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QUININE SULPHATE 300MG COATED TABLETS

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for alternative UK supply
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE SULPHATE 300MG COATED TABLETS

Read all of this leaflet carefully before you start using this medicine.
− Keep this leaflet. You may need to read it again.
− If you have further questions, please ask your doctor, nurse or pharmacist.
− This medicine has been prescribed for you personally and you should not pass
it on to others.
It may harm them, even if their symptoms are the same as yours.
− If any of the side effects gets serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Quinine Sulphate Tablets are and what they are
used for
2. Before you take Quinine Sulphate Tablets
3. How Quinine Sulphate Tablets should be taken
4. Possible side effects
5. How to store Quinine Sulphate Tablets
6. Further information
1. WHAT QUININE SULPHATE TABLETS ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is Quinine Sulphate 300mg
Coated Tablets. Quinine Sulphate Tablets contain the
anti-malarial drug quinine sulphate and are used to treat a
type of malaria known as falciparum malaria (malignant
malaria). Malaria is a disease caused by infection with a
malaria parasite. This is carried by mosquitoes, which
flourish in tropical and subtropical countries. Human beings
become infected as a result of being bitten by malaria
carrying mosquitoes. Quinine sulphate has a relaxant
action on skelatal muscle. Your doctor may have prescribed
this medicine for the treatment of night leg cramps.
2. BEFORE YOU TAKE QUININE SULPHATE TABLETS
Do not take quinine sulphate tablets if you:
• are allergic to quinine or any of the other ingredients in
the tablet
• have problems with your eye sight
• suffer from tinnitus (ringing noises in the ear)
• have blood in the urine (or have had during a previous
attack of malaria)
• you have been told you have haemolysis (a disorder
affecting the red blood cells)
• suffer from myasthenia gravis (a disease characterised
by weakness of certain groups of muscles)
• are pregnant or breast-feeding, unless the benefits
outweigh the risks
Take special care with quinine sulphate tablets
You should let your doctor know and ask their advice, if
you suffer from, or have ever had:
• an enzyme deficiency, called glucose-6-phosphate
dehydrogenase deficiency
• your doctor has told you that you have a blood condition
known as hypoprothrombinaemia
• irregular heart beat or other heart problems
• you have been told by your doctor that you have an
intolerance to some sugars
• an adverse reaction to quinine, including that found in
tonic water and other beverages. Quinine may cause
thrombocytopenia, a blood condition which causes you
to bleed and bruise easily
Taking other medicines
Your medicine may interfere with other medicines that you
are taking. Please inform your doctor or pharmacist if you
are taking, or have recently taken, any other medicine
even those not prescribed. Do not take with:

• Chloroquine, Mefloquine, Halofantrine (used to treat
malaria)
• Pimozide and thioridazine (used to treat depressive
illnesses)
• Astemizole, Terfenadine (used to treat allergies)
• Amiodarone (used to treat heart conditions)
• levacetylmethadol (a pain killer)
Dose adjustment may be needed if you take the following
drugs:
• Antibacterials e.g. rifampicin (used to treat tuberculosis
and leprosy) and moxifloxacin (used to treat chest
infections and sinusitis)
• Digoxin, Flecainide and Quinidine (used to treat heart
conditions)
• Anticoagulants e.g. warfarin (used to prevent blood clots)
• Antifungals e.g. ketoconazole (used to treat fungal
infections)
• HIV protease inhibitors e.g. nelfinavir (used in the
treatment of AIDS)
• Barbiturates, carbamazepine and phenytoin (used to
treat epilepsy)
• Ciclosporin, used in the treatment of rheumatoid arthritis
and in transplant surgery
• Tablets used to treat diabetes such as gliclazide and
tolbutamide
• Suxamethonium (used during anaesthesia)
• Amantadine, used for Parkinson’s disease and to treat
virus infections
Your doctor will advise you about this.
Pregnancy and breast-feeding
Before taking your medicine, tell your doctor if you are
pregnant or trying to become pregnant. You should not
take quinine sulphate when you are pregnant or
breast-feeding, unless the benefits outweigh the risks. This
medicine should not be used to treat cramps during
pregnancy.
Large doses of quinine can cause foetal abnormalities or
induce abortion. You should not breast-feed a baby that
might have glucose-6-phosphate dehydrogenase (G6PD)
deficiency.
Driving and using machines
This medicine may cause visual disturbances and vertigo.
If affected, do not drive or operate any tools or machines.
Important information about some of the ingredients
of quinine sulphate tablets
This medicine contains lactose. 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 TABLETS
Always take your medicine exactly as your doctor has
instructed you. You should check with your doctor or
pharmacist, if you are unsure. Do not take more than your
doctor has recommended.

