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ALLOPURINOL TABLETS 300MG

Active substance(s): ALLOPURINOL

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

24-0414/5

Colours Used

Customer

Ennogen

Black

Description

Uricto 100/300 Leaflet

Keyline

Market

UK

Language

English

Size

160 x 310 mm

Min. Font Size

8.5 pt

Page No.

1 of 2

Version No.

6

Date

16-12-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

PACKAGE LEAFLET: INFORMATION FOR THE USER

Uricto 100mg and 300mg Tablets
[Allopurinol]
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 or nurse.
! 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 or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Uricto Tablets are and what they are
used for
2. What you need to know before you take Uricto
Tablets
3. How to take Uricto Tablets
4. Possible side effects
5. How to store Uricto Tablets
6. Contents of the pack and other information
1. WHAT URICTO TABLETS ARE AND WHAT
THEY ARE USED FOR
Uricto Tablets contain a medicine called allopurinol. It
works by slowing down the speed of certain chemical
reactions in your body.
Uricto Tablets are used:! To prevent gout. This is a disease where your
body produces too much of a substance called
'uric acid'. The uric acid builds up in your joints
and tendons and forms crystals. These cause an
inflammatory reaction. The inflammation causes
the skin around certain joints to become swollen,
tender and sore when only slightly touched.
Severe pain may also be felt on slight movement
of the joint
! To prevent other conditions where there is a build
up of uric acid in the body. This includes kidney
stones.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE URICTO TABLETS
Do not take Uricto Tablets if you:
! Are hypersensitive (allergic) to allopurinol or any
of the other ingredients of Uricto Tablets (listed in
section 6).
Warnings and precautions
Talk to your doctor, or pharmacist or nurse before
taking Uricto Tablets if you:
! Have liver or kidney problems. Your doctor may
give you a lower dose or ask you to take it less
often each day. You will also be monitored more
closely
! Have heart problems or high blood pressure
! Have been told by your doctor that you have an
intolerance to some sugars as this medicine
contains lactose
! Are currently having an attack of gout.
Serious skin rashes (hypersensitivity syndrome,
Stevens- Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of Uricto
Tablets.
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 Uricto
Tablets 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.
In case you have kidney stones, the kidney stones will
become smaller and may enter your urinary tract.
Other medicines and Uricto Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
In particular tell your doctor if you are taking any of
the following:
! Azathioprine (to treat rheumatoid arthritis and after
organ transplants)
! Ciclosporin (to treat psoriasis, rheumatoid arthritis
or after organ transplants)
! 6-mercaptopurine (used to treat some cancers
and bowel diseases)
! Cyclophosphamide, doxorubicin, bleomycin or
procarbazine (drugs used to treat leukaemias and
some cancers)
! 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)
! Indigestion remedies (should not be taken within 3
hours of taking Uricto)
! Vidarabine, used to treat herpes or chickenpox.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice if you are
pregnant, planning on becoming pregnant or are
breastfeeding. Please check with your doctor if you
are taking these tablets and want to breastfeed your
baby.
Driving and using machines
These tablets can cause some people to feel drowsy,
giddy or have problems with co-ordination. If you are
affected do not drive or operate machinery as your
alertness may be impaired.
Uricto Tablets contain lactose
Uricto Tablets contain 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 URICTO TABLETS
Always take Uricto Tablets exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are unsure.
Swallow the tablet with a drink of water
Take with or just after food.
Adults:
The usual starting dose is 100 to 200mg each day.
Your doctor will monitor the uric acid levels in your
blood or urine at regular intervals and will adjust the
dose to suit you as necessary. The maintenance dose
is usually 200mg to 600mg daily. The maximum single
dose is 300mg. It is unlikely that you will be
prescribed more than 900mg per day.

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

24-0414/5

Colours Used

Customer

Ennogen

Black

Description

Uricto 100/300 Leaflet

Keyline

Market

UK

Language

English

Size

160 x 310 mm

Min. Font Size

8.5 pt

Page No.

2 of 2

Version No.

