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QUININE SULPHATE TABLETS 300MG

Active substance: QUININE SULPHATE

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QUININE SULPHATE :00320514-02........... 148 X 280mm

5/30/14

1:28 PM

Page 1

Patient Information Leaflet

QUININE SULPHATE 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 further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. 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 or nurse. This includes any
possible side effects not listed in this leaflet.
See section-4.
In this leaflet:
1. What Quinine Sulphate is and what it is used
for
2. What you need to know before you take
Quinine Sulphate
3. How to take Quinine Sulphate
4. Possible side effects
5. How to store Quinine Sulphate
6. Contents of the pack and other information

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

Quinine sulphate 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 Sulphate

Do not take Quinine Sulphate 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 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
have conduction defects of the heart (this is
where the heart cannot conduct electrical
signals properly)
have blood in your urine
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 Sulphate
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 sulphate tablets
if you are pregnant, planning to become
pregnant or breast-feeding unless advised to
by your doctor. Quinine sulphate tablets
should not be used for night cramps
during pregnancy.

Driving and using machines
Quinine sulphate 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 Sulphate contains lactose and
sucrose
These tablets contain lactose and 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 Sulphate

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

Dosage
The usual dose for adults and children is
given below
For uncomplicated malaria (you may be given
another medicine for malaria with or after this
course of quinine):

QUININE SULPHATE :00320514-02........... 148 X 280mm

• 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 - 200mg at bedtime
which may be increased maximum to 300mg.
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 tablets than you should
If you or anyone else has taken too many
tablets, contact your nearest hospital casualty
department or doctor immediately. Bring 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 and
changes in vision. Severe poisoning can produce
convulsions, coma, respiratory depression and
death.
If you forget to take Quinine Sulphate

Do not worry just take your tablets as soon as you
remember, then go on as before. Do not take a
double dose to make up for a forgotten dose.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 Quinine sulphate
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

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1:28 PM

Page 2

• 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 Sulphate

Keep this medicine out of the sight and reach
of children
• Do not use this medicine after the expiry date
which is stated on the label, carton and
blister after ‘EXP’. The expiry date refers to
the last day of that month.
• 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 protect
the environment.

6. Contents of the pack and other
information

What Quinine Sulphate tablets contain
• The active substance is Quinine Sulphate.
Each tablet contains 300mg Quinine
Sulphate.
• The other ingredients are: lactose, maize
starch, magnesium stearate, stearic acid,
purified talc, sodium croscarmellose,
opaglos, sucrose and titanium dioxide.
See end of section 2 for further information on
lactose and sucrose.
What Quinine Sulphate look like and
contents of the pack
• Quinine Sulphate tablets are white, round,
biconvex sugar coated tablets.
• Pack sizes for Quinine Sulphate are “25,
28, 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 / 0032

Reference: 00320514/02

The leaflet was last revised in May 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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