Allopurinol Teva 300 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Allopurinol
Available from:
Teva Pharma B.V.
ATC code:
M04AA; M04AA01
INN (International Name):
Allopurinol
Dosage:
300 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Preparations inhibiting uric acid production; allopurinol
Authorization status:
Marketed
Authorization number:
PA0749/099/003
Authorization date:
2010-09-10

Body:

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Allopurinol Teva

100mg/200mg/300mg Tabs All

TEI (TPW) V7

54139

Leaflet

160 x 460mm

AM

08-05-18

1.1

AM

09-05-18

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ALLOPURINOL TEVA 100 mg

AND 300 mg TABLETS

Allopurinol

PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

WHAT IS IN THIS LEAFLET

1. What Allopurinol Teva is and what it is

used for

2. What you need to know before you take

Allopurinol Teva

3. How to take Allopurinol Teva

4. Possible side effects

5. How to store Allopurinol Teva

6. Contents of the pack and other

information

What Allopurinol Teva is and

what it is used for

Allopurinol Teva 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 Teva tablets are used for the

long term, preventive 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.

What you need to know before

you take Allopurinol Teva

Do not take Allopurinol Teva:

if you are allergic to allopurinol or any

of the other ingredients of this medicine

(listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before

taking Allopurinol Teva if:

you have problems with your liver and

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.

you are currently having an attack of gout.

Serious skin rashes have been reported with

the use of allopurinol that can be more

common in patients with chronic renal

impairment. These serious skin rashes can

include Hypersensitivity syndrome, Stevens-

Johnson syndrome and toxic epidermal

necrolysis. All 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. If you

develop a rash or these skin symptoms, stop

taking allopurinol and contact your doctor

immediately.

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.

Other medicines and Allopurinol Teva

Tell your doctor or pharmacist if you are

taking/using, have recently taken/used or

might take/use any other medicines.

Tell your doctor or pharmacist if you are

taking any of the following:

6-mercaptopurine ( used to treat blood

cancer)

azathioprine, ciclosporin (used to

suppress the immune system)

Please note, ciclosporin side effects may

occur more frequently.

vidarabine (used in the treatment of

herpes)

Please note, vidarabine side effects can

occur more frequently. Take special care

if these occur.

salicylates (used to reduce pain, fever or

inflammation e.g. acetylicsalicylic acid)

probenecid (used to treat gout)

chlorpropamide (used to treat diabetes)

Chlorpropamide dose reduction may be

necessary, particularly in patients with

reduced kidney function.

warfarin, phenprocoumon,

acenocoumarol (used to thin the blood)

Your doctor will monitor your blood

clotting values more frequently and if

necessary, reduce the dose of these

medicines.

phenytoin (used to treat epilepsy)

theophylline (used to treat asthma and

other breathing diseases)

Your doctor will measure theophylline

blood levels, particularly when treatment

with allopurinol begins, or following any

dosage changes.

ampicillin or amoxicillin (used to treat

bacterial infections)

Patients should receive other antibiotics

where possible, as allergic reactions are

more likely to occur.

cytostatics (used to treat aggressive

tumours)

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..

didanosine (used to treat HIV infection)

captopril (used to treat high blood

pressure)

The risk of skin reactions can be raised,

especially if your kidney function is

chronically reduced.

aluminium hydroxid (used to neutralise

the acid in the stomach)

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.

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.

Driving and using machines

Allopurinol Teva tablets can cause dizziness,

drowsiness, and can affect your

coordination. If you are affected, DO NOT

drive, operate machinery or participate in

dangerous activities.

Allopurinol Teva contains lactose

This medicinal product 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.

How to take Allopurinol Teva

Always take this medicine exactly as your

doctor or pharmacist 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 recommended 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 Teva in divided doses to reduce

these effects.

If you have a serious kidney problem

you may be asked to take less than

100 mg each day

or you may be asked to take 100 mg at

longer intervals than one day

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)

100 - 400 mg/day given as 3 divided doses.

Use in children is rarely indicated except in

some types of cancer, especially in

leukaemia and certain enzyme disorders, for

example Lesch-Nyhan syndrome.

If you take more Allopurinol Teva 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.

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 Teva

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 Teva

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.

If you have any further questions on the use

of this medicine, ask your doctor or

pharmacist or nurse

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

taking the medicine and/or tell your doctor

immediately:

An unexpected skin reaction (possibly in

association with fever, swollen glands,

joint pain, unusual blistering or bleeding,

kidney problems or a sudden onset

of fits).

