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1. Quinine Sulphate Tablets 300mg
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QUININE SULPHATE :00320514 -02........... 14	8 X 280mm 5/30/14 1:28 PM Page 1

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 further questions, ask your doctor or pharmacist.

•    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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section-4.

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 conduction defects of the heart (this is where the heart cannot conduct electrical signals properly)

•    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

•    consume excessive amounts of beverages that contain quinine such as tonic water

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 and sucrose

These tablets contain lactose and sucrose. 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.

♦ Dosage

The usual dose for adults and children is given below

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 tablets than you should

If you or anyone else has taken too many tablets, contact your nearest hospital casualty department or doctor immediately. Bring 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 worry just take your tablets as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.

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

•    Talk to 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.

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 and 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 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 and sucrose.

•    What Quinine Sulphate 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

Reference: 00320514/02

The leaflet was last revised in May 2014