Quinine Bisulphate 300mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUININE BISULPHATE 300 mg TABLETS
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 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
V_/
THIS LEAFLET CONTAINS
1. What Quinine Bisulphate is for
2. Before you take Quinine Bisulphate
3. How to take Quinine Bisulphate
4. Possible side effects
5. How to store Quinine Bisulphate
6. Further information
1. WHAT QUININE BISULPHATE IS FOR
Quinine Bisulphate belongs to a group of medicines called anti-protozoal agents. It can be 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 Bisulphate can also be used to treat night time leg cramps, as it has a relaxing effect on skeletal muscle.
If you are not sure why you have been prescribed these tablets then please ask your doctor.
2. BEFORE YOU TAKE QUININE BISULPHATE
Do not take Quinine Bisulphate and tell your doctor if you:
• are allergic to quinine or any of its salts (such as Quinine Sulphate or Quinine Bisulphate) or any of the other ingredients in the tablets (see section 6 of this leaflet ‘Further Information')
• suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing or swallowing and slurred speech
• have inflammation of the optic nerve (optic neuritis), which may cause problems with your eyesight
• suffer from ringing noises in your ears (tinnitus)
• have blood in your urine.
Take special care with Quinine Bisulphate
Tell your doctor before you take this medicine if you:
• have irregular heart beats or other heart problems
• have glucose-6-phosphate dehydrogenase (G6PD) deficiency. This is a genetic disorder where the red blood cells are broken down under stressful conditions or due to taking medicines
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Do not take more than the prescribed dose as a condition called cinchonism may occur even with normal doses. Please see section 4 of this leaflet ‘Possible Side Effects' for the symptoms of cinchonism and tell your doctor immediately if you notice any of them.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Quinine Bisulphate can affect the way some medicines work. Also some medicines can affect the way Quinine Bisulphate works.
In particular, tell your doctor or pharmacist if you are taking any of the following:
• Chloroquine, Mefloquine, Halofantrine (used to treat malaria)
• Pimozide, Thioridazine (used to treat mental health problems)
• Oral hypoglycaemics (drugs used to treat diabetes)
• Ciclosporin (to prevent transplant rejection)
• Amiodarone, Quinidine, Digoxin or Flecainide (used to treat heart conditions)
• Moxifloxacin, Rifampicin (used to treat bacterial infections)
• Azole antifungals (drugs used to treat fungal infection such as fluconazole)
• Anticoagulants (used to prevent blood clots)
• Suxamethonium (used as a muscle relaxant)
• HIV medicines
• Barbiturates, Carbamazepine and Phenytoin (used in epilepsy).
Tell your doctor before you take this medicine if you are due to have a typhoid vaccine, as your vaccination will need to be completed at least 3 days before your first dose of Quinine Bisulphate.
Pregnancy and breast-feeding
You should not take Quinine Bisulphate if you are pregnant, planning to become pregnant or are breast-feeding unless advised to by your doctor. Large doses of Quinine Bisulphate may cause fetal abnormalities.
This medicine should not be used to treat leg cramps during pregnancy.
Driving and using machines
This medicine may cause problems with your vision. If affected, do not drive or operate any tools or machines.
3. HOW TO TAKE QUININE BISULPHATE
Always take Quinine Bisulphate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist, if you are unsure.
This medicine should be taken by mouth.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition.
For the treatment of malaria:
Adults including the elderly: The usual dose is 600 mg (2 x 300 mg tablets) every 8 hours for 7 days.
Children: Your doctor will work out the exact dose for your child based on your child's body weight. The usual dose is 10 mg of quinine bisulphate per kg of body weight, given every 8 hours for 7 days.
If you have kidney or liver disease you may be given a different dose.
For the treatment of night time leg cramps:
Adults including the elderly: The usual dose is 300 mg (1 tablet) at bedtime.
Children: This medicine should not be used for the relief of night time leg cramps in children.
If you take more Quinine Bisulphate than you should
If you or your child accidentally takes too many tablets, tell a doctor or go to a hospital casualty department at once. Take this leaflet or the medicine container with you. This is so the doctor knows what you or your child has taken.
If you forget to take Quinine Bisulphate
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 one you have missed.
If you stop taking Quinine Bisulphate
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Quinine Bisulphate can cause side effects, although not everybody gets them.
If you notice any of the following side effects, tell your doctor immediately or go to a hospital casualty department at once:
• an allergic reaction which may cause an itchy skin rash, swelling of the face, lips, tongue or throat, wheezing or tightness in the chest (asthma)
• a condition called cinchonism which may cause a ringing in the ears, loss of hearing, problems with your vision (blurred vision, changes in colour perception or field of vision)
If these occur while taking Quinine Bisulphate for leg cramps, stop taking this medicine and tell your doctor immediately
• slowed heart rate, irregular heart beats
• blood or reddish colour in the urine
• damage to the kidneys which may cause a change in the amount of urine passed, swollen ankles, feeling or being sick, loss of appetite, confusion
• increased or unexplained bruising, bleeding more easily, nosebleeds, signs of frequent infections such as fever, chills or sore throat, excessive tiredness, breathlessness or abnormal paleness of the skin. These may be a sign that you have a blood disorder. Your doctor may wish to test your blood.
Tell your doctor or pharmacist if you notice any of the following side effects:
• feeling or being sick, diarrhoea, stomach ache
• low blood sugar levels which may cause hunger, sweating, nervousness, confusion, weakness, trembling
• headache, dizziness or a feeling of spinning (vertigo), confusion, excitement.
• muscle weakness
• fever, hot flushing or rash of the skin, redness or colour change of the skin, red and raised lumps (hives), sensitivity to sunlight.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original container and keep the container tightly closed.
Do not use the tablets after the expiry date, which is stated on the container. The expiry date refers to the last day of that month.
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 Quinine Bisulphate tablets contain
The active substance (the ingredient that makes the tablets work) is quinine bisulphate.
The other ingredients in the tablets are microcrystalline cellulose, colloidal anhydrous silica, guar galactomannan, magnesium stearate, hypromellose, ethylcellulose, diethyl phthalate, titanium dioxide (E171) and beeswax.
What Quinine Bisulphate tablets look like and contents of the pack
Quinine Bisulphate tablets are round, white, film coated tablets with the marking MP38 on one side.
The tablets are available in containers of 16, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 140, 150, 168,180, 500, 1000, 5000, 10000 and 50000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited 15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited 310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 07/2010