Leukeran 2 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorambucil

Available from:

Aspen Pharma Trading Limited

ATC code:

L01AA; L01AA02

INN (International Name):

Chlorambucil

Dosage:

2 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Nitrogen mustard analogues; chlorambucil

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEUKERAN 2MG FILM-COATED TABLETS
chlorambucil
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 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 or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Leukeran is and what it is used for
2.
What you need to know before you take Leukeran
3.
How to take Leukeran
4.
Possible side effects
5.
How to store Leukeran
6.
Contents of the pack and other information
1.
WHAT LEUKERAN IS AND WHAT IT IS USED FOR
Leukeran contains an active substance called chlorambucil which
belongs to a group of medicines
called cytotoxics (also called chemotherapy). This medicine is used to
treat certain type of cancers
affecting human blood and lymphatic system. Your doctor will be able
to explain how Leukeran might
help in your particular condition.
Leukeran is used in patients with:
-
HODGKIN'S DISEASE AND NON-HODGKIN’S LYMPHOMA.
Together, these form a group of diseases
called lymphomas. They are cancers formed from cells of the lymphatic
system.
-
CHRONIC LYMPHOCYTIC LEUKAEMIA.
A type of blood cancer where the bone marrow produces a
large number of abnormal white blood cells.
-
WALDENSTROM'S MACROGLOBULINAEMIA.
A rare lymphoma associated with an uncontrolled
increase of B-cells, a type of white blood cell, resulting in the
release of an abnormal protein
into the blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEUKERAN
DO NOT TAKE LEUKERAN IF:
You are allergic to chlorambucil or any of the other ingredients of
this medicine (listed in section 6).
Leukeran should not be used for the treatment of non-malignant cancer.
If you

Summary of Product characteristics

Health Products Regulatory Authority
30 June 2022
CRN00CYG2
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Leukeran 2 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of the active ingredient chlorambucil.
Excipient(s) with known effect:
Each tablet also contains 67.65 mg of lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet. (Tablet).
Brown, round, biconvex tablet, engraved on one side with “L” and
“GX EG3” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Leukeran is indicated in the treatment of:-
- Hodgkin's disease;
- Certain forms of non-Hodgkin's lymphoma;
- Chronic lymphocytic leukaemia;
- Waldenstrom's macroglobulinaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
THE RELEVANT LITERATURE SHOULD BE CONSULTED FOR FULL DETAILS OF THE
TREATMENT SCHEDULES USED.
LEUKERAN IS AN ACTIVE CYTOTOXIC AGENT AND SHOULD ONLY BE ADMINISTERED
UNDER THE DIRECTION OF A SPECIALIST
ONCOLOGY SERVICE HAVING THE FACILITIES FOR REGULAR MONITORING OF
CLINICAL BIOCHEMICAL AND
HAEMATOLOGICAL EFFECTS DURING AND AFTER ADMINISTRATION.
Posology
_Hodgkin's disease_
Used as a single agent in the palliative treatment of advanced
disease, a typical dosage is 0.2 mg/kg/day for 4‑8 weeks.
Leukeran is usually included in combination therapy and a number of
regimes have been used.
Leukeran has been used as an alternative to nitrogen mustard with a
reduction in toxicity but similar therapeutic results.
_Non‑Hodgkin's lymphoma_
Used as a single agent the usual dosage is 0.1‑0.2 mg/kg/day for
4‑8 weeks initially; maintenance therapy is then given either
by a reduced daily dosage or intermittent courses of treatment.
Leukeran is useful in the management of patients with advanced diffuse
lymphocytic lymphoma and those who have relapsed
after radiotherapy.
There is no significant difference in the overall response rate
obtained with chlorambucil as a single agent and combination
chemotherapy in patien