Quinine Bisulphate Tablets 300 Mg
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 further questions, please ask your doctor or your 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, 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 Bisulfate Tablets are and what they are used for
2. What you need to know before you take Quinine Bisulfate Tablets
3. How to take Quinine Bisulfate Tablets
4. Possible side effects
5. How to store Quinine Bisulfate Tablets
6. Contents of the pack and other information
Quinine Bisulfate 300 mg Tablets contain the anti-malarial drug quinine bisulfate and are used to treat malaria. Malaria is a disease caused by infection with a malaria parasite. This is carried by mosquitoes, which flourish in tropical and subtropical countries. Human beings become infected as a result of being bitten by malaria carrying mosquitoes. Quinine bisulfate has a relaxant action on skeletal muscle. Your doctor may have prescribed this medicine for the treatment of night leg cramps.
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 medication (listed in section 6)
• have problems with your eye sight (due to inflammation of the optic nerve)
• have blood in the urine
• suffer from myasthenia gravis (condition causing muscle weakness)
• suffer from ringing in the ears
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
• have irregular heart beat or other heart problems
• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (as this can cause anaemia)
Other medicines and Quinine Bisulfate tablets
Tell your doctor of pharmacist if you are taking, have recently taken or might take any other medicines. Especially:
• Digoxin or Flecainide, used to treat heart conditions
• Anticoagulants, used to prevent blood clots
• Barbiturates, carbamazepine and phenytoin, used in the treatment of epilepsy
• Terfenadine used for allergic reactions
• Amantadine used to treat Parkinson’s disease or some viral infections
• Ciclosporin, used following an organ transplant
• Moxifloxacin, or rifampicin antibiotics used to treat bacterial infections
• Ketoconazole, used in the treatment of fungal skin infections
• Drugs used to treat diabetes
• Suxamethonium used to relax muscles
• Chloroquine and mefloquine, artemether with lumefantrine for the treatment of malaria
• Pimozide and thioridazine, used to treat mental disorders such as schizophrenia
• Amiodarone, used to treat heart conditions
• Medicines, used in treating HIV infections e.g. nelfinavir
• Quinidine, used to treat abnormal heart rhythm.
• Cimetidine used to treat stomach ulcers or acid reflux and indigestion
Pregnancy, breast-feeding and fertility:
Before taking your medicine, tell your doctor if you are pregnant or trying to become pregnant. You should not take quinine bisulfate 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.
Driving and using machines
This medicine may cause visual disturbances. If affected, do not drive or operate any tools or machines.
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.
For the treatment of Malaria:
Adults and children over 11 years, including the elderly:
The usual dose is 300 mg (2 x 300 mg tablets) three times daily for 7 to 10 days.
Children aged 11 years and under:
10 mg/kg every eight hours for 7 days
For the treatment of Night Cramps:
Adults:
300 mg (1 tablet) at bedtime.
Children:
This medicine should not be used for the relief of night leg cramps in children.
Kidney and liver problems:
If you have kidney or liver disease you may be given a different dose.
If you take more of your medicine than you should
If you take too many tablets tell your doctor or hospital casualty department straight away. Take your medicine with you.
If you forget to take your medicine
If you do forget to take a dose of your medicine at the correct time, take it as soon as you remember, then carry on as before. However, never take a double dose to make up for forgotten individual doses.
If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your condition may re-occur or get worse.
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Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine. All medicines can have some unwanted effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Stop taking your medicine and tell your doctor immediately, or go to accident and emergency if you notice any of the following:
• Allergic reactions - swelling of the lips, face, throat or tongue, flushing, fever, chill or sore throat, asthma or sensitivity to light
• Disturbed vision (blurred vision, changes in colour perception or field of vision, total blindness), ringing in the ears or loss of hearing and irregular heartbeats. These symptoms are normally only severe in quinine overdose
• Changes to blood cells- if you notice that you are bruising easily or have frequent nose bleeds, tell your doctor who may want to give you a blood test. These can be signs of blood or bone marrow problems
• A severe reduction in the number of white blood cells can make infections more likely or a reduction of red blood cells can make the skin pale (anaemia) and cause weakness or breathlessness.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
• Headache, dizziness, confusion or agitation
• Feeling or being sick (nausea or vomiting), abdominal pain or diarrhoea
• Itchy skin rash
• Muscle weakness
• Low blood sugar levels
• Low blood pressure
• Kidney problems (decreased urine production or no urine, or reddish colour in the urine)
• Miscarriage
These are some of the more common side effects of quinine and are usually associated with long-term treatment with Quinine Bisulfate 300 mg Tablets.
The list of side effects mentioned above is not completed. If you should suffer from any of these side effects or any other undesired effect please tell your doctor or pharmacist. Do not be alarmed by this list of possible side effects. You may not experience any of them.
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
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What Quinine Bisulfate tablets contain:
• The active substance is Quinine Bisulfate. Each tablet contains 300 mg of quinine Bisulfate
• The other ingredients are: pregelatinised starch, powdered cellulose, crospovidone, magnesium stearate, anhydrous colloidal silica, shellac, povidone, dextrin, sucrose, kaolin, talc and titanium dioxide (E171).
What Quinine Sulfate tablets look like and contents of the pack
• Quinine Bisulfate tablets are white, sugar coated, deep convex tablet
• These tablets are available as follows:
- Container packs of 28, 42, 50, 56, 84, 100, 112, 250, 500 and 1000.
- Blister packs of 28, 42, 56, 84 and 112.
• 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 Bisulfate Tablets 300mg; PL 17907/0514 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.
V4 07-07-16 D0 K
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