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QUININE BISULFATE TABLETS BP 300MG

Active substance(s): QUININE BISULFATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

QUININE BISULFATE TABLETS 300 mg
[Quinine Bisulfate]

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 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 side effects not listed in this
leaflet. See section 4.

What is in this leaflet:

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

1. What Quinine Bisulfate Tablets are and
what they are used for
Quinine Bisulfate is one of a group of medicines called
anti-protozoal agents.
Quinine Bisulfate Tablets are used to:
• Treat malaria.
• Treat and prevent nocturnal (night-time) leg cramps in
adults and the elderly.

2. What you need to know before you take
Quinine Bisulfate Tablets
Do not take Quinine Bisulfate if you:

• Are allergic to quinine or any other ingredients of this
medicine (listed in section 6).
• Have problems with your eyes or difficulty seeing.
• Suffer from tinnitus (ringing or buzzing in the ears).
• Have blood in the urine (haemoglobinuria).
• Suffer from muscle weakness (myasthenia gravis)..

Warnings and precautions

Talk to your doctor or pharmacist before taking Quinine
Bisulfate Tablets if you:
• Are sensitive to Quinine. See section 4 for possible
symptoms.
• Have had malaria for a long time.
• Have irregular heartbeats or other heart disease.
• Have conduction defects of the heart (this is where the
heart cannot conduct electrical signals properly).
• Suffer from severe glucose-6-phosphate dehydrogenase
deficiency (G6PD), this can cause episodes of anaemia
after eating certain foods such as fava beans or certain
drugs to prevent malaria or dapsone.
• Intend on using the medicine for nocturnal leg cramps.
• Have previously experienced any adverse reaction to
quinine, including that in tonic water or other beverages.
Quinine may cause thrombocytopenia (reduction in blood
platelet counts).
• Suffer from kidney or liver problems.
You should not take more than the prescribed dose as
a condition called ‘cinchonism’ may occur even with a
normal dose. Please see section 4 ‘Possible side effects’
for symptoms of cinchonism and tell your doctor if you
experience any of them.
Tell your doctor if you were born with or have any condition
that causes an abnormal heart rhythm.

Other medicines and Quinine Bisulfate Tablets:

Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines including any
medicines obtained without a prescription, especially:
• Anticoagulants (to stop your blood clotting).
• Cardiac glycosides (medicines for your heart such as
digoxin).
• Chloroquine, artemether with lumefantrine or mefloquine,
halofantrine or primaquine (also to treat malaria).
• Cimetidine (to treat stomach ulcers or acid reflux and
indigestion).
• Flecainide, quinidine or amiodarone (to treat irregular heart
rhythms).
• Pimozide or thioridazine (to treat some mental disorders).
• Rifampicin or moxifloxacin (antibiotics).
• Barbiturates, carbamazepine or phenytoin (medicines to
treat epilepsy).
• Oral hypoglycaemics (to treat diabetes).
• HIV protease inhibitors (drugs to treat HIV infections such
as ritonavir).
• Azole antifungals (drugs to treat fungal infections such as
ketoconazole).
• Ciclosporin (used following transplant surgery and to treat
various inflammatory diseases).
• Amantadine (an antiviral to treat influenza and Parkinson’s
disease).
• Suxamethonium (a muscle relaxant used in surgery, tell the
anaesthetist you are taking Quinine Bisulfate Tablets).
• Terfenadine (used in the treatment of allergies).
• Medicines which are known to cause disturbances in heart
rhythm.
If you see another doctor or go into hospital, let them know
what medicines you are taking.

Pregnancy and breast-feeding:

Do not take the tablets if you are pregnant, trying to become
pregnant or breast-feeding. Quinine Bisulfate Tablets should
not be used for night cramps during pregnancy. Consult your
doctor or pharmacist if in doubt.

Driving and using machines:

Quinine may affect your vision or cause vertigo (a feeling of
dizziness or ‘spinning’). If you are affected, DO NOT drive or
operate machinery.

Quinine Bisulfate Tablets contain lactose:

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.

3. How to take Quinine Bisulfate Tablets

Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
These tablets should be swallowed with some water.