Skin rashes are the most common side

effect with allopurinol (may affect up to

1 in 10 people).

Rare (may affect up to 1 in 1,000 people)

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).

Very rare (may affect up to 1 in 10,000 people)

Allergic reactions

If you have an allergic reaction, stop taking

allopurinol and see a doctor straight away.

The signs may include:

Skin rash, flaking skin, boils or sore lips

and mouth.

Swelling of the face, hands, lips, tongue

or throat.

Difficulty swallowing or breathing.

Very rarely signs may include sudden

wheeziness, fluttering or tightness of the

chest and collapse.

Do not take any more tablets unless your

doctor tells you to do so.

If you experience any of the following while

you are taking Allopurinol Teva, stop taking

your tablets and tell your doctor as soon as

possible:

The following common side effects have

been reported (may affect up to 1 in

10 people):

Increased level of thyroid stimulating

hormone in the blood

The following uncommon side effects have

been reported (may affect up to 1 in

100 people):

nausea, vomiting (very rarely, blood may

be present) and diarrhoea

symptoms of allergic reactions including

itchy rash

increase in results of liver function tests

The following rare side effects have been

reported (may affect up to 1 in 1,000 people):

joint pain or painful swelling in the groin,

armpits or neck

jaundice (yellowing of the skin and whites

of the eyes)

may affect your liver or kidney function.

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 (may affect up to 1 in

10,000 people):

high temperature

blood in the urine

a change in your normal bowel habit, or

unusual foul-smelling bowel movements

high fat levels in the blood

a general feeling of being unwell

weakness, numbness, unsteadiness on

feet, inability to move muscles (paralysis)

or loss of consciousness, pins and needles

convulsions, fits or depression

headache, dizziness, drowsiness or

disturbance of vision

chest pain, high blood pressure or a slow

pulse

retention of fluid leading to swelling

(oedema) particularly of the ankles

male infertility or 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)

and other problems with sight

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

swollen glands, usually goes away once

treatment with allopurinol ends

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.

You may occasionally feel sick, but this can

usually be avoided by taking allopurinol after

meals. Tell your doctor if this problem

persists.

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 HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie;

E-mail:medsafety@hpra.ie. By reporting side

effects you can help provide more

information on the safety of this medicine.

How to store Allopurinol Teva

Transparent aluminium blisters

Keep this medicine out of the sight and reach

of children.

Do not use this medicine after the expiry

date which is stated on the carton and blister

after EXP. The expiry date refers to the last

day of that month.

This medicinal product does not require any

special storage conditions.

Do not throw away any medicines via

wastewater <or household waste>. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will help

protect the environment.

HDPE Bottles

Keep this medicine out of the sight and reach

of children.

Do not use this medicine after the expiry

date which is stated on the carton and bottle

after EXP. The expiry date refers to the last

day of that month.

Store in the original packaging.

Keep the bottle tightly closed in order to

protect from light.

Do not throw away any medicines via

wastewater <or household waste>. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will help

protect the environment.

Content of the pack and other

information

What Allopurinol Teva contains

The active substance is allopurinol.

Each 100 mg tablet contains 100 mg

allopurinol.

Each 300 mg tablet contains 300 mg

allopurinol.

The other ingredients are lactose

monohydrate, silica colloidal anhydrous,

maize starch, powdered cellulose, sodium

starch glycolate, sodium laurilsulfate,

povidone K30 and magnesium stearate

(E470b).

What Allopurinol Teva looks like and

contents of the pack

Allopurinol Teva 100 mg tablets are white,

round, biconvex tablets, debossed “4K1”

on one side and plain on the other.

Allopurinol Teva 300 mg tablets are white,

round, biconvex tablets, debossed “2K1”

on one side and plain on the other.

The product is available in transparent

aluminium blisters in the following pack

sizes:

Allopurinol Teva 100 mg tablets: 20, 25, 28,

30, 50, 60, 90, 98, 100, 105 and 500 tablets

and Hospital Pack of 50

Allopurinol Teva 300 mg tablets: 20, 28, 30,

50, 60, 90, 98, 100, 105 and 500 tablets and

Hospital Pack of 50

The product is also available in HDPE Bottles

in the following pack sizes:

Allopurinol Teva 100 mg tablets: 30 Tablets

in 35 ml Bottle or 100 Tablets in 35 ml Bottle

Allopurinol Teva 300 mg tablets: 30 Tablets

in 35 ml Bottle or 100 Tablets in 100 ml Bottle

Not all pack sizes may be marketed.

