ANAGRELIDE APOTEX anagrelide (as hydrochloride) 0.5 mg capsule bottle

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

anagrelide hydrochloride, Quantity: 0.61 mg (Equivalent: anagrelide, Qty 0.5 mg)

Διαθέσιμο από:

Arrotex Pharmaceuticals Pty Ltd

Φαρμακοτεχνική μορφή:

Capsule, hard

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

100 capsules

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

ANAGRELIDE APOTEX capsules are indicated for the treatment of essential thrombocythaemia.

Περίληψη προϊόντος:

Visual Identification: White body and white cap hard gelatine capsules containing white to off-white fine powder; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-08-20

Φύλλο οδηγιών χρήσης

ANAGRELIDE APOTEX
1
ANAGRELIDE APOTEX
_Anagrelide Hydrochloride _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 this medicine
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 THIS MEDICINE IS
USED FOR
ANAGRELIDE APOTEX Capsules
contain the active ingredient
anagrelide hydrochloride, 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. By preventing too many
platelets from being made,
ANAGRELIDE APOTEX can help
prevent these problems.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is only available on a
doctor's prescription.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
anagrelide
•
any of the other ingredients listed
at the end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
severe liver problems
•
sensitivity to lactose or
microcrystalline cellulose.These
may cause a probl

Αρχείο Π.Χ.Π.

1
AUSTRALIAN PRODUCT INFORMATION
ANAGRELIDE APOTEX
(Anagrelide hydrochloride) capsules
1
NAME OF THE MEDICINE
Anagrelide hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule of ANAGRELIDE APOTEX contains 0.5 mg of anagrelide base
(as anagrelide
hydrochloride)
ANAGRELIDE APOTEX (anagrelide hydrochloride) is an orally active
quinazolin derivative.
EXCIPIENTS WITH KNOWN EFFECT:
Each capsule contains sugars as lactose monohydrate and sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ANAGRELIDE APOTEX is available as opaque, white capsules.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ANAGRELIDE APOTEX capsules are indicated for the treatment of
essential thrombocythaemia.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with anagrelide capsules should be initiated under close
medical supervision. The
recommended starting dosage of anagrelide APOTEX 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 x 10
9
/L and 400 x
10
9
/L. The dose should be increased by not more than 0.5 mg/day in any
one week. 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
(see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
2
HEPATIC IMPAIRMENT
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 is not recommended for patients with severe hepatic
impairment.
PATIENT MONITORING
To monitor the effect of anagrelide and prevent the occurrence of