Anagrelide Zentiva 0,5 mg, harde capsules

Krajina: Holandsko

Jazyk: holandčina

Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktívna zložka:

ANAGRELIDEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; ANAGRELIDE

Dostupné z:

Zentiva Pharma GmbH

ATC kód:

L01XX35

INN (Medzinárodný Name):

ANAGRELIDEHYDROCHLORIDE 1-WