COSURIC/ALLOPURINOL 300 MG TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the patient

Allopurinol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Cosuric is and what it is used for

• 2. What you need to know before you take Cosuric

• 3. How to take Cosuric

• 4. Possible side effects

• 5. How to store Cosuric

• 6. Contents of the pack and other information

1. what cosuric is and what it is used for

The name of this medicine is Cosuric. It contains the active ingredient allopurinol. Allopurinol works by slowing down chemical reactions in your body to lower the level of a substance called uric acid in the blood and urine.

Allopurinol is used to reduce or prevent the formation of urate/uric acid build-up in conditions where your body produces too much of uric acid. These may include gout (the build up of uric acid crystals in your joints and tendons), some types of kidney stones or certain other types of kidney problems, or when you are having treatment for cancer.

Use in children is rarely indicated, except in some types of cancer (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.

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

2. what you need to know before you take cosuric- are allergic to allopurinol or any of the other ingredients of this medicine, listed in section 6

• – are currently suffering from an acute attack of gout

If you are not sure, talk to your doctor or pharmacist before taking Cosuric.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cosuric if you:

• – have liver or kidney problems, Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely.

• – have heart problems or high blood pressure and you take diuretics and/or a medicine called ACEinhibitors

• – have cancer or Lesch-Nyhan syndrome, as the amount of uric acid may increase in your urine. To prevent this, you need to assure you drink sufficiently to dilute your urine.

• – have kidney stones, the kidney stones will become smaller and may enter your urinary tract.

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 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, African or Indian origin. If you develop a rash or these skin symptoms, stop taking Cosuric and contact your doctor immediately.

Other medicines and Cosuric

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following:

• mercaptopurine to treat bowel diseases and some cancers
• azathioprine or ciclosporin to suppress the immune system and stop the rejection of organs after transplants
• vidarabine (adenine arabinoside), an anti-viral used to treat herpes or chickenpox
• aspirin to treat pain, inflammation or fever
• any other medicine to treat gout, such as probenecid
• chlorpropamide used in the treatment of diabetes
• medicines used to thin the blood and stop blood clots forming, such as warfarin
• phenytoin used to treat epilepsy and prevent seizures
• theophylline to treat breathing problems and asthma
• ampicillin or amoxicillin to treat bacterial infections
• medicines used to treat some cancers and leukaemias, such as cyclophosphamide, doxorubicin, bleomycin, procarbazine and mechlorethamine
• didanosine, an anti-viral used in the treatment of HIV
• diuretics, medicines to increase urine production
• medicines known as ‘ACE inhibitors’ used to treat high blood pressure and heart problems, such as captopril, enalapril, lisinopril and ramipril

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this or any medicine.

Driving and using machines

Cosuric may make you feel sleepy, dizzy or unco-ordinated. If affected, do not drive or operate machinery.

3. how to take cosuric

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

Swallow the tablet with a glass of water after food.

You should drink plenty of fluids while you are taking Cosuric.

Your doctor will decide on the most appropriate dose for you depending on the severity of your condition.

You doctor will usually start with a low dose of allopurinol (e.g. 100 mg/day), to reduce the risk of possible side effects. Your dose will be increased if necessary.

The recommended dose is:

Adults : Initially, a starting dose of 100 mg once a day, this may be increased as follows;

100 – 200 mg daily for mild gout

300 – 600 mg daily for moderately severe gout

700 – 900 mg daily for severe gout

Daily doses more than 300 mg should be taken in divided doses.

Children : Your doctor will decide on the amount of Cosuric to give to your child based on their weight and the condition they are taking the medicine for. The maximum dose is 400 mg daily.

If you are an older person, or have reduced liver or kidney function, your doctor may prescribe a lower dose or ask you to take it at longer intervals.

If you take more Cosuric than you should

Contact your doctor or go to the nearest hospital casualty department immediately. Take the medicine pack with you so the doctor knows what has been taken.

If you forget to take Cosuric

Don’t worry, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cosuric

Do not stop taking your medicine without talking to your doctor.

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 you get any of the following side effects, stop taking Cosuric and see your doctor or go to the nearest hospital emergency department straight away:

• serious, potentially life-threatening allergic reactions involving itching, red raised lumps (hives), skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis), appearing initially as reddish target-like spots or circular patches often with central blisters. The rash may progress to widespread blistering or peeling of the skin. Additional signs include swelling of the face, tongue or throat which may cause difficulty breathing and wheezing, ulcers in the mouth, throat, nose or genitals, sore mouth and lips, red swollen eyes (conjunctivitis), enlarged lymph glands, fever, joint pain, flu-like symptoms and abnormal liver function tests

If you develop these conditions with Cosuric, you must not restart taking this medicine at any time.

If you get any of the following serious side effects, see a doctor as soon as possible:

• changes to your blood, such as altered numbers of white blood cells, red blood cells or blood platelets. This may cause symptoms including unexplained bleeding, bruising, increased risk of infections, sore throat, fever, weakness, breathlessness, pale skin or general illness. A blood test should be taken. These effects are more likely to occur in people with liver or kidney problems.

Tell your doctor or pharmacist if you get any of the following side effects:

feeling sick (nausea), being sick (vomiting)

• abnormal liver function tests
• diarrhoea

Rare (may occur in up to 1 in 1000 people):

• inflammation of the liver (hepatitis), the symptoms of which include yellowing of the skin or whites of the eyes (jaundice), darker urine and paler stools

Very rare (may occur in up to 1 in 10,000 people):

• an infection of the hair follicle causing a painful swollen area in which pus collects (boil)
• abnormal glucose metabolism (diabetes). Your doctor may wish to measure the level of sugar in your blood to check if this is happening.
• high levels of cholesterol in your blood (hyperlipidaemia)
• depression
• sleepiness, headache, taste disturbances, loss of coordination, nerve damage causing weakness, burning, pricking, tingling or numbness, inability to move muscles (paralysis), unconsciousness
• visual disturbances, cataracts
• a feeling of dizziness or “spinning” (vertigo)
• chest pain (angina), a slowed heart beat
• high blood pressure (hypertension)
• inflammation of the mouth, change of bowel habit, excess fat in stools, blood in vomit
• hair loss, hair colour changes, rapid swelling of skin tissue usually affects the eyes, lips or genitals
• blood in the urine
• male infertility, inability to get or maintain an erection (erectile dysfunction), enlargement of breasts in men
• build up of fluid in tissues causing swelling (oedema), a general feeling of being unwell, weakness or lack of energy, fever

Not known (can not be estimated form available data):

Aseptic meningitis (inflammation of the membranes that surround the brain and spinal cord): symptoms include neck stiffness, headache, nausea, fever or consciousness clouding. Seek medical attention immediately if these occur.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store cosurickeep your medicine in a dry place, below 25°c. keep the tablets in the container in which they were given to you.

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.

Do not throw away any 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 informationthe active substance is allopurinol. each cosuric 100 mg tablet contains 100 mg allopurinol and each cosuric 300 mg tablet contains 300 mg allopurinol.

The other ingredients are povidone, polyethylene glycol 6000, dextrose monohydrate and stearic acid.

What Cosuric Tablets look like and contents of the pack

Cosuric 100 mg Tablets are white round tablets marked ‘COSURIC 100’.

Cosuric 300 mg Tablets 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. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited

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

Manufacturer

DDSA Pharmaceuticals Ltd.,

Road, off York Road, London SW11 3SE

For any information about this medicine, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 12/2021

6