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nogen Pharma I

PACKAGE LEAFLET: INFORMATION FORTHE USER

Quinine Sulphate 200mg and 300mg tablets

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Read all ofthis leaflet carefully before you start faking this medicine.

•    Keep this leaflet. You may need to read it again.

|* If you have any further questions, ask your I doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them,

I 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,

I please tell your doctor or pharmacist.

Iln this leaflet:

i1. What Quinine Sulphate 200mg and 300mg tablets are and what they are used for

2.    Before you take Quinine Sulphate 200mg and 300mg tablets

3.    How to take Quinine Sulphate 200mg and

'    300mg tablets

|4. Possible side effects

5. How to store Quinine Sulphate 200mg and

I 300mg tablets

|6. Further information

1. WHAT QUININE SULPHATE 200MG AND 300MG TABLETS ARE AND WHAT THEY ARE USED FOR

iQuinine Sulphate tablets contain the active jingredient quinine sulphate. Quinine sulphate belongs to a group of medicines called 'antiprotozoal' agents.

|Quinine Sulphate tablets are used to:

• Treatmalaria

L Treat and prevent nocturnal (night-time) leg i cramps in adults and the elderly

2. BEFORE YOU TAKE QUININE SULPHATE 200MG AND 300MG TABLETS

Do not take Quinine Sulphate tablets ifyou:

|* Are allergic (hypersensitive) to quinine, quinine sulphate or any of the other ingredients in this I product

|* 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 (tinnitus)

•    Suffer from muscle weakness (myasthenia I gravis)

p Have haemoglobinuria (blood in the urine)

[Take special care with Quinine Sulphate gablets:

Check with your doctor or pharmacist before using pour medicine if:

^ 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 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. _

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 ifyou experience any ofthem.

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 breastfeeding

Do not take these tablets if you are pregnant, trying to become pregnant or are breastfeeding. Quinine Sulphate tablets should not be used for night cramps during pregnancy. Talk to your doctor or pharmacist ifyou are unsure.

Driving and using machines

These tablets may affect your vision or make you feel dizzy. Make sure you are not affected before you drive or operate machinery.

Important information about some of the ingredients in this medicine

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.

3. HOW TO TAKE QUININE SULPHATE TABLETS

Always take Quinine Sulphate tablets exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Quinine Sulphate tablets should be swallowed with ^ater.

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 ^ulphadoxine/pyrimethamine combination medicine.

|For treatment and prevention of night-time leg cramps:

200mg to 300mg at bedtime.

Children:

Use in children is not recommended.

ilfyou take more Quinine Sulphate tablets than you should

Ifyou 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 lomiting, ear/hearing problems and headache. |Fatalities have been reported in adults after doses .of 2-8g.

|lfyou forget to take Quinine Sulphate tablets

.Ifyou 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.

Ilfyou stop taking Quinine Sulphate tablets

ilfyou 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.

Low blood pressure    |

Changes in the heart rhythm Breathing difficulties    '

Feeling sick (nausea),    being    sick    |    h

(vomiting), diarrhoea, stomach pain m Flushed skin, itching, increased    ¹    ™

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. STORING QUININE SULPHATE TABLETS

Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Do not store above 25°C. 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 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

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

Like all medicines, Quinine Sulphate tablets can pause side effects, although not everyone gets them.

What Quinine Sulphate tablets contain:

Quinine Sulphate 300mg tablets contain 300mg of quinine sulphate in each tablet.

Quinine Sulphate 200mg tablets contain 200mg of quinine sulphate in each tablet.

The other ingredients are: lactose, maize starch, magnesium sterate, Stearic acid, talc, sodium Croscarmellose, opaglos, sucrose and titanium dioxide (E171).

^Jlergic reactions may occur. The signs may include swelling of your face or throat, shortness of breath orwheezing and skin rashes. If this |happens, tell your doctor straight away you may need urgent medical treatment.

'ifyou 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 kant to give you a blood test.

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, 50,100,and 500 tablets.

Tins containing 1,000 tablets Ward packs containing 100 tablets

Quinine Sulphate tablets may cause 'cinchonism barly symptoms include tinnitus (ringing in the pars), impaired hearing and vision, headache, confusion, nausea. More severe symptoms include Lomiting, severe eyesight problems, including jblindness, effects on the heart and brain.

Ilfyou experience any ofthese effects stop jtreatment and seek immediate medical advice.

bther side effects include:

|* Low blood glucose levels (hypoglycaemia)

•    Headache, vertigo (spinning sensation), excitement, agitation, confusion, loss of consciousness, coma, death

•    Visual disturbances

•    Ringing in the ears, deafness

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 was last amended in November 2012