Chlorambucil 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlorambucil

Available from:

Aspen Pharma Trading Ltd

ATC code:

L01AA02

INN (International Name):

Chlorambucil

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010100; GTIN: 5060249171737

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORAMBUCIL 2 MG 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 Chlorambucil is and what it is used for
2. What you need to know before you take Chlorambucil
3. How to take Chlorambucil
4. Possible side effects
5. How to store Chlorambucil
6. Contents of the pack and other information
1. WHAT CHLORAMBUCIL IS AND WHAT IT IS USED FOR
Chlorambucil contains a medicine called chlorambucil. This belongs to
a group of medicines called
cytotoxics (also called chemotherapy). Chlorambucil is used to treat
some types of cancer and
certain blood problems. It works by reducing the number of abnormal
cells your body makes.
Chlorambucil is used for:
-
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 white blood cell cancer where
the bone marrow
produces a large number of abnormal white 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.
Ask your doctor if you would like more explanation about these
diseases.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORAMBUCIL
DO NOT TAKE CHLORAMBUCIL :
-
If you are allergic (hypersensitive) to chlorambucil or any of the
other ingredients

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlorambucil 2 mg 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 the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Brown, round, biconvex, film-coated tablets, one side engraved with
“L” and the other side
engraved
‘GX EG 3’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chlorambucil is indicated in the treatment of Hodgkin's disease,
certain forms
of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, and
Waldenstrom's macroglobulinaemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The relevant literature should be consulted for full details of the
treatment schedules used.
Chlorambucil is an active cytotoxic agent for use only under the
direction of physicians
experienced in the administration of such agents.
Posology
_HODGKIN’S DISEASE _
_ _
_Adults _
_ _
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. Chlorambucil is usually included in
combination therapy and a
number of regimes have been used. Chlorambucil has been used as an
alternative to nitrogen
mustard with a reduction in toxicity but similar therapeutic results.
_Paediatric population _
Chlorambucil may be used in the management of Hodgkin’s disease in
children. The dosage
regimes are similar to those used in adults.
_NON-HODGKIN’S LYMPHOMA _
_Adults _
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.
Chlorambucil 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 patients w