Anagrelide 0.5 mg Hard Capsules

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Anagrelide

Verfügbar ab:

Athlone Laboratories Ltd

ATC-Code:

L01XX; L01XX35

INN (Internationale Bezeichnung):

Anagrelide

Dosierung:

0.5 milligram(s)

Darreichungsform:

Capsule, hard

Therapiebereich:

Other antineoplastic agents; anagrelide

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2018-04-20

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAGRELIDE 0.5MG HARD CAPSULES
Anagrelide
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
1.
WHAT ANAGRELIDE IS AND WHAT IS IT USED FOR
Anagrelide contains the active substance, anagrelide. Anagrelide is a
medicine which interferes with the
development of platelets. It reduces the number of platelets produced
by the bone marrow, which results
in a decrease in the platelet count in the blood towards a more normal
level. For this reason it is used to
treat patients with essential thrombocythaemia.
Essential thrombocythaemia is a condition which occurs when the bone
marrow produces too many of the
blood cells known as platelets. Large numbers of platelets in the
blood can cause serious problems with
blood circulation and clotting.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGRELIDE
DO NOT TAKE ANAGRELIDE
•
If you are allergic to anagrelide or any of the other ingredients of
this medicine (listed in section
6). An allergic reaction may be recognised as a rash, itching, swollen
face or lips, or shortness of
breath;
•
If you have moderate or severe liver problems;
•
If you have moderate or severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Anagrelide:
•
If you have or think you might have a problem with

Fachinformation

Health Products Regulatory Authority
24 January 2023
CRN00D9S3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
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). Excipientswith known effect:
Each hard capsule contains lactose monohydrate (50.00 mg) and lactose
(37.14mg)
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). During clinical development doses of 10
mg/day have been used.
The effects of treatment with anagrelide must be monitored on a
regular basis (see section 4.4). If the starting dose is > 1
mg/day p