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Allopurinol 300mg Tablets

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PATIENT INFORMATION LEAFLET

Allopurinol

100 mg and 300 mg Tablets

PLEASE READ THIS LEAFLET CAREFULLY BEFORE

YOU START TAKING THIS MEDICINE

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL

THE PRESCRIBED COURSE OF ALLOPURINOL

IF YOU HAVE ANY QUESTIONS CONCERNING YOUR

MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR

MORE INFORMATION

What is in your medicine?

The name of this medicine is Allopurinol. Each tablet contains the active ingredient Allopurinol, together with the following inactive ingredients: povidone, macrogol 6000, glucose and stearic acid.

Allopurinol is available in two strengths, 100 mg and 300 mg.

Allopurinol 100 mg Tablets contain Allopurinol 100 mg. Allopurinol 300 mg Tablets contain Allopurinol 300 mg.

Allopurinol 100 mg are white round tablets marked MP46. Allopurinol 300 mg are white round tablets marked MP47.

Both strengths of Allopurinol tablets are available in containers of 16, 21, 28, 30, 50, 56, 60, 84, 90, 112, 120, 140, 150, 168, 180, 250, 1000, 5000, 50000 tablets and in strips of 16, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 140, 150, 168, 180 tablets.

The Manufacturer is:

DDSA Pharmaceuticals Limited

310 Old Brompton Road, London SW5 9JQ

The Product Licence holder is:

Genethics (UK) Limited

Boumpoulinas 11, 1st Floor, Nicosia, P.C. 1060, Cyprus

The active ingredient in Allopurinol tablets, Allopurinol, is known as a xanthine-oxidase inhibitor and belongs to a group of medicines known as enzyme inhibitors.

Why have you been prescribed Allopurinol?

This medicine is used for the treatment and prevention of kidney stones, and for the prevention of gout.

If you are not sure why you have been prescribed Allopurinol, then please ask your doctor.

Before taking your medicine

Before taking this medicine, tell your doctor:

•    If you have ever had any unusual or allergic reactions to Allopurinol or any of the other ingredients contained in the medicine.

•    If you suffer from attacks of gout.

•    If you have kidney problems.

•    If you have liver problems.

•    If you are pregnant or planning a pregnancy.

•    If you are breast-feeding.

•    If you are allergic to any foods, preservatives or dyes.

Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin.

These serious skin reactions can be more common in people of Han Chinese or Thai origin.

If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.

Use in pregnancy & while breast-feeding

If you are pregnant or breast-feeding contact your doctor before taking this medicine.

Can you take Allopurinol with other medicines?

There are some medicines that can interfere with Allopurinol. It is very important to tell your doctor or pharmacist about all the medicines that you are taking, whether or not any medicines were prescribed by your doctor or bought without a prescription from the pharmacy or elsewhere. Your doctor will be able to identify medicines you should not take with Allopurinol.

It is important to tell your doctor:

•    If you are taking anticoagulants (blood thinners) such as warfarin or nicoumalone.

•    If you are taking chlorpropamine (to treat diabetes).

•    If you are taking Non-Steroidal Anti-Inflammatory Drugs such as azathioprine and 6-mercaptopurine.

•    If you are taking cyclophosphamide used in the treatment of leukaemia and lymph gland problems.

When and how to take these tablets

The tablets are to be taken by mouth and only in the doses prescribed by your doctor. Do not take more and do not take more often. Try to take your medication at the same time every day. The tablets should be taken with water and after a meal.

You will be prescribed the lowest dose necessary to control your symptoms. Do not stop taking your medicine or change the dose unless your doctor tells you to.

Usual dosages are stated below:

Adults:

300 mg - 900 mg per day. The average adult dose is 300 mg and this may be taken as a single dose. Doses exceeding 300 mg should be given in divided doses. It may take up to three weeks to adjust the dosage to the desired effect.

Children:

The daily dose is 10 - 20 mg per kilo bodyweight.

Elderly:

The dose should be maintained at the smallest necessary level.

Dosages will be reduced if you have kidney problems.

What to do if too many tablets are taken at the same time

If you accidentally take more tablets than recommended contact your nearest doctor or hospital casualty department at once. Take any remaining tablets with you and keep in the original container or packaging so that they can be identified.

What if you miss a dose?

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose. If you feel that this medicine is not working as well after you have taken it for a short time (3-4 days) do not increase the dose, instead check with your doctor.

What side effects can Allopurinol have?

If you experience any of the following, stop your tablets and tell your doctor immediately:

Rare (affects less than 1 in 1000 people)

•    fever and chills, headache, aching muscles (flu-like symptoms) and generally feeling unwell

•    any changes to your skin, for example ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes), widespread blisters or peeling

•    Serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities in blood and liver function tests (these may be signs of a multi-organ sensitivity disorder)

Skin reactions are the most common side effect of Allopurinol, and can occur at any time during treatment. These reactions can take the form of a rash, peeling or flaky skin, or dry scaly skin.

Allopurinol can cause difficulty with walking, dizziness, sleepiness, depression, nervousness, visual disorders, cataracts, discoloured/spotty skin, inflammation of the mouth (stomatitis), reduction in heart rate, sexual problems, infertility, hair loss, discoloured hair, angina (chest pain), high blood pressure, changes in the composition of blood and urine.

If you notice any of the above reactions or side effects, or if you notice other unusual or worrying changes to your health contact your doctor.

Storing your medicine

Containers: Do not store above 25°C. Keep the container tightly closed.

Strips: Do not store above 25°C. Store in the original package.

You must keep this medicine in a safe place where children cannot get it. Your medicine could harm them.

If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist.

On the container you will find the words "expiry date" followed by numbers indicating the day, month and year. This is the date after which the medicine is no longer fit for use. Do not use the medicine after this date but return it to your doctor or 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.

Allopurinol 100 mg Tablets Product Licence PL 34109/0001 Allopurinol 300 mg Tablets Product Licence PL 34109/0002

This leaflet was revised in November 2012

ALP0100and0300T/LEA003