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Quinine Sulfate 200mg Tablets

5409

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quinine Sulfate 200 mg Tablets

[Quinine Sulfate]


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 or nurse.

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

What is in this leaflet:

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

2.    What you need to know before you take Quinine Sulfate Tablets

3.    How to take Quinine Sulfate Tablets

4.    Possible side effects

5.    How to store Quinine Sulfate Tablets

6.    Contents of the pack and other information

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

Quinine Sulfate is one of a group of medicines called

antiprotozoal agents.

Quinine Sulfate Tablets are used to:

•    Treat malaria

•    Treat and prevent nocturnal (night-time) leg cramps in adults and the elderly when sleep is regularly disturbed.


Children and adolescents

Quinine sulphate 200mg tablets are not suitable for children weighing less than 20kg or less than 5 years old.

Other medicines and Quinine Sulfate Tablets:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines especially:

•    Anticoagulants such as warfarin (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, eg phenobarbital, carbamazepine or phenytoin (medicines to treat epilepsy)

•    Oral hypoglycaemics (to treat diabetes)

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

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

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

•    Suxamethonium (a muscle relaxant used in surgery, tell the anaesthetist you are taking Quinine Sulfate Tablets)

•    Medicines to treat fungal infections (fluconazole, itraconazole, ketoconazole).

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


2. What you need to know before you take Quinine Sulfate Tablets

Do not take Quinine Sulfate Tablets if you:

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

•    Have problems with your eyes or difficulty seeing

•    Suffer from inflammation of the optic nerve causing problems with your eye sight

•    Have blood in the urine (haemoglobinuria)

•    Suffer from a particular type of muscle weakness (myasthenia gravis).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Quinine Sulfate Tablets if you:

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

•    If you have previously had side effects such as low platelet count when taking quinine

•    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.


Pregnancy or Breast feeding:

Do not take the tablets if you are pregnant, trying to become pregnant or breast feeding unless advised to by your doctor. Quinine Sulfate 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.

If you are affected, DO NOT drive or operate machinery. Important information about some of the ingredients of Quinine Sulfate 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 Sulfate Tablets

Always take Quinine Sulfate 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 adolescents over 12 years:

600mg at 8 hour intervals for 7 days.

Children under 12 years:

10mg/kg at 8 hour intervals for 7 days.

Quinine sulphate 200mg tablets are not suitable for children weighing less than 20kg or less than 5 years old.

Nocturnal leg cramps:

Adults (including elderly people):

200mg at bedtime. The maximum dose is 300mg.

Do not take more than the prescribed dose.

It may take up to 4 weeks before you notice any reduction in the frequency of leg cramps.


During this time your doctor should monitor you to make sure that the medicine is suitable for you. He/she should monitor you at three monthly intervals thereafter. From time to time, your doctor may stop treatment with quinine sulphate to see if the condition returns or worsens.

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

If you take more Quinine Sulfate 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 Sulfate Tablets:

If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. 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 Sulfate 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 this medicine 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

•    Fits

•    Loss of consciousness

•    Rashes

•    Headache

•    Nausea

•    Visual disturbances

•    Abdominal pain

•    Confusion

•    Agitation

•    Diarrhoea

•    Fever

•    Flushed skin

•    Itching

•    Muscle weakness

•    Vomiting

•    Dizziness

•    Swelling of face or neck.

Other side effects include:

•    Low blood pressure

•    Low blood glucose levels (hypoglycaemia)

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

•    Discolouring of urine

•    Sensation of movement

•    Skin sensitivity to sunlight

•    Aggravation of myasthenia gravis

•    Eczema (dermatitis)


•    Fluid retention

•    Kidney failure

•    Changes in heart rhythm and the way the heart beats

•    Difficulty breathing

•    Reduced counts of all types of blood cells, failure to product new blood cells with a risk of infection

•    Blurred vision

•    Unusual bleeding or bruising under the skin

•    Abnormal blood clotting.

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 http://www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Quinine Sulfate Tablets

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Quinine Sulfate Tablets 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 Sulfate Tablets 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.    Contents of the Pack and Other Information

What Quinine Sulfate Tablets contain:

The active substance(s) is Quinine Sulfate.

The other ingredients are:    Lactose

Microcrystalline cellulose Maize starch

Colloidal anhydrous silica Purified talc Magnesium stearate Sodium starch glycollate

Ingredients for coating:

Hypromellose

Opadry white Y-1-7000 (containing methylhydroxy-propylcellulose, titanium dioxide, polyethylene glycol 400) Carbauba Wax

What Quinine Sulfate Tablets look like and contents of the pack:

Description:

A white, biconvex film-coated tablet, plain on both sides.

The tablets are supplied in PVC/aluminium foil blister packs containing either 5, 7,10,14, 15, 20, 21,25, 28, 30, 56, 60,

84, 90,100,112,120, 168, 180, 250 or 500 tablets.

Marketing Authorisation Holder and Manufacturer:

Strides Shasun (UK) Ltd

Unit 4, Metro Centre, Tolpits Lane,

Watford, Hertfordshire WD18 9SS,

United Kingdom.

This leaflet was last revised in: 09/2016.


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