ALLOPURINOL 100 MG TABLETS

Active substance: ALLOPURINOL

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231-30-86304-V LEA ALLOPURINOL A/S TAB TUK

1

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168222

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179071

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0951-0175 TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Eastbourne.
Packing line: Uhlmann.
Text update.

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231-10-05303
50 17007 05303 3
1606 (1001000111)
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231-10-05291
50 17007 05291 3

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IN THIS LEAFLET:

1. What Allopurinol is and what it is used for
2. Before you take Allopurinol
3. How to take Allopurinol
4. Possible side effects
5. How to store Allopurinol
6. Further information

1 WHAT ALLOPURINOL IS AND WHAT
IT IS USED FOR

Pharma code 1606

(Main)

• Allopurinol belongs to a group of medicines
called enzyme inhibitors, which act to control
the speed at which special chemical changes
occur in the body.
• Allopurinol tablets are used for the long term,
preventative treatment of gout and may be used
in other conditions associated with an excess of
uric acid in the body, including kidney stones
and other types of kidney disease.

2 BEFORE YOU TAKE ALLOPURINOL
DO NOT take Allopurinol and talk to your doctor
if you:
• are intolerant or allergic (hypersensitive) to
Allopurinol or any of the other ingredients of
this medicine (see section 6)
• are currently having an attack of gout or have
just had an attack of gout.
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
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.
Take special care with Allopurinol:
Talk to your doctor before you start to take this
medicine if you:
• are suffering from, or have previously suffered
from any form of liver or kidney disease. Your
doctor may give you a lower dose or ask you
to take it less often than each day. They will
also monitor you closely
• have heart problems or have high blood
pressure
• are pregnant or trying to become pregnant.
If you develop a rash or these skin symptoms,
stop taking Allopurinol, seek urgent advice from
a doctor and tell him that you are taking this
medicine:
• Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of
Allopurinol, appearing initially as reddish
target-like spots or circular patches often with
central blisters on the trunk
• Additional signs to look for include ulcers in
the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes)
• These potentially life-threatening skin rashes
are often accompanied by flu-like symptoms.
The rash may progress to widespread
blistering or peeling of the skin.
• The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment

Child:

179071

231-10-05303
50 17007 05303 3
1606 (1001000111)
N/A
N/A
Univers

231-10-05291
50 17007 05291 3

8.5 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

323 mm
160 mm
mm
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• If you have developed Stevens-Johnson
syndrome or toxic epidermal necrolysis with
the use of Allopurinol, you must not be
re-started on Allopurinol at any time.
Taking other medicines
Tell your doctor before you start to take this
medicine if you are taking:
• other medication to treat gout e.g. probenecid
• large doses of aspirin-type drugs (salicylates)
• medicines for high blood pressure or heart
disease such as diuretics (“water tablets”) e.g.
furosemide, or ACE inhibitors e.g. fosinopril,
captopril
• any medicines used to thin your blood
(anticoagulants) e.g. warfarin
• mercaptopurine (used to treat leukaemia)
• ciclosporin or azathioprine (used to suppress
the immune system)
• didanosine (used to treat HIV infections)
• chlorpropamide (used to treat diabetes)
• vidarabine (adenine arabinoside), used in the
treatment of herpes
• phenytoin (used to treat epilepsy)
• theophylline (used for respiratory problems)
• the antibiotics amoxicillin or ampicillin
• cyclophosphamide, doxorubicin, bleomycin,
procarbazine, mechloroethamine or any other
anti-cancer medication.
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant
or are breast-feeding, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Allopurinol Tablets can cause dizziness, drowsiness
and can affect your coordination. If you are
affected DO NOT drive, operate machinery or
participate in dangerous activities.
Important information about some of the
ingredients of Allopurinol
Patients who are intolerant to lactose should
note that Allopurinol tablets contain a small
amount of lactose. If your doctor has told you
that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3 HOW TO TAKE ALLOPURINOL
Always use Allopurinol exactly as your doctor has
told you. Check with your doctor or pharmacist
if you are not sure.
The tablets should be swallowed whole, preferably
with a drink of water. You should take your tablets
after a meal. You should drink plenty of fluids
(2 - 3 litres a day) while you are taking this medicine.
The usual dose is:
• Adults (including the elderly)
Starting dose: 100 - 300 mg/day
When you start your treatment, your doctor
may also prescribe an anti-inflammatory
medicine or colchicine for a month or more, to
prevent attacks of gouty arthritis.
Your dose of allopurinol may be adjusted
depending on the severity of the condition.
The maintenance dose is:
• mild conditions, 100 - 200 mg/day
• moderately severe conditions, 300 - 600 mg/day
• severe conditions, 700 - 900 mg/day.
Your dose may also be altered by your doctor if
you have reduced kidney and liver function,
particularly if you are elderly.
If the daily dose exceeds 300 mg/day and you
are suffering from gastro-intestinal side effects
such as nausea or vomiting (see section 4),
your doctor may prescribe allopurinol in
divided doses to reduce these effects.
• Children (under 15 years)
100 - 400 mg/day.
Treatment may be started together with an
anti-inflammatory medicine or colchicine, and
the dose adjusted if you have reduced kidney
and liver function, or divided to reduce
gastro-intestinal side effects, as for Adults above.
If you take more Allopurinol than you should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately.

