Puri-Nethol 50 mg Tablets

País: Malta

Idioma: anglès

Font: Medicines Authority

Disponible des:

Aspen Pharma Trading Limited 3016 Lake Drive City West Businees Campus Dublin 24, Ireland

Codi ATC:

L01BB02

Designació comuna internacional (DCI):

MERCAPTOPURINE 50 mg

formulario farmacéutico:

TABLET

Composición:

MERCAPTOPURINE 50 mg

tipo de receta:

POM

Área terapéutica:

ANTINEOPLASTIC AGENTS

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estat d'Autorització:

Authorised

Data d'autorització:

2022-11-30

Informació per a l'usuari

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

Fitxa tècnica

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 acute
leukaemia and the literature and current treatment guidelines
_ _