ANAGRELIDE Lupin anagrelide (as hydrochloride monohydrate) 0.5 mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

anagrelide hydrochloride, Quantity: 0.57 mg (Equivalent: anagrelide, Qty 0.5 mg)

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Anagrelide hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: povidone; magnesium stearate; Gelatin; lactose monohydrate; croscarmellose sodium; titanium dioxide; microcrystalline cellulose; lactose

Administration route:

Oral

Units in package:

100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ANAGRELIDE Lupin capsules are indicated for the treatment of essential thrombocythaemia

Product summary:

Visual Identification: A capsule with an opaque white body and cap, filled with white to off-white powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-08-03

Patient Information leaflet

ANAGRELIDE SCP/JULY2017/CMI-00
1
Anagrelide SCP
_contains the active ingredient ANAGRELIDE (as hydrochloride
monohydrate) _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about ANAGRELIDE SCP.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ANAGRELIDE SCP
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What ANAGRELIDE SCP is
used for
ANAGRELIDE SCP capsules contain a
medicine called anagrelide (as
hydrochloride monohydrate) which
acts upon the bone marrow and
prevents it from producing too
many of the blood cells known as
‘platelets’.
In a disease such as
‘thrombocythaemia’, the bone
marrow produces too many of
these cells, and the very large
numbers of platelets in the blood
can cause serious problems with
blood circulation. ANAGRELIDE SCP
capsules can help prevent these
problems.
Before you take
ANAGRELIDE SCP
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ANAGRELIDE SCP IF
YOU:
•
have an allergy to anagrelide or
any of the ingredients listed at
the end of this leaflet
•
have severe liver problems
•
are pregnant or breast feeding.
DO NOT TAKE ANAGRELIDE SCP IF
THE EXPIRY DATE (EXP.) PRINTED ON
THE PACK HAS PASSED.
DO NOT TAKE ANAGRELIDE SCP IF
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
DO NOT USE ANAGRELIDE SCP
TO TREAT ANY OTHER COMPLAINT
UNLESS YOUR DOCTOR TELLS YOU TO.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU HAVE
ANY OF THE FOLLOWING:
•
you have any allergies,
•
you have had or now have any
liver or kidney disease
•
you have heart disease, heart
failure or are at high risk of
vascular events (thrombosis or
bleeding).
TELL YOUR DOCTOR IF YOU ARE
ALLERGIC TO ANY OTHER MEDICINES,
FOODS, DYES OR PRESERVATIVE

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ANAGRELIDE SCP, (ANAGRELIDE AS HYDROCHLORIDE MONOHYDRATE) CAPSULES
_ _
1. NAME OF THE MEDICINE
Anagrelide.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Anagrelide capsules contain the active ingredient anagrelide (as
hydrochloride monohydrate) equivalent to
0.5 mg of anagrelide.
Excipients with known effect: lactose & lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
ANAGRELIDE SCP is a capsule with an opaque white body and cap
Each ANAGRELIDE SCP capsules contain 0.5 mg of anagrelide as the
active ingredient.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
ANAGRELIDE SCP capsules are indicated for the treatment of essential
thrombocythaemia.
4.2. DOSE AND METHOD OF ADMINISTRATION
Treatment
with
ANAGRELIDE
SCP
capsules
should
be
initiated
under
close
medical
supervision.
The
recommended starting dosage of ANAGRELIDE SCP for adult patients is 1
mg /day, which should be
administered orally in two divided doses (0.5 mg/dose). The starting
dose should be maintained for at least a
week. The dose should then be adjusted to the lowest effective dose
required to reduce and maintain platelet
count below 600 x 10
9
/L and ideally at levels between 150-400 x 10
9
/L. The dose should be increased by not
more than 0.5 mg/day in any one week.
For patients with moderate hepatic impairment, the recommended
starting dose is 0.5 mg/day, to be
maintained for a minimum of one week with close monitoring of
cardiovascular effects. ANAGRELIDE SCP is
not recommended for patients with severe hepatic impairment.
Dosage should not exceed 10 mg/day or 2.5 mg in a single dose because
of the hypotensive effect of anagrelide
see Section 5.1 PHARMACODYNAMIC PROPERTIES. The decision to treat
asymptomatic young adults with
essential thrombocythaemia should be individualised.
To monitor the effect of anagrelide and prevent the occurrence of
thrombocytopenia, platelet counts should
be performed every two days during the first week of treatment and at
l