Quinine Bisulphate Tablets Bp 300mg
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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Read all of this leaflet carefully before you start faking this medicine.
• Keep this leaflet. You may need to read it again L If you have any further questions, ask your
doctor or pharmacist
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Iln this leaflet:
|1. What Quinine Bisulphate Tablets are and what they are used for
I2. Before you take Quinine Bisulphate Tablets p. How to take Quinine Bisulphate Tablets 4. Possible side effects |5. How to store Quinine Bisulphate Tablets 16. Further information.
1. WHAT QUININE BISULPHATE TABLETS ARE AND WHAT THEY ARE USED FOR:
|Quinine Bisulphate Tablets contains a medicine called Quinine Bisulphate. This belongs to a group oftherapeutic medicines originally obtained from |the bark of the cinchona tree and used for the |treatment of malaria and muscle cramps.
|Quinine Bisulphate Tablets are used for the treatment of chloroquine-resistant strains of Talciparium malaria.
[They are also used for the treatment and prevention of leg cramps occurring at night when the cramps cause regular disruption of sleep.
2. BEFORE YOU TAKE QUININE BISULPHATE TABLETS
Do not take Quinine Bisulphate Tablets if:
L You have previously experienced sensitivity to quinine, quinine bisulphate, or any of the other ingredients in this medicine L You have red coloured urine (Haemoglobinuria) p You have Tinnitus (ringing or buzzing in the ears)
I* You have Myasthenia gravis, a neuromuscular disease causing muscle weakness
• You have problems with or pain in your eyes.
Take special care with Quinine Bisulphate Tablets if:
|* You have an irregular heartbeat such as atrial , fibrillation or other heart disease
• You suffer from severe glucose-6-phosphate dehydrogenase deficiency (G6PD). This can cause episodes ofanaemia after eating certain
' foods such as fava beans or certain drugs to prevent malaria or dapsone.
• You consume excessive amounts of beverages that contain quinine such as tonic water.
|* You have had malaria for a long time.
^ou should not take more than the prescribed [dose ofQuinine Bisulphate Tablets as a condition called 'cinchonism' may occureven Uith normal doses. See section 4. 'Possible pide effects' for symptoms of cinchonism and tell your doctor if you experience any of them.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription especially:
• Cardiac glycosides e.g. digoxin used to treat heart conditions
• Anticoagulants to stop the blood clotting
• Rifampicin or Moxifloxacin used to treat infections
• Barbiturates, Carbamazepine or Phenytoin, medicines used to treat epilepsy
• Flecainide,Quinidineor Amiodarone usedto treat irregular heart rhythms
• Mefloquine, Chloroquine, Halofantrine, Artemether with Lumefantrine or Primaquine also used to treat malaria
• Ciclosporin used following transplant surgery
• Pimozide or Thioridazine used to treat some mental disorders
• Oral hypoglycaemics used to treat diabetes
• Suxamethonium a muscle relaxant used during surgery, tell your anaesthetist you are taking quinine tablets
• Azole antifungals used to treat fungal infections e.g. ketoconazole
• HIVproteaseinhibitors usedtotreatHIV infections.
• Amantidine to treat Parkinson's disease or some viral infections
• Terfenadine to treat allergy symptoms
• Cimetidine to treat stomach ulcers or acid reflux and indigestion
Pregnancy and Breast-feeding:
Do not take these tablets if you are pregnant, trying to become pregnant or are breast-feeding. Quinine Bisulphate Tablets should not be used for night cramps during pregnancy. Talk to your doctor or pharmacist if you are unsure.
Driving and using machines:
These tablets may affect your vision or make you feel dizzy. They may also cause muscle weakness and confusion. Make sure you are not affected before you drive or operate machinery.
Important information about some of the ingredients in this medicine:
Quinine Bisulphate Tablets contain sucrose. Ifyou have been told by your doctor that you have an intolerance to some sugars, you should consult your doctor before taking these tablets.
3. HOW TO TAKE QUININE BISULPHATE TABLETS
Always take Quinine Bisulphate Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Quinine Bisulphate Tablets should be swallowed with a little water.
