5375

PACKAGE LEAFLET: INFORMATION FOR THE USER

QUININE BISULPHATE TABLETS 300 mg

[Quinine Bisulphate]

Read all of this leaflet carefully before you start taking this medicine.

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

•    If you have any further questions, ask your doctor, health care provider or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, 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, please tell your doctor or pharmacist.

In this leaflet:

1.    What are Quinine Bisulphate Tablets and what are they used for

2.    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.    Further information

1.    What are Quinine Bisulphate Tablets and what are they used for

Quinine Bisulphate is one of a group of medicines called antiprotozoal agents.

Quinine Bisulphate Tablets are used to:

•    Treat malaria.

•    Treat and prevent nocturnal (night-time) leg cramps in adults and the elderly.

2.    Before you take Quinine Bisulphate Tablets

Do not take Quinine Bisulphate if you:

•    Are hypersensitive (allergic) to quinine or any other ingredients in this medicine (See section 6. Further information).

•    Have problems with your eyes or difficulty seeing.

•    Suffer from tinnitus (ringing or buzzing in the ears).

•    Have blood in the urine (haemoglobinuria).

•    Suffer from muscle weakness (myasthenia gravis).

Take special care with Quinine Bisulphate if you:

•    Are sensitive to Quinine. See section 4 for possible symptoms.

•    Have had malaria for a long time.

•    Have irregular heartbeats or other heart disease.

•    Have conduction defects of the heart (this is where the heart cannot conduct electrical signals properly).

•    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.

•    Consume excessive amounts of beverages that contain quinine such as tonic water.

You should not take more than the prescribed dose as a condition called ‘cinchonism' may occur even with a normal dose. Please see section 4 ‘Possible side effects' for symptoms of cinchonism and tell your doctor if you experience any of them.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines or any medicines obtained without a prescription:

•    Anticoagulants (to stop your blood clotting).

•    Cardiac glycosides (medicines for your heart such as digoxin).

•    Chloroquine, artemether with lumefantrine or mefloquine, halofantrine (also to treat malaria).

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

•    Flecainide, quinidine or amiodarone (to treat irregular heart rhythms).

•    Pimozide or thioridazine (to treat some mental disorders)

•    Rifampicin or moxifloxacin (antibiotics).

•    Barbituates, carbamazepine or phenytoin (medicines to treat epilepsy).

•    Oral hypoglycaemics (to treat diabetes).

•    HIV protease inhibitors (drugs to treat HIV infections such as ritonavir).

•    Azole antifungals (drugs to treat fungal infections such as ketoconazole).

•    Ciclosporin (used following transplant surgery and to treat various inflammatory diseases).

•    Amantadine (an antiviral to treat influenza and parkinson's disease).

•    Suxamethonium (a muscle relaxant used in surgery, tell the anaesthetist you are taking quinine bisulphate tablets).

If you see another doctor or go into hospital, let them know what medicines you are taking.

Pregnancy or Breast feeding:

Do not take the tablets if you are pregnant, trying to become pregnant or breast feeding. Quinine Bisulphate Tablets should not be used for night cramps during pregnancy. Consult your doctor or pharmacist if in doubt.

Driving and using machines:

Quinine 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 of Quinine Bisulphate Tablets:

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Quinine Bisulphate Tablets

Always take Quinine Bisulphate Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

These tablets should be swallowed with some water.

Malaria

Adults (including elderly) and children over 12 years:

600mg at 8 hour intervals for 7 days

Children under 12 years:

10mg/kg at 8 hour intervals for 7 days

Nocturnal leg cramps

Adults (including elderly people):

The recommended dose is 300mg at bedtime.

5375

Dimension: 180 x 250 mm

Front Side

ARTWORK DETAIL LABEL

It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps. Your doctor will monitor your progress.

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

If you take more Quinine Bisulphate Tablets than you should:

If you accidentally take more than your prescribed dose, contact your nearest hospital casualty department, or tell your doctor immediately. Take any remaining tablets and the container with you.

If you forget to take Quinine Bisulphate Tablets:

If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. However, do not take a double dose to make up for a forgotten dose.

If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor.

If you stop taking Quinine Bisulphate Tablets:

Continue to take the tablets for as long as your doctor tells you to. If you are taking them for malaria you must take the full course. If you stop too soon the infection may recur.

4. Possible Side Effects

Like all medicines Quinine Bisulphate Tablets can cause side effects, although not everybody gets them. Contact your doctor at once if the following effects occur:

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

If you notice that you are bruising easily, have frequent nose bleeds or other unusual bleeding, notice a reddish discolouration of your urine, or you have more sore throats and infections than usual, tell your doctor who may want to give you a blood test.

Symptoms of Quinine overdose (cinchonism) can occur at normal doses in some patients.

If you are sensitive to Quinine you may experience any of these symptoms. Consult your doctor if these effects are troublesome or continue:

•    ringing in the ears

•    deafness

•    rashes

•    headache

•    nausea

•    visual disturbances

•    abdominal pain

•    confusion

•    agitation

•    diarrhoea

•    fever

•    flushed skin

•    itching

•    muscle weakness

•    vomiting

•    dizziness.

Other side effects include:

•    a reduction in the function of the kidneys (symptoms include decrease in urine output, drowsiness, nausea and breathlessness)

•    low blood pressure

•    low blood glucose levels (hypoglycaemia).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5.    How to store Quinine Bisulphate Tablets

Keep out of the reach and sight of children.

Keep the tablets stored below 25°C in a dry place and in the original packaging.

Do not use Quinine Bisulphate Tablets 300 mg after the expiry date stated on the label. The expiry refers to the last day of that month.

Remember, this medicine is for you only. Never give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Do not use Quinine Bisulphate Tablets 300 mg if you notice visible signs of deterioration.

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.

6.    Further Information

What Quinine Bisulphate Tablets 300 mg contain:

The active substance(s) is Quinine Bisulphate BP/Ph.Eur.

The other ingredients are: Lactose

Microcrystalline cellulose Povidone K30 Maize Starch Sodium starch glycollate Colloidal anhydrous silica Purified talc Magnesium stearate Pregelatinised maize starch

Ingredients for Coating: Hydroxypropylmethylcellulose Diethyl phthalate Opadry white Carnauba wax

What Quinine Bisulphate Tablets 300 mg look like and contents of the pack:

Quinine Bisulphate Tablets are white, biconvex film-coated tablets.

The tablets are supplied in PVC/aluminium foil blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer:

Co-Pharma Limited Unit 4, Metro Centre,

Tolpits Lane, Watford,Herts.

UK, WD 18 9SS Tel: 01923 255580 Fax: 01923 255581

This leaflet was last revised in 09/2013

5376

Dimension: 180 x 250 mm

9LK

Back Side

ARTWORK DETAIL LABEL