QUININE SULPHATE 200MG TABLETS BP

Active substance: QUININE SULPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 156

• amiodarone, quinidine or flecainide (used
to treat an irregular heartbeat)
• pimozide or thioridazine (used in the
PACKAGE LEAFLET: INFORMATION
treatment of mental illness)
FOR THE USER
• terfenadine (used in the treatment of
allergies)
Read all of this leaflet carefully before you
• moxifloxacin or rifampicin (antibiotics)
start taking this medicine.
• antifungals (to treat infections)
• Keep this leaflet. You may need to read it
• ciclosporin (used to prevent transplant
again.
rejection)
• If you have any further questions, ask your
• halofantine, chloroquine, mefloquine or
doctor or pharmacist.
artemether with lumefantrine or
• This medicine has been prescribed for
primaquine (also to treat malaria)
you. Do not pass it on to others. It may
• cimetidine (to treat stomach ulcers or acid
harm them, even if their symptoms are
reflux and indigestion)
the same as yours.
• amantadine (to treat Parkinsons Disease
• If any of the side effects get serious, or if
or some viral infections)
you notice any side effects not listed in
• suxamethonium (a muscle relaxant)
this leaflet, please tell your doctor or
• carbamazepine or phenytoin
pharmacist.
(anticonvulsants)
IN THIS LEAFLET:
• antifungal medicines, e.g. fluconazole,
itraconazole, ketoconazole
1. What Quinine Sulphate is and what it is
• barbiturates, e.g. phenobarbital
used for
• medicines to prevent blood clots forming,
2. Before you take Quinine Sulphate
e.g. warfarin
3. How to take Quinine Sulphate
• medicines to treat diabetes e.g.
4. Possible side effects
metformin, tolbutamide, glimepiride
5. How to store Quinine Sulphate
• medicines used in the treatment of HIV
6. Further information
e.g. ritonavir, indinavir, nelfinavir.

1

WHAT QUININE SULPHATE IS AND
WHAT IT IS USED FOR

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

2

BEFORE YOU TAKE QUININE
SULPHATE

Do NOT take Quinine Sulphate if you:
• are allergic (hypersensitive) to quinine
sulphate or any of the other ingredients of
this medicine (see section 6)
• have kidney problems resulting in the
presence of blood in your urine
• have inflammation of the optic nerve
causing problems with your eye sight
• suffer from tinnitus (ringing in the ears)
• have myasthenia gravis (a disorder in
which the muscles are weak and tire easily)
• have problems with your eyes or difficulty
seeing.
Take special care with Quinine Sulphate
Tell your doctor before you start to take this
medicine if you:
• suffer from heart, kidney or liver problems
• have irregular heart beats or other heart
disease
• have had malaria for a long time
• 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.

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
You should not take Quinine Sulphate
tablets if you are pregnant, planning to
become pregnant or breast-feeding unless
advised by your doctor.
Quinine Sulphate is not recommended for
use during pregnancy for the prevention of
night cramps.
Driving and using machines
Quinine Sulphate may affect your vision or
cause vertigo (a feeling of dizziness or
“spinning”). If you are affected, DO NOT
drive or operate machinery.
Important information about some of the
ingredients of Quinine Sulphate
Patients who are intolerant to sucrose
should note that Quinine Sulphate 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 SULPHATE

Always take Quinine Sulphate exactly as
your doctor has told you. You should 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:
You should not take more than the
Adults (including the elderly)
prescribed dose as a condition called
• Prevention of night cramp:
‘cinchonism’ may occur even with normal
One 200 mg tablet before going to bed.
doses. Please see section 4 ‘Possible side
Do not take more than the prescribed dose.
effects’ for symptoms of cinchonism and tell
It may take up to 4 weeks before you see a
your doctor if you experience any of them.
reduction in the frequency of night time
cramps.
Taking other medicines
Your doctor will monitor the effects of
Talk to your doctor if you are taking any of
your treatment and adjust it accordingly.
the following:
Maximum dose - 300 mg at bedtime.
• anticoagulants (to stop your blood from
clotting)
• Treatment of malaria (you may be given
• cardiac glycosides (for your heart such as
another medicine for malaria with or after
digoxin)
this course of quinine):

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

QUININE SULPHATE 200 mg
AND 300 mg TABLETS BP

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Adults (including elderly) and children
over 12 years - 600 mg every eight hours
for 5-7 days.

