Patient leaflet - ALLOPURINOL 300 MG TABLETS, ZYLORIC 300 MG TABLETS
Zyloric® 300mg tablets
(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 onto others. It may harm them, even if their symptoms 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.
The name of your medicine is Zyloric 300mg tablets but will be referred to as Zyloric throughout this leaflet. Please note that the leaflet also contains information about another strength Zyloric 100mg tablets
What is in this leaflet:
-
1. What Zyloric is and what it is used for
-
2. What you need to know before you take Zyloric
-
3. How to take Zyloric
-
4. Possible side effects
-
5. How to store Zyloric
-
6. Contents of the pack and other information
1. what zyloric is and what it is used for
Zyloric contains a medicine called allopurinol.
It works by slowing down the speed of certain chemical reactions in your body to lower the level of uric acid in the blood and urine.
Zyloric is used:
- to reduce or prevent the formation of urate/uric acid deposition in conditions where your body produces too much of a substance called uric acid. These may include gout or some types of kidney stones or certain other types of kidney problems or when you are having treatment for cancer or some other conditions. In gout the uric acid builds up in your joints and tendons as crystals. These crystals cause an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. You can also find you get severe pain when the joint is moved.
2. what you need to know before you take zyloricdo 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.
- you have thyroid problms.
Take special care with Zyloric:
- Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in patients taking allopurinol. Frequently, the rash can involve ulcers f the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often precede 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 Ch nese, Thai or Korean origin.
Chronic kidney disease may increase the risk in these patients additionally. 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.
Children
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:
- aspirin
- 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.
If aluminium hydroxide is taken concomitantly, allopurinol may have an attenuated effect. There should be an interval of at least 3 hours between taking both medicines.
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides), blood dyscrasias occur more frequently than when these active substances are administered alone. Blood count monitoring should therefore be performed at regular intervals.
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. Allopurinol is excreted in the human breast milk. Allopurinol during breast-feeding is not recommended.
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 900mg 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 400mg which is to be taken straight after your dialysis.
Use in children (under 15 years)
The usual dose ranges from 100 to 400mg 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:
Hypersensitivity
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.
Rare (may affect less than 1 in 1000 people)
- fever and chills, headache, aching muscles (flu-like symp oms) and generally feeling unwell
- serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities blood and liver function tests (these may be signs of a multi-organ sensitivity disorder).
- bleeding in the lips, eyes, m uth, nose or genitals.
- any changes to your skin, for example; ulcers of the mouth,
throat, nose, genitals, c njunctivitis (red and swollen eyes), widespread blisters or peeling.
Very rare (may affect up to 1 in 10,000 people)
- serious allergic reaction which causes swelling of the face or throat
- serious potentially life-threatening allergic reaction
Do not take any more tablets unless your doctor tells you to do so.
Other side effects
Common (may aff ct up to 1 in 10 people)
- skin rash
- increased level of thyroid stimulating hormone in the blood.
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
Very rare (may affect up to 1 in 10,000 people)
- occasionally Zyloric 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
- cataracts
- hair loss or discolouration
- depression
- 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.
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: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store zyloric
- Keep out of the sight and reach of children.
- Do not store above 25°C.
- Store in dry place.
- Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
- If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
- Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat zyloric containsthe active ingredient in zyloric is allopurinol.
Each tablet contains 300mg of the active ingredient allopurinol. The other ingredients are lactose, maize starch, polyvinyl pyrrolidone and magnesium stearate.
What Zyloric looks like and contents of the pack
Zyloric is white, round and is marked ‘C9B’ and a break-line on one side and plain on the reverse.
Zyloric are available as blister packs of 30 tablets.
Manufactured by: Teofarma S.r.l., Viale Certosa, 8/A – 27100 Pavia, Italy. Or
Delpharm Bretigny, Usine du Petit Paris, 91220 Bretigny-Sur-Orge, France.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Zyloric ® 300mg tablets; PL 18799/2732 ____
Leaflet date: 01.09.2020 IPOM
Zyloric is a registered trademark of the Aspen Global Inc.
Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 5153 763 to obtain the leaflet in a format suitable for you.
Package Leaflet: Information for the User
Allopurinol 300mg tablets
(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 onto others. It may harm them, even if their symptoms 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.
The name of your medicine is Allopurinol 300mg tablets but will be referred to as Allopurinol throughout this leaflet. Please note that the leaflet also contains information about another strength Allopurinol 100mg tablets
What is in this leaflet:
-
1. What Allopurinol is and what it is used for
-
2. What you need to know before you take Allopurinol
-
3. How to take Allopurinol
-
4. Possible side effects
-
5. How to store Allopurinol
-
6. Contents of the pack and other information
1. what allopurinol is and what it is used for
Allopurinol contains a medicine called allopurinol.
