Quinine Bisulphate Tablets Bp 300mg
PATIENT INFORMATION LEAFLET
Quinine Bisulphate
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
What is in your medicine?
The name of this medicine is Quinine Bisulphate. Each tablet contains 300 mg of Quinine Bisulphate, together with the following ingredients: fumed silicon dioxide, guar gum, magnesium stearate, hydroxypropylmethylcellulose, ethylcellulose, titanium dioxide, diethyl phthalate, beeswax and microcrystalline cellulose.
Quinine Bisulphate tablets are round, white, film-coated and 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, 50000 tablets.
The Manufacturer of Quinine Bisulphate tablets is:
DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE
The Product Licence holder of Quinine Bisulphate tablets is:
Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus
What are Quinine Bisulphate tablets for?
Quinine Bisulphate tablets belong to a group of medicines known as the anti-malarials, and are used in the treatment of malaria resistant to the medicine chloroquine. Quinine Bisulphate tablets are also used in the prevention of night cramps.
Check before you take Quinine Bisulphate
Before taking this medicine, tell your doctor if you have had any unusual or allergic reactions to Quinine Bisulphate, or to any of the other ingredients.
Also tell your doctor or pharmacist if you are allergic to any other substances such as foods, preservatives or dyes.
Because the presence of other medical problems may affect the use of Quinine Bisulphate, make sure to tell your doctor if you have had any of the following:
• Optic neuritis (inflammation of the optic nerve)
• Haemoglobinuria (a break-down blood product in the urine)
• Asthma
• Heart disease, including Auricular fibrillation (rapid beating of the heart)
• Myaesthenia gravis (a type of muscle weakness)
• Glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency)
It is important to tell your doctor if you are pregnant, or likely to become pregnant.
Precautions while using this medicine
If you develop any new medical problems while using this medicine, check with your doctor or pharmacist. Although you can take these tablets with other medicines, it is important to tell your doctor or pharmacist about all the medicines that you are taking, whether or not they were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere.
It is important for your doctor or pharmacist to know if you are taking any of the following:
• Digoxin (for heart conditions)
• Cimetidine (for stomach ulcers)
• Anticoagulants (blood thinners)
• Flecainide or amiodarone (alterations of the heart beat)
• Terfenadine or astemizole (relief of hay fever and nettle rash (urticaria))
• Pimozide or thioridazine (tranquillisers)
• Other antimalarial medicines
Because visual disturbances may occur when taking Quinine Bisulphate, ability to drive or use machines may be impaired. It is inadvisable, therefore, to drive or operate machinery.
Use in pregnancy and breast-feeding
Quinine Bisulphate should not be used during pregnancy unless there is no alternative treatment available because there is risk of birth defects. Quinine is excreted in breast milk, and although no problems have been reported it is not recommended except on the specific authorisation of your doctor.
Quinine Bisulphate should not be used during pregnancy to treat cramps.
Proper use of this medicine
Take this medicine by mouth and only in the doses prescribed by your doctor. Your pharmacist can also help if you are not sure. You should take these tablets exactly as your doctor has ordered. Do not take more than your doctor has recommended and do not take it more often or for a longer time than your doctor ordered. Do not stop the treatment without talking to your doctor first. You may feel well but the tablets are helping to prevent another attack of your disease.
Dosages:
In the treatment of chloroquine-resistant malaria
Adults and the elderly: 600 mg of quinine 8-hourly for 7 days.
Children: 10 mg of quinine per kg bodyweight 8-hourly for 7 days
In the treatment of night cramps
Adults and the elderly: 200-300 mg at night.
Children: Not recommended
If you forget to take your medicine, just carry on with the next dose as normal. Do not take an extra dose to make up for the missed dose. If you are not sure, ask your doctor or pharmacist for advice.
If you feel that this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.
What to do in case of taking an overdose
If you think you or anyone else has taken an overdose of this medicine, you must obtain emergency help at once. Contact your doctor or go to the Accident & Emergency Department of your nearest hospital at once. Take with you any remaining tablets in the original container so that the medicine can be identified.
The symptoms of overdose are those of 'cinchonisn', including headache, fever, convulsions, vomiting, confusion, blindness (which could be permanent), deafness, loss of consciousness, low blood pressure, and feeble pulse. Overdose could result in breathing problems, renal failure and coma.
Large doses of quinine can induce abortion.
Undesirable effects that may occur with the use of Quinine Bisulphate
Quinine may cause 'cinchonism' which generally occurs in overdose, but may rarely also occur at normal doses. Early symptoms are tinnitus (ringing in the ears), impaired hearing and vision, headache, nausea, abdominal pain, diarrhoea, generalised itching and dizziness. More severe symptoms include vomiting, severe eyesight problems, including blindness, and effects on the heart and brain.
Quinine bisulphate can reduce the number of certain types of blood cells. If you get a sore throat or high temperature, or become gradually more tired and pale, or notice bruises or nose bleeds, stop taking quinine and contact your doctor. Kidney function may be impaired.
In people who are allergic to quinine, small doses may cause reactions including rash, fever, face swelling and asthma.
If you suffer any of these symptoms or any other effects whilst taking this medicine, contact your doctor or pharmacist.
If you feel unwell whilst taking tablets for night cramps, stop taking the medicine and talk to your doctor.
Storing your medicine
You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.
Keep your medicine in a dry place and store below 25°C. Keep the tablets in the closed container in which they were given to you.
If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist. Only keep the medicine if the doctor tells you to.
On the label you will find the words "Expiry Date" followed by some numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
This leaflet was revised in December 2008