QUININE SULFATE 200 MG TABLETS - patient leaflet, side effects, dosage

QUININE SULFATE 200 MG 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 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

• 1. What Quinine Sulfate Tablets are and what they are used for

• This medicine belongs to a group of medicines called 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 sulfate tablets

Do not take this medicine if you:

• are allergic to quinine (including that in tonic water and other beverages), quinoline or any of the other ingredients of this medicine (listed in section 6).
• have blood in your urine
• haveringing in your ears
• suffer from muscle weakness (myasthenia gravis)
• problems with your eyes or difficulty seeing
• have been told you have a disorder affecting the red blood cells (haemolysis)

Warnings and Precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• have irregular heart beats or other heart disease
• have had malaria for a long time
• suffer from severe glucose-6-phosphate dehydrogenase deficiency (G6PD), 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.

Other Medicines and Quinine Sulfate Tablets

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 or primaquine, halfantrine (also to treat malaria)
• cimetidine (to treat stomach ulcers or acid reflux and indigestion)
• amantadine (to treat Parkinsons Disease or some viral infections)
• ciclosporin (to prevent transplant rejection)
• flecainide, quinidine or amiodarone (to treat irregular heart beats)
• astemizole or terfenadine (for allergic reactions)
• pimozide or thioridazine (to treat some mental disorders)
• moxifloxacin, rifampicin, or antifunglas (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).

Pregnancy, breast-feeding and fertility:

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.

Driving and using machines

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.

3. how to take quinine sulfate tablets

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with water.

The recommended dose is:

Malaria (you may be given another medicine for malaria with or after this course of quinine): Adults (including elderly) and children over 12 years of age: 600 mg every eight hours for 5–7 days.

Children under 12 years : 10 mg/kg of bodyweight every eight hours for 7 days.

If you have kidney or liver disease you may be given a different dose.

Night cramps:

Adults (including elderly): 200 mg at bedtime. It may take up to 4 weeks before you notice any reduction in the time of leg cramps.

If you take more Quinine Sulfate Tablets than you should

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 causuality department or tell your doctor immediately. Symptoms include loss of consciousness, coma, difficulty breathing, changes in heart beat and heart function, renal failure, fits, ‘ringing’ in the ears, loss of hearing, headache, feeling or being sick, changes in vision, low blood potassium (causing muscle twitching/weakness or abnormal heart rhythm) and low blood sugar and sweating. Some of these side effects can be fatal. High doses of quinine may also cause miscarriage in pregnant women.

If you forget to take the tablets

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 the next dose at the right time.

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

4. possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Contact your doctor at once if the following effects occur:

• allergic reactions -itchy skin rash, swelling of the lips, face, throat or tongue, flushing, fever, asthma or sensitivity to light
• sores in the mouth, nose, and eyes, a skin rash, blistering (Stevens-Johnson syndrome)
• 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 heart beats, death. If these occur while taking Quinine Sulfate tablets for leg cramps, treatment should be stopped and a doctor contacted straight away.
• changes to blood cells as seen in blood or urine tests. 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.
• diarrhoea, feeling or being sick, abdominal pain, low blood sugar.
• muscle weakness, excitement, agitation, ‘spinning’ sensation’, confusion, loss of consciousness, coma, death.
• 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.
• aggrevation of Myasthenia gravis (disorder characterised by muscle weakness, difficulty chewing or swallowing and slurred speech).
• kidney damage, water retention, slowed heart rate, changes in heart rhythm and the way the heart beats, eczema, miscarriages (at very high concentrations), kidney failure, low production of urine, a fall in blood pressure and weak pulse.

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 Website: 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.

5. how to store quinine sulfate tablets

• Keep this medicine out of the sight and reach of children.
• Store in the original package in order to protect from heat, light and moisture.
• Do not use this medicine after the expiry date printed on the carton or label (EXP). The expiry date refers to the last day of that month.
• Do not throw 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 Sulfate tablets contain:

• The active substance is Quinine Sulfate. Each tablet contains 200 mg or 300 mg of Quinine sulfate.
• The other ingredients are: powdered cellulose, stearic acid, magnesium stearate
• Talc, anhydrous colloidal silica, sodium starch glycolate, dextrin, gelatin, titanium dioxide (E171), sucrose

What Quinine Sulfate tablets look like and contents of the pack

• Quinine Sulfate tablets are white, sugar coated, deep convex tablets.
• These tablets are available as follows:

• – Container packs of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets.

• – Blister packs of 28, 42, 56, 84 and 112 tablets.

• Not all pack sizes may be marketed.