6

Date

16-12-15

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Children:
The dose in children is based on 10mg to 20mg/kg of
body weight/day. Your doctor will prescribe the correct
dosage. Use in children is mainly for certain types of
cancers and enzyme disorders.
Elderly patients:
Your doctor will prescribe the lowest dose of Uricto
Tablets that best controls your symptoms.

Quality Control (QC)

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Patients with severe kidney problems:
You may be asked to take less than 100mg a day, or
you may be asked to take 100mg at a longer interval
than each day. The exact dose will be prescribed by
your doctor.
If you are receiving kidney dialysis two or three times
a week, your doctor may prescribe a dose of 300 or
400mg which will be to take straight away after your
dialysis.
Patients with liver problems:
A reduced dose will be prescribed by your doctor.
If you take more Uricto Tablets than you should
If you take too many tablets by mistake contact your
nearest hospital casualty department or tell your
doctor immediately. Take your tablet pack with you.

Production

blood in the urine, a change in bowel habit
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) or slow pulse.
lack of voluntary coordination of muscle
movements (ataxia).
sensation of tingling, prickling or burning
skin (paraesthesia).

Other (frequency cannot be estimated from the data):
! worsening of gout, dizziness, diarrhoea, stomach
pain, kidney stones, 'wet dreams'.
Many of the above mentioned side effects should
disappear when treatment is stopped.
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
By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE URICTO TABLETS

If you stop taking Uricto Tablets
Do not stop taking Uricto Tablets without consulting
your doctor.
If you forget to take Uricto Tablets
If you have forgotten to take a dose, take it as soon as
you remember it. However, if it is almost time to take
your next dose, skip the missed dose. Do not take a
double dose. If you have trouble remembering to take
the tablets, tell your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everyone gets them.
If you experience any of the following, stop your
tablets and tell your doctor immediately:
! allergic reactions:
?
itchy or flaky skin rash
?
swelling of the face, lips, tongue or throat, or
difficulty breathing or swallowing
! blood abnormalities:
?
changes in the amounts of blood cells, causing
increased bruising, nosebleeds, sore throats or
infections
! serious hypersensitivity reactions:
?
fever, enlargement of lymph nodes, joint
pain, increase in white cells, swollen blood
vessels, inflammation of the liver (hepatitis),
jaundice (yellowing of the skin or whites of the
eyes), kidney damage (blood in the urine) or
fits
?
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.
Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:
Uncommon (occurs in less than 1 in 100 users):
! feeling or being sick (occasionally with blood)
! changes in liver function tests.
Very rare (occurs in less than 1 in 10,000 users):
! Uricto Tablets may affect the Lymph Nodes
! weakness, 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 or discolouration
! cataracts, changes in vision

Check the expiry date printed on the label or side of
the box. Do not use after the expiry date stated on the
label.
Blister packs: Do not store above 25°C. Keep the
blister in the outer carton to protect from light and
moisture.
Securitainers: Store in a cool, dry place and protect
from light.
In case of any visible signs of deterioration, you
should discard the package.
Medicines should not be disposed of via waste water
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures help to protect the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Uricto Tablets contain:
Uricto Tablets 100mg and 300mg contain the active
substance Allopurinol100mg and 300mg respectively
in each tablet.
The other ingredients are: lactose, maize starch,
povidone, magnesium stearate and sodium starch
glycollate.
What Uricto Tablets look like and contents of the
pack
Uricto Tablets 100mg are white, circular biconvex,
uncoated tablets, with A1 embossed on one side.
Diameter: 9.5mm.
Uricto Tablets 300mg are white, circular, biconvex,
uncoated tablets, with ‘A’ & ‘2’ debossed on either side
of score line on one side and plain on other side.
Diameter: 11.00mm.
Uricto Tablets 100mg are supplied in packs of 28,
30, 56, 60, 84, 90 or 250 tablets.
Uricto Tablets 300mg are packed into packs of 28,
30, 56, 60, 84, 90 or 250 tablets.
Marketing Authorisation Holder and Manufacturer
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last revised in December 2015.

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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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