It works by slowing down the speed of certain chemical reactions in your body to lower the level of uric acid in the blood and urine.
Allopurinol is used:
- to reduce or prevent the formation of urate/uric acid deposition in conditions where your body produces too much of a substance called uric acid. These may include gout or some types of kidney stones or certain other types of kidney problems or when you are having treatment for cancer or some other conditions. In gout the uric acid builds up in your joints and tendons as crystals. These crystals cause an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. You can also find you get severe pain when the joint is moved.
2. what you need to know before you take allopurinoldo not take allopurinol if: you are allergic (hypersensitive) to allopurinol or any of the other ingredients of allopurinol (listed in section 6).
If you are not sure, talk to your doctor or pharmacist before taking Allopurinol.
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.
- you have thyroid rob ems.
Take specia care with Allopurinol:
- Serious skin rashes (Hypersensitivity syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in patients taking allopurinol. Frequently, the rash can involve ulcers f the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often precede 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 Ch nese, Thai or Korean origin.
Chronic kidney disease may increase the risk in these patients additionally. 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.
Children
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 Allopurinol
Tell your doctor or pharmacist if you are taking any of the following:
- aspirin
- 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.
If aluminium hydroxide is taken concomitantly, allopurinol may have an attenuated effect. There should be an interval of at least 3 hours between taking both medicines.
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides), blood dyscrasias occur more frequently than when these active substances are administered alone. Blood count monitoring should therefore be performed at regular intervals.
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 Allopurinol can affect the way some medicines work. Also some other medicines can affect the way Allopurinol works.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding. Allopurinol is excreted in the human breast milk. Allopurinol during breast-feeding is not recommended.
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.
Allopurinol 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 allopurinol
Always take Allopurinol 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 900mg 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 400mg which is to be taken straight after your dialysis.
Use in children (under 15 years)
The usual dose ranges from 100 to 400mg each day.
If you take more Allopurinol than you should
If you take more Allopurinol 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 Allopurinol
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 Allopurinol
Do not stop taking your Allopurinol 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:
Hypersensitivity
Uncommon (may affect less than 1 in 100 people)
If you have a hypersensitivity (allergic) reaction, stop taking Allopurinol 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.
Rare (may affect less than 1 in 1000 people)
- fever and chills, headache, aching muscles (flu-like symp oms) and generally feeling unwell
- serious hypersensitivity reactions involving fever, skin rash, joint pain, and abnormalities blood and liver function tests (these may be signs of a multi-organ sensitivity disorder).
- bleeding in the lips, eyes, m uth, nose or genitals.
- any changes to your skin, for example; ulcers of the mouth,
throat, nose, genitals, c njunctivitis (red and swollen eyes), widespread blisters or peeling.
Very rare (may affect up to 1 in 10,000 people)
- serious allergic reaction which causes swelling of the face or throat
- serious potentially life-threatening allergic reaction
Do not take any more tablets unless your doctor tells you to do so.
Other side effects
Common (may aff ct up to 1 in 10 people)
- skin rash
- increased level of thyroid stimulating hormone in the blood.
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
Very rare (may affect up to 1 in 10,000 people)
- occasionally Allopurinol 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.
- Allopurinol 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
- cataracts
- hair loss or discolouration
- depression
- 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.
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: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. how to store allopurinol
- Keep out of the sight and reach of children.
- Do not store above 25°C.
- Store in dry place.
- Do not take the tablets after the expiry date which is stated on the carton and blister labels after ‘Exp’. The expiry date refers to the last day of that month.
- If the tablet becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.
- Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat allopurinol containsthe active ingredient in allopurinol is allopurinol.
Each tablet contains 300mg of the active ingredient allopurinol. The other ingredients are lactose, maize starch, polyvinyl pyrrolidone and magnesium stearate.
What Allopurinol looks like and contents of the pack
Allopurinol is white, round and is marked ‘C9B’ and a break-line on one side and plain on the reverse.
Allopurinol are available as blister packs of 30 tablets.
Manufactured by: Teofarma S.r.l., Viale Certosa, 8/A – 27100
Pavia, Italy. Or
Delpharm Bretigny, Usine du Petit Paris, 91220 Bretigny-Sur-Orge, rance.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Allopurinol 300mg tablets; PL 18799/2732
Leaflet date: 01.09.2020 |POM |
Blind or partially sighted?
Is this leaflet hard to see or read?
Call 0208 5153 763 to obtain the leaflet in a format suitable for you.