Puri-Nethol 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mercaptopurine monohydrate

Available from:

Aspen Pharma Trading Limited

ATC code:

L01BB; L01BB02

INN (International Name):

Mercaptopurine monohydrate

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Purine analogues; mercaptopurine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

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
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 vaccinated with yel

Summary of Product characteristics

Health Products Regulatory Authority
15 May 2023
CRN00D5R2
Page 1 of 12
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 mercaptopurine
monohydrate.
Excipients with known effect:
Each tablet contains 59mg of the excipient lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
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
4.1 THERAPEUTIC INDICATIONS
Mercaptopurine monohydrate is indicated for the treatment of acute
leukaemia in adults, adolescents and children. It may be
utilised in:

Acute lymphoblastic leukaemia (ALL);

Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML
M3).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Mercaptopurine monohydrate treatment should be supervised by a
physician or other healthcare professional experienced in
the management of patients with ALL and APL (AML M3).
POSOLOGY
The dose is governed by cautiously monitored haematotoxicity and the
dose should be carefully adjusted to suit the individual
patient in accordance with the employed treatment protocol.
Depending on phase of treatment, starting or target doses should be
lower in patients with reduced or absent Thiopurine
Methyl Transferase (TPMT) enzyme activity (see section 4.4).
For adults and children, the usual dose is 2.5 mg/kg bodyweight per
day, or 50 to 75mg/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
mercaptopurine monohydrate.
The dosage should be carefully adjusted to suit the individual
patient.
Mercaptopurine monohydrate has been used in various combination
therapy schedules for