Quinine Bisulphate Tablets Bp 300mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE BISULPHATE TABLETS 300 mg
[Quinine Blsulphate]
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 side effects not listed in this leaflet. See section 4.
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 is one of a group of medicines called antiprotozoal agents.
Quinine Bisulphate Tablets are used to:
• Treat malaria.
• Treat and prevent nocturnal (night-time) leg cramps in adults and the elderly.
2. What you need to know before you take Quinine Bisulphate Tablets
Do not take Quinine Bisulphate if you:
• Are hypersensitive (allergic) to quinine or any other ingredients in this medicine (See 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).
Warnings and precautions
Talk to your doctor or pharmacist before taking Quinine Bisulphate 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 dehydrogenase deficiency (G6PD), this can cause episodes of anaemia after eating certain foods such as fava beans or certain drugs to prevent malaria or dapsone.
• Consume excessive amounts of beverages that contain quinine such as tonic water.
• 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).
• Are likely to undertake a urine test while taking the medicine as quinine can affect the results of certain urine tests.
You should not take more than the prescribed dose as a condition called ‘cinchonism’ may occur even with a normal dose. 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:
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:
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).
Barbituates, 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 bisulphate tablets), terfenadine (used in the treatment of allergies).
If you see another doctor or go into hospital, let them know what medicines you are taking.
Pregnancy or Breast feeding:
Do not take the tablets if you are pregnant, trying to become pregnant or breast feeding. Quinine Bisulphate Tablets should not be used for night cramps during pregnancy. Consult your doctor or pharmacist if in doubt.
Driving and using machines:
Quinine may affect your vision or cause vertigo (a feeling of dizziness or ‘spinning’). If you are affected, DO NOT drive or operate machinery.
Quinine Bisulphate Tablets contain lactose:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Quinine Bisulphate Tablets
Always take Quinine Bisulphate Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
These tablets should be swallowed with some water.
Malaria
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
Nocturnal leg cramps
Adults (including elderly people):
The recommended dose is 300mg at bedtime.
It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps. Your doctor will monitor your progress.
If you have kidney or liver disease you may be given a different dose.
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If you take more Quinine Bisulphate Tablets than you should:
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 Quinine Bisulphate Tablets:
If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. However, 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.
If you stop taking Quinine Bisulphate Tablets:
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.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor at once if the following effects occur:
• Allergic reaction - itchy skin rash, swelling of the lips, face, throat or tongue, flushing, fever, asthma or sensitivity to light.
If you notice that you are bruising easily, have frequent nose bleeds or other unusual bleeding, notice a reddish discolouration of your urine, or you have more sore throats and infections than usual, tell your doctor who may want to give you a blood test.
Symptoms of Quinine overdose (cinchonism) can occur at normal doses in some patients.
If you are sensitive to Quinine you may experience any of these symptoms. Consult your doctor if these effects are troublesome or continue:
• Ringing in the ears, deafness.
• Headache, confusion, agitation.
• Nausea, vomiting, abdominal pain, diarrhoea.
• Visual disturbances.
• Fever.
• Flushed skin, itching, rashes.
• Muscle weakness.
• Dizziness.
The following side effects have also been reported:
• 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.
• 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.
• Problems with blood clotting.
• Aggravation of myasthenia gravis.
• Excretion of protein in your urine which may cause a colour change.
• Reduction in the number of blood cells.
• The rupture or destruction of red blood cells.
• Fall in blood pressure coupled with a 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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Quinine Bisulphate Tablets
Keep out of the sight and reach of children.
Keep the tablets stored below 25°C in a dry place and in the original packaging.
Do not use Quinine Bisulphate Tablets after the expiry date stated on the label. The expiry refers to the last day of that month.
Remember, this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.
Do not use Quinine Bisulphate Tablets if you notice visible signs of deterioration.
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.
6. Contents of the pack and other information
What Quinine Bisulphate Tablets contain:
The active substance(s) is Quinine Bisulphate BP/Ph.Eur. I The other ingredients are: Lactose ;
Microcrystalline cellulose Povidone K30 Maize Starch Sodium starch glycollate Colloidal anhydrous silica Purified talc Magnesium stearate Pregelatinised maize starch
Ingredients for Coating: Hydroxypropylmethylcellulose Diethyl phthalate Opadry white Carnauba wax
What Quinine Bisulphate Tablets look like and contents of the pack:
Quinine Bisulphate Tablets are white, biconvex film-coated tablets.
The tablets are supplied in PVC/aluminium foil blister packs containing 28 tablets.
Marketing Authorisation Holder and Manufacturer:
Co-Pharma Limited Unit 4, Metro Centre,
Tolpits Lane, Watford,Herts.
This leaflet was last revised in 05/2016.
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Dimension: 180 x 250 mm
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