QUININE SULPHATE TABLETS 300MG

Active substance: QUININE SULPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Patient information leaflet

QUININE SULPHATE 300MG 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 other questions, or if there is something you do not understand, please ask your
doctor or pharmacist.

This medicine has been prescribed for you only. Never give it to someone else. It may not be
the right medicine for 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.
In this leaflet:
1. What Quinine Sulphate is and what it is used for
2. What you need to know before you take Quinine Sulphate
3. How to take Quinine Sulphate
4. Possible side effects
5. How to store Quinine Sulphate
6. Contents of the pack and other information

1. WHAT QUININE SULPHATE IS AND WHAT IT IS USED FOR
Quinine sulphate belongs to a group of medicines called anti-protozoal agents and they are used to
treat:

malaria

and prevent night cramps in adults and the elderly when sleep is regularly disrupted.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUININE SULPHATE
Do not take Quinine Sulphate if you:







are allergic (hypersensitive) to quinine or any of the other ingredients of this medicine (listed in
section 6)
have haemolytic anaemia (tiredness caused by the destruction of red blood cells)
have tinnitus (ringing sound in the ears)
have optic neuritis (loss of vision or difficulty seeing)
have haemoglobinuria (high concentration of haemoglobin in urine)
have myasthenia gravis (suffer from muscle weakness)

Warnings and precautions
Talk to your doctor or pharmacist before taking these tablets if you:

have irregular heartbeats or other heart problems

have blood in your urine

suffer from kidney or liver problems

have had malaria for a long time

suffer from glucose-6-phosphate dehydrogenase deficiency (G6PD), this can increase the risk of
the destruction of red blood cells during quinine therapy

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 Sulphate
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Tell your doctor if you are taking any of the following medicines, as special care may be
required:

warfarin (to prevent blood clots)

chloroquine (for rheumatoid arthritis, malaria)

cimetidine (to treat stomach ulcer)

digoxin (for heart problems)

amantadine (to treat Parkinsons Disease or some viral infections)

halofantrine, mefloquine or artemether with lumefantrine or primaquine (also to treat malaria)

flecainide, quinidine or amiodarone (to treat irregular heartbeats)

terfenadine (for allergic reactions)

ciclosporin (to prevent transplant rejection)

pimozide or thioridazine (to treat some mental disorders)

moxifloxacin or rifampicin (to treat infections)

metformin (medicines to treat diabetes)

suxamethonium (a muscle relaxant)

ritonavir, indinavir (HIV medicines)

barbiturates, phenytoin or carbamazepine (anticonvulsants)
Pregnancy and breast feeding
You should not take Quinine sulphate tablets if you are pregnant, planning to become pregnant or
breast-feeding unless advised to by your doctor. Quinine sulphate tablets should not be used for
night cramps during pregnancy.
Driving and using machines
Quinine sulphate tablets may affect your vision or cause vertigo (a feeling of dizziness or spinning).
Make sure you are not affected before you drive or operate machinery.
Quinine Sulphate contains lactose
These tablets contain lactose. If you have been told by you 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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure. Swallow the tablets with water.
For uncomplicated malaria (you may be given another medicine for malaria with or after this course
of quinine):



Adults, the elderly and children over 12 years - Two tablets every eight hours for 7 days.
Children under 12 years - Equivalent of 10mg/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.

For the relief of nocturnal cramps:


Adults and the elderly
200mg at bedtime which may be increased maximum to 300mg.
It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps.

Do not take more than the recommended dose
If you take more Quinine Sulphate than you should
If you or anyone else has taken too many tablets, contact your nearest hospital casualty department or
doctor immediately. Take any remaining tablets with you to show the doctor.
Symptoms of overdose include loss of consciousness, difficulty breathing, changes in heart beat, fits,
‘ringing’ in the ears, loss of hearing, headache, feeling or being sick and changes in vision. Severe
poisoning can produce convulsions, coma, respiratory depression and death.
If you forget to take Quinine Sulphate
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 or pharmacist.

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 serious side effects occur:





allergic reactions –itchy skin rash, swelling of the lips, face, throat or tongue, flushing, fever,
asthma or sensitivity to light
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 sulphate 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

Tell your doctor if you notice any of the following side effects or notice any other effects not
listed:







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
aggravation of myasthenia gravis
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

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 SULPHATE
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton, blister after
‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25˚C.

Protect from light and moisture.

Store in the original package (for blister packs and bottles).
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 to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Quinine Sulphate tablets contain



The active substance is Quinine Sulphate. Each tablet contains 300mg Quinine Sulphate.
The other ingredients are: lactose, maize starch, magnesium stearate, stearic acid, purified talc,
sodium croscarmellose, opaglos, sucrose and titanium dioxide.

See end of section 2 for further information on lactose.
What Quinine Sulphate tablets look like and contents of the pack:
Quinine Sulphate tablets are white, round, biconvex sugar coated tablets.
Pack sizes for Quinine Sulphate are “25, 28, 50, 56, 100, 250, 500 and 1000 tablets. Not all pack
sizes may be marketed.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER:
Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433
To request a copy of this leaflet in large print or audio format or additional copies, please contact the
licence holder at the address (or telephone, fax) above.
PL 04556 / 0032

POM

Reference: 00320813/01
This leaflet was last revised in August 2013

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)