Quinine Bisulphate Tablets 300mg
Patient Information Leaflet Quinine Bisulphate 300mg 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Quinine Bisulphate tablets are and what they are used for
2. What you need to know before you take Quinine Bisulphate tablets
3. How to take Quinine Bisulphate tablets
4. Possible side effects
5. How to store Quinine Bisulphate tablets
6. Contents of the pack and other information
1. What Quinine Bisulphate tablets are and what they are used for
Quinine Bisulphate 300mg Tablets (referred to as Quinine Bisulphate Tablets throughout this leaflet) contain the active substance Quinine Bisulphate. This belongs to a group of medicines known as the antimalarials. Quinine Bisulphate Tablets are used:
• To treat malaria resistant to the medicine chloroquine.
• In the prevention of night cramps.
2. What you need to know before you take Quinine Bisulphate tablets Do not take Quinine Bisulphate tablets and tell your doctor if you have:
• an allergy (hypersensitivity) to quinine (including that in tonic waters or other beverages), quinoline or any of the other ingredients (see section 6)
• blood in your urine
• ringing in your ears
• suffer from muscle weakness (myasthenia gravis)
• problems with your eyes or difficulty seeing
• asthma
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Quinine Bisulphate tablets if:
• you have irregular heart beats or other heart disease •you have had malaria for a long time
•you suffer from severe glucose6phosphatedehydrogenase deficiency (G6PD), 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.
Other medicines and Quinine Bisulphate tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:
• anticoagulants (to stop your blood from clotting)
• cardiac glycosides (for your heart such as digoxin)
• chloroquine, mefloquine, artemether with lumefantrine or primaquine (also to treat malaria)
• cimetidine (to treat stomach ulcers or acid refluxand indigestion)
• amantadine (to treat Parkinsons Disease or some viral infections)
• ciclosporin (to prevent transplant rejection)
• flecainide, quinidine or amiodarone (to treat irregular heart beats)
• 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)
PREGNANCY AND BREASTFEEDING
You should not take Quinine Bisulphate tablets if you are pregnant or breastfeeding,think you may be pregnant or are planning to have baby unless advised to by your doctor.
Quinine Bisulphate tablets should not be used for night cramps during pregnancy.
Driving and using machines
Quinine Bisulphate tablets may affect your vision.
Make sure you are not affected before you drive or operate machinery.
3. How to take Quinine Bisulphate tablets
Take this medicine by mouth and only in the doses prescribed by your doctor. Your pharmacist can also help if you are not sure. Do not take more of the product than the doctor recommends and do not take it more often or for a longer time that your doctor advises. Do not stop the treatment without talking to your doctor first. You may feel well but the tablets are helping to prevent another attack of your disease. If you feel that this medicine is not working as well after you have taken it for a short time (4 weeks) do not increase the dose, instead check with your doctor.
Dosages:
In the treatment of chloroquine-resistant malaria:
Adults and the elderly: 600mg (2 tablets) at 8 hourly intervals for 7 days.
Children: 10mg per kg bodyweight at 8 hourly intervals for 7 days.
In the treatment of night cramps
Adults and elderly: 300mg at night.
Children: Not recommended.
If you forget to take your medicine, just carry on with the next dose as normal. Do not take an extra dose to make up for the missed dose. If you are not sure, ask your doctor or pharmacist for advice. If you feel that this medicine is not working as well after you have taken it for a short time (4 weeks) do not increase the dose, instead check with your doctor.
If you take more Quinine Bisulphate 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 casualty department or tell your doctor immediately. This situation can lead to permanent loss of vision and can lead to death.
Symptoms include headache, dizziness, vomiting, low blood pressure, difficulty in breathing, ‘ringing’ in the ears, loss of hearing (reversible) or temporary deafness, flushing, blurred vision, feeling or being sick, palpitations, changes in heart rhythm, kidney failure, fits, loss of consciousness and coma. Doses of 2-8 gram have resulted in death in some adult patients. High doses of quinine can also adversely affect the foetus and may cause miscarriage in pregnant women. Large doses can also induce abortion.
If you suspect you have been given too much, you should tell the doctor immediately.
4. Possible side effects
Like all medicines, Quinine Bisulphate tablets can 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
• 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 Bisulphate 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, high temperature, become gradually more tired and pale then tell your doctor who may want to give you a blood test.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• 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.
• aggrevation of Myasthenia gravis.
• 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.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom Yellow Card Scheme
Freephone: 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays)
Website: www.mhra.gov.uk/yellowcard
5. How to store Quinine Bisulphate tablets
Do not store above 25°C. Store in the original pack or in containers which prevents the access of moisture.
Keep out of the sight and reach of children.
Do not use after the expiry date. This date is printed on your pack.
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.
REMEMBER
This medicine is only for you. Never give it to someone else, even if their symptoms are the same as yours. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
6. Contents of the pack and other information What Quinine bisulphate tablets contains
Your tablets are called Quinine Bisuslphate Tablets 300mg. Each tablet contains 300mg of the active ingredient Quinine Bisulphate. Each tablet also contains microcrystaline cellulose, fumed silicon dioxide, guar gum, magnesium stearate, hydroxypropylmethylcellulose, ethylcellulose, titanium dioxide, diethyl phthalate, dichloromethane, methanol, petroleum spirit and beeswax.
What quinine bisulphate tablets looks like and contents of the pack
Quinine Bisulphate Tablets are round, white film coated tablets marked QBS over 300 on one side and R on the reverse and are available in containers of 16, 21, 28, 30, 50, 56, 60, 84, 90 and 100 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder:
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer:
DDSA Pharmaceuticals Ltd., Chatfield Road, Off York Road, London SW11 3SE.
This leaflet was last revised in December 2013