PACKAGE INFORMATION LEAFLET: INFORMATION FOR THE USER

QUININE SULPHATE TABLETS BP 300mg Quinine Sulphate

Read all of this 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.

•    If you have any further questions, ask your doctor or pharmacist

•    This 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet:

1.    What Quinine Sulphate tablets are and what they are used for

2.    What you need to know before you take the Quinine Sulphate tablets

3.    How to take Quinine Sulphate tablets

4.    Possible side effects

5.    How to store Quinine Sulphate tablets

6.    Contents of the pack and other information

1. What Quinine Sulphate tablets are and what they are used for

The name of your medicine is Quinine sulphate tablets BP

300mg. The active ingredient is Quinine sulphate.

Quinine sulphate belongs to a group of medicines called

anti-protozoal agents and they are used to treat:

•    malaria

•    and prevent night cramps in adults and the elderly when sleep is regularly disrupted

2. What you need to know before you take Quinine Sulphate tablets

Do not take Quinine sulphate tablets and tell your doctor if you

have:

•    an allergy (hypersensitivity) to quinine (including that in tonic waters or other beverages), quinoline or any of the other ingredients (see section 6)

•    blood in your urine

•    ringing in your ears

•    suffer from muscle weakness (myasthenia gravis)

•    problems with your eyes or difficulty seeing

Warnings and Precautions

Check with your doctor or pharmacist before taking Quinine

sulphate tablets if you:

•    have irregular heart beats or other heart disease

•    have had malaria for a long time

•    suffer from severe glucose-6-phosphate dehydrogenase deficiency (G6PD), this can cause episodes of anaemia after eating certain foods such as fava beans (favism) or certain drugs including drugs to prevent malaria and dapsone

•    have liver or kidney problems

You should not take more than the prescribed dose as a condition called 'cinchonism' may occur even with normal doses. Please 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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    anticoagulants (to stop your blood from clotting such as warfarin)

•    cardiac glycosides (for your heart such as digoxin)

•    chloroquine, mefloquine, artemether with lumefantrine or primaquine (also to treat malaria)

•    cimetidine (to treat stomach ulcers or acid reflux and indigestion)

•    amantadine (to treat Parkinsons Disease or some viral infections)

•    ciclosporin (to prevent transplant rejection)

•    flecainide, quinidine or amiodarone (to treat irregular heart beats)

•    terfenadine (for allergic reactions)

•    pimozide or thioridazine (to treat some mental disorders)

•    moxifloxacin, rifampicin or antifungals (to treat infections)

•    medicines to treat diabetes

•    suxamethonium (muscle relaxant)

•    HIV medicines

•    barbiturates, carbamazepine or phenytoin (used in epilepsy)

Pregnancy, breast-feeding and fertility

•    If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

•    Quinine Sulphate tablets should not be used for night cramps during pregnancy.

Driving and using machines

Do not drive or operate machinery if you experience any problems with your vision while you are taking this medicine.

Quinine sulphate tablets contain Lactose and Sucrose

The tablets contain lactose and sucrose. If you have been told that you have an intolerance to some sugars, please check with your doctor before taking these tablets.

3. How to take Quinine Sulphate tablets

•    Always take Quinine Sulphate tablets exactly as your doctor has told you.

•    You should check with your doctor or pharmacist if you are not sure.

•    The tablets should be swallowed with a drink of water. Doses:

For the treatment of malaria (you may be given another medicine for malaria with or after this course of quinine):

Adults (including the elderly) and children aged 12 years and over: The usual dose is 2 tablets every eight hours for 7 days.

Children under 12 years - 10mg per kg of body weight every eight hours for 7 days.

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

For the treatment of night cramps

Adults and the elderly: Take 1 tablet at night. It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps.

If you take more tablets than you should:

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms include loss of consciousness, difficulty breathing, changes in heart beat, fits, 'ringing' in the ears, loss of hearing, headache, feeling or being sick and changes in vision.

If you forget to take Quinine Sulphate Tablets:

If you forget to take a dose, take another dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

4. Possible Side Effects

Like all medicines Quinine Sulphate tablets can cause side effects, although not everybody gets them.

Contact your doctor at once if the following effects occur:

•    allergic reactions -itchy skin rash, swelling of the lips, face, throat or tongue, flushing, fever, asthma or sensitivity to light

•    cinchonism -abdominal pain, diarrhoea, disturbed vision (blurred vision, changes in colour perception or field of vision,

total blindness), headache, feeling or being sick, ringing in the ears or impaired hearing, rashes, loss of consciousness, fits, shock due to heart problems, irregular heart beats, death. If these occur while taking Quinine sulphate tablets for leg cramps, treatment should be stopped and a doctor contacted straight away.

•    changes to blood cells, if you notice that you are bruising or bleeding easily, have frequent nose bleeds, or you have more sore throats and infections than usual tell your doctor who may want to give you a blood test.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    diarrhoea, feeling or being sick, abdominal pain, low blood sugar.

•    muscle weakness, excitement, agitation, 'spinning sensation', confusion, loss of consciousness, coma, death.

•    headache, changes in vision, 'ringing' in the ears, loss of hearing.

•    swollen, itchy, flaky, red or raised patches of skin, rashes, sensitivity to light.

•    aggravation of Myasthenia gravis.

•    kidney damage, water retention, slowed heart rate, hypotension, changes in heart rhythm and the way the heart beats, eczema, miscarriages (at very high concentrations), difficulty breathing.

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 this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. By

reporting side effects you can help provide more information

on the safety of this medicine.

5. How to store Quinine Sulphate tablets

•    Keep this medicine out of the sight and reach of children

•    Tablet Containers: Do not store above 25⁰C. Store in the original container. Keep the container tightly closed.

Blister cartons: Do not store above 25⁰C. Store in the original package. Keep the blister in the outer carton.

•    Do not use tablets after the expiry date shown on the label or carton. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.Contents of the pack and other information

What Quinine Sulphate tablets contain

•    The active substance is Quinine Sulphate. Each tablet contains 300mg Quinine sulphate.

•    The other ingredients are Lactose, Colloidal Silicon Dioxide, Potato Starch, Magnesium Stearate, Sodium Starch Glycollate (Type A), Sodium Lauryl Sulphate, Gelatin, Talc, Sucrose and Titanium Dioxide (E171) and Carnauba Wax.

What Quinine Sulphate tablets look like and the contents of

the pack

•    The tablets are bi-convex, white and sugar coated.

•    The tablets are supplied in packs of 28, 56 or 500 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address:    Bristol Laboratories Limited,

Unit 3, Canalside,

Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom

Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

E-mail:    info@bristol-labs.co.uk

Quinine sulphate tablets BP 300mg; PL 17907/0011

This leaflet was last revised in October 2013.

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, e-mail) above.

V5 31-10-13 DO