Zyloric

Main information

  • Trade name:
  • Zyloric Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Zyloric Tablet
    Malaysia
  • Language:
  • English

Other information

Status

  • Source:
  • NPRA - National Pharmaceutical Regulatory Agency - Bahagian Regulatori Farmasi Negara
  • Authorization number:
  • MAL19973571, MAL19972499
  • Last update:
  • 28-05-2018

Patient Information leaflet

Consumer Medication Information Leaflet (RiMUP)

1

ZYLORIC TABLET

Allopurinol (100mg, 300mg)

What is in the leaflet

What Zyloric is used for

How Zyloric works

Before you use Zyloric

How to use Zyloric

While you are using it

Side effects

Storage and Disposal of

Zyloric

Product Description

Manufacturer and Product

Registration Holder

Date of Revision

What Zyloric is used for

Zyloric is used to treat the

following conditions:

high levels of uric acid in

the blood (hyperuricemia)

associated with gout or

when you are having

treatment for cancer.

Kidney stones formation

or certain other types of

kidney problems.

How Zyloric works

Zyloric contains Allopurinol as

the active ingredient. Allopurinol

works by reducing the amount of

uric acid in the body.

Ask your doctor if you have

any questions about why this

medicine has been prescribed

for you. Your doctor may have

prescribed it for another reason.

Before you use Zyloric

When you must not use it

Do not take this medicine if

you have an allergy to:

Allopurinol

any of the other ingredients

listed at the end of this

leaflet

serum urate concentration is

increased without deposition

signs of uric acid

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering. If it has

expired or is damaged, return it to

your pharmacist for disposal.

If you are not sure whether you

should start taking this

medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

conditions:

Kidney disease

Liver disease

Heart problems or high

blood pressure and you are

taking diuretics and/or a

medicine called ACE-

inhibitors

Serious skin rashes

(Stevens-Johnson syndrome

(SJS), toxic epidermal

necrolysis (TEN),

hypersensitivity syndrome

called Drug Rash with

Eosinophilia and Systemic

Symptoms (DRESS)).

sugar intolerance

acute gout attack

cancer

certain enzyme disorders

Tell your doctor if you are

pregnant, plan to become

pregnant or breastfeeding. Your

doctor will discuss with you the

risks and benefits involved.

If you have not told your

doctor any of the above, talk to

he/she before taking Zyloric.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that

you get without a prescription

from your pharmacy,

supermarket or health food shop.

Some medicines and Zyloric

may interfere with each other.

These include:

medicine used for

chemotherapy (e.g. 6-

mercaptopurine,

azathioprine and

Cyclophosphamide)

vidarabine, used to treat

chickenpox

medicines used to reduce uric

acid levels (e.g. Probenecid)

aspirin

medicine used to treat

diabetes (e.g.

Chlorpropamide)

medicines used to thin the

blood (Anticoagulants e.g.

Warfarin)

medicine used to treat fits

(epilepsy) (e.g. Phenytoin)

theophylline, used for

breathing problems

medicines used to treat

bacterial infections

(antibiotics e.g. Ampicillin

and Amoxicillin)

cyclosporine is a medicine

used to suppress the

immune system following

organ transplant

didanosine, used to treat

HIV infection

These medicines may be

affected by Zyloric or may

affect how well it works. You

may need different amounts of

your medicines, or you may

need to take different

medicines.

If you not sure whether you are

taking any of these medicines,

check with your doctor or

pharmacist.

Your doctor and pharmacist

have more information on

medicines to be careful with or

avoid while taking this

medicine.

How to use Zyloric

Follow all directions given to

you by your doctor and

pharmacist carefully.

These directions may differ

from the information contained

in this leaflet.

If you do not understand the

instructions on the pack, ask

your doctor or pharmacist for

help.

Consumer Medication Information Leaflet (RiMUP)

2

How much to use

The usual starting dose for

adults is 100mg daily. The

following dosage schedules are

suggested:

100 to 200mg daily in

mild conditions

300 to 600mg daily in

moderately severe

conditions

700 to 900mg daily in

severe conditions

Children under 15 years

10 – 20 mg/kg body weight

daily up to a maximum of

400mg daily.

Lower doses are used in the

elderly or if you have kidney

impairment, liver impairment.

When to use it

Take Zyloric after meal.

How long to use it

Continue taking Zyloric for as

long as your doctor

recommends.

If you forget to use it

Take your dose as soon as you

remember, and continue to take

it as you would normally.

If it is almost time for your

next dose, skip the dose you

missed and take your next dose

when you are meant to.

