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ZYLORIC 100MG TABLETS

Active substance(s): ALLOPURINOL

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ASPEN Artwork Panel

00000000000000

AW Version:
1

Package Leaflet: Information for the User

Zyloric® 100 mg and 300 mg tablets

New Item Code:
17-2237

allopurinol

Replacement:
12000000109355

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.
• you have thyroid problems.
Take special care with Zyloric:
• Serious skin rashes (Hypersensitivity syndrome, StevensJohnson syndrome, toxic epidermal necrolysis) 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 influenzalike 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, Thai or Korean origin. Chronic kidney disease
may increase the risk in these patients additionally. If you
develop a rash or these skin symptoms, stop taking
allopurinol and contact your doctor immediately.
• If you have cancer or Lesch-Nyhan syndrome the amount
of uric acid may increase in your urine. To prevent this, you
need to assure to drink sufficiently to dilute your urine.

Market:
United Kingdom - Malta

Children
Use in children is rarely indicated, except in some types of
cancer (especially leukaemia) and certain enzyme disorders
such as Lesch-Nyhan syndrome.

Product Name:
Zyloric

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.

BLACK

Manufacturing Site:
ABO
Drawing Ref. Number:
BE12_170X297
Drawing Version:
04
Originated by:
David Leiva

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.

Originated at:
APTL

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.

Originated on:
13 Dec 2017
Amended on:
N/A

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines.
This is because Zyloric can affect the way some medicines work.
Also some other medicines can affect the way Zyloric works.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are
pregnant, might become pregnant or are breast-feeding.
Allopurinol is excreted in the human breast milk. Allopurinol
during breastfeeding is not recommended.
Driving and using machines
You may feel drowsy, giddy or have problems with your
coordination. If this happens, do not drive or use any tools
or machines.
Zyloric contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Zyloric
Always take Zyloric exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
Take the tablet after food and swallow it with a glass of water.
The recommended dose ranges from 100 to 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.

160 mm Measuring Bar

Number of Colours:
1

ASPEN Artwork Panel • May 2013 • Version 5

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

• In case you have kidney stones, the kidney stones will
become smaller and may enter your urinary tract.

PHARMA CODE N° xxx

PHARMA CODE N° xxx

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.

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1 of 2

Malta
Website: www.‌‌medicinesauthority.gov.‌‌mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.

4. Possible side effects

PHARMA CODE N° xxx

Hypersensitivity
Uncommon (may affect less than 1 in 100 people)
If you have a hypersensitivity (allergic) reaction, stop taking
Zyloric and see a doctor straight way. The signs may include:
• flaking skin, boils or sore lips and mouth
• very rarely signs may include sudden wheeziness,
fluttering or tightness in the chest and collapse.
Rare (may affect less than 1 in 1000 people)
• fever and chills, headache, aching muscles (flu-like
symptoms) and generally feeling unwell
• 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).
• bleeding in the lips, eyes, mouth, nose or genitals.
• any changes to your skin, for example; ulcers of the
mouth, throat, nose, genitals, conjunctivitis (red and
swollen eyes), widespread blisters or peeling.
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
• increased level of thyroid stimulating hormone in
the blood.
Uncommon (may affect up to 1 in 100 people):
• feeling sick (nausea) or being sick (vomiting)
• abnormal liver tests.
Rare (may affect up to 1 in 1000 people)
• liver problems such as liver inflammation
Very rare (may affect up to 1 in 10,000 people)
• occasionally Zyloric 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.

New Item Code:
17-2237
Replacement:
12000000109355
Market:
United Kingdom - Malta
Product Name:
Zyloric

5. How to store Zyloric

Number of Colours:
1

• Keep this medicine out of the sight and reach of children.
• Do not use Zyloric after the expiry date which is stated on
the carton after ‘EXP’. The expiry date refers to the last
day of that month.
• Keep your tablets in the original packaging.
• Do not store above 25°C.
• 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.

BLACK

Manufacturing Site:
ABO
Drawing Ref. Number:
BE12_170X297

6. Contents of the pack and other information
What Zyloric contains
• The active substance is allopurinol.
• The other ingredients are lactose, maize starch, povidone,
magnesium stearate and purified water.

Drawing Version:
04
Originated by:
David Leiva

What Zyloric looks like and contents of the pack
Zyloric tablets contain 100 or 300 mg allopurinol. Each
100 mg tablet is white to off-white, round and marked with
a score line, Z1. Each 300 mg tablet is white to
off-white, round and marked with a score line, Z3.
• Zyloric 100 mg tablets come in 4 strips of 25 tablets.
• Zyloric 300 mg tablets come in 2 strips of 14 tablets.

Originated at:
APTL
Originated on:
13 Dec 2017

Marketing Authorisation Holder and Manufacturer

Amended on:
N/A

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus, Dublin 24,
Ireland Service-Tel: +800 00404142
Manufacturer
Aspen Bad Oldesloe GmbH,
Industriestrasse 32-36,
D 23843
Bad Oldesloe Germany
Medical Information Enquiries
For any Medical Information enquiries about this product,
please contact:
24 Hour Helpline +441748 823 391 (free phone UK only
0800 0087 392)
Malta
24 Hour Helpline +356 21497982
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name: Zyloric 100 mg tablets /
Zyloric 300 mg tablets
Reference number: PL 39699/0001 / PL 39699/0002
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in: December 2017.

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160 mm Measuring Bar

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.

AW Version:
1

ASPEN Artwork Panel • May 2013 • Version 5

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.

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:
UK
Yellow Card Scheme, Website:
www.‌‌mhra.gov.‌‌uk/yellowcard.

Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side effects
may happen with this medicine:

ASPEN Artwork Panel

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.

PHARMA CODE N° xxx

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.

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