Adults and elderly patients:
For treatment of malaria:
600mg, every 8 hours for a period of 7 days.
This is followed by an appropriate dose of a sulphadoxine/pyrimethamine combination medieine.— — — — — — — — —
for treatment and prevention of night-time leg |cramps:
200mg to 300mg at bedtime.
|Children:
It is not recommended for use in children.
|lfyou take more Quinine Bisulphate Tablets than you should:
Ilf you take too many tablets tell a doctor straight pway. Take your medicine with you. The more serious effects of an overdose include fits, Abnormal heart beats, severe visual disturbances, |loss of consciousness and dangerously shallow breathing as well as other effects such as Vomiting, ear/hearing problems and headache. Fatalities have been reported in adults after doses of 2-8g.
• Flushed skin, itching, increased sensitivity to light, rashes, swollen, itchy, flakey, red or raised patches of skin
• Muscle weakness
• A reduction in the function of the kidneys (symptoms include decrease in urine output, drowsiness, nausea and breathlessness)
• Miscarriages - at very high dosages
If any of the side effects gets serious, or if you notice any effects not listed in this leaflet, tell your doctor or pharmacist.
5. HOW TO STORE QUININE BISULPHATE TABLETS
,lfyou forget to take Quinine Bisulphate Tablets:
|lf you forget to take a dose, take the missed dose as soon as you remember. If your next dose is due within 4 hours, skip the missed dose and take your |next dose at the usual time.
Check the expiry date printed on the label or side of the container. Do not use after the expiry date stated on the label.
Do not store above 25°C and protect from light. Store in the original package.
l|fyou stop taking Quinine Bisulphate Tablets:
|lf you are taking Quinine Bisulphate Tablets for malaria you must take the complete course prescribed for you. Even if you feel better the [infection may still be present and may reoccur if the treatment is stopped too soon.
4. POSSIBLE SIDE EFFECTS
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
Keep out of the reach and sight of children.
Like all medicines Quinine Bisulphate Tablets can pause side effects, although not everyone gets them.
^Ilergic reactions may occur. The signs may include swelling of your face or throat, changes in the heart rhythm, shortness of breath or wheezing pnd skin rashes. If this happens, tell your doctor straight away you may need urgent medical treatment.
'if you notice that you are bruising more easily,
|have frequent nose bleeds or other unusual bleeding, oryou have more sore throats and infections than usual, tell your doctor who may ^ant to give you a blood test.
Quinine Bisulphate Tablets may cause cinchonism. |Early symptoms include tinnitus (ringing in the ears), impaired hearing and vision, headache, confusion, nausea. More severe symptoms include pomiting, severe eyesight problems, including blindness, effects on the heart and brain and a reduction in kidney function (symptoms include pecrease in urine output, drowsiness, nausea and breathlessness).
ilfyou experience any ofthese effects stop treatment and seek immediate medical advice.
Other side effects include:
• Low blood glucose levels (hypoglycaemia) l Headache, vertigo (spinning sensation),
excitement, agitation, confusion, loss of consciousness, coma, death l Visual disturbances |* Ringing in the ears, deafness
• Low blood pressure
l Changes in the heart rhythm |* Breathing difficulties
• Feeling sick (nausea), being sick (vomiting), diarrhoea, stomach pain
6. FURTHER INFORMATION
What Quinine Bisulphate Tablets contain:
Each tablet contains 300mg of the active ingredient Quinine Bisulphate BP. Other excipients are: starch, povidone (E1201), talc, stearic acid, sodium starch glycollate, sucrose, titanium dioxide (E171), shellac (E904), acetylated monoglyceride (E472a) and industrial methylated spirits.
What Quinine Bisulphate Tablets look like and contents of the pack:
White sugar coated tablets.
Quinine Bisulphate Tablets are supplied in securitainers in pack sizes of25, 50,100, 500 and 1,000.
Marketing Authorisation Holder:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
Clonmel Healthcare Limited Waterford Road Clonmel Co Tipperary Republic of Ireland
This leaflet was last amended in November 2012.