Mercaptopurine Silver Pharma 50 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mercaptopurine

Available from:

Silver Pharma S.L.

ATC code:

L01BB02

INN (International Name):

Mercaptopurine

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

mercaptopurine

Authorization date:

2021-07-02

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MERCAPTOPURINE SILVER PHARMA 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 or pharmacist .
-
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,or pharmacist . This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mercaptopurine Silver Pharma is and what it is used for
2.
What you need to know before you take Mercaptopurine Silver Pharma
3.
How to take Mercaptopurine Silver Pharma
4.
Possible side effects
5.
How to store Mercaptopurine Silver Pharma
6.
Contents of the pack and other information
1.
WHAT MERCAPTOPURINE SILVER PHARMA IS AND WHAT IT IS USED FOR
This medicine contains the active substance mercaptopurine monohydrate
which belongs to a group of
medicines called cytotoxics (also called chemotherapy). Mercaptopurine
is used to treat leukaemia (cancer
of the blood) and works by reducing the number of new blood cells your
body makes.
Mercaptopurine is used for:
-
Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML
M3)
- a fast
growing disease that increases the number of white blood cells
produced by the bone marrow. This
can cause infections and bleeding.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Mercaptopurine Silver Pharma
DO NOT TAKE MERCAPTOPURINE SILVER PHARMA :
-
if you are allergic (hypersensitive) to mercaptopurine or any of the
other ingredients of this
medicine (listed in section 6).
-
if you are just giving the vaccine of the yellow fever while taking
mercaptopurine, because it may
be fatal..
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mercaptopurine Silver
Pharma if:
•
you have

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2022
CRN00D3V6
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mercaptopurine Silver Pharma 50 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active substance mercaptopurine (as
monohydrate).
Excipient with known effect:
Each tablet contains 46.13 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Pale yellow 6 mm round tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mercaptopurine is indicated for the treatment of acute leukaemia in
adults, adolescents and children.. It may be utilised in:
- Acute promyelocytic leukaemia (APL)/Acute myeloid leukaemia M3 (AML
M3).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
6-mercaptopurine treatment should be supervised by a physician or
other healthcare professional experienced in the
management of patients with APL (AML M3).
Posology
_ _
_Adults and paediatric population_
_ _
For adults and children the usual recommended 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 6-mercaptopurine.
Daily dose intake in the evening is recommended (see Method of
administration in this section).
The dosage should be carefully adjusted to suit each individual
patient.
In overweight children, dose may be close to the maximum daily dose.
Therefore, close monitoring of the response to
treatment is recommended (see section 5.2).
6-mercaptopurine has been used in various combination therapy
schedules for acute leukaemia and the literature and
applicable treatment guidelines should be consulted for details.
_ _
_ _
_ _
_Elderly_
It is advisable to monitor renal and hepatic function in these
patients, and if impaired function is observed, reduction of the
6-mercaptopurine dosage should be considered.
_Renal impairment_
Consideration should be given to red