Download PATIENT INFORMATION LEAFLET ZYLORIC® 300mg TABLETS

PATIENT INFORMATION LEAFLET
®
ZYLORIC 300mg TABLETS
Allopurinol
- Please read this carefully before you start to take your medicine.
- Keep it safe as you may want to read it again.
- This leaflet contains important information about your Zyloric Tablets. If you want to know more about
your illness or your medicine, ask your pharmacist or doctor.
WHAT IS IN YOUR ZYLORIC TABLETS?
Zyloric 300mg Tablets are white tablets, imprinted with ‘C9 B’, and a single scored line on one side, plain
on the other side.
Each tablet contains 300mg of the active ingredient, allopurinol.
There are also some inactive ingredients: lactose monohydrate, maize starch, povidone and magnesium
stearate.
Pack sizes: Blister packs of 30 tablets contained in an outer cardboard carton
PRODUCT PROCURED FROM WITHIN THE EU & REPACKAGED BY THE PARALLEL PRODUCT
AUTHORISATION HOLDER:
PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath, Ashbourne, Co. Meath.
MANUFACTURER
Zyloric Tablets are manufactured by Teofarma S.r.l. – Viale Certosa, 8/A, 27100 Pavia, Italy.
WHAT ARE ZYLORIC TABLETS FOR?
Zyloric Tablets belong to a group of medicines called enzyme inhibitors, which act to control the speed at
which certain chemical changes occur in your body.
Zyloric Tablets are used to treat conditions where there is too much uric acid in the body, such as gout,
certain types of kidney disease and kidney stones, and some enzyme disorders which lead to the build up
of too much uric acid.
WHO CAN TAKE ZYLORIC TABLETS?
This medicine suits most people but there are a few people who should not take it. Ask yourself these
questions to check whether Zyloric is right for you.
Have you ever had an allergy (rash, itching, shortness of breath) to Zyloric, allopurinol or any of the
tablet ingredients listed above?
Are you pregnant, trying to become pregnant or breast-feeding?
Are you suffering, or have you suffered, from liver or kidney disease?
Are you taking medicines for heart disease or high blood pressure?
Are you having an attack of gout at the moment?
If you answer “YES” to any of the questions above, or if you are not sure, check with your doctor first
before taking the medicine.
Zyloric may cause drowsiness, giddiness and affect your co-ordination. If affected do not drive,
operate machinery or participate in dangerous activities.
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 reactions 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.
Zyloric may interact with other medicines. It is important to let your doctor know if you are taking any
of the following drugs (please check with your doctor if you are not sure):
- 6-mercaptopurine
- azathioprine
- adenine arabinoside (vidarabine)
- probenecid
- aspirin (or related drugs called salicylates)
- chloropropamide
- drugs which thin the blood (anticoagulants)
- phenytoin
- theophylline
- ampicillin or amoxicillin
- drugs used for the treatment of cancer
- cyclosporin
- didanosine
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.
HOW DO YOU TAKE ZYLORIC TABLETS
It is important to take your medicine as directed. You must take it in the way your doctor has told you to.
The label on the pack will tell you how many tablets to take and how often to take them. If the label does
not say or if you are not sure, ask your doctor or pharmacist.
Adults: The amount of Zyloric that people can take can be very different. Your doctor will decide on a
dose of Zyloric that is right for you.
The usual starting dose is in the range 100 to 300mg daily, which may be taken as a single dose, after a
meal. The tablets should be taken with a little water to make swallowing easier. The dose may be
increased up to 900mg daily, depending on the severity of your condition.
Dosage higher than 300mg should be given in divided doses not exceeding 300mg at any one time.
The Elderly: Your doctor may decide to use a lower dose than the above.
Children less than 15 years old: The usual dose is in the range 100 – 400mg daily.
If you forget to take a dose, take another one as soon as you remember and then go on as before.
Do not stop taking your Zyloric Tablets unless your doctor tells you to.
If you take too many tablets or someone else takes your medicine by mistake, tell your doctor at once.
DO ZYLORIC TABLETS HAVE SIDE EFFECTS?
Zyloric tablets can cause side effects in some people. If you experience any of the following while you are
taking Zyloric please tell your doctor or pharmacist at once:
high temperature
joint pain or painful swelling in the groin, armpits or neck
jaundice (yellowing of the skin and eyes)
nausea and vomiting (in some cases, blood may be present)
a general feeling of being unwell
weakness, numbness or loss of consciousness
headache, dizziness, drowsiness or disturbance of vision
chest pain, high blood pressure or a slow pulse
retention of fluid leading to swelling (oedema) particularly of the ankles
feeling thirsty, tired and losing weight; these may be symptoms of diabetes. Your doctor may wish to
measure the level of sugar in your blood to help decide if this is happening.
Check with your doctor immediately if you experience any of the following:
a reaction of any kind such as a skin rash, flaking skin, boils or sore lips and mouth
or very rarely, sudden wheeziness, fluttering or tightness in the chest; collapse
THESE SYMPTOMS MAY MEAN THAT YOU ARE ALLERGIC TO ZYLORIC. Do NOT take more tablets
unless your doctor tells you to do so.
If you experience any of the following, stop your tablets and tell your doctor immediately:
Rare (affects less than 1 in 100 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).
Occasionally Zyloric tablets may affect your blood or lymphatic system. These effects have usually
occurred in people with liver or kidney problems. However, tell your doctor as soon as you can if you
notice that you are bruising more easily than usual, or if you develop a sore throat or other signs of an
infection.
Rarely, Zyloric may affect your liver or kidney function. Very rare side effects of Zyloric include infertility,
impotence, enlargement of the breasts, in men as well as women, a change in your normal bowel habit,
change in taste perception, cataracts, hair loss or discolouration, convulsions, fits or depression.
Tell your doctor or pharmacist if you notice any other side effects, which are not mentioned here.
LOOKING AFTER YOUR ZYLORIC TABLETS:
Keep out of the reach and sight of children.
Do not store above 25 C.
Store your tablets in the original pack.
Do not take the tablets after the ‘Exp' date shown on the blister and carton (this refers to the last date
of the stated month on which the product can be used).
Return any unwanted tablets to your pharmacist. Medicine should not be disposed of via waste water
or household waste. These medicines will help protect the environment.
REMEMBER
This medicine is for you. Never give it to anyone else. It may harm them even if their symptoms
are the same as yours.
Zyloric is a registered trademark of Aspen Global Incorporated.
Parallel Product Authorisation Number:
Zyloric 300mg tablets
PPA 465/17/2
Date of Leaflet Preparation by PCO Manufacturing on: May 2013