• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Quinine Sulfate Tablets are and what they are used for.
2. What you need to know before you take Quinine Sulfate Tablets.
3. How to take Quinine Sulfate Tablets.
4. Possible side effects.
5. How to store Quinine Sulfate Tablets.
6. Contents of the pack and other information.

• Are allergic to quinine or any other ingredients of this medicine (Listed in section 6).
• Have problems with your eyes or difficulty seeing.
• Suffer from tinnitus (ringing or buzzing in the ears).
• Have blood in the urine (haemoglobinuria).
• Suffer from muscle weakness (myasthenia gravis).

Talk to your doctor or pharmacist before taking Quinine Sulfate Tablets if you:

• Are sensitive to Quinine. See section 4 for possible symptoms.
• Have had malaria for a long time.
• Have irregular heartbeats or other heart disease.
• Have conduction defects of the heart (this is where the heart cannot conduct electrical signals properly).
• Suffer from severe glucose-6-phosphate dehyrogenase deficiency (G6PD), this can cause episodes of anaemia after eating certain foods such as fava beans or certain drugs to prevent malaria or dapsone.
• Intend on using the medicine for nocturnal leg cramps.
• Have previously experienced any adverse reaction to quinine, including that in tonic water or other beverages. Quinine may cause thrombocytopenia (reduction in blood platelet counts).
• Suffer from kidney or liver problems.

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

Tell your doctor if you were born with or have any condition that causes an abnormal heart rhythm.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including any medicines obtained without a prescription, especially:

• Anticoagulants (to stop your blood clotting).
• Cardiac glycosides (medicines for your heart such as digoxin).
• Chloroquine, artemether with lumefantrine or mefloquine, halofantrine or primaquine (also to treat malaria).
• Cimetidine (to treat stomach ulcers or acid reflux and indigestion).
• Flecainide, quinidine or amiodarone (to treat irregular heart rhythms).
• Pimozide or thioridazine (to treat some mental disorders).
• Rifampicin or moxifloxacin (antibiotics).
• Barbiturates, carbamazepine or phenytoin (medicines to treat epilepsy).
• Oral hypoglycaemics (to treat diabetes).
• HIV protease inhibitors (drugs to treat HIV infections such as ritonavir).
• Azole antifungals (drugs to treat fungal infections such as ketoconazole).
• Ciclosporin (used following transplant surgery and to treat various inflammatory diseases).
• Amantadine (an antiviral to treat influenza and Parkinson’s disease).
• Suxamethonium (a muscle relaxant used in surgery, tell the anaesthetist you are taking Quinine Sulfate Tablets).
• Terfenadine (used in the treatment of allergies).
• Medicines which are known to cause disturbances in heart rhythm.

If you see another doctor or go into hospital, let them know what medicines you are taking.

Do not take the tablets if you are pregnant, trying to become pregnant or breast feeding. Quinine Sulfate Tablets should not be used for night cramps during pregnancy. Consult your doctor or pharmacist if in doubt.

Quinine may affect your vision or cause vertigo (a feeling of dizziness or ‘spinning’). If you are affected, DO NOT drive or operate machinery.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. is essentially ‘sodium-free’.

Adults (including elderly) and children over 12 years:

600mg at 8 hour intervals for 7 days

Children under 12 years:

10mg/kg at 8 hour intervals for 7 days

Adults (including elderly people):

200mg at bedtime. The maximum dose is 300mg.

It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps. Your doctor will monitor your progress.

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 accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor, immediately. Take any remaining tablets and the container with you.

An overdose of Quinine 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.
• Sever eyesight problems including blindness.
• Effects on the heart, kidneys and brain.
• Low blood sugar.
• Muscle weakness, tiredness or cramps.
• Tingling or numbness.
• Feeling your heart beat irregularly (palpitations).
• Large doses can cause abortion.

If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor.

Continue to take the tablets for as long as your doctor tells you to. If you are taking them for malaria you must take the full course. If you stop too soon the infection may recur.

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.

The active substance is Quinine Sulfate BP/Ph.Eur

The other ingredients are: Lactose

Microcrystalline cellulose

Maize Starch

Sodium starch glycolate

Colloidal anhydrous silica

Purified talc

Magnesium stearate

Ingredients for Coating: Hypromellose

Diethyl phthalate

Description: Film-coated tablet

A White, round, biconvex, film coated tablets marked “3” on one side and plain on the other side.

Polypropylene tablet containers with polyethylene caps and option use of fillers. PVC /aluminium foil blisters.

Pack sizes: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500.

Not all pack sizes may be marketed.