Malaria

Adults (including elderly) and children over 12 years:
600mg at 8 hour intervals for 7 days
Children under 12 years:
10mg/kg at 8 hour intervals for 7 days

Nocturnal leg cramps

Adults (including elderly people):
The recommended dose is 300mg at bedtime.
It may take up to 4 weeks before you notice any reduction
in the frequency of leg cramps. Your doctor will monitor your
progress.
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.

Dimension: 180 x 250 mm

Front Side

QUININE BISULFATE TABLETS 300 mg
Co-pharma

Pack Insert
----

180 x 250 mm Same Size
1035101
Black
Change Control Record ID: 164917
Front & Back Printing. To be supplied unfold.
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.

1034586
1
9.0

If you take more Quinine Bisulfate Tablets than you
should:

If you accidentally take more than your prescribed dose,
contact your nearest hospital casualty department, or tell
your doctor immediately. Take any remaining tablets and the
container with you.
An overdose of Quinine 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.
− Sever eyesight problems including blindness.
− Effects on the heart, kidneys and brain.
− Low blood sugar.
− Muscle weakness, tiredness or cramps.
− Tingling or numbness.
− Feeling your heart beat irregularly (palpitations).
− Large doses can cause abortion.

If you forget to take Quinine Bisulfate Tablets:

If you forget to take a dose, take another as soon as you
remember and then your next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you are elderly, it is particularly important to take this
medicine exactly as directed by the doctor.

If you stop taking Quinine Bisulfate Tablets:

Continue to take the tablets for as long as your doctor tells
you to. If you are taking them for malaria you must take the
full course. If you stop too soon the infection may recur.
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
• Allergic reaction - itchy skin rash, swelling of the lips, face,
throat or tongue, flushing, fever, asthma or sensitivity to light.
• Unexplained bruising or bleeding, or frequent nose bleeds.
• A serious illness with blistering of the skin, mouth, eyes and
genitals (Stevens-Johnson Syndrome).
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
heart beats, death. If these occur while taking Quinine
Bisulfate Tablets for leg cramps, treatment should be
stopped and a doctor contacted straight away.
• Changes to blood cells, if you notice that you have more
sore throats and infections than usual tell your doctor who
may want to give you a blood test.

• 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.
• Aggravation of myasthenia gravis.
• Excretion of protein in your urine which may cause a colour
change.
• Fall in blood pressure coupled with a weak pulse.

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 Bisulfate Tablets

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place and in the original packaging.
Do not use this medicine after the expiry date which is stated on
the label. The expiry date refers to the last day of that month.
Remember, this medicine is for you only. Never give it to
anyone else. It may harm them, even if their symptoms are
the same as yours.
Do not use this medicine if you notice visible signs of deterioration.
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 Bisulfate Tablets contain:
The active substance is Quinine Bisulfate BP/Ph.Eur.
The other ingredients are: Lactose

Microcrystalline cellulose

Povidone K30

Maize Starch

Sodium starch glycollate

Colloidal anhydrous silica

Purified talc

Magnesium stearate

Pregelatinised maize starch
Ingredients for Coating:




Hydroxypropylmethylcellulose
Diethyl phthalate
Opadry white
Carnauba wax

What Quinine Bisulfate Tablets look like and contents of
the pack:
Quinine Bisulfate Tablets are white, biconvex film-coated
tablets.
The tablets are supplied in PVC/aluminium foil blister packs
containing 28 tablets.

The following side effects have also been reported:

This leaflet was last revised in 01/2018.

• 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.

1035101

If you feel unwell whilst taking Quinine Bisulfate for night cramps,
stop taking the tablets and talk to your doctor immediately.

Marketing Authorisation Holder and Manufacturer:
Co-pharma
Unit 4, Metro Centre,
Tolpits Lane, Watford, Herts,
WD18 9SS, UK
Tel: 01923 255580
Fax: 01923 255581

Dimension: 180 x 250 mm

Back Side

QUININE BISULFATE TABLETS 300 mg
Co-pharma

Pack Insert
----

180 x 250 mm Same Size
1035101
Black
Change Control Record ID: 164917
Front & Back Printing. To be supplied unfold.
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.

1034586
1
9.0

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Further information

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