Quinine Sulfate 200mg Film-coated Tablets

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

1. What Quinine sulfate tablets are and what they 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 (including that in tonic waters or other beverages), quinoline or any of the other ingredients of this medicine (listed in section 6)
• have blood in your urine
• have ringing in your ears
• suffer from muscle weakness (myasthenia gravis)
• have problems with your eyes or difficulty seeing
• Have been told you have a disorder affecting the red blood cells (haemolysis).

Talk to your doctor, pharmacist or nurse before taking Quinine sulfate tablets if you:

• have irregular heartbeats or other heart disease
• have had malaria for a long time
• suffer from severe glucose-6-phosphate dehydrogenase deficiency (G6PD), as this can cause episodes of anaemia after eating certain foods such as fava beans (favism) or take certain drugs including dapsone and drugs to prevent malaria
• Were born with or have any condition that causes an abnormal heart rhythm.

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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

• anticoagulants (to stop your blood from clotting)
• cardiac glycosides (for your heart, such as digoxin)
• chloroquine, mefloquine, artemether with lumefantrine, primaquine, halofantrine (also to treat malaria)
• cimetidine (to treat stomach ulcers or acid reflux and indigestion)
• amantadine (to treat Parkinson's Disease or some viral infections)
• ciclosporin (to prevent transplant rejection)
• flecainide, quinidine or amiodarone (to treat irregular heartbeats)
• astemizole or terfenadine (for allergic reactions)
• pimozide or thioridazine (to treat some mental disorders)
• moxifloxacin, rifampicin or antifungals (to treat infections)
• medicines to treat diabetes
• suxamethonium (muscle relaxant)
• HIV medicines
• barbiturates, carbamazepine or phenytoin (used in epilepsy)
• medicines which are known to cause disturbances in heart rhythm
• levacetylmethadol (a pain killer).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not take quinine sulfate 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.

Quinine sulfate tablets may affect your vision and cause vertigo (dizziness or spinning sensation). Make sure you are not affected before you drive or operate machinery.

This medicine contains less than 1 mmol (23mg) sodium per tablet, that is to say essentially 'sodium-free'.

• Malaria (you may be given another medicine for malaria with or after this course of quinine):
  Adults (including elderly) and children over 12 years - 600mg every eight hours for 5-7 days
  Children aged 10-12 years - 10mg per kg of body weight every eight hours for 7 days
  Children under 10 years - Not recommended.
  If you have kidney or liver disease you may be given a different dose.
• Night cramps: Adults (including elderly) - The recommended dose is 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.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.

Symptoms include loss of consciousness, difficulty breathing, changes in heartbeat and heart function, kidney failure, fits, 'ringing' in the ears, loss of hearing, headache, being sick, changes in vision, low blood potassium (causing muscle twitching/weakness or abnormal heart rhythm), low blood sugar and sweating. Some of these side effects can be fatal. High doses of quinine may also cause miscarriage in pregnant women.

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

• diarrhoea, feeling or being sick, abdominal pain, low blood sugar.
• tightness in chest, difficulty breathing or wheezing
• 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 (disorder characterised by muscle weakness, difficulty chewing or swallowing and slurred speech).
• kidney damage, kidney failure, low production of urine, water retention, slowed heart rate, changes in heart rhythm and the way the heart beats, a fall in blood pressure and weak pulse, eczema, miscarriages (at very high concentrations).

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance (the ingredient that makes the tablet work) is 200mg quinine sulfate.

The active substance (the ingredient that makes the tablet work) is 300mg quinine sulfate. The other ingredients are microcrystalline cellulose, croscarmellose sodium, povidone, sodium laurilsulfate, purified Talc, hydrogenated vegetable oil, magnesium stearate.

The coating material OPADRY TF 266G580006-White contains: hypromellose (E464), hydroxypropyl cellulose (E463), macrogol (E1521), medium chain triglycerides, rice starch.

Quinine sulfate 200mg Film coated tablet are white to off white film-coated, round shaped, biconvex tablet plain on both sides, with diameter of 9.70mm.

Quinine sulfate 300mg Film coated tablet are white to off white film-coated, round shaped, biconvex tablet, debossed with 'L' on one side and plain on other side, with diameter of 11.10mm.

These tablets will be packed in Aluminium-PVC White opaque film blister packs of 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s and 120s.

Not all pack sizes may be marketed.