Top of page cut-off to middle of registration mark: 44 mm.

Read all of this leaflet carefully before you start
using this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

168222

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Trackwise Parent:

21 January 2013

PL 00289/0951-0175 TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Eastbourne.
Packing line: Uhlmann.
Text update.

Base Font Size:

PANTONE® GREEN

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
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ALLOPURINOL 100 mg AND 300 mg
TABLETS

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231-30-86304-V LEA ALLOPURINOL A/S TAB TUK

Version:

21 January 2013

An overdose is likely to cause effects including
nausea, vomiting, diarrhoea, or dizziness.
Please take this leaflet, any remaining tablets, and
the container with you to the hospital or doctor
so that they know which tablets were consumed.
If you forget to take Allopurinol
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. DO NOT take a double dose to make up
for a forgotten dose. Take the remaining doses at
the correct time.
If you stop taking Allopurinol
You should continue to take these tablets for as long
as your doctor tells you to. DO NOT stop taking
your medicine without talking to your doctor first.
Ask your doctor or pharmacist if you have any
further questions on the use of this product.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Allopurinol can cause side
effects, although not everybody gets them.
Stop taking Allopurinol and contact your doctor
immediately if you experience:
• an unexpected skin reaction (possibly in
association with fever, swollen glands, joint
pain, unusual blistering or bleeding, kidney
problems (blood in the urine) or a sudden
onset of fits).
Skin rashes are the most common side effect
with allopurinol (affecting fewer than one
person in 10 but more than one person in 100).
Stop taking your tablets and tell your doctor
immediately or go to your nearest hospital
casualty department if you experience any of
the following symptoms:
• swelling of the face, hands, lips, tongue or throat
• difficulty swallowing or breathing
• sudden wheeziness.
A few people may develop a severe allergic
reaction to allopurinol, this is an uncommon side
effect (affecting less than one person in 100 but
more than one person in 1,000) but is a very
serious side effect.
If you experience any of the following while you
are taking Allopurinol, stop taking your tablets
and tell your doctor as soon as possible:
The following uncommon side effects have been
reported (affecting less than one person in 100
but more than one person in 1,000):
• any changes to your skin, for example ulcers of
the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes),
widespread blisters or peeling
• nausea, vomiting (very rarely, blood may be
present) and diarrhoea
• 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)
• fever and chills, headache, aching muscles
(flu-like symptoms) and generally feeling unwell.
The following rare side effects have been
reported (affecting less than one person in 1,000
but more than one person in 10,000):
• jaundice (yellowing of the skin and whites of
the eyes)
• may affect your liver or kidney function
(diagnosed by blood and/or urine tests)
• formation of stones in the urinary tract,
symptoms may include blood in the urine and
pain in the abdomen, flank, or groin.
The following very rare side effects have been
reported (affecting less than one person in 10,000):
• potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported (see section 2)
• reduction in the number of white blood cells,
which makes infections more likely
• serious allergic reaction which causes swelling
of the face or throat
• reduction in blood platelets, which increases
risk of bleeding or bruising (thrombocytopenia)
• high temperature
• lethargy
• blood in the urine (haematuria)
• a change in your normal bowel habit, or
unusual foul-smelling bowel movements
• high fat levels in the blood (diagnosed by
blood tests)
• a general feeling of being unwell

