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ALLOPURINOL TABLETS BP 100MG

Active substance(s): ALLOPURINOL

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Package leaflet: Information for the user

Allopurinol 100mg
and 300mg tablets
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.

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, 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.

Other medicines and Allopurinol tablets

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines:
• azathioprine (to treat rheumatoid arthritis and after organ
transplants)
• with administration of allopurinol and cytostatics (e.g.
cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl
halogenides, blood dyscrasias occurs more frequently than when
these active substances are administered alone. Blood count
monitoring should therefore be performed at regular intervals
• 6-mercaptopurine (used to treat some cancers and bowel diseases)
• cyclophosphamide, doxorubicin, bleomycin or procarbazine (drugs
used to treat leukaemias and some cancers)
• adenine arabinoside
• probenecid (used in gout)
• phenytoin (used in epilepsy)
• theophylline (to treat asthma)
• ampicillin or amoxicillin (antibiotics)
• aspirin or related medicines (salicylates)
• drugs to prevent blood from clotting (such as warfarin)
• chlorpropamide (used in diabetes)
• didanosine (antiviral)
• diuretics (water tablets) or ACE inhibitors such as captopril (used in
high blood pressure)
• 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.

What is in this leaflet:
1 What Allopurinol tablets are and what
they are used for
2 What you need to know before you take
Allopurinol tablets
3 How to take Allopurinol tablets
4 Possible side effects
5 How to store Allopurinol tablets
6 Contents of the pack and other
information
1 What Allopurinol tablets are and what they are

used for

Allopurinol tablets are used in:
• the management of gout and other conditions associated with
too much uric acid in the body, such as kidney disease, metabolic
disorders, certain skin diseases, cancer and treatment with diuretic
(“water tablets”).
• certain types of kidney stones.

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 medicine. Allopurinol is excreted in
the human breast milk. Allopurinol during breast-feeding is not
recommended.

2 What you need to know before you take

Allopurinol tablets

Do not take Allopurinol tablets and tell your doctor if you:
• are allergic to Allopurinol tablets or any of the other ingredients of
this medicine (listed in section 6).
• are currently suffering from an acute attack of gout.

Driving and using machines

Allopurinol tablets may make you feel dizzy, affect your coordination or make you sleepy. Make sure you are not affected
before you drive or operate machinery.

Warning and precautions:

Talk to your doctor or pharmacist before using Allopurinol tablets
if you:
• have severe liver or kidney disease or kidney problems, you may
be given a lower dose.
• have a condition which causes increased levels of urate in the body
(eg Lesch-Nyhan syndrome).
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 influenzalike symptoms fever, headache, body ache (flu-like symptoms).

Allopurinol contains lactose

If you have been told you have an intolerance to some sugars,
contact your doctor before taking this medicine, as it contains
lactose.

3 How to take Allopurinol Tablets

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
You should swallow the tablets with a little water after meals, if
possible.

Continued top of next column

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148x210 Leaflet Reel Fed Profile (BST)

Allopurinol Tablets
100 & 300mg x 28’s (UK)

Allopurinol 100mg & 300mg 28 Tablets PIL - UK
approved for print/date

Item number:

BBBA1604

Originator:
S.Anson
Origination Date: 19.12.17
Revision Date:
Revised By:

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Dimensions:
148 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

JDE No.:
Non Printing Colours

1. Black

1. Profile

2.

2.

Pharmacode: 2474

3.

3.

Date Sent:
12/12/17
Technologist: R.Wrey

4.

Date sent:
n/a
Date received: n/a

Technically Approved

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

Colours

5.

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Approval

50943816

Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Version 2
01.11.2017

Drink plenty of fluids while you are on this medicine. Before starting
treatment with allopurinol your doctor may give you an anti-inflammatory
drug or colchicine, this helps prevent you getting acute gout attacks.
If you are taking allopurinol for cancer then treatment with allopurinol will
begin before treatment with cancer drugs.
Doses:
Adults:
The recommended starting dose is 100-300mg once a day, this may be
increased to 200-600mg a day in divided doses. A maximum dose of over
900mg a day is rarely needed.
Children (usually restricted to metabolic disease or cancer): 10-20mg
per kg of body weight a day.
Elderly or patients with kidney disease: Your doctor may prescribe a
smaller dose.

If you take more Allopurinol tablets than you should:

If you (or someone else) swallow a lot of the tablets at the same time, or
if you think a child has swallowed any of the tablets, contact your nearest
hospital casualty department or tell your doctor immediately.

