Hanixol 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

6-mercaptopurine

Available from:

Primecrown 2010 Limited

ATC code:

L01BB; L01BB02

INN (International Name):

6-mercaptopurine

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

Purine analogues; mercaptopurine

Authorization date:

2020-07-31

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HANIXOL
 50 MG TABLETS
6-mercaptopurine
WHAT IS IN THIS LEAFLET
1. What Hanixol 50 mg Tablets are and what they are used for
2. What you need to know before you take Hanixol 50 mg Tablets
3. How to take Hanixol 50 mg Tablets
4. Possible side effects
5. How to store Hanixol 50 mg Tablets
6. Contents of the pack and other information
1.
WHAT HANIXOL 50 MG TABLETS ARE AND WHAT THEY ARE USED FOR
Hanixol 50 mg Tablets contain a medicine called 6-mercaptopurine.
This belongs to a group of medicines called cytotoxics (also called
chemotherapy). Hanixol 50 mg Tablets are used to treat cancer of the
blood
(leukaemia) in adults, adolescents and children.
It works by reducing the number of new blood cells your body makes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HANIXOL 50 MG TABLETS
DO NOT TAKE HANIXOL 50 MG TABLETS:
If you are allergic to 6-mercaptopurine or any of the other
ingredients of this
medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Hanixol 50 mg Tablets:
-
If you have recently received, or are due to receive, a vaccination
(vaccine). If you take Hanixol, 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 Hanixol
-
If you have a genetic disease called TPMT (thiopurine
methyltransferase)
deficiency.
-
If you are allergic to a medicine called azathioprine (also used to
treat
cancer).
-
If you have reduced liver function or liver damage.
-
If you have a genetic disease called Lesch-Nyhan syndrome.
-
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 are pregnant or breast-feeding. If you are male, please note
the
risk of teratogenic effect.
-
If you are taking at the same time allopurinol.
-
If you are taking at the sa

Summary of Product characteristics

Health Products Regulatory Authority
31 July 2020
CRN009SCS
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hanixol 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of 6-mercaptopurine.
Excipient with known effect
- Lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
_Product imported from the UK_
Round 6 mm yellowish tablets, scored on one side and plain on the
other.
4 CLINICAL PARTICULARS
As per PA22756/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22756/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Lactose anhydrous
Maize starch
Starch, pregelatinized
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.
After first opening the bottle: 7 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from light.
Health Products Regulatory Authority
31 July 2020
CRN009SCS
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Type III 20 ml amber glass bottle containing 25 tablets with a
polypropylene child-proof cap and silica gel desiccant.
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 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/072/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 31
st
July 2020
10 DATE OF REVISION OF THE TEXT