Hanixol 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mercaptopurine

Available from:

Fontus Health Ltd

ATC code:

L01BB02

INN (International Name):

Mercaptopurine

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010300; GTIN: 5060421930879

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HANIXOL 50 MG TABLETS
6-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 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 (as
monohydrate). 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 monohydrate 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

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 monohydrate.
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 monohydrate treatment should be initiated and
supervised by a doctor or
other healthcare professional experienced in the management of
patients with acute leukemia.
6-mercaptopurine monohydrate may be taken with food or on an empty
stomach, but patients
should standardise the method of administration. 6-mercaptopurine
monohydrate should not be
taken with milk or dairy products (see section 4.5). 6-mercaptopurine
monohydrate 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 monohydrate.
The dosage should be carefully adjusted to suit the individual
patient.
6-mercaptopurine monohydrate 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 monohydrate 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 the
6-mercaptop