2. What you need to know before you take Zyloric
Do not take Zyloric if:
- you are allergic (hypersensitive) to allopurinol or any of the other ingredients of Zyloric (listed in Section 6).
If you are not sure, talk to your doctor or pharmacist before taking Zyloric.
Warnings and Precautions
Talk to your doctor or pharmacist before taking your medicine if:
- you are of Han Chinese, African or Indian origin
- you have problems with your liver or kidneys. 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.
- you have heart problems or high blood pressure and you take diuretics and/or a medicine called ACE-inhibitors.
- you are currently having an attack of gout.
Take special care with Zyloric:
- Skin rashes have been reported in patients taking 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. If you develop a rash or these skin symptoms, stop taking allopurinol and contact your doctor immediately.
- If you have cancer or Lesch-Nyhan syndrome the amount of uric acid may increase in your urine. To prevent this, you need to assure to drink sufficiently to dilute your urine.
- In case you have kidney stones, the kidney stones will become smaller and may enter your urinary tract.
Use in children is rarely indicated, except in some types of cancer (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.
Other medicines and Zyloric
Tell your doctor or pharmacist if you are taking any of the following:
- theophylline, used for breathing problems
- medicines used for fits (epilepsy), phenytoin
- vidarabine, used to treat herpes or chickenpox
- antibiotics (ampicillin or amoxicillin)
- didanosine, used to treat HIV infection
- medicines used for cancer
- medicines used to reduce your immune response (immunosuppressants)
- medicines used to treat diabetes
- medicines for heart problems or high blood pressure such as ACE inhibitors or water tablets (diuretics)
- medicines used to thin your blood (anticoagulants), such as warfarin
- any other medicine to treat gout.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Zyloric can affect the way some medicines work. Also some other medicines can affect the way Zyloric works.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
You may feel drowsy, giddy or have problems with your coordination. If this happens, do not drive or use any tools or machines.
Zyloric contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Zyloric
Always take Zyloric exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take the tablet after food and swallow it with a glass of water.
The recommended dose ranges from 100 to 900 mg each day. You will usually start on a low dose, which will be increased if necessary.
If you are an older person or if you have reduced liver or kidney function, your doctor may prescribe a lower dose or to take it at longer intervals. If you have dialysis two or three times a week, your doctor may prescribe a dose of 300 or 400 mg which is to be taken straight after your dialysis.
Use in children (under 15 years)
The usual dose ranges from 100 to 400 mg each day.
If you take more Zyloric than you should
If you take more Zyloric than you should, contact a doctor or go to hospital straight away. Take the medicine pack with you. Signs of an overdose may include nausea, vomiting, diarrhoea and dizziness.
If you forget to take Zyloric
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Zyloric
Do not stop taking your Zyloric without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Uncommon (may affect less than 1 in 100 people)
If you have a hypersensitivity (allergic) reaction, stop taking Zyloric and see a doctor straight way.
The signs may include:
- flaking skin, boils or sore lips and mouth
- very rarely signs may include sudden wheeziness, fluttering or tightness in the chest and collapse.
Do not take any more tablets unless your doctor tells you to do so.
Other side effects
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people):feeling sick (nausea) or being sick (vomiting)
- abnormal liver tests.
Rare (may affect up to 1 in 1000 people)
- liver problems such as liver inflammation
- more serious hypersensitivity reactions involving fever, joint pain, abnormalities in blood, bleeding in the lips, eyes, mouth, nose or genitals, ulcers of the mouth, throat, nose, genitals, conjunctivitis (red and swollen eyes), widespread blisters or peeling.
Very rare (may affect up to 1 in 10,000 people)
- occasionally Zyloric tablets may affect your blood, which can manifest as bruising more easily than usual, or you may develop a sore throat or other signs of an infection. These effects usually occur in people with liver or kidney problems. Tell your doctor as soon as possible.
- Zyloric may affect the lymph nodes
- high temperature
- blood in your urine (haematuria)
- high levels of cholesterol in your blood (hyperlipidaemia)
- a general feeling of being unwell or feeling weak
- weakness, numbness, unsteadiness on your feet, feeling unable to move muscles (paralysis) or loss of consciousness
- headache, dizziness, drowsiness or disturbance of your vision
- chest pain (angina), high blood pressure or a slow pulse
- male infertility or erectile dysfunction
- enlargement of the breasts, in men as well as women
- a change in your normal bowel habit
- a change in taste
- hair loss or discolouration
- lack of voluntary coordination of muscle movements (ataxia)
- sensation of tingling, tickling, pricking or burning of skin (paraesthesia)
- build up of fluid leading to swelling (oedema) particularly of your ankles
- abnormal glucose metabolism (diabetes). Your doctor may wish to measure the level of sugar in your blood to check if this is happening.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard.
6. Contents of the pack and other information
What Zyloric contains
- The active substance is allopurinol.
- The other ingredients are lactose, maize starch, povidone, magnesium stearate and purified water.
What Zyloric looks like and contents of the pack
Zyloric tablets contain 100 or 300 mg allopurinol. Each 100 mg tablet is white to off-white, round and marked with a score line, Z1. Each 300 mg tablet is white to off-white, round and marked with a score line, Z3.
- Zyloric 100 mg tablets come in 4 strips of 25 tablets.
- Zyloric 300 mg tablets come in 2 strips of 14 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Service-Tel: +800 00404142
Aspen Bad Oldesloe GmbH
Medical Information Enquiries
For any Medical Information enquiries about this product, please contact:
24 Hour Helpline +441748 823 391 (free phone UK only 0800 0087 392)
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Zyloric 100 mg tablets / Zyloric 300 mg tablets
Reference number: PL 39699/0001 / PL 39699/0002
This is a service provided by the Royal National Institute of Blind People.