Quinine Sulphate Tablets Bp 300 Mg
dnnogen Pharmal
HEW i !
| Quinine Sulphate 200mg and 300mg Tablets
(quinine sulphate)
^eid all of this leaflet carefully before you start taking this medicine bocauso 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.
» Tills 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,
I pharmacist or nurse. This includes any possible I side effects not listed in this leaflet. See section 4.
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|What Is In this leaflet:
1. What Quinine Sulphate Tablets are and what I they are used for
ft. What you need to know before you take Quinine Sulphate Tablets b. How to take Quinine Sulphate Tablets )4. Possible side effects 5. How to store Quinine Sulphate Tablets b. Contents of the pack and other Information
Quinine Sulphate Tablets contain Ihe active ingredient quinine sulphate. Quinine sulphate Ibelongs to a group of medicines called 'antiprotozoal' agents.
Quinine Sulphate Tablets are used to:
L Treat malaria
p Treat and prevent nocturnal (night-time) leg cramps in adults and the elderly
|Do not take Quinine Sulphate Tablets If you:
• Are allergic (hypersensitive) to quinine, quinine I sulphate or any of the other ingredients in this
| product (listed in section 6)
• Have previously had an allergic reaction to
' quinine found in beverages such as tonic water )• Have problems with your eyes or difficulty seeing (optic neuritis)
• Have a ringing in your ears (tinnilus)
|i Suffer from muscle weakness (myasthenia . gravis)
• Have haemoglobinurla (blood In the urine).
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.Warnings and precautions
Talk to your doctor, pharmacist or nurse before Itaking Quinine Sulphate Tablets if: p You have an Irregular heartbeat such as atrial fibrillation or other heart disease l You suffer from severe glucose-6-phosphate | dehydrogenase deficiency (G6PD). This can cause episodes of anaemia after eating certain I foods such as fava beans or certain drugs to | prevent malaria or dapsone • You consume excessive amounts of beverages I that contain quinine such as tonic water |> You have had malaria for a long time.
• You have kidney or liver disease as your doctor may need to adjust the amount you need to take or how often you need to take tills medicine.
You should not take more than the prescribed dose of Quinine Sulphate Tablets as a condition called 'cinchonism' may occur even with normal doses. See section 4. 'Possible side effects' for symptoms of cinchonism and tell your doctor If you experience any of them.
Other medicines and Quinine Sulphate Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any oilier medicines, in particular:
• Cardiac glycosides o.g. digoxin used lo treat heart conditions
Anticoagulants to stop the blood clotting Rifampicin or Moxiftoxacin used to treat Infections
Barbiturates, Carbamazepine or Phenytoln, medicines used to treat epilepsy Flecainide, QuinidineorAmiodarone used to treat irregular heart rhythms Mefloquine, Chloroqulne, Halofanlrine, Artemettier with Lumefantrine or Primaquine also used lo 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 Torfenadine to treat allergy symptoms Cimetidine to treat stomach ulcers or acid reflux and indigestion.
Pregnancy and breastfeeding Do nol take these tablets if you are pregnant, frying to become pregnant or are breaslfecding. Quinine Sulphate tablets should not bo 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. Make sure you are not affected beforo you drive or operate machinery.
Quinine Sulphate 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.
Always take Quinine Sulphate Tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist jfyou_arejjnsure.
Quinine Sulphate tablets should be swallowed with (water.
^Adults and elderly patients:
|For treatment of malaria:
(GOOmg, every 8 hours for a period of 7 days.
This is followed by an appropriate dose of a kulphadoxine/pyrimethamine combination piedidne.
(ror treatment and prevention of night-time leg (cramps:
200mg to 300mg at bedtime.
(Children:
Use in children is not recommended.
|if you take more Quinine Sulphate Tablets than
fiou should
f you take too many tablets tell a doctor straight (away. 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 v/ell as other effects such as vomiting, ear/hearing problems and headache. (Fatalities have been reported in adults after doses pf 2-8g.
If you forget to take Quinine Sulphate 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.
If you stop taking Quinine Sulphate Tablets jlf you are taking Quinine Sulphate 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.
Like all medicines, this medicine can cause side loffects, although not everyone gets them.
^Allergic reactions may occur. The signs may Include swelling of your face or throat, shortness of (breath or wheezing and skin rashes. If this happens, tell your doctor straight away you Lay need urgent medical treatment.
(If you notice that you are bruising more easily, have frequent nose bleeds or other unusual Weeding, or you have more sore throats and (nfections than usual, tell your doctor who may want to give you a blood test.
puinine Sulphate Tablets may cause 'dnchonlsm early symptoms include tinnitus (ringing in tire tears), Impaired hearing and vision, headache, |confus!on, nausea. More severe symptoms include .vomiting, severe eyesight problems, Including blindness, effects on the heart and brain.
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(f you experience any of these effects stop reatment and seek Immediate medical advice.
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pther 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
Changes In the heart rhythm I m
Feeling sick (nausea), being sick mm
(vomiting), diarrhoea, stomach pain I ■
Flushed skin, itching, increased | ■
sensitivity to light, rashes, swollen, ^ itchy, flakey, red or raised patches of I 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 report any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can provide more information on the safety of this medicine.
Check the expiry date printed on the label or side of the box. Do not use after the expiry dato stated on the label.
Store in a cool, dry place and protect from light.
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 Sulphate Tablets contain: Each tablet contains either 200mg or 300mg of quinino sulphate.
The other ingredients are: lactose, maize starch, magnesium sterate, stearic add, talc, sodium croscarmellose, opaglos, sucrose and titanium dioxide (E171).
What Quinine Sulphate Tablets look like and contents of the pack:
Quinine Sulphate Tablets are white, round, biconvex sugar coated tablets.
Quinine Sulphate Tablets are available in: Securitainers and plastic containers containing 25, 28, 50,100 and 500 tablets.
Tins containing 1,000 tablets.
Ward packs containing 100 tablets.
Marketing Authorisation Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer Clonmel Healthcare Limited Waterford Road Clonmel, County Tipperary Ireland
This leaflet v/as last revised in October 2015.