Patient leaflet - Quinine Sulphate tablets BP 300 mg

1. WHAT QUININE SULPHATE TABLETS ARE AND WHAT THEY ARE USED FOR

Quinine Sulphate Tablets contain the active substance quinine sulphate. Quinine Sulphate Tablets are an antimalarial drug also used for muscle disorders.

Quinine Sulphate Tablets are used to:

! Treat chloroquine-resistant malaria

! Treat and prevent nocturnal (night-time) leg

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:

! If you are allergic to quinine sulphate or any of

the other ingredients of this medicine (listed in section 6)

! If you have previously had an allergic reaction

to quinine (including that in tonic waters or other beverages) or quinoline

! If you have kidney problems resulting in the

presence of blood in your urine

(haemoglobinuria)

! If you have inflammation of the optic nerve

causing problems with your eye sight ! If you have ringing in your ears (tinnitus) ! If you suffer from muscle weakness

(myasthenia gravis).

! If you have been told you have a disorder

affecting the red blood cells (haemolysis).

Warnings and precautions

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

! You have an irregular heartbeat such as atrial

fibrillation or other heart disease

! You suffer from severe glucose-6-phosphate

dehydrogenase (G6PD) deficiency, a rare hereditary disease. 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

! You have had malaria for a long time ! You have kidney or liver disease as your doctor

may need to adjust the amount you need to take or how often you need to take this medicine.

! You were born with or have any condition that

causes an abnormal heart rhythm.

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 if you experience any of them.

Other medicines and Quinine Sulphate Tablets

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

! Anticoagulants (to stop your blood from clotting,

such as warfarin)

! Cardiac glycosides (for your heart, such as

digoxin)

! Chloroquine, mefloquine, artemether with

lumefantrine, primaquine, halofantrine (also to treat malaria)

! Cimetidine (to treat stomach ulcers or acid

reflux and indigestion)

! Amantadine (to treat Parkinson's disease or

some viral infections)

! Ciclosporin (to prevent transplant rejection) ! Flecainide, quinidine or amiodarone (to treat

irregular heartbeats)

! Astemizole or terfenadine (for allergic

reactions)

! Pimozide or thioridazine (to treat some mental

disorders)

! Moxifloxacin or rifampicin (antibiotics) ! Antifungal medicines (to treat infections, such

as fluconazole, itraconazole, ketoconazole) ! Medicines to treat diabetes such as metformin,

tolbutamide, glimepiride

! Suxamethonium (muscle relaxant)

! Carbemazepine, phenytoin or barbiturates e.g.

phenobarbital (medicines to treat epilepsy) ! Medicines used in the treatment of HIV e.g.

ritonavir, indinavir, nelfinavir

! Medicines which are known to cause

disturbances in heart rhythm.

! Levacetylmethadol (a pain killer).

Pregnancy and breast-feeding

You should not take Quinine Sulphate Tablets if you are pregnant, planning to become pregnant or breast-feeding unless advised to by your doctor. Quinine Sulphate Tablets are not recommended for use during pregnancy for the prevention of night cramps.

Large doses of quinine can cause foetal abnormalities or induce abortion. You should not breast-feed a baby that might have glucose-6 phosphate dehydrogenase (G6PD) deficiency.

Driving and using machines

Quinine Sulphate Tablets may affect your vision and cause vertigo (dizziness or spinning sensation). If you are affected, do not drive or operate machinery.

Quinine Sulphate Tablets contain lactose and sucrose

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

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

3. HOW TO TAKE QUININE SULPHATE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Quinine Sulphate Tablets should be swallowed with water.

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 recommended dose is 600mg every eight hours for 7 days.

Children under 12 years:

The recommended dose is 10mg per kg of bodyweight every eight hours for 7 days.

The dosage depends on the weight of the child. Your doctor will calculate the appropriate dose for your child. This dose should be given every eight hours for 7 days.

For the treatment and prevention of night-time leg cramps

Adults (including the elderly):

The recommended dose is one 200mg tablet before going to bed. 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 night-time leg cramps.

Your doctor will monitor the effects of your treatment and adjust it accordingly.

Patients with kidney or liver problems

A lower dose than the recommended adult dose or increased time between doses should be used if you have kidney or liver problems.

If you take more Quinine Sulphate 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.

An overdose of Quinine Sulphate Tablets may cause 'cinchonism'. Early symptoms are: ! Tinnitus (ringing in the ears), impaired hearing

and vision, headache, feeling sick, being sick, fits

! Rashes, confusion, hot and flushed skin.

More severe symptoms include:

! Nervous system disorders, stomach problems,

shallow breathing, loss of consciousness ! Severe eyesight problems including blindness ! Effects on the heart, kidneys and brain ! Shock, low blood sugar.

Large doses can also cause abortion.

Take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were taken.

If you forget to take Quinine Sulphate Tablets

If you 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. Do not take a double dose to make up for a forgotten dose.

If you stop taking Quinine Sulphate Tablets

If you 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking the tablets and tell your doctor immediately, or go to the casualty department at your nearest hospital:

! Allergic reactions - swelling of the lips, face,

throat or tongue leading to severe difficulty in breathing or swallowing; itchy skin rash or hives

! A widespread rash with blisters and peeling

skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) ! 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 heartbeats, 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 as seen in blood or

urine tests, 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.

If you feel unwell whilst taking Quinine Sulphate Tablets for night-time leg

cramps, stop taking the tablets and talk to your doctor immediately.

The following side effects have also been reported:

! 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 (disorder characterised by muscle weakness, difficulty chewing or swallowing and slurred speech) ! Kidney damage, kidney failure, low production of urine, water retention

! Slowed heart rate, changes in heart rhythm and the way the heart beats, a fall in blood pressure and weak pulse

! Eczema

! Miscarriages (at very high dosages) ! Difficulty breathing, asthma

! Problems with blood clotting

! Fever

! Tightness in chest or wheezing.

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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Store in a cool, dry place and protect from light. In case of any visible signs of deterioration, you should discard the package.

Do not throw away 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 either 200mg or 300mg of quinine sulphate.

The other ingredients are: lactose, maize starch, magnesium stearate, stearic acid, talc, sodium croscarmellose, calcium carbonate, polyethylene glycol, polyvinylpyrrolidone, opaglos, sucrose and titanium dioxide (E171).

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, 28, 50, 100 and 500 tablets.

Tins containing 1,000 tablets.

Ward packs containing 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Ennogen Healthcare International Ltd Unit G3, Riverside Industrial Estate,