL 04556 / 0030

Reference: 00301114/02

POM

Date leaflet last revised: November 2014

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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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