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QUININE SULFATE 300 MG TABLETS

Active substance(s): QUININE SULFATE / QUININE SULFATE

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TEVA QUININE

Version:

SULFATE A/S TAB TUK
Dimensions:
Length:
Width:

1

Colours Used:

15 September 2016

BLACK

323 mm
160 mm

PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

Quinine Sulfate
200 And 300 mg 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. 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. This includes any
possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:

Pharma code 156

1. What Quinine Sulfate is and what it is
used for
2. What you need to know before you take
Quinine Sulfate
3. How to take Quinine Sulfate
4. Possible side effects
5. How to store Quinine Sulfate
6. Contents of the pack and other information

1

What Quinine Sulfate is and what
it is used for

Quinine Sulfate is an antimalarial drug also
used for muscle disorders.
Quinine Sulfate is used:
• to prevent night cramps
• for the treatment of chloroquine-resistant
malaria.

2

What you need to know before
you take Quinine Sulfate

Do not take Quinine Sulfate:
• if you are allergic to quinine sulfate or any
of the other ingredients of this medicine
(listed in section 6).
• if you have kidney problems resulting in
the presence of blood in your urine
• if you have inflammation of the optic nerve
causing problems with your eye sight
• if you suffer from tinnitus (ringing in the
ears)
• if you have myasthenia gravis (a disorder
in which the muscles are weak and tire
easily)
• if you have problems with your eyes or
difficulty seeing.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Quinine Sulfate.
Tell your doctor before you start to take this
medicine:
• if you suffer from heart, kidney or liver
problems
• if you have irregular heart beats or other
heart diseas
• if you have had malaria for a long time
• if you 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.
Other medicines and Quinine Sulfate
Tell your doctor if you are taking or have
recently taken or might take any 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)
• pimozide or thioridazine (used in the
treatment of mental illness)
• terfenadine (used in the treatment of
allergies)
• moxifloxacin or rifampicin (antibiotics)
• antifungals (to treat infections)
• ciclosporin (used to prevent transplant
rejection)
• halofantrine, chloroquine, mefloquine or
artemether with lumefantrine or
primaquine (also to treat malaria)
• cimetidine (to treat stomach ulcers or acid
reflux and indigestion)
• amantadine (to treat Parkinsons Disease
or some viral infections)
• suxamethonium (a muscle relaxant)
• carbamazepine or phenytoin
(anticonvulsants)
• antifungal medicines, e.g. fluconazole,
itraconazole, ketoconazole
• barbiturates, e.g. phenobarbital
• medicines to prevent blood clots forming,
e.g. warfarin
• medicines to treat diabetes e.g.
metformin, tolbutamide, glimepiride
• medicines used in the treatment of HIV
e.g. ritonavir, indinavir, nelfinavir.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
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
by your doctor.
Quinine Sulfate is not recommended for use
during pregnancy for the prevention of
night cramps.
Driving and using machines
Quinine Sulfate may affect your vision or
cause vertigo (a feeling of dizziness or
“spinning”). If you are affected, DO NOT
drive or operate machinery.
Quinine Sulfate contains sucrose
Patients who are intolerant to sucrose
should note that Quinine Sulfate 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 Sulfate

Always take this medicine exactly as your
doctor has told you. 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):
Use in children and adolescents
Adults (including elderly) and children over
12 years - 600 mg every eight hours for 5-7
days.
Children under 12 years - 10 mg per kg of
body weight every eight hours for 7 days.

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

Package leaflet: Information for the user

TEVA UK QUININE

Version:

SULFATE A/S TAB TUK
Dimensions:
Length:
Width:

1

Colours Used:

15 September 2016

BLACK

323 mm
160 mm

PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.
If you take more Quinine Sulfate than you
should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child
has accidentally swallowed any of the
tablets, contact your nearest hospital
casualty department or your doctor
immediately.
An overdose of Quinine Sulfate may cause
‘cinchonism’. Early symptoms are:
• tinnitus (ringing in the ears), impaired
hearing and vision, headache, feeling sick,
being sick, fits
• rashes, confusion, hot and flushed skin.
More severe symptoms include:
• nervous system disorders, stomach
problems, shallow breathing, loss of
consciousness
• severe eyesight problems including
blindness
• effects on the heart, kidney and brain
• shock, low blood sugar.
Large doses can 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.
If you forget to take Quinine Sulfate
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. Do not take a
double dose to make up for a forgotten
dose. Take the remaining doses at the
correct time.
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.
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
heartbeats, 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, 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.
• a serious illness with blistering of the skin,
mouth eyes and genitals
(Stevens-Johnson Syndrome)
If you feel unwell whilst taking Quinine
Sulfate 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 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
• 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
• problems with blood clotting
• aggravation of myasthenia gravis
• Asthma, fever.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. 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

Keep this medicine out of the sight and
reach of children.
The tablets should be stored below 25°C in
the package or container supplied. Do not
transfer them to another container.
Do not use this medicine after the expiry
date which is stated on the outer packaging.
The expiry date refers to the last day of that
month.
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 Sulfate Tablets contain:
• The active substance is quinine sulfate.
• The other ingredients are alginic acid
(E400), magnesium stearate (E572), maize
starch, sucrose, talc (E553), gelatin and
titanium dioxide (E171). The printing ink
contains shellac (E904), black iron oxide
(E172) and propylene glycol (E1520). The
tablet polish contains shellac (E904),
carnauba wax (E903) and white beeswax
(E901).
What Quinine Sulfate Tablets look like and
contents of the pack:
• The Quinine Sulfate 200 mg Tablets are
white, biconvex, sugar-coated tablets.
They are plain on one side, marked 200
over 1205 on the reverse.
• The Quinine Sulfate 300 mg Tablets are
white, biconvex, sugar-coated tablets.
They are plain on one side, marked 300
over 1206 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.
The Quinine Sulfate 300 mg Tablets are
also available in pack sizes of 25 and 50.
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: August 2016
PL 00289/5242R-5243R

12087-ZD
160 x 323

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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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