Marketing Authorisation Holder and

Manufacturer

Teva Pharma B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturers

TEVA Pharmaceutical Works Private Limited

Company

Pallagi út 13,

4042 Debrecen

Hungary

TEVA UK Ltd

Brampton Road,

Hampden Park,

Eastbourne,

East Sussex,

BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

GALIEN LPS

98 Rue Bellocier,

89100 Sens,

France

This medicinal product is authorised in the

Member States of the EEA under the

following names:

Belgium:

Allopurinol TEVA 100 and

300 mg tabletten

Bulgaria:

ALODAGRA 100 mg

tablets

Denmark:

Allopurinol “Teva”

France:

Allopurinol Teva 100, 200

and 300 mg, comprimé

Ireland:

Allopurinol Teva 100 and

300 mg tablets

Italy:

Allopurinolo Teva Italia

100 and 300 mg

compresse

The Netherlands:

Allopurinol 100, 200 and

300 mg PCH, tabletten

Sweden:

Allopurinol Teva 100 and

300 mg tabletter

UK:

Allopurinol 100 mg,

200 mg and 300 mg

Tablets

This leaflet was last revised in April 2018.

H54139

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Allopurinol Teva 300 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 300 mg allopurinol.

Excipient(s) with known effect:

Each tablet contains lactose monohydrate, equivalent to 171 mg lactose.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet.

White, round biconvex tablets, debossed 2K1 on one side, plain on the other.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Allopurinol Teva is indicated in adults, children and adolescents:

Adults

All forms of hyperuricaemia not controllable by diet including secondary hyperuricaemia of differing origin and

in clinical complications of hyperuricaemic states, particularly manifest gout, urate nephropathy and for the

dissolution and prevention of uric acid stones

The management of recurrent mixed calcium oxalate stones in concurrent hyperuricaemia, when fluid, dietary

and similar measures have failed.

Children and adolescents

Secondary hyperuricaemia of differing origin

Uric acid nephropathy during treatment of leukaemia

Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial or total hypoxanthin-guanin

phosphoribosyl transferase deficiency) and adenine phosophoribosyl transferase deficiency.

4.2 Posology and method of administration

Posology

For oral use.

Adults:

2 - 10 mg/kg bodyweight/day or 100 - 200 mg daily in mild conditions, 300 - 600 mg daily in moderately severe

conditions, or 700 - 900 mg daily in severe conditions. Allopurinol should be introduced at low dosage e.g. 100mg/day to

reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution

should be exercised if renal function is poor (see Dosage recommendations in renal disorders).

Paediatric population (up to the age of 15):

10 - 20 mg/kg bodyweight / day up to a maximum of 400 mg daily given as 3 divided doses.

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Use in children is rarely indicated except in malignant conditions, especially in leukaemia and certain enzyme disorders, for

example Lesch-Nyhan syndrome.

Elderly:

No specific dosage recommendations, the lowest dosage which produces satisfactory urate reduction should be used. Refer

to dosage advice under Dosage recommendations in renal disorders (also see section 4.4).

Dosage recommendations in renal disorders:

Allopurinol and its metabolites are excreted by the kidney; therefore impairment of renal function may lead to retention of

the drug and/or its metabolites. The plasma half lives may as a consequence be prolonged. The following schedule may

serve as guidance for dose adjustments at renal impairment:

Creatinine clearance

Dosage

>20 ml/min

normal dose

10-20 ml/min

100-200 mg per day

<10 ml/min

100 mg/day or longer dose intervals

Serious consideration should be given in the presence of impaired renal function, to initiating treatment with a maximum

dose of 100 mg/day and increasing it

only if the serum and/or urinary rate response is unsatisfactory.

In severe renal

insufficiency, it may be advisable to use less than 100 mg/day or to use single doses of 100 mg at longer intervals than one

day.

If plasma oxipurinol

concentration monitoring is available,

the dose should be adjusted to maintain plasma oxipurinol

levels below 100 micromol/Litre (15.2 microgram/ml).

