Quinine Sulfate 300 Mg Tablets
10 mm 10 mm
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5 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
What is in this leaflet:
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
This medicine belongs to a group of medicines called anti-prozoal agents and they are used to treat:
• malaria.
• and prevent night cramps in adults and the elderly when sleep is regularly disrupted
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).
• blood in your urine
• ringing in your ears
• suffer from muscle weakness (myasthenia gravis)
• problems with your yes or difficulty seeing
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 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.
Taking other medicines
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 (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)
• 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)
Pregnancy, breast-feeding and fertility:
You should not take this medicine if you are pregnant, planning to become pregnant or breast-feeding unless advised to by your doctor. Quinine Sulfate tablets should not be used at for night cramps during pregnancy.
Driving and using machines
Quinine Sulfate tablets may affect your vision. Make sure you are not affected before you drive or operate machinery.
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:
Treatment of malaria
Adults, the elderly and children over 12 years of age: 600mg every 8 hours. Children: 10mg/kg bodyweight every eight hours.
The above doses are usually given for 7 days.
Prevention of night cramps
Adults, the elderly and children over 12 years of age: 200 - 300mg at bedtime.
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, difficulty breathing, changes in heart beat, fits, ringing in the ears, loss of hearing, headache, feeling or being sick and change in vision.
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 night time.
If you stop taking this medicine
Do not stop taking your tablets, even if you feel well unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
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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
• 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, 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.
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
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.
• 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.
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.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Limited,
Unit 3, Canalside, Northbridge road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom.
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Quinine Sulfate 200 mg Tablets; PL 17907/0515 Quinine Sulfate 300 mg Tablets; PL 17907/0516
The leaflet was last revised in July 2016
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V3 13-07-16 D0 K
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