If you feel unwell whilst taking Quinine
Sulphate 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,
Patients with kidney or liver problems
abdominal pain, low blood sugar
A lower dose than the usual adult dose or
• muscle weakness, excitement, agitation,
increased time between doses should be
‘spinning’ sensation’, confusion, loss of
used if you have kidney or liver problems.
consciousness, coma, death
If you take more Quinine Sulphate than you • headache, changes in vision, ‘ringing’ in
should
the ears, loss of hearing
If you (or someone else) swallow a lot of the • swollen, itchy, flaky, red or raised patches
tablets all together, or if you think a child has
of skin, rashes, sensitivity to light
accidentally swallowed any of the tablets,
• kidney damage, water retention, slowed
contact your nearest hospital casualty
heart rate, changes in heart rhythm and
department or your doctor immediately.
the way the heart beats, eczema,
An overdose of Quinine Sulphate may cause
miscarriages (at very high concentrations),
‘cinchonism’. Early symptoms are:
difficulty breathing
• tinnitus (ringing in the ears), impaired
• problems with blood clotting
hearing and vision, headache, feeling sick, • aggravation of myasthenia gravis.
being sick, fits
If any of the side effects get serious, or if you
• rashes, confusion, hot and flushed skin.
notice any side effects not listed in this
More severe symptoms include:
leaflet, please tell your doctor or pharmacist.
• nervous system disorders, stomach
problems, shallow breathing, loss of
5 HOW TO STORE QUININE SULPHATE
consciousness
• severe eyesight problems including
Keep out of the reach and sight of children.
blindness
The tablets should be stored below 25°C in
• effects on the heart, kidney and brain
the package or container supplied. Do not
• shock, low blood sugar.
transfer them to another container. Do not
use Quinine Sulphate after the expiry date
Large doses can cause abortion.
that is stated on the outer packaging. The
Please take this leaflet, any remaining
expiry date refers to the last day of that
tablets, and the container with you to the
month. Medicines should not be disposed of
hospital or doctor so that they know which
via wastewater or household waste. Ask your
tablets were consumed.
pharmacist how to dispose of medicines no
longer required. These measures will help to
If you forget to take Quinine Sulphate
protect the environment.
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
6 FURTHER INFORMATION
double dose to make up for a forgotten
What Quinine Sulphate Tablets contain:
dose. Take the remaining doses at the
• The active ingredient is quinine sulphate
correct time.
• The other ingredients are alginic acid
If you have any further questions on the use
(E400), magnesium stearate (E572), maize
of this product, ask your doctor or pharmacist.
starch, sucrose, talc (E553), gelatin and
titanium dioxide (E171). The printing ink
POSSIBLE SIDE EFFECTS
4
contains shellac (E904), black iron oxide
(E172) and propylene glycol (E1520). The
Like all medicines, Quinine Sulphate can
tablet polish contains shellac (E904),
cause side effects, although not everybody
carnauba wax (E903) and white beeswax
gets them.
(E901).
If any of the following happen, stop taking
What Quinine Sulphate Tablets look like and
the tablets and tell your doctor immediately
contents of the pack:
or go to the casualty department at your
• The Quinine Sulphate 200 mg Tablets are
nearest hospital:
white, biconvex, sugar-coated tablets.
• an allergic reaction (swelling of the lips,
They are plain on one side, marked 200
face or neck leading to severe difficulty in
over 1205 on the reverse.
breathing; skin rash or hives)
• The Quinine Sulphate 300 mg Tablets are
• unexplained bruising or bleeding.
white, biconvex, sugar-coated tablets.
These are very serious but rare side effects.
They are plain on one side, marked 300
You may need urgent medical attention or
over 1206 on the reverse.
hospitalisation.
• The product is available in pack sizes of 7,
Contact your doctor at once if the following
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110,
effects occur:
112, 120, 150, 160, 168, and 500 tablets.
• cinchonism – abdominal pain, diarrhoea,
The Quinine Sulphate 300 mg Tablets are
disturbed vision (blurred vision, changes
also available in pack sizes of 25 and 50.
in colour perception or field of vision, total Not all pack sizes may be marketed.
blindness), headache, feeling or being
Marketing Authorisation Holder and
sick, ringing in the ears or impaired
Manufacturer
hearing, rashes, loss of consciousness,
The Marketing Authorisation holder and
fits, shock due to heart problems, irregular
company responsible for manufacture is
heartbeats, death. If these occur while
TEVA UK Limited, Eastbourne, BN22 9AG.
taking Quinine Sulphate tablets for leg
cramps, treatment should be stopped and
This leaflet was last revised: April 2012
a doctor contacted straight away
• changes to blood cells, if you notice that
PL 00289/5242R-5243R
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
12087-Y
blood test.
Children under 12 years - 10 mg per kg of
body weight every eight hours for 7 days.

160 x 323

Expand view ⇕

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.

Hide
(web1)