Puri-Nethol 50 mg Tablets

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Mercaptopurine monohydrate

Prieinama:

IMED Healthcare Ltd.

ATC kodas:

L01BB02

INN (Tarptautinis Pavadinimas):

Mercaptopurine monohydrate

Dozė:

50 milligram(s)

Vaisto forma:

Tablet

Gydymo sritis:

mercaptopurine

Leidimo data:

2019-11-01

Pakuotės lapelis

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 been vac

Prekės savybės

Health Products Regulatory Authority
12 April 2022
CRN00CWLT
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 mercaptopurine monohydrate
Excipient with known effect: lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from The Netherlands: _
Pale yellow, round tablets, biconvex, scored on one side, engraved 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
Hydrolysed maize starch
Stearic acid
Magnesium stearate
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
12 April 2022
CRN00CWLT
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Store in the original bottle and carton in order to protect from
light.
Keep the bottle tightly closed in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle with cap containing 25 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
SAFE HANDLING
It is recommended that mercaptopurine monohydrate tablets should be
handled following the prevailing local
recommendations and/or regulations for the handling and disposal of
cytotoxic agents.
DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATIO