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QUININE SULFATE 200 MG TABLETS

Active substance(s): QUININE SULFATE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 156

• anticoagulants (to stop your blood from
clotting)
• cardiac glycosides (for your heart such as
Package leaflet: Information for the user
digoxin)
• amiodarone, quinidine or flecainide (used
Read all of this leaflet carefully before you
to treat an irregular heartbeat)
start taking this medicine because it
• pimozide or thioridazine (used in the
contains important information for you.
treatment of mental illness)
• Keep this leaflet. You may need to read it
• terfenadine (used in the treatment of
again.
allergies)
• If you have any further questions, ask your
• moxifloxacin or rifampicin (antibiotics)
doctor or pharmacist.
• antifungals (to treat infections)
• This medicine has been prescribed for
• ciclosporin (used to prevent transplant
you. Do not pass it on to others. It may
rejection)
harm them, even if their signs of illness
• halofantine, chloroquine, mefloquine or
are the same as yours.
artemether with lumefantrine or
• If you get any side effects, talk to your
primaquine (also to treat malaria)
doctor or pharmacist. This includes any

cimetidine (to treat stomach ulcers or acid
possible side effects not listed in this
reflux and indigestion)
leaflet. See section 4.
• amantadine (to treat Parkinsons Disease
What is in this leaflet:
or some viral infections)
• suxamethonium (a muscle relaxant)
1. What Quinine Sulfate is and what it is

carbamazepine or phenytoin
used for
(anticonvulsants)
2. What you need to know before you take

antifungal medicines, e.g. fluconazole,
Quinine Sulfate
itraconazole, ketoconazole
3. How to take Quinine Sulfate
• barbiturates, e.g. phenobarbital
4. Possible side effects

medicines to prevent blood clots forming,
5. How to store Quinine Sulfate
e.g. warfarin
6. Contents of the pack and other

medicines to treat diabetes e.g.
information
metformin, tolbutamide, glimepiride
What
Quinine
Sulfate
is
and
what
• medicines used in the treatment of HIV
1 it is used for
e.g. ritonavir, indinavir, nelfinavir.
Quinine Sulfate is an antimalarial drug also Please tell your doctor or pharmacist if you
are taking or have recently taken any other
used for muscle disorders.
medicines, including medicines obtained
Quinine Sulfate is used:
without a prescription.
• to prevent night cramps
• for the treatment of chloroquine-resistant Pregnancy, breast-feeding and fertility
You should not take Quinine Sulfate tablets
malaria.
if you are pregnant, planning to become
What
you
need
to
know
before
pregnant or breast-feeding unless advised
2 you take Quinine Sulfate
by your doctor.
Quinine Sulfate is not recommended for use
Do not take Quinine Sulfate:
during pregnancy for the prevention of
• if you are allergic to quinine sulfate or any night cramps.
of the other ingredients of this medicine
Driving and using machines
(listed in section 6).
Quinine Sulfate may affect your vision or
• if you have kidney problems resulting in
cause vertigo (a feeling of dizziness or
the presence of blood in your urine
“spinning”). If you are affected, DO NOT
• if you have inflammation of the optic
drive or operate machinery.
nerve causing problems with your eye
sight
Quinine Sulfate contains sucrose
• if you suffer from tinnitus (ringing in the
Patients who are intolerant to sucrose
ears)
should note that Quinine Sulfate tablets
• if you have myasthenia gravis (a disorder contain a small amount of sucrose. If you
in which the muscles are weak and tire
have been told by your doctor that you have
easily)
an intolerance to some sugars, contact your
• if you have problems with your eyes or
doctor before taking this medicinal product.
difficulty seeing.
3 How to take Quinine Sulfate
Warnings and precautions
Always
take this medicine exactly as your
Talk to your doctor or pharmacist before
doctor has told you. Check with your doctor
taking Quinine Sulfate.
or pharmacist if you are not sure. Do not
Tell your doctor before you start to take this take more than your doctor has
medicine:
recommended.
• if you suffer from heart, kidney or liver
If you see another doctor or go into hospital,
problems
let them or the staff know what medicines
• if you have irregular heart beats or other
you are taking.
heart diseas
• if you have had malaria for a long time
The tablets should be swallowed preferably
• if you suffer from glucose 6-phosphate
with a drink of water.
dehydrogenase (G6PD) deficiency, a rare
The usual dose is:
hereditary disease. This can cause
Adults (including the elderly)
episodes of anaemia after eating certain
• Prevention of night cramp:
foods such as fava beans (favism) or
One 200 mg tablet before going to bed.
certain drugs including drugs to prevent
Do not take more than the prescribed dose.
malaria and dapsone.
It may take up to 4 weeks before you see a
You should not take more than the
reduction in the frequency of night time
prescribed dose as a condition called
cramps.
‘cinchonism’ may occur even with normal
Your doctor will monitor the effects of
doses. Please see section 4 ‘Possible side
your treatment and adjust it accordingly.
effects’ for symptoms of cinchonism and tell
Maximum dose - 300 mg at bedtime.
your doctor if you experience any of them.
• Treatment of malaria (you may be given
Other medicines and Quinine Sulfate
another medicine for malaria with or after
this course of quinine):
Tell your doctor if you are taking or have
recently taken or might take any other
Use in children and adolescents
medicines.
Adults (including elderly) and children over
Talk to your doctor if you are taking any of
12 years - 600 mg every eight hours for 5-7
the following:
days.

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

Quinine Sulfate
200 And 300 mg Tablets

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children under 12 years - 10 mg per 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.
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.
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 25oC 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.

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: April 2016
PL 00289/5242R-5243R

12087-ZC
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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