ANAGRELIDE

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

ANAGRELIDE

Mevcut itibaren:

Kent Pharmaceuticals Limited

ATC kodu:

L01XX35

INN (International Adı):

ANAGRELIDE

Doz:

0.5 Milligram

Farmasötik formu:

Capsules Hard

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

anagrelide

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2018-04-20

Bilgilendirme broşürü

150 mm
400 mm
15 mm
10 mm
29 mm
A
TEXT DIRECTION
FRONT PAGE
17 mm
12 mm
PHARMA CODE
READING DIRECTION
10 mm
10 mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ANAGRELIDE 0.5MG HARD CAPSULES
Anagrelide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of
section 4 for how to report side effects.
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 FURTHER QUESTIONS, ASK YOUR DOCTOR OR PHARMACIST. • 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 PHARMACIST.
THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. WHAT IS IN THIS LEAFLET
1. What Anagrelide is and what it is used for
2. What you need to know before you take Anagrelide
3. How to take Anagrelide
4. Possible side effects
5. How to store Anagrelide
6. Contents of the pack and other information
IF YOU TAKE MORE ANAGRELIDE THAN YOU
SHOULD
If you take more Anagrelide than you should or
if someone else has taken your medicine, tell
a doctor or pharmacist immediately. Show
them the pack of Anagrelide.
IF YOU FORGET TO TAKE ANAGRELIDE
Take your capsules as soon as you remember.
Take your next dose at the usual time. Do not
take a double dose to make up for a forgotten
dose.
POSSIBLE SIDE EFFECTS
Like all medicines, Anagrelide can cause
side effects, although not everybody gets
them. If you are worried, speak to your
doctor.
_SERIOUS SIDE EFFECTS:_
Uncommon: Heart failure (signs include
shortness of breath, chest pain, swelling of
the legs due to fluid build-up), severe
problem with the rate or rhythm of the heart
beat (ventricular tachycardia,
supraventricular tacycardia or atrial
fibrillation), inflammation o

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Anagrelide 0.5 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg anagrelide (as anagrelide
hydrochloride monohydrate).
Excipients with known effect:
Each hard capsule contains lactose monohydrate (50.00 mg) and lactose
anhydrous (37.14 mg)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
A white hard capsule containing white to off-white fine powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anagrelide is indicated for the reduction of elevated platelet counts
in at risk essential thrombocythaemia (ET) patients
who are intolerant to their current therapy or whose elevated platelet
counts are not reduced to an acceptable level by
their current therapy.
An at risk patient
An at risk essential thrombocythaemia patient is defined by one or
more of the following features:
> 60 years of age or
a platelet count > 1000 x 10
9
/l or
a history of thrombo-haemorrhagic events
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Anagrelide should be initiated by a clinician with
experience in the management of essential
thrombocythaemia.
Posology
The recommended starting dose of anagrelide 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 one week. After
one week the dose may be titrated, on an individual
basis, to achieve the lowest effective dose required to reduce and/or
maintain a 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 increment must not exceed more than 0.5 mg/day in any
one-week and the recommended maximum single dose should not exceed 2.5
mg (see section 4.9)