If you forget to take Allopurinol tablets:

Do not take a double dose to make up for a forgotten dose. If you forget
to take a dose take it as soon as you remember it and then take the next
dose at the right time.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you experience any of the following, stop your tablets and tell your
doctor immediately:
• allergic reactions:
• itchy or flaky skin rash, blistered, peeling skin or sore lips and mouth.
• swelling of the face, lips, tongue or throat, or difficulty breathing or
swallowing, severe boils.
• changes in the amounts of blood cells (as seen in blood tests); causing
increased bruising, nosebleeds, sore throats or infections.
• fever, swollen lymph glands, joint pain, swollen blood vessels, yellowing
of the skin or eyes and inflammation of the liver (hepatitis, including
hepatic necrosis and granulomatous hepatitis), kidney damage (blood
in the urine), or fits.
• Drug-induced hypersensitivity reaction that includes fever, rash
and blood abnormalities (Drug rash with eosinophilia and systemic
symptoms - DRESS)
• 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).
• itchy skin rash caused by allergic reaction – pale red irregular raised
patches with severe itching (hives)
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic
epidermal necrolysis) have been reported (see section 2).
Tell your doctor if you notice any of the following side effects or notice
any other effects not listed:
Common (may affect up to 1 in 10 people):
• rash
• increased level of thyroid stimulating hormone in the blood.
Uncommon (may affect up to 1 in 100 people):
• feeling or being sick (occasionally with blood)
• changes in liver function tests.

Very rare (may affect up to 1 in 10,000 people):
• lack of muscle control/coordination, difficulty controlling muscles,
weakness or loss of strength, numbness, ‘pins and needles’, ‘spinning’
sensation, unable to move muscles (paralysis), drowsiness, loss of
consciousness
• feeling thirsty, tired and losing weight; these may be signs of diabetes,
taste changes, build up of fluid leading to swelling (oedema)
• high levels of cholesterol in the blood (hyperlipidaemia)
• depression
• hair loss, discolouration of hair
• cataracts, changes in vision
• blood in the urine, a change in bowel habit, inflammation of the mouth,
vomiting blood
• pale, bulky, greasy, offensive stools due to increased amount of fat in the
faeces (steatorrhea)
• high temperature, a general feeling of being unwell, headache
• high blood pressure
• enlarged breasts in men and women, difficulty maintaining erection,
infertility
• chest pain (angina), slow heart beat
• high levels of urea in the blood due to kidney failure
• occasionally allopurinol 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.
Not known (frequency cannot be estimated from the available data):
worsening of gout, dizziness, diarrhoea, stomach pain, kidney stones,
‘wet dreams’, joint pain, blood vessels inflammation (causing rash, fever,
sweating, fatigue and weight loss)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 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 tablets

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place.
Do not use this medicine after the expiry date which is stated
on the label/carton/bottle. 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 dispose of
any medicines you no longer use. These measures will help
protect the environment.

6 Contents of the pack and other information
What Allopurinol tablets contain

• The active substance (the ingredient that makes the tablets
work) is Allopurinol. Each tablet contains either 100mg or
300mg of the active ingredient.
• The other ingredients are maize starch, carmellose sodium,
cellulose, sodium lauryl sulfate, lactose, magnesium stearate.

What Allopurinol tablets look like and contents
of the pack
Allopurinol tablets are circular, biconvex, white, uncoated
tablets.
Pack sizes are 28 tablets.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in December 2017
Actavis, Barnstaple, EX32 8NS, UK

50943816 BBBA1604

148x210 Leaflet Reel Fed Profile (BST)

Allopurinol Tablets
100 & 300mg x 28’s (UK)

Allopurinol 100mg & 300mg 28 Tablets PIL - UK
approved for print/date

Item number:

BBBA1604

Originator:
S.Anson
Origination Date: 19.12.17
Revision Date:
Revised By:

Proof Round

1

Dimensions:
148 x 210
Min Body Text Size: 7pt
Supplier:
Actavis UK

JDE No.:
Non Printing Colours

1. Black

1. Profile

2.

2.

Pharmacode: 2474

3.

3.

Date Sent:
12/12/17
Technologist: R.Wrey

4.

Date sent:
n/a
Date received: n/a

Technically Approved

6.

UK-Eire-Artwork-Support@accord-healthcare.com

FMD info

NA (not a carton)



No



Yes



Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

Colours

5.

Technical
Approval

50943816

Details

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Version 2
01.11.2017

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