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Black

Quinine Sulphate 300mg - 28 Tabs
Wockhardt UK

Alternative UK supply
(w)148 x (h)210mm
7pt.
618
Quinine Sulphate_300mg Lit_106978-3.ai
Adobe Illustrator CS5
Helvetica Medium / Bold
5th Mayrch, 2015
R 1st PDF sent on - 11TH MARCH 2015
R 2nd PDF sent on - 11TH APRIL 2015
R 3rd PDF sent on - 30TH JUNE 2015

CHANGE CONTROL : Version changes due to change in:
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Changes in detail: • Regulatory text amends
• Wockhardt logo shifted to right side (pg2/2)

Your medicine should be taken by mouth as follows:
For the treatment of Falciparum Malaria:
Adults: The usual dose is 600mg (two 300mg tablets)
every eight hours for seven days.
Children: The usual dose is 10mg quinine sulphate per kg
of body weight, given every eight hours for seven days.
For the treatment of Night Cramps:
Adults (including the elderly): 300mg (one tablet) at
bedtime.
Children: This medicine should not be used for the relief
of night leg cramps in children under 10 years of age.
If you take more quinine sulphate tablets than you
should
If you take too many tablets tell a doctor or hospital
casualty department straight away. Take your medicine
with you.
If you forget to take quinine sulphate tablets
If you do forget to take a dose of your medicine at the
correct time, take as soon as you remember, then carry on
as before. However, never take a double dose to make up
for the forgotten individual doses.
Keep taking this medicine until your doctor tells you to
stop. Do not stop taking it just because you feel better. If
you stop taking the medicine, your condition may re-occur
or get worse.
4. POSSIBLE SIDE EFFECTS
Tell your pharmacist or doctor as soon as possible if you
do not feel well while you are taking this medicine. All
medicines can have some unwanted effects. Sometimes
they are serious, most of the time they are not. You may
need medical treatment if you get some of the side effects.
Stop taking your medicine and tell your doctor
immediately, or go to accident and emergency if you
notice any of the following:
• Shortness of breath or difficulty breathing
• Asthma
• Hot flushing or rash of the skin, itching, or swelling
• Shock
• Difficulty swallowing
• Tiredness, weakness
• Sensitivity to sunlight
• Increased or unexplained bruising, or bleeding more
readily, or more frequent nose bleeds
• Signs of frequent infections such as fever, sore throat or
mouth ulcers
• Irregular heart beats to heart problems
• Decreased urine production or no urine, blood, or
reddish colour in the urine
• Face swelling
Quinine may cause ‘cinchonism’ which generally occurs in
overdose, but may rarely also occur at normal doses.
These can be very severe side effects of your medicine. If
you have them you may have had an allergic reaction to
quinine. You may need urgent medical attention. All of
these side effects are very rare.
Tell your doctor or pharmacist if you notice any of the
following and they worry you:
• Ringing in the ears, loss of hearing
• Headache, dizziness, confusion
• Feeling or being sick (nausea or vomiting)
• Diarrhoea, stomach ache
• Blurred vision (mild), problems with colour vision or
tunnel vision
• Low blood sugar
These are some of the more common side effects of
quinine and are usually associated with long-term
treatment with Quinine Sulphate Tablets.

The list of side effects mentioned above is not complete. If
you should suffer from any of these side effects or any
other undesired effect please tell your doctor or
pharmacist. Do not be alarmed by this list of possible side
effects. You may not experience any of them.
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 national reporting
systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta:
ADR Reporting,
Website: www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE QUININE SULPHATE TABLETS
Keep out of the reach and sight of children.
Do not use your medicine after the expiry date shown on
the carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Quinine Sulphate Tablets contain
The active ingredient in Quinine Sulphate Tablets is
quinine sulphate. These tablets contain 300mg of the
active ingredient. The other ingredients are lactose
monohydrate, maize starch, microcrystalline cellulose,
sodium starch glycollate, povidone, magnesium stearate,
opaglos (ethanol, yellow carnauba wax and white
beeswax), mineral water sugar, calcium carbonate, talc,
titanium dioxide (E171), acacia spray-dried, syrup, white
beeswax, printing ink containing water,
polyvinylpyrrolidone (E1201), ammonium hydroxide
(E527), methylparaben, dimethylpolysiloxane (E900),
methylated silica, erythrosine (E127), Brilliant Blue FCF
(E133) and tartrazine (E102).
What Quinine Sulphate Tablets look like and contents
of the pack
Quinine Sulphate 300MG Coated Tablets are white,
circular, sugar-coated tablets printed Q 300 W in black. The
tablets are available in packs of 28 tablets.
This leaflet is a summary. It does not contain the complete
information about your medicine. If you have any further
questions or are not sure about anything, ask your doctor
or pharmacist who have access to additional information.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
This leaflet was revised in: 06/2015
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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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