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QUININE SULFATE TABLETS BP 200MG

Active substance(s): QUININE SULFATE

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Quinine Sulfate 200mg 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
1 What Quinine sulfate tablets are and
what they are used for
2 What you need to know before you take
Quinine sulfate tablets
3 How to take Quinine sulfate tablets
4 Possible side effects
5 How to store Quinine sulfate tablets
6 Contents of the pack and other
information

1 What Quinine sulfate tablets are and
what they are used for

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

2 What you need to know before you take
Quinine sulfate tablets

Do not take Quinine sulfate tablets if:
• y ou 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)
• y ou have blood in your urine
• y ou have ringing in your ears
• y ou suffer from muscle weakness (myasthenia gravis)
• y ou have 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:
• a nticoagulants (to stop your blood from clotting)
• c ardiac glycosides (for your heart, such as digoxin)
• c hloroquine, mefloquine, artemether with
lumefantrine, primaquine, halofantrine (also to treat
malaria)
• c imetidine (to treat stomach ulcers or acid reflux and
indigestion)
• a mantadine (to treat Parkinsons Disease or some viral
infections)
• c iclosporin (to prevent transplant rejection)
• f lecainide, quinidine or amiodarone (to treat irregular
heart beats)
• t erfenadine (for allergic reactions)
•p
 imozide or thioridazine (to treat some mental
disorders)
•m
 oxifloxacin, rifampicin or antifungals (to treat
infections)
•m
 edicines to treat diabetes
• s uxamethonium (muscle relaxant)
•H
 IV medicines
•b
 arbiturates, carbamazepine or phenytoin (used in
epilepsy)
•m
 edicines 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 top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Quinine Sulfate Tablets
200mg x 28’s (UK)

Quinine Sulfate 200mg 28 Tablets PIL - UK
approved for print/date

Item number:

BBBA1626

Originator:
S.Anson
Origination Date: 05.01.18
Revision Date:
Revised By:

Proof Round

1

JDE No.:

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

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: 4188

5.

Technical
Approval

50943980

Version 2
01.11.2017

3 How to take Quinine sulfate tablets

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:
•M
 alaria (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) - 200mg 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.

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 effects occur:
•a
 llergic reactions – itchy skin rash, swelling of the lips, face,
throat or tongue, flushing, fever, asthma or sensitivity to light
• s ores in the mouth, nose, and eyes, a skin rash, and blistering
(Stevens Johnson syndrome)
• c inchonism – 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.
• c hanges 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:
•d
 iarrhoea, feeling or being sick, abdominal pain, low blood
sugar.
•m
 uscle 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.
• a ggravation of Myasthenia gravis (disorder characterised
by muscle weakness, difficulty chewing or swallowing and
slurred speech).
• k idney 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, 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 sulfate tablets

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.

6 Contents of the pack and other
information

What Quinine sulfate tablets contain
• T he active substance (the ingredient that makes
the tablet work) is 200mg quinine sulfate.
• T he other ingredients are sodium lauryl sulfate,
povidone, microcrystalline cellulose (E460),
croscarmellose sodium, magnesium stearate,
hydrogenated vegetable oil.
• T he coating contains hydroxypropylmethyl
cellulose, 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,
film-coated 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
50943980 BBBA1626

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Quinine Sulfate Tablets
200mg x 28’s (UK)

Quinine Sulfate 200mg 28 Tablets PIL - UK
approved for print/date

Item number:

BBBA1626

Originator:
S.Anson
Origination Date: 05.01.18
Revision Date:
Revised By:

Proof Round

1

JDE No.:

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

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: 4188

5.

Technical
Approval

50943980

Version 2
01.11.2017

+ Expand Transcript

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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