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QUININE SULFATE TABLETS BP 300MG

Active substance(s): QUININE BISULFATE / QUININE SULFATE

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Quinine Sulfate 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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet
Quinine sulfate tablets are and what
1 What

they are used for
you need to know before you take
2 What

Quinine sulfate tablets
to take Quinine sulfate tablets
3 How

side effect
4 Possible

to store Quinine sulfate tablets
5 How

of the pack and other
6 Contents

information
Quinine sulfate tablets are and what
1 What

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

you need to know before you take
2 What

Quinine sulfate tablets

Do not take Quinine sulfate tablets if:
• you are allergic to quinine (including that in tonic
waters or other beverages), quinoline or any of the
other ingredients of this medicine (listed in section 6)
• 
blood in your urine
• 
ringing in your ears
• 
suffer from muscle weakness (myasthenia gravis)
• 
problems with your eyes or difficulty seeing

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Quinine sulfate tablets:
• 
if you have irregular heart beats or other heart
disease
• 
if you have had malaria for a long time
• if you suffer from severe glucose-6-phosphate
dehydrogenase deficiency (G6PD), 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
• 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 sulfate tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Especially:
• 
anticoagulants (to stop your blood from clotting)
• 
cardiac glycosides (for your heart such as digoxin)
• 
chloroquine, mefloquine, artemether with
lumefantrine, primaquine, halofantrine (also to treat
malaria)
• 
cimetidine (to treat stomach ulcers or acid reflux and
indigestion)
• 
amantadine (to treat Parkinsons Disease or some viral
infections)
• 
ciclosporin (to prevent transplant rejection)
• 
flecainide, quinidine or amiodarone (to treat irregular
heart beats)
• 
terfenadine (for allergic reactions)
• 
pimozide or thioridazine (to treat some mental
disorders)
• 
moxifloxacin, rifampicin or antifungals (to treat
infections)
• 
medicines to treat diabetes
• 
suxamethonium (muscle relaxant)
• 
HIV medicines
• barbiturates, carbamazepine or phenytoin (used in
epilepsy)
• medicines which are known to cause disturbances in
heart rhythm.
Pregnancy, breast-feeding and fertility
You should not take Quinine sulfate tablets if you are
pregnant, planning to become pregnant or breast-feeding
unless advised to by your doctor. Quinine sulfate tablets
should not be used for night cramps during pregnancy.
Driving and using machines
Quinine sulfate tablets may affect your vision and cause
vertigo (dizziness or spinning sensation). Make sure you
are not affected before you drive or operate machinery.
Continued over page

Continued top of next column

148x210 Leaflet Reel Fed Profile (BST)

Quinine Sulfate Tablets
300mg x 28’s (UK)

Quinine Sulfate 300mg 28 Tablets PIL - UK
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

2

JDE No.:

BBBA1628
Dimensions:
148 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

S.Anson
05.01.18
11.01.18
S.Anson

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

Date Sent:
20/12/17
Technologist: R.Wrey

4.

Date sent:
n/a
Date received: n/a

Technically Approved

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 9791

5.

Technical
Approval

50943998

Version 2
01.11.2017

to take Quinine sulfate tablets
3 How


Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the tablets with water.
The recommended dose is:
• 
Malaria (you may be given another medicine for malaria
with or after this course of quinine):
Adults (including elderly) and children over 12 years 600mg every eight hours for 5-7 days
Children under 12 years - 10mg per kg of body weight
every eight hours for 7 days
If you have kidney or liver disease you may be given a
different dose.
• 
Night cramps:
Adults (including elderly) - 300mg at bedtime. It may take
up to 4 weeks before you notice any reduction in the
frequency of leg cramps.
If you take more Quinine sulfate tablets than you should
If you (or someone else) swallow a lot of tablets at the same
time, or you think a child may have swallowed any, contact
your nearest hospital casualty department or tell your doctor
immediately. Symptoms include loss of consciousness, coma,
difficulty breathing, changes in heart beat and heart function,
renal failure, fits, ‘ringing’ in the ears, loss of hearing, headache,
feeling or being sick, changes in vision, low blood potassium
(causing muscle twitching/weakness or abnormal heart
rhythm) and low blood sugar, and sweating. Some of these
side effects can be fatal. High doses of quinine may also cause
miscarriage in pregnant women.
If you forget to take Quinine sulfate tablets
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 medicine,
ask your doctor, pharmacist or nurse.

side effect
4 Possible


Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Contact your doctor at once if the following effects occur:
• 
allergic reactions – itchy skin rash, swelling of the lips, face,
throat or tongue, flushing, fever, asthma or sensitivity to
light
• sores in the mouth, nose, and eyes, a skin rash, and
blistering (Stevens Johnson syndrome)
• 
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
sulfate tablets for leg cramps, treatment should be stopped
and a doctor contacted straight away.
• 
changes to blood cells as seen in blood or urine tests, 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.

Tell 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 (disorder characterised
by muscle weakness, difficulty chewing or swallowing and
slurred speech).
• 
kidney damage, kidney failure, low production of urine,
water retention, slowed heart rate, changes in heart rhythm
and the way the heart beats, a fall in blood pressure
and weak pulse rate, 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.

to store Quinine sulfate tablets
5 How


Keep out of the sight and reach of children.
Store below 25°C in a dry place
Do not use Quinine sulfate tablets after the expiry date stated
on the label/carton/bottle. The expiry date refers to the last
day of that month.
Do not throw away 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.

of the pack and other
6 Contents

information

What Quinine sulfate tablets contain
• The active substance (the ingredient that makes
the tablet work) is 300mg quinine sulfate.
• The other ingredients are sodium lauryl sulfate,
povidone, microcrystalline cellulose (E460),
croscarmellose sodium, magnesium stearate,
hydrogenated vegetable oil.
• The coating contains
hydroxypropylmethylcellulose, hydroxypropyl
cellulose, medium chain triglycerides, macrogol
3350, titanium dioxide (E171).
What Quinine sulfate tablets look like and
contents of the pack
Quinine sulfate tablets are white, circular, filmcoated tablets.
Pack sizes are 28 tablets
Marketing Authorisation Holder and
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Date of last revision: December 2017

Continued top of next column
50943998 BBBA1628

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Quinine Sulfate Tablets
300mg x 28’s (UK)

Quinine Sulfate 300mg 28 Tablets PIL - UK
approved for print/date

Item number:
Originator:
Origination Date:
Revision Date:
Revised By:

Proof Round

2

JDE No.:

BBBA1628
Dimensions:
148 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

S.Anson
05.01.18
11.01.18
S.Anson

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

Date Sent:
20/12/17
Technologist: R.Wrey

4.

Date sent:
n/a
Date received: n/a

Technically Approved

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 9791

5.

Technical
Approval

50943998

Version 2
01.11.2017

+ Expand Transcript

Further information

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

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