TEVA UK Ref: 231-30-12087-ZA LEA QUININE SULPHATE A/S TAB TUK Version: 4    29 May 2015

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QUININE SULPHATE 200 mg AND 300 mg TABLETS BP

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms 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.    Before you take Quinine Sulphate

3.    How to take Quinine Sulphate __ 4. Possible side effects

5.    How to store Quinine Sulphate

6.    Further information

OWHAT 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.

©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.

•    amiodarone, quinidine or flecainide (used to treat an irregular heartbeat)

•    pimozide or thioridazine (used in the treatment of mental illness)

•    terfenadine (used in the treatment of allergies)

•    moxifloxacin or rifampicin (antibiotics)

•    antifungals (to treat infections)

•    ciclosporin (used to prevent transplant rejection)

•    halofantine, chloroquine, mefloquine or artemether with lumefantrine or primaquine (also to treat malaria)

•    cimetidine (to treat stomach ulcers or acid reflux and indigestion)

•    amantadine (to treat Parkinsons Disease or some viral infections)

•    suxamethonium (a muscle relaxant)

•    carbamazepine or phenytoin (anticonvulsants)

•    antifungal medicines, e.g. fluconazole, itraconazole, ketoconazole

•    barbiturates, e.g. phenobarbital

•    medicines to prevent blood clots forming, e.g. warfarin

•    medicines to treat diabetes e.g. metformin, tolbutamide, glimepiride

•    medicines used in the treatment of HIV e.g. ritonavir, indinavir, nelfinavir.

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.

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.

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.

Taking other medicines

Talk to your doctor if you are taking any of the following:

•    anticoagulants (to stop your blood from clotting)

•    cardiac glycosides (for your heart such as digoxin)

^ 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:

Adults (including the elderly)

•    Prevention of night cramp:

One 200 mg tablet before going to bed.

Do not take more than the prescribed dose. It may take up to 4 weeks before you see a reduction in the frequency of night time cramps.

Your doctor will monitor the effects of your treatment and adjust it accordingly. Maximum dose - 300 mg at bedtime.

•    Treatment of malaria (you may be given another medicine for malaria with or after this course of quinine):

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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

Children under 12 years - 10 mg per 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.

If you take more Quinine Sulphate than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has accidentally swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose of Quinine Sulphate 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

•    severe eyesight problems including blindness

•    effects on the heart, kidney and brain

•    shock, low blood sugar.

Large doses can cause abortion.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Quinine Sulphate 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 double dose to make up for a forgotten dose.Take the remaining doses at the correct time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Quinine Sulphate 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:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

•    unexplained bruising or bleeding.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

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 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.

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, 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

•    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

•    problems with blood clotting

•    aggravation of myasthenia gravis. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE QUININE SULPHATE

Keep out of the reach and sight of children.

The tablets should be stored below 25°C in the package or container supplied. Do not transfer them to another container. Do not use Quinine Sulphate after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.

^ FURTHER INFORMATION

What Quinine Sulphate Tablets contain:

•    The active ingredient is quinine sulphate

•    The other ingredients are alginic acid (E400), magnesium stearate (E572), maize starch, sucrose, talc (E553), gelatin and titanium dioxide (E171).The printing ink contains shellac (E904), black iron oxide (E172) and propylene glycol (E1520). The tablet polish contains shellac (E904), carnauba wax (E903) and white beeswax (E901).

What Quinine Sulphate Tablets look like and contents of the pack:

•    The Quinine Sulphate 200 mgTablets are white, biconvex, sugar-coated tablets. They are plain on one side, marked 200 over 1205 on the reverse.

•    The Quinine Sulphate 300 mgTablets are white, biconvex, sugar-coated tablets. They are plain on one side, marked 300 over 1206 on the reverse.

•    The product is available in pack sizes of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160, 168, and 500 tablets. The Quinine Sulphate 300 mgTablets are also available in pack sizes of 25 and 50.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: May 2015.

PL 00289/5242R-5243R

TEUZD