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1. Quinine Sulphate 300mg Tablets
2. Quinine Sulphate 300mg Tablets

CP.QSU.300T.V5P3 PATIENT INFORMATION LEAFLET

QUININE SULPHATE 300mg TABLETS

Please read this leaflet carefully before you start to take this medicine.

*    If you have further questions, please ask your doctor or your pharmacist.

*    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

IN THIS LEAFLET

1.    What your medicine is and what it is used for

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    Storing your medicine

6.    More information

The name of your medicine is Quinine Sulphate 300mg Tablets.

Quinine Sulphate 300mg Tablets contain the anti-malarial drug quinine sulphate 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 sulphate has a relaxant action on skeletal muscle. Your doctor may have prescribed this medicine for the treatment of night leg cramps.

Do not use your medicine if you:

•    are allergic to quinine or any of its salts or any of the other ingredients in the tablet (Please note: quinine is an ingredient in some tonic waters and other beverages.)

•    have problems with your eye sight (due to inflammation of the optic nerve)

•    suffer from tinnitus (ringing noises in the ear)

•    have blood in the urine

•    suffer from myasthenia gravis (condition causing muscle weakness).

Take special care with your medicine

You should let your doctor know and ask their advice, if you suffer from, or have ever had:

•    an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (as this can cause anaemia)

•    irregular heart beat or other heart problems

•    have had malaria for a long time

Treatment for night leg cramps should be discontinued if side effects occur. If you are elderly, there is a greater risk of having side effects.

Children

This medicine should not be used for the relief of night leg cramps in children.

Taking other medication

Your medicine may interfere with other medicines that you are taking. Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicine even those not prescribed, especially:

•    Digoxin or flecainide, amiodarone, quinidine - 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

•Antifungal medicines, e.g. ketoconazole

•    Drugs used to treat diabetes

•    Suxamethonium, used to relax muscles

•    Chloroquine, halofantrine, mefloquine and artemether with lumefantrine - for the treatment of malaria

•    Pimozide and thioridazine, used to treat mental disorders such as schizophrenia

•    Medicines used in treating HIV infections e.g. nelfinavir

•    Cimetidine used to treat stomach ulcers or acid reflux and indigestion

Pregnancy and breast-feeding

Before taking your medicine, tell your doctor if you are pregnant or trying to become pregnant. You should not take Quinine Sulphate 300mg Tablets when you are pregnant or breast-feeding, unless the benefits outweigh the risks.

This medicine should not be used to treat night leg cramps during pregnancy.

Large doses of quinine can affect the developing baby.

Driving and using machines

This medicine may cause visual disturbances. If affected, do not drive or operate any tools or machines.

Important information about some of the ingredients

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take your medicine exactly as your doctor has instructed you. You should check with your doctor or pharmacist, if you are unsure. Do not take more than your doctor has recommended.

Your medicine should be taken by mouth as follows:

For the treatment of Malaria:

Adults (including the elderly) and children over 12 years:

The usual dose is 600mg (2 x 300mg tablets) three times a day for 7 days.

Children under 12 years:

The usual dose is 10mg per kg of body weight, given every 8 hours for 7 days.

Kidney and liver problems:

If you have a kidney or liver disease you may be given a different dose.

For the treatment of Night Cramps:

Adults (including the elderly):

200-300mg at bedtime.

If there is no benefit after 4 weeks, the treatment should be stopped.

Children:

This medicine should not be used for the relief of night leg cramps in children.

Kidney and liver problems:

If you have a 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 a doctor or hospital casualty department straight away. Take your medicine with you.

If you forget to take your medicine

If you 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 the forgotten dose.

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.

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 nosebleeds, 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.

Do not use your medicine after the expiry date shown on the carton.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Do not store your medicine above 25°C. Store in a dry place and protect from light.

Store in the original package and do not transfer your medicine to another container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What your medicine contains

Quinine Sulphate 300mg Tablets contain 300mg of the active ingredient quinine sulphate.The other ingredients are starch, sucrose, povidone, sodium starch glycollate, talc, magnesium stearate, bleached shellac, titanium dioxide (E171), beeswax, carnauba wax, water and ethanol.

What your medicine looks like and contents of the pack

Quinine Sulphate 300mg Tablets are plain, white, sugar-coated tablets.These tablets are available in packs of 28 and 500.

Not all pack sizes may be marketed.

This leaflet is a summary. It does not contain the complete information about your medicine. If you have any further questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

Marketing Authorisation holder

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.

Company responsible for release of this medicine

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 OGR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham,

DE12 7DT, U.K.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham,

DE12 7DT, U.K.

PL 06453/0040.

This leaflet was revised in May 2012.

Tell your doctor or pharmacist if you notice any of the following:

•    Headache, dizziness, confusion or agitation

•    Feeling or being sick (nausea or vomiting), abdominal pain or diarrhoea

•    Itchy skin rash, swollen and red skin

•    Muscle weakness

•    Low blood sugar levels

•    Low blood pressure

•    Kidney problems (decreased urine production or no urine, blood, or reddish colour in the urine)

•    Miscarriages (at very high concentrations)

If you 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.

CP.QSU.300T.V5P3