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ALLOPURINOL 100 MG TABLETS

Active substance(s): ALLOPURINOL

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Zyloric® 100 mg Tablets

2621
14.03.16[4]

(allopurinol)
PATIENT INFORMATION LEAFLET
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.
Your medicine is available by using the above name but will be referred to
as Zyloric throughout the following leaflet.
Zyloric Tablets are also available in 300 mg strength.
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 tablets contain 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 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.
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.
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 co-ordination.
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:
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.
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)
- skin rash
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
- 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.
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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
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 take this medicine after the expiry date shown on the pack.
The expiry date refers to the last day of that month.
Do not store above 25oC.
Store in the original package.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Return any unused or unwanted tablets to your pharmacist for disposal.
Only keep them if your doctor tells you to. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zyloric contains
- The active substance is allopurinol.
- Each tablet contains 100 mg allopurinol.
- The other ingredients are lactose monohydrate, maize starch, povidone
and magnesium stearate.
What Zyloric looks like and contents of the pack
Zyloric tablets are tablets are white to off-white, round and marked with a
score line on one side and plain on the other side.
Available in pack sizes of 25, 30 and 100 tablets.

Manufacturer and Product Licence holder
Manufactured by Faes Farma, S.A., C/Máximo Aguirre, 14, Leiona, Viscaya,
E-48940, Spain.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2621

Leaflet revision and issue date (Ref.) 14.03.16[4]
Zyloric is a trademark of Aspen Global Incorporated.

Alllopurinol® 100 mg Tablets

2621
14.03.16[4]

PATIENT INFORMATION LEAFLET
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.
Your medicine is available by using the above name but will be referred to
as Alllopurinol throughout the following leaflet.
Alllopurinol Tablets are also available in 300 mg strength.
What is in this leaflet:
1 What Alllopurinol is and what it is used for
2 What you need to know before you take Alllopurinol
3 How to take Alllopurinol
4 Possible side effects
5 How to store Alllopurinol
6 Contents of the pack and other information
1. WHAT ALLLOPURINOL IS AND WHAT IT IS USED FOR
Alllopurinol tablets contain 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.
Alllopurinol 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 ALLLOPURINOL
Do not take Alllopurinol if:
- you are allergic (hypersensitive) to allopurinol or any of the other
ingredients of Alllopurinol (listed in Section 6).
If you are not sure, talk to your doctor or pharmacist before taking
Alllopurinol.
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 Alllopurinol:
- 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.
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 Alllopurinol
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.
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 Alllopurinol can
affect the way some medicines work. Also some other medicines can affect
the way Alllopurinol 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 co-ordination.
If this happens, do not drive or use any tools or machines.
Alllopurinol 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 ALLLOPURINOL
Always take Alllopurinol 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 Alllopurinol than you should
If you take more Alllopurinol 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 Alllopurinol
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 Alllopurinol
Do not stop taking your Alllopurinol 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 Alllopurinol 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)
- skin rash
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 Alllopurinol 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.
- Alllopurinol 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.
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 the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. HOW TO STORE ALLLOPURINOL
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the pack.
The expiry date refers to the last day of that month.
Do not store above 25oC.
Store in the original package.
If the tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Return any unused or unwanted tablets to your pharmacist for disposal.
Only keep them if your doctor tells you to. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Alllopurinol contains
- The active substance is allopurinol.
- Each tablet contains 100 mg allopurinol.
- The other ingredients are lactose monohydrate, maize starch, povidone
and magnesium stearate.
What Alllopurinol looks like and contents of the pack
Alllopurinol tablets are tablets are white to off-white, round and marked with
a score line on one side and plain on the other side.
Available in pack sizes of 25, 30 and 100 tablets.

Manufacturer and Product Licence holder
Manufactured by Faes Farma, S.A., C/Máximo Aguirre, 14, Leiona, Viscaya,
E-48940, Spain.
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2621

Leaflet revision and issue date (Ref.) 14.03.16[4]

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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