Dose recommendations in renal dialysis:

Allopurinol and its metabolites are removed by renal dialysis. If dialysis is required two to three times a week

consideration should be given to an alternative dosage schedule of 300-400 mg allopurinol immediately after each

dialysis with none in the interim.

Dosage in hepatic impairment:

Reduced doses should be used in patients with hepatic impairment.

Periodic liver function tests are recommended

during the early stages of therapy.

Treatment of high urate turnover conditions e.g. neoplasia, Lesch-Nyhan syndrome:

is advisable to correct

existing hyperuricaemia and/or hyperuricosuria with allopurinol

before commencing cytotoxic

therapy. It is important to ensure adequate hydration to maintain optimum diuresis and to attempt alkalinisation of urine to

increase solubility of urinary urate/uric acid. The dose of allopurinol should be in the lower range.

If urate nephropathy or other pathology has compromised renal function, advice provided in Dosage recommendations in

renal disorder should be followed.

These steps may reduce the risk of xanthine and/or oxipurinol deposition complicating the clinical situation. (see sections

4.5 and 4.8).

Monitoring Advise: Dosage should be adjusted by monitoring serum urate concentrations and urinary urate/uric acid

levels at appropriate intervals.

Method of administration

Allopurinol may be taken orally once a day. To increase gastrointestinal tolerability,

it should be taken after a meal. If

the daily dosage exceeds 300 mg and gastrointestinal intolerance is evident, a divided dosage regimen may be appropriate.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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4.4 Special warnings and precautions for use

Acute gouty attacks: Allopurinol treatment should not be started until an acute attack of gout has completely subsided,

as further attacks may be precipitated.

In the early stages of treatment with allopurinol, as with uricosuric agents, an acute attack of gouty arthritis may be

precipitated. Therefore it is advisable to give prophylaxis with a suitable anti-inflammatory agent or colchicine for at

least one month. The literature should be consulted for details of appropriate dosage and precautions and warnings.

If acute attacks develop in patients receiving allopurinol, treatment should continue at the same dosage while the acute

attack is treated with a suitable anti-inflammatory agent.

Allopurinol should not be prescribed to patients treated with azathioprine or 6-mercaptopurine unless the dose of these

drugs is reduced to one-quarter of the previously prescribed dose (see section 4.5).

Allopurinol should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs.

Hepatic or renal impairment

Reduced doses should be used in patients with hepatic or renal impairment (See Section 4.2). Patients under treatment

for hypertension or cardiac insufficiency, for example with diuretics or ACE inhibitors, may have some concomitant

impairment of renal function and allopurinol should be used with care in this group.

Asymptomatic hyperuricaemia per se is generally not considered an indication for use of allopurinol. Fluid and dietary

modification with management of the underlying cause may correct the condition.

Xanthine deposition: In conditions where the rate of urate formation is greatly increased (e.g. malignant disease and its

treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently

to allow deposition in the urinary tract. This risk may be minimised by adequate hydration to achieve optimal urine

dilution.

Impaction of uric acid renal stones: Adequate therapy with allopurinol will lead to dissolution of large uric acid renal

pelvic stones, with the remote possibility of impaction in the ureter.

In the treatment of renal gout and uric acid stones, the volume of urine produced should be at least 2 litres per day and

the urinary pH should be kept in the range of 6.4 – 6.8.

Hypersensitivity syndrome, SJS and TEN: Allopurinol hypersensitivity reactions can manifest in many different ways,

including maculopapular exanthema, hypersensitivity syndrome (also known as DRESS) and Stevens-Johnson

Syndrome (SJS)/toxic epidermal necrolysis (TEN). These reactions are clinical diagnoses, and their clinical

presentations remain the basis for decision making. If such reactions occur at any time during treatment, allopurinol

should be withdrawn immediately. Rechallenge should not be undertaken in patients with hypersensitivity syndrome

and SJS/TEN. Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions (see section 4.8 –

Immune system disorders and Skin and subcutaneous tissue disorders).

Chronic renal impairment

Patients with chronic renal impairment may be at increased risk of developing hypersensitivity reactions including

SJS/TEN associated with allopurinol. Extra vigilance for the signs of hypersensitivity syndrome or SJS/TEN is required

and the patient should be informed of the need to stop treatment immediately and permanently at the first appearance of

symptoms (see section 4.8).

