Hanixol 50 mg Tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Mercaptopurine

Предлага се от:

Fontus Health Limited

АТС код:

L01BB; L01BB02

INN (Международно Name):

Mercaptopurine

дозиране:

50 milligram(s)

Лекарствена форма:

Tablet

Терапевтична област:

Purine analogues; mercaptopurine

Статус Оторизация:

Not marketed

Дата Оторизация:

2019-08-19

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
HANIXOL 50 MG TABLETS
6-mercaptopurine
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 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
methyltransfera

Данни за продукта

Health Products Regulatory Authority
16 April 2020
CRN009Q75
Page 1 of 10
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.
Excipients with known effect:
-Lactose anhydrous: 59 mg per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Round 7.4 mm yellowish tablet, scored
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hanixol 50 mg tablets is indicated for the treatment of APL (acute
promyelocytic leukaemia) and AML M3 (acute myeloid
leukaemia M3) in adults, adolescents and children.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
6-mercaptopurine treatment should be initiated and supervised by a
doctor or other healthcare professional experienced in
the management of patients with acute leukemia.
6-mercaptopurine may be taken with food or on an empty stomach, but
patients should standardise the method of
administration. 6-mercaptopurine should not be taken with milk or
dairy products (see section 4.5). 6-mercaptopurine should
be taken at least 1 hour before or 2 hours after ingestion of milk or
dairy products.
Populations
ADULTS AND CHILDREN
For adults and children, the usual dose is 2.5 mg/kg bodyweight per
day, or 50 to 75 mg/m
2
body surface area per day, but the
dose and duration of administration depend on the nature and dosage of
other cytotoxic agents given in conjunction with
6-mercaptopurine.
The dosage should be carefully adjusted to suit the individual
patient.
6-mercaptopurine has been used in various combination therapy
schedules and the literature should be consulted for details.
Studies carried out in children with acute lymphoblastic leukaemia
suggested that administration of 6-mercaptopurine in the
evening lowered the risk of relapse compared with morning
administration.
ELDERLY
It is advisable to monitor renal and hepatic function in these
patients, and if there is any impairment, consideration should be
given to reducing t