Do not take a double dose to

make up for the dose that you

missed. This may increase the

chance of you getting an

unwanted side effect.

If you use too much

(overdose)

Immediately telephone your

doctor for advice or go to

Emergency Department at your

nearest hospital if you think

that you or anyone else may

have taken too much Zyloric.

Do this even if there are no

signs of discomfort or

poisoning syndrome including

nausea, vomiting, diarrhoea

and dizziness.

You may need urgent medical

attention.

While you are using it

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking Zyloric.

Immediately stop taking

Zyloric and check with your

doctor if a skin rash or other

allergic reaction occurs.

If you are about to start taking

any new medicine tell your

doctor and pharmacist that you

are taking Zyloric.

Things you must not do

Do not stop taking your

medicine or lower the dosage

without checking with your

doctor.

Do not take Zyloric to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have

the same condition as you.

Things to be careful of

Zyloric may make some people

feel drowsy, giddy or have

problems with coordination, do

not driving or operating

machinery if you are affected.

Side effects

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not.

The most common side effect is

serious skin rash.

Stop taking allopurinol and contact

your doctor immediately, if you

experience the following side

effects:

cancer in lymphatic

system that cause fast-

growing of white blood

cells

allergic reaction: itchy or

flaky skin rash, bruising or

peeling off of the skin,

fever, swollen lymph

glands, joint pain, change

in blood composition.

Related to inflammation of

blood vessel and tissue:

enlargement of both liver

and spleen, inflammation

of the liver (hepatitis),

kidney failure, seizure.

If you have kidney and/or liver

problems, you may have an

increased chance of getting

side effects like:

lowered white blood cell

count

blood deficiency and

caused failure on bone

marrow development

low platelet count

The following side effects may

occur with this medicine:

boils, diabetes, high level

of fat in the blood

depression, coma,

paralysis, nerve disorders

including lack of muscle

control, pin and needles,

sleepiness, headache,

change in taste

cataract, visual impairment

dizziness, chest pain, slow

heart beat, high blood

pressure

vomiting, nausea,

vomiting blood, offensive

fatty diarrhoea, swollen

mouth, change in bowel

habits

abnormal in liver function

test

swelling of the subdermal

layers of skin

hair loss, changes in hair

colour

blood in urine, high level

of urea in blood

infertility in male,

difficulty maintain an

erection, enlargement of

breast in men

water retention, feeling or

being sick, tiredness.

Ask for the advice of your doctor

or pharmacist if you have any

concerns about the effects of

taking this medicine.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell. Other

side effects not listed above may

also occur in some people.

Consumer Medication Information Leaflet (RiMUP)

3

You may report any side

effects or adverse drug

reactions directly to the

National Centre for Adverse

Drug Monitoring by calling

Tel: 03-78835550, or visiting

the website npra.moh.gov.my

(Public → Reporting

Medicinal Problems / Side

Effects / AEFI / Vaccine

Safety).

Storage and Disposal of

Zyloric

Storage

Keep your medicine in its

original packaging until it is

time to take them.

If you take the tablets out of the

pack, they may not keep well.

Store below 30°C.

Do not store your medicine, or

any other medicine, in the

bathroom or near a sink.

Keep it where children cannot

reach it.

Disposal

If your doctor or pharmacist

tells you to stop taking this

medicine or it has passed its

expiry date, ask your

pharmacist what to do with any

medicine that is left over.

Product Description

What it looks like

Zyloric Tablet 100mg:

Round, white biconvex,

bisected tablets, debossed with

Z1 on one side.

Zyloric Tablet 300mg:

Round, white biconvex,

bisected tablets, debossed with

Z3 on one side.

Ingredients

Active ingredient:

Allopurinol

Inactive ingredients:

Povidone

Maize starch

Lactose monohydrate

Magnesium stearate

MAL number

Zyloric Tablet 100mg:

MAL19973571AZ

Zyloric Tablet 300mg:

MAL19972499AZ

Manufacturer

Aspen Port Elizabeth (Pty) Ltd

Corner of Fairclough and

Gibaud Road Korsten 6020,

Port Elizabeth, Republic of

South Africa.

Product Registration Holder

Aspen Medical Products

Malaysia Sdn Bhd

(1004761-W)

Unit 1302A, Level 13A,

Uptown 1, 1 Jalan SS21/58,

Damansara Uptown, 47400

Petaling Jaya, Selangor,

Malaysia.

Date of Revision

28/07/2017

Serial Number

BPFK(R4/1)09052017/00097

22-8-2018

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The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

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