HLA-B*5801 allele: The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol

related hypersensitivity syndrome and SJS/TEN. The frequency of the HLA-B*5801 allele varies widely between

ethnic populations: up to 20% in Han Chinese population, 8-15% in the Thai, about 12% in the Korean population and

1-2% in individuals of Japanese or European origin.

Screening for HLA-B*5801 should be considered before starting treatment with allopurinol in patient subgroups where

the prevalence of this allele is known to be high. Chronic kidney disease may increase the risk in these patients

additionally. In case that no HLA-B*5801 genotyping is available for patients with Han Chinese, Thai or Korean

descent the benefits should be thoroughly assessed and considered outweigh the possible higher risks before starting

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therapy. The use of genotyping has not been established in other patient populations.

If the patient is a known carrier of HLA-B*5801 (especially in those who are from Han Chinese, Thai or Korean

descent, allopurinol should not be started unless there are no other reasonable therapeutic options and the benefits are

thought to exceed risks. Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN is required and the patient

should be informed of the need to stop treatment immediately at the first appearance of symptoms (see section 4.8).

SJS/TEN can still occur in patients who are found to be negative for HLA-B*5801 irrespective of their ethnic origin.

Thyroid disorders: Increased TSH values (>5.5 µIU/ml) were observed in patients on long-term treatment with

allopurinol (5.8%) in a long term open label extension study. Caution is required when allopurinol is used in patients

with alteration of thyroid function.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption

should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

6-mercaptopurine and azathioprine: At concomitant administration with allopurinol,

the dose of 6-mercaptopurine or

azathioprine should be reduced to 25% of

the usual

dose.

Allopurinol

an inhibitor

xanthine oxidase and

counteracts the metabolic inactivation of azathioprine and 6-mercaptopurine. Serum concentrations of these medicinal

products can reach toxic levels unless dose reduction is undertaken.

Vidarabine (Adenine Arabinoside):

Evidence suggests that

the plasma half-life of

vidarabine is increased in the

presence of

allopurinol.

When the two products are used concomitantly extra vigilance is necessary,

to recognise

enhanced toxic effects.

Salicylates and uricosuric agents: Oxipurinol,

the major metabolite of allopurinol and itself therapeutically active,

excreted by the kidney in a similar way to urate. Hence, drugs with uricosuric activity such as probenecid or large doses

of salicylate may accelerate the excretion of oxipurinol. This may decrease the therapeutic activity of allopurinol, but

the significance needs to be assessed in each case.

Chlorpropamide: If allopurinol is given concomitantly with chlorpropamide when renal function is poor, there may be

an increased risk of

prolonged hypoglycaemic activity because allopurinol

and chlorpropamide may compete for

excretion in the renal tubule.

Coumarin anticoagulants:

There

have

been rare

reports

increased effect

warfarin and other

coumarin

anticoagulants

when co-administered with allopurinol.

Therefore,

patients

receiving anticoagulants

must

carefully monitored.

Phenytoin:

Allopurinol

may inhibit

hepatic

oxidation of

phenytoin but

clinical

significance

been

demonstrated.

Theophylline: Inhibition of the metabolism of theophylline has been reported. The mechanism of the interaction may be

explained by xanthine oxidase being involved in the biotransformation of theophylline in man.

Theophylline levels

should be monitored in patients starting or increasing allopurinol therapy.

Ampicillin/Amoxicillin: An increase in frequency of skin rash has been reported among patients receiving ampicillin or

amoxicillin concurrently with allopurinol

compared to patients who are not

receiving both drugs.

The cause of the

reported association has not

been established.

However,

is recommended that

in patients receiving allopurinol

alternative to ampicillin or amoxicillin is used where available.

Cytostatics:

With administration of

allopurinol

and cytostatics

(e.g.

cyclophosphamide,

doxorubicin,

bleomycin,

procarbazine,

alkyl

halogenides),

blood dyscrasias

occur

more frequently than when these active substances

administered alone.

Blood count monitoring should therefore be performed at regular intervals.

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Ciclosporin:

Reports

suggest

that

the plasma concentration of

ciclosporin may be increased during concomitant

treatment with allopurinol.

The possibility of enhanced ciclosporin toxicity should be considered if the drugs are co-

administered.

Didanosine: In healthy volunteers and HIV patients receiving didanosine, plasma didanosine C

and AUC values

were approximately doubled with concomitant allopurinol treatment (300 mg daily) without affecting terminal half life.

