TEMOZOLOMIDE LUPIN temozolomide 5 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

temozolomide, Quantity: 5 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Temozolomide

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: colloidal anhydrous silica; purified water; Gelatin; sodium starch glycollate; tartaric acid; stearic acid; lactose; microcrystalline cellulose; indigo carmine; iron oxide yellow; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

20, 5

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Temozolomide is indicated for the treatment of:,- patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment. - recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,Temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

Product summary:

Visual Identification: 5 mg capsules (light green opaque, size 4) marked with black imprint TMZ 5 mg; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-01-07

Patient Information leaflet

TEMOZOLOMIDE ALPHAPHARM
1
TEMOZOLOMIDE
ALPHAPHARM
_Temozolomide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Temozolomide
Alphapharm. It does not contain all
the available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
Temozolomide Alphapharm against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TEMOZOLOMIDE
ALPHAPHARM IS USED
FOR
Temozolomide Alphapharm is used
to treat patients with brain tumours.
Temozolomide Alphapharm is also
used to treat adult patients with
advanced metastatic malignant
melanoma.
Your doctor, however, may prescribe
Temozolomide Alphapharm for
another purpose.
This medicine belongs to a group of
medicines called cytotoxic or
chemotherapy medicines.
It works by killing cancer cells and
stopping cancer cells from growing
and multiplying.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Temozolomide Alphapharm capsules
are used to treat children 3 years and
older, with specific forms of brain
tumour (glioblastoma multiforme or
anaplastic astrocytoma, showing
recurrence or progression after
standard therapy).
BEFORE YOU TAKE
TEMOZOLOMIDE
ALPHAPHARM
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TEMOZOLOMIDE
ALPHAPHARM IF YOU HAVE AN ALLERGY
TO:
•
any medicine containing
temozolomide or dacarbazine
(DTIC)
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing, difficulty breathing or
a tight feeling in your chest
•
swelling of the face, lips, tongue
or other parts of the body, that
may lead to difficulty swallowing
•
rash, itching or hives on the skin
DO NO

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
TEMOZOLOMIDE ALPHAPHARM (TEMOZOLOMIDE) CAPSULES
_ _
1. NAME OF THE MEDICINE
Temozolomide
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg
temozolomide, as the active
ingredient. Excipient with known effect:
Excipients with known effect:
gelatin (contains sulfites)
sugars (as lactose) in the 5mg and 20 mg capsules
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
5 mg capsules
Light green opaque, size 4, marked with black imprint “TMZ 5 mg”.
20 mg capsules
Rich yellow opaque, size 1, marked with black imprint “TMZ 20 mg”.
100 mg capsules
Flesh opaque, size 1, marked with black imprint “TMZ 100 mg”.
140 mg capsules
Powder blue opaque, size 1, marked with black imprint “TMZ 140
mg”.
180 mg capsules
Medium orange opaque, size 1, marked with black imprint “TMZ 180
mg”.
250 mg capsules
Buff opaque, size 0, marked with black imprint “TMZ 250 mg”.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Temozolomide is indicated for the treatment of:
• patients with newly diagnosed glioblastoma multiforme
concomitantly with radiotherapy and then as
adjuvant treatment.
• recurrence of anaplastic astrocytoma and glioblastoma multiforme
following standard therapy.
Temozolomide is also indicated as first line treatment for patients
with advanced metastatic malignant
melanoma.
4.2. DOSE AND METHOD OF ADMINISTRATION
Temozolomide Alphapharm capsules are intended for oral administration.
Anti-emetic therapy may be administered prior to or following
administration of temozolomide.
Temozolomide capsules should be administered in the fasting state at
least one hour before a meal. If
vomiting occurs after the dose is administered, a second dose should
not be administered that day.
Temozolomide Alphapharm – AUSTRALIAN PRODUCT INFORMATION
2
Temozolomide capsules must not be opened or chewed, but are to be
swallowed whole with a glass of
water. If a capsule becomes damaged, av