Melphalan 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Melphalan

Available from:

Aspen Pharma Trading Ltd

ATC code:

L01AA03

INN (International Name):

Melphalan

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: 5060249171751

Patient Information leaflet

Package Leaflet: Information for the User
MELPHALAN 2MG TABLETS
melphalan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions about your illness or your medicine,
ask your
doctor, nurse or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor, nurse or pharmacist.
IN THIS LEAFLET:
1
What Melphalan is and what it is used for
2
Before you take Melphalan
3
How to take Melphalan
4
Possible side effects
5
How to store Melphalan
6
Further information
1 WHAT MELPHALAN IS AND WHAT IT IS USED FOR
Melphalan tablets contain a medicine called melphalan. This belongs to
a group of
medicines called cytotoxics (also called chemotherapy). Melphalan is
used to treat
cancer. It works by reducing the number of abnormal cells your body
makes.
Melphalan is used for:
•
MULTIPLE MYELOMA - a type of cancer that develops from cells in the
bone
marrow called plasma cells. Plasma cells help to fight infection and
disease by
producing antibodies
•
Advanced CANCER OF THE OVARIES
•
Advanced BREAST CANCER
•
POLYCYTHAEMIA VERA - a disease which increases the number of red cells
in
your blood. This makes the blood thicken and causes blood clots. This
leads to
headaches, dizziness and shortness of breath
Ask your doctor if you would like more explanation about these
diseases.
2 BEFORE YOU TAKE MELPHALAN
DO NOT TAKE MELPHALAN IF:
•
You are allergic (hypersensitive) to melphalan or any of the other
ingredients of
Melphalan tablets (See section 6: Further information)
Do not take if the above applies to you. If you are not sure, talk to
your doctor or
pharmacist before taking Melphalan.
TAKE SPECIAL CARE WITH MELPHALAN
Before you take Melphalan, tell your doctor or pharmacist if:
•
you have had radioth

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Melphalan 2 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg melphalan
3
PHARMACEUTICAL FORM
Film-coated tablets
MELPHALAN are white to off-white film-coated, round, biconvex tablets
engraved
“GX EH3” on one side and “A” on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Melphalan Tablets are indicated in the treatment of multiple myeloma
and advanced
ovarian adenocarcinoma.
Melphalan either alone or in combination with other drugs has a
significant
therapeutic effect in a proportion of patients suffering from advanced
breast
carcinoma.
Melphalan is effective in the treatment of a proportion of patients
suffering from
polycythaemia vera.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Since Melphalan is myelosuppressive, frequent blood counts are
essential during
therapy and the dosage should be delayed or adjusted if necessary (see
_Special _
_Warnings and_ _Precautions for Use)_.
Oral administration in Adults:_ _The absorption of Melphalan after
oral administration
is variable. Dosage may need to be cautiously increased until
myelosuppresion is
seen, in order to ensure that potentially therapeutic levels have been
reached.
Multiple Myleloma:
Numerous regimes have been used and the scientific literature should
be consulted for
details. The administration of Melphalan and prednisone is more
effective than
Melphalan alone. The combination is usually given on an intermittent
basis, although
the superiority of this technique over continuous therapy is not
established. A typical
oral dosage schedule is 0.15 mg/kg bodyweight/day in divided doses for
4 days
repeated at intervals of six weeks. Prolonging treatment beyond one
year in
responders does not appear to improve results.
Ovarian adenocarcinoma:
A typical regimen is 0.2 mg/kg bodyweight/day orally for 5 days. This
is repeated
every 4-8 weeks, or as soon as the bone marrow has recovered.
Melphalan has also
been used intravenously in the treatment of ova