Co-administration of these 2 drugs is generally not recommended. If concomitant use is unavoidable, a dose reduction

of didanosine may be required, and patients should be closely monitored.

Captopril: With concomitant administration of allopurinol and captopril, the risk of skin reactions can be raised,

especially in cases of chronic renal failure.

Aluminium hydroxide: 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.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is insufficient evidence of the safety of allopurinol in human pregnancy. Animal reproductive toxicity studies have

shown conflicting results (see section 5.3).

Allopurinol should be used in pregnancy only where there is no safer alternative and when the disease itself carries risks for

the mother or child.

Breast-feeding

Allopurinol and its metabolite oxipurinol is excreted in the human breast milk.

Concentrations of 1.4mg/litre allopurinol and 53.7 mg/litre oxipurinol have been demonstrated in breast milk from

woman taking allopurinol 300 mg/day. However, there are no data concerning the effects of allopurinol or its

metabolites on the breast-fed baby.

Allopurinol during breast-feeding is not recommended.

4.7 Effects on ability to drive and use machines

Since adverse reactions such as vertigo, somnolence and ataxia have been reported in patients receiving allopurinol,

patients should exercise caution before driving, using machinery or participating in dangerous activities until they are

sure that allopurinol does not adversely affect performance.

4.8 Undesirable effects

For this product there is no modern clinical documentation which can be used as support for determining the frequency of

undesirable effects. Undesirable effects may vary in their incidence depending on the dose received and also when given in

combination with other therapeutic agents.

The frequency categories assigned to the adverse drug reactions below are estimates: for most reactions, suitable data for

calculating incidence are not available. Adverse drug reactions identified through post-marketing surveillance were

considered to be rare or very rare. The following convention has been used for the classification of frequency:

Very common (

1/10);

Common (

1/100 to <1/10);

Uncommon (

1/1,000 to <1/100);

Rare (

1/10,000 to <1/1,000);

Very rare (<1/10,000);

Not known (cannot be estimated from the available data).

The incidence of adverse reactions is higher in the presence of renal and/or hepatic disorder.

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Infections and infestations

Very rare: furunculosis.

Blood and lymphatic system disorders

Very rare: agranulocytosis, thrombocytopenia, aplastic anaemia, granulocytosis, leukopenia, leukocytosis, eosinophilia

and pure red cell aplasia

Very rare reports have been received of thrombocytopenia, agranulocytosis and aplastic anaemia, particularly in individuals

with impaired renal and/or hepatic function, reinforcing the need for particular care in this group of patients.

Immune system disorders

Uncommon: hypersensitivity reactions.

Very rare: angioimmunoblastic lymphadenopathy.

Serious hypersensitivity reactions, including skin reactions associated with exfoliation, fever, lymphadenopathy, arthralgia

and/or eosinophilia including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis occur rarely (see Skin and

subcutaneous tissue disorders). Associated vasculitis and tissue response may be manifested in various ways including

hepatitis, renal impairment, acute cholangitis, xanthine stones and very rarely, seizures. Very rarely acute anaphylactic

shock has been reported. If such reactions do occur, it may be at any time during treatment, allopurinol should be

withdrawn immediately and permanently.

Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions. When generalised hypersensitivity

reactions have occurred, renal and/or hepatic disorder has usually been present particularly when the outcome has been

fatal.

Angioimmunoblastic lymphadenopathy has been described very rarely following biopsy of a generalised

lymphadenopathy. It appears to be reversible on withdrawal of allopurinol.

A delayed multi-organ hypersensitivity disorder (known as hypersensitivity syndrome or DRESS) with fever, rashes,

vasculitis, lymphadenopathy, pseudo lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly, abnormal liver

function tests and vanishing bile duct syndrome (destruction and disappearance of the intrahepatic bile ducts) occurring in

various combinations. Other organs may also be affected (e.g. liver, lungs, kidneys, pancreas, myocardium, and colon). If

such reactions do occur, it may be at any time during treatment, allopurinol should be withdrawn immediately and

permanently.

When generalised hypersensitivity reactions have occurred, renal and/or hepatic disorder has usually been present

particularly when the outcome has been fatal.

Metabolism and nutrition disorders

Very rare: diabetes mellitus, hyperlipidaemia.

Psychiatric disorders

Very rare: depression.

Nervous system disorders

Very rare: coma, paralysis, ataxia, neuropathy, paraesthesiae, somnolence, headache, taste perversion.

