PACKAGE LEAFLET: INFORMATION FOR THE USER

QUININE BISULPHATE TABLETS BP 300 mg

(quinine bisulphate)

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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Quinine is and what it is used for.

2.    Before you take Quinine.

3.    How to take Quinine.

4.    Possible side effects.

5.    How to store Quinine.

6.    Further information.

1.    WHAT QUININE IS AND WHAT IT IS USED FOR

Quinine belongs to a group of medicines called blood schizontocides, which act against the human malaria parasites. It may be prescribed by your doctor:

•    to help treat malaria

•    as a muscle relaxant to help prevent night cramps in the legs.

2.    BEFORE YOU TAKE QUININE Do not take Quinine if:

•    you are allergic (hypersensitive) to quinine or any of the other ingredients of this medicine

•    you suffer from tinnitus (ringing in the ears)

•    you suffer from optic neuritis (inflammation of the nerve in the eye)

•    you have noticed blood in your urine (haemoglobinuria)

•    you suffer from myasthenia gravis (muscle weakness).

Take special care with Quinine - You should tell your doctor before taking this medicine if:

•    you have a heart condition

•    you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase

•    you are having a blood or urine test.

You should not take more than the prescribed dose as a condition called 'cinchonism' may occur even with normal doses. Please see section 4 for symptoms of cinchonism and tell your doctor if you experience any of them.

Taking other medicines - Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following:

•    anticoagulants e.g. warfarin (to thin the blood)

•    digoxin, flecainide, quinidine or amiodarone (to treat a heart condition)

•    chloroquine, mefloquine, artemether with lumefantrine or halofantrine (to treat malaria)

•    ciclosporin (to prevent transplant rejection)

•    pimozide, thioridazine, barbiturates, carbamazepine or phenytoin (to treat some mental disorders and also epilepsy)

•    moxifloxacin or rifampicin (to treat infections)

•    medicines to treat diabetes

•    suxamethonium (muscle relaxant)

•    fluconazole and other similar antifungal drugs

•    ritonavir, saquinavir or similar (to treat HIV/AIDS).

Pregnancy and breast-feeding - Quinine should not be given to pregnant or breast-feeding mothers unless the benefits to the mother outweigh the risks to the baby. Ask your doctor or pharmacist for advice before taking any medicine. Quinine bisulphate tablets should not be used for night cramps during pregnancy.

Driving and using machines - Do not drive or operate machinery if you have eyesight problems while taking this medicine.

Important information about some of the ingredients of Quinine -This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3. HOW TO TAKE QUININE

Always take Quinine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

•    Swallow the tablets with a glass of water

•    If you vomit the whole or some of the tablet within 1 hour of taking it, take another tablet immediately.

The usual dose is:

For malaria - Adults including the elderly -

Two tablets (600 mg) three times daily for 7 days.

Children - The dose to be given will depend on the weight of the child. The usual dose is 10 mg per kg of body weight three times daily for 7 days.

You may be asked to take another antimalarial medicine by your doctor if you are known or thought to be resistant to quinine.

For night cramps in the legs - Adults (including elderly) - One tablet at bedtime. It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps.

If you take more Quinine than you should - Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

Symptoms of overdose include fits, feeling or being sick, ringing in the ears, deafness, headache, widening of blood vessels, severe eyesight problems (including blurred vision and blindness), loss of consciousness, coma, shallow breathing, irregular heartbeat, cardiac arrest, chest pain, low blood pressure, miscarriage, low levels of potassium in the blood.

If you forget to take Quinine-Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Quinine - Do not stop taking Quinine before speaking to your doctor first.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Quinine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Quinine and tell your doctor immediately or go to your nearest hospital emergency department:

•    allergic reactions - itchy skin rash, swelling of the lips, face, throat or tongue, flushing, fever, shortness of breath, difficulty breathing, sensitivity to light or asthma (wheezing)

•    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 or vertigo. If these occur while taking Quinine for leg cramps, treatment should be stopped and a doctor contacted immediately.

•    a reduction in blood platelets or blood clotting factors which can cause increased or unexplained bruising, more frequent nosebleeds

•    a reduction in the number of white blood cells causing more infections than usual, fever, severe chills, sore throat or mouth ulcers

•    reduction in the number of red blood cells causing weakness or breathlessness, tiredness, headaches, dizziness, looking pale.

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

•    irregular heart beats

•    kidney problems such as passing reduced amount of urine, blood in the urine

•    low sugar levels in the blood (hypoglycaemia) which may cause sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, or a fast, pounding heart beat

•    agitation and confusion

•    muscle weakness.

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOWTO STORE QUININE

Keep out of the reach and sight of children.

Do not use Quinine after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Store in a dry place below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Quinine contains-The active substance is quinine bisulphate. Each tablet contains 300 mg of quinine bisulphate. The other ingredients are lactose, microcrystalline cellulose, povidone, pregelitanised starch, silica, talc, magnesium stearate and sodium starch glycollate.The coating includes hypromellose (E464), macrogol, lactose monohydrate, titanium dioxide (E171) and carnauba wax.

What Quinine looks like and contents of the pack-

Your medicine is in the form of a coated tablet.

Quinine is available in plastic containers or blister packs of 5,7,10,14,15, 20, 21,25, 28,30, 56,60,84,90, 100,112,120,168,180,250 and 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer -

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL.

This leaflet was last approved in: 10/2010