Puri-Nethol 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mercaptopurine monohydrate

Available from:

PCO Manufacturing Ltd.

ATC code:

L01BB02

INN (International Name):

Mercaptopurine monohydrate

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

mercaptopurine

Authorization date:

2020-05-15

Patient Information leaflet

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
PURI-NETHOL
® 50 MG TABLETS
mercaptopurine monohydrate
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, 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Puri-Nethol is and what it is used for
2.
What you need to know before you take Puri-Nethol
3.
How to take Puri-Nethol
4.
Possible side effects
5.
How to store Puri-Nethol
6.
Contents of the pack and other information
1.
WHAT PURI-NETHOL IS AND WHAT IT IS USED FOR
Puri-Nethol contains the active substance mercaptopurine monohydrate.
Mercaptopurine
monohydrate belongs to a group of medicines called cytotoxics (also
called chemotherapy) and
works by reducing the number of new blood cells your body makes.
Puri-Nethol is used to treat cancer of the blood (leukaemia) in
adults, adolescents and children.
This is a fast-growing disease which increases the number of new white
blood cells. These new
white blood cells are immature (not fully formed) and unable to grow
and work properly. They
therefore cannot fight infections and may cause bleeding. Ask your
doctor if you would like
more explanation about this disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PURI-NETHOL
DO NOT TAKE PURI-NETHOL:
If you are allergic to Puri-Nethol (mercaptopurine monohydrate) or any
of the other ingredients
of this medicine (see section 6).
Do not get vaccinated with yellow fever vaccine whilst you are taking
Puri-Nethol because it
may be fatal.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before taking Puri-Nethol
if:
•
you have

Summary of Product characteristics

Health Products Regulatory Authority
16 March 2022
CRN00CTCW
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Puri-Nethol 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active substance mercaptopurine
monohydrate.
Excipients with known effect:
Each tablet contains the excipient lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
_Product imported from Italy_
Pale yellow, round tablets, biconvex, scored on one side, engraved
'GX' and 'EX2' or 'PT' and '50' on either side of the scoreline
and plain on the other side.
The scoreline is only to facilitate breaking of the tablets for ease
of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA1691/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1691/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose monohydrate
Maize starch
Modified maize starch
Stearic acid
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original container in order to protect from light.
Keep the container tightly closed in order to protect from moisture.
Health Products Regulatory Authority
16 March 2022
CRN00CTCW
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle containing 25 tablets with a child resistant
closure with a heat seal liner.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
SAFE HANDLING
It is recommended that 6‑mercaptopurine tablets should be handled
following the prevailing local recommendations and/or
regulations for the handling and disposal of cytotoxic agents.
DISPOSAL
Any unused product or waste material should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park