Eye disorders

Very rare: cataract, visual disorder, macular changes.

Ear and labyrinth disorders

Very rare: vertigo.

Cardiac disorders

Very rare: angina, bradycardia.

Vascular disorders

Very rare: hypertension.

Gastrointestinal disorders

Uncommon: vomiting, nausea, diarrhoea

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Very rare: recurrent haematemesis, steatorrhoea, stomatitis, changed bowel habit.

In early clinical studies, nausea and vomiting were reported. To increase gastrointestinal tolerability, allopurinol should

be taken after a meal.

Hepatobiliary disorders

Uncommon: asymptomatic increases in liver function tests.

Rare: hepatitis (including hepatic necrosis and granulomatous hepatitis).

Hepatic dysfunction has been reported without overt evidence of more generalised hypersensitivity.

Skin and subcutaneous tissue disorders

Common: rash.

Rare: Steven-Johnson Syndrome / Toxic Epidermal Necrolysis

Very rare: angioedema, fixed drug eruption, alopecia, discoloured hair.

Skin reactions are the most common reactions and may occur at any time during treatment. They may be pruritic,

maculopapular, sometimes scaly, sometimes purpuric and rarely exfoliative. Allopurinol should be withdrawn immediately

should such reactions occur. After recovery from mild reactions, allopurinol may, if desired, be re-introduced at a small

dose (e.g. 50 mg/day) and gradually increased. If the rash recurs, allopurinol should be permanently withdrawn as more

severe hypersensitivity may occur (see Immune system disorders).

The clinical diagnosis of SJS/TEN remains the basis for decision making. If such reactions occur at any time during

treatment, allopurinol should be withdrawn immediately and permanently.

Angioedema has been reported to occur with and without signs and symptoms of a more generalised hypersensitivity

reaction.

Musculoskeletal and connective tissue disorders

Very rare: muscle pain

Renal and urinary disorders

Rare: Urolithiasis

Very rare: haematuria, uraemia.

Reproductive system and breast disorders

Very rare: male infertility, erectile dysfunction, gynaecomastia.

General disorders and administration site conditions

Very rare: oedema, general malaise, asthenia, fever.

Fever has been reported to occur with and without signs and symptoms of a more generalised allopurinol hypersensitivity

reaction (see Immune system disorders).

Investigations

Common: blood thyroid stimulating hormone increased.

The occurrence of increased thyroid stimulating hormone (TSH) in the relevant studies did not report any impact on

free T4 levels or had TSH levels indicative of subclinical hypothyroidism.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Ingestion of up to 22.5 g allopurinol without adverse effect has been reported. Symptoms and signs including nausea,

vomiting, diarrhoea and dizziness have been reported in a patient who ingested 20 g allopurinol. Recovery followed

general supportive measures. Massive absorption of allopurinol may lead to considerable inhibition of xanthine oxidase

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activity, which should have no untoward effects unless affecting concomitant medication, especially with 6-

mercaptopurine and/or azathioprine. Adequate hydration to maintain optimum diuresis facilitates excretion of

allopurinol and its metabolites. If considered necessary haemodialysis may be used.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Preparations inhibiting uric acid production. ATC Code: M04A A01

Mechanism of action

Allopurinol is a xanthine-oxidase inhibitor. Allopurinol and its main metabolite oxipurinol lower the level of uric acid

in plasma and urine by inhibition of xanthine oxidase, the enzyme catalyzing the oxidation of hypoxanthine to xanthine

and xanthine to uric acid. In addition to the inhibition of purine catabolism in some but not all hyperuricaemic patients,

de novo purine biosynthesis is depressed via feedback inhibition of hypoxanthine-guanine phosphoribosyltransferase.

Other metabolites of allopurinol include allopurinol-riboside and oxipurinol-7 riboside.

5.2 Pharmacokinetic properties

Absorption

Allopurinol is active when given orally and is rapidly absorbed from the upper gastrointestinal tract. Studies have detected

allopurinol in the blood 30-60 minutes after dosing. Estimates of bioavailability vary from 67% to 90%. Peak plasma levels

of allopurinol generally occur approximately 1.5 hours after oral administration of allopurinol, but fall rapidly and are

barely detectable after 6 hours. Peak levels of oxipurinol generally occur after 3-5 hours after oral administration of

allopurinol and are much more sustained.