• weakness, numbness, unsteadiness on feet,
inability to move muscles (paralysis) or loss of
consciousness, pins and needles
• sleepiness
• difficulty in controlling movements (ataxia)
• convulsions, fits or depression
• coma
• headache, feeling of dizziness or spinning,
drowsiness or disturbance of vision
• chest pain, high blood pressure or a slow pulse
• vomit blood (Haematemesis)
• retention of fluid leading to swelling (oedema)
particularly of the ankles
• male infertility (inability to achieve a pregnancy
after one year of regular contraceptive-free
intercourse)
• inability to get or maintain an erection, or
ejaculation during sleep ("wet dreams")
• enlargement of the breasts, in men as well as
women
• a change in taste perception, inflammation in
the mouth
• cataracts (clouding of the lens of the eye)
• boils (small tender red lumps on the skin)
• hair loss or discolouration
• 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 decide if this is happening
• muscle pain.
You may occasionally feel sick, but this can
usually be avoided by taking allopurinol after
meals. Tell your doctor if this problem persists.
Occasionally, allopurinol may affect your blood
or lymphatic system. These effects have usually
occurred in people with liver or kidney problems.
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.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5 HOW TO STORE ALLOPURINOL
Keep out of the reach and sight of children.
Do not store above 25ºC. Store in the original
package. Do not use Allopurinol after the expiry
date that is stated on the carton. The expiry date
refers to the last day of that month.
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 FURTHER INFORMATION
What Allopurinol contains:
• Each 100 mg tablet contains 100 mg of
Allopurinol
• Each 300 mg tablet contains 300 mg of
Allopurinol
• The other ingredients are lactose monohydrate,
colloidal anhydrous silica, maize starch,
powdered cellulose, sodium starch glycolate,
sodium lauryl sulphate, povidone and
magnesium stearate.
What Allopurinol looks like and contents of the pack:
• Allopurinol 100 mg Tablets are white, round,
biconvex tablets, debossed “4K1” on one side
and plain on the other
• Allopurinol 300 mg Tablets are white, round,
biconvex tablets, debossed either “2K1” or
"BERK 2K1" on one side and plain on the other.
• The 100 mg tablets are available in pack sizes of
7, 10, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110,
112, 120, 150, 160, 168, 250 and 500 tablets.
• The 300 mg tablets are available in packs of
28 and 84.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is TEVA UK
Limited, Brampton Road, Hampden Park,
Eastbourne, BN22 9AG.
Company responsible for manufacture: Teva
Pharmaceutical Works Private Limited
Company, 4042 Debrecen, Pallagi út 13, Hungary.

This leaflet was last revised: September 2012
86304-V
PL 00289/0951 and PL 00289/0175
160 x 323

Ref:
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mith
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Sign & Date:

231-30-86304-V LEA ALLOPURINOL A/S TAB TUK

1

Trackwise Parent:

168222

21 January 2013
Child:

179071

PL 00289/0951-0175 TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Eastbourne.
Packing line: Uhlmann.
Text update.

Digitally signed by
Karen Goldsmith
DN: cn=Karen
Goldsmith, o=TEVA
UK, ou=Post-Licensing
Team Leader,
email=karen.goldsmit
h@tevauk.com, c=GB
Date: 2013.01.23
15:31:37 Z

Artwork Checker;
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Final approval by MA Holder confirming receipt of MHRA/IMB
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8.5 Pt

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D:
Foil Width:
Perforated:

323 mm
160 mm
mm
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

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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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