Quinine Bisulphate Tablets Bp 300mg
a
nnogen Pharmaj
~"~a | Quinine Bisulphate Tablets BP 300mg
I (quinine bisulphale)
|Read all of Ibis 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.
I If you have any further questions, ask your | doctor or pharmacist or nurse.
. This medicine has been prescribed for you I only. Do not pass it on to others. It ntay harm | (Item, even if their signs of illness are the same as yours.
L If you get any side effects, talk to your doctor,
I pharmacist or nurse. This includes any possible side effects not listed In this leaflet. See section I 4.
what Is In this leaflet:
|1. What Quinine Blsulphate 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
puinine Bisulphate Tablets contains a medicine called Quinine Bisulphate. This belongs to a group bf therapeutic medicines originally obtained from file bark of the cinchona tree and used for the treatment of malaria and muscle cramps.
I
puinine 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 khe cramps cause regular disruption of sleep.
To not take Quinine Blsulphate Tablets if:
You have previously experienced sensitivity to quinine, quinine blsulphate, or any of the other ingredients in this medicine (listed in section 6) You have red coloured urine (Haemoglobinuria) You have Tinnitus (ringing or buzzing In the ears)
You have Myasthenia gravis, a neuromuscular disease causing muscle weakness.
framings and precautions
Talk to your doctor, pharmacist or nurse before
taking Quinine Bisulphate Tablets if:
|> You have problems with or pain in your eyes.
• You have an irregular heartbeat sucti as atrial I fibrillation or other heart disease
ft You suffer from severe glucose-6-phosphate dehydrogenase deficiency (G6PD). This can I cause episodes of anaemia after eating certain | foods such as fava beans or certain drugs to prevent malaria or dapsone L You consume excessive amounts of beverages | that contain quinine such as tonic water
• You have had malaria for a long lime.
You should not take more than the prescribed dose of Quinine Bisulphate Tablets as a condition called 'clnchonlsm' may occur even with normal doses. See section 4. 'Possible side effects' for symptoms of cinchonlsm and tell your doctor If you experience any of them.
Other medicines and Qulnlno Bisulphate Tablets
Talk to your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, In particular:
• 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, Quinidine or Amlodarone used to treat irregular heart rhythms Mefloquine, Chtoroquine, Halofantrine, Artemethor 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 HIV protease inhibitors used to treat HIV 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.
Quinine Blsulphate Tablets contain lactose If you have been told by your doctor that you have an Intolerance to some sugars, you should consult your doctor before taking these tablets.
tiWV
Always lake Quinine Bisulphate Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Quinine Blsulphate Tablets should be swallowed with a little water.
'Adults and elderly patients:
For treatment of malaria:
liQOmg, every 8 hours for a period of 7 days.
[This is followed by an appropriate dose of a sulphadoxine/pyrimethamine combination medicine.
I
For treatment and prevention of night-time leg tramps:
pOOrng to 300rng at bedtime.
^Children:
jit is not recommended for use in children.
if you take more Quinine Bisulphate Tablets jthan you should:
If you take too many tablets tell a doctor straight bway. Take your medicine with you. The more petious effects of an overdose include fits, abnormal heart beats, severe visual disturbances, loss of consciousness and dangerously shallow preathing as well as other effects such as vomiting, ear/hearing problems and headache. iFatalities have been reported in adults after doses jof 2-Sg.
if you forget to take Quinine Bisulphatc .Tablets:
if you forget to tako 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 lime.
If you stop taking Quinine Bisulphatc Tablets: f you are taking Quinine Bisulphate Tablets for (nalaria you must take the complete course prescribed for you. Even if you feel better the infection may still be present and may reoccur if (he treatment Is stopped too soon.
Like all medicines, this medicine can cause side bffects, allhough not everyone gels them.
Allergic reactions may occur. The signs may Include swelling of your face or throat, changes in (he heart rhythm, shortness of breath or wheezing and skin rashes. If this happens, tell your doctor btraight away you may need urgent medical (reatment.
kf you notice lhat you are bruising more easily, have frequent nose bleeds or other unusual bleeding, or you have more sore throats and Infections than usual, tell your doctor who may (want to give you a blood test.
iQuinine Bisulphate Tablets may cause clnchonism. |Early symptoms Include tinnitus (ringing In the ears), impaired hearing and vision, headache, (confusion, nausea. More severe symptoms Include .vomiting, severe eyesight problems, including blindness, effects on the heart and brain and a (eduction in kidney function (symptoms include decrease in urine output, drowsiness, nausea and breathlessness).
I
(f you experience any of these effects stop reatment and seek Immediate medical advice.
I
Other side effects Include:
'• Low blood glucose levels (hypoglycaemia)
( Headache, vertigo (spinning sensalion), excitement, agitation, confusion, loss of consciousness, coma, death
Visual disturbances Ringing in the ears, deafness Low blood pressure Changes in the head rhythm Breathing difficulties Feeling sick (nausea), being sick (vomiting), diarrhoea, stomach pain 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.
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 the leaflet. You can also repod any side effects directly via the Yellow Card Scheme at: VAVw.mhra.gov.uk/yellowcard.
By repoding side effects you can provide more Information on the safety of this medicine.
Check the expiry dale 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.
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed of via 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 sight and reach of children.
What Quinine Blsulphate Tablets contain:
Each tablet contains 300mg of quinine bisulphate. I Other excipients are: starch, povidone (E1201), ,
talc, stearic acid, sodium starcli glycollate, sucrose, titanium dioxide (E171), shellac (E904), | acetylated monoglyceride (E472a) and Industrial . methylated spirits.
What Quinine Blsulphate Tablets look like and contents of the pack:
White sugar coated tablets.
Quinine Bisulphate Tablets are supplied in securitainers in pack sizes of 25. 28,50, 100, 500 and 1000 tablets.
Not all pack sizes may be marketed.
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 revised in December 2015.