Distribution

Allopurinol is negligibly bound by plasma proteins and therefore variations in protein binding are not thought to

significantly alter clearance. The apparent volume of distribution of allopurinol is approximately 1.6 litre/kg, which

suggests relatively extensive uptake by tissues. Tissue concentrations of allopurinol have not been reported in humans, but

it is likely that allopurinol and oxipurinol will be present in the highest concentrations in the liver and intestinal mucosa

where xanthine oxidase activity is high.

Oxipurinol is a less potent inhibitor of xanthine oxidase than allopurinol, but the plasma half-life of oxipurinol is far more

prolonged. Estimates range from 13 to 30 hours in man. Therefore effective inhibition of xanthine oxidase is maintained

over a 24 hour period with a single daily dose of allopurinol. Patients with normal renal function will gradually accumulate

oxipurinol until a steady-state plasma oxipurinol concentration is reached. Such patients, taking 300 mg of allopurinol per

day will generally have plasma oxipurinol concentrations of 5-10 mg/litre.

Biotransformation

Approximately 20% of the ingested allopurinol is excreted in the faeces in 48

72 hours. Elimination of allopurinol is

mainly by metabolic conversion to oxipurinol by xanthine oxidase and aldehyde oxidase, with less than 10% of the

unchanged drug excreted in the urine. Allopurinol has a plasma half-life of about 1 to 2 hours.

Elimination

Oxipurinol is eliminated unchanged in the urine but has a long elimination half-life because it undergoes tubular

reabsorption. Reported values for the elimination half-life range from 13.6 hours to 29 hours. The large discrepancies in

these values may be accounted for by variations in study design and/or creatinine clearance in the patients.

Pharmacokinetics in patients with renal impairment.

Allopurinol and oxipurinol clearance is greatly reduced in patients with poor renal function resulting in higher plasma

levels in chronic therapy. Patients with renal impairment, where creatinine clearance values were between 10 and 20

ml/min, showed plasma oxipurinol concentrations of approximately 30mg/litre after prolonged treatment with 300 mg

allopurinol per day. This is approximately the concentration which would be achieved by doses of 600 mg/day in those

with normal renal function. A reduction in the dose of allopurinol is therefore required in patients with renal impairment.

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Pharmacokinetics in elderly patients.

The kinetics of the drug are not likely to be altered other than due to deterioration in renal function (see Pharmocokinetics

in patients with renal impairment).

5.3 Preclinical safety data

Teratogenicity

One study in mice receiving intraperitoneal doses of 50 or 100 mg/kg on days 10 or 13 of gestation resulted in foetal

abnormalities, however in a similar study in rats at 120 mg/kg on day 12 of gestation no abnormalities were observed.

Extensive studies of high oral doses of allopurinol in mice up to 100 mg/kg/day, rats up to 200 mg/kg/day and rabbits

up to 150 mg/kg/day during days 8 to 16 of gestation produced no teratogenic effects.

An in vitro study using foetal mouse salivary glands in culture to detect embryotoxicity indicated that allopurinol

would not be expected to cause embryotoxicity without also causing maternal toxicity.

In animal experiments, long-term application of high doses of allopurinol resulted in formation of xanthin precipitates

(urolithiasis), which led to morphological changes in uriniferous organs

There are no additional non-clinical data considered relevant to clinical safety beyond those included in other sections

of this SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose Monohydrate

Silica colloidal anhydrous

Maize Starch

Powdered cellulose

Sodium Starch Glycolate (Type A)

Sodium laurilsulfate

Povidone K30

Magnesium Stearate (E470b)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Transparent PVC/PVdC/Aluminium blister:

This medicinal product does not require any special storage conditions.

HDPE Bottles:

Store in the original packaging.

Keep the bottle tightly closed in order to protect from light.

6.5 Nature and contents of container

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Transparent PVC/PVdC/Aluminium blister. The pack sizes available are:

20, 28, 30, 50, 60, 90, 98, 100, 105 and 500 tablets and Hospital Pack of 50

HDPE Bottles.

The pack sizes available are :

30 Tablets in 35 ml Bottle or 100 Tablets in 100 ml Bottle

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Teva Pharma B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

8 MARKETING AUTHORISATION NUMBER

PA0749/099/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 10th September 2010

Date of last renewal: 30th August 2013

10 DATE OF REVISION OF THE TEXT

May 2018

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