PATIENT INFORMATION LEAFLET

COSURIC/Allopurinol 100 mg & 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 COSURIC 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 Cosuric. Each tablet contains the active ingredient Allopurinol BP, together with the following inactive ingredients; povidone, polyethylene glycol 6000, dextrose monohydrate, stearic acid, purified water.

Cosuric is available in two strengths, 100 mg & 300 mg. Cosuric tablets 100 mg contain Allopurinol BP 100 mg. Cosuric tablets 300 mg contain Allopurinol BP 300 mg.

Cosuric 100 mg are white round tablets marked COSURIC 100.

Cosuric 300 mg are white round tablets marked COSURIC 300.

Both strengths of Cosuric 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 blister packs of 16, 21, 50, 56, 60, 84, 90, 100, 112, 120, 140, 150, 168, 180 tablets.

The name and address of the Product Licence holder is:

Chelonia Healthcare Limited

Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, Cyprus

The Manufacturer of Cosuric is:

DDSA Pharmaceuticals Ltd.,

Chatfield Road, off York Road, London SW11 3SE

The active ingredient in Cosuric 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 Cosuric?

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 Cosuric, 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 Cosuric 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 Cosuric with other medicines?

There are some medicines that can interfere with Cosuric. 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 Cosuric.

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 should try to drink about 2 litres of fluid a day while you are taking COSURIC tablets.

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: Initially 100 mg per day. This dose may be increased depending on how well you respond to treatment. Usual maintenance dose in mild conditions 100200 mg daily; in moderately severe conditions 300-600 mg daily, in severe conditions 700-900 mg daily. Doses more than 300 mg should be taken in divided doses.

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 or liver 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 Cosuric 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 Cosuric, 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.

Cosuric can cause stomach problems such as nausea and vomiting, a spinning sensation known as vertigo, drowsiness, visual and taste disorders, high blood pressure, hair loss, liver disorders, pins and needles, various blood disorders.

Other reported side effects include feeling weak, difficulty with walking, sleepiness, coma, depression, loss of movement, cataract, inflammation of the mouth (stomatitis), changed bowel habit, sexual problems, infertility, diabetes, boils, discoloured hair, angina (chest pain), reduction in heart rate, puffiness due to water retention, swelling of all soft tissues, changes in the composition of blood and urine, swollen breasts.

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

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

Keep your medicine in a dry place, below 25°C. Keep the tablets in the container in which they were given to you.

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.

PL No's: 33414/0002 & 33414/0003

This leaflet was revised in November 2012