Puri-Nethol 50 mg Tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

6-mercaptopurine

제공처:

Primecrown 2010 Limited

ATC 코드:

L01BB; L01BB02

INN (국제 이름):

6-mercaptopurine

복용량:

50 milligram(s)

약제 형태:

Tablet

치료 영역:

Purine analogues; mercaptopurine

승인 날짜:

2020-07-24

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
PURI-NETHOL
 50 MG TABLETS
6-mercaptopurine
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 6-mercaptopurine. 6-
mercaptopurine 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PURI-NETHOL
DO NOT TAKE PURI-NETHOL:
If you are allergic to Puri-Nethol (6-mercaptopurine) or any of the
other
ingredients of this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Puri-Nethol:
•
If you have recently received, or are due to receive, a vaccination
(vaccine). If you take Puri-Nethol, you should not have a live
organism
vaccine (for example; flu vaccine, measles vaccine, BCG vaccine, etc.)
until advised it is safe to do so by your doctor. This is because some
vaccines may give you an infection if you receive them while you are
taking Puri-Nethol
•
If you have reduced liver function or liver damage
•
If you have a genetic condition called TPMT (thiopurine
methyltransferase) deficiency
•
If you have an allergy to a medicine called azathioprine (also used to
treat cancer)
•
If you have a kidney problem
•
Tell your doctor whether you have, or have not, had chicken pox,
shingles or hepatitis B (a liver disease caused by a virus)
•
If you have a genetic condition called Lesch-Nyhan Syndrome
If you are receiving immunosuppressive therapy, taking Puri-Nethol
could put
you at greater risk of:
•
tumours, including skin cancer. Therefore, when taking Puri-Nethol,
avoid
excessive exposure to sunlight, wear p

제품 특성 요약

Health Products Regulatory Authority
28 July 2020
CRN009SCV
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 6-mercaptopurine.
Excipient with known effect
Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
_Product imported from the UK_
Round pale yellow tablets marked with GX/EX2 on either side of the
scoreline on one side and plain on the other.
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
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 is 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
28 July 2020
CRN009SCV
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Amber glass bottle with a child resistant high density
polyethylene/polypropylene closure with induction heat seal liners
(IHS).
Pack size: 25 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
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
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex
UB5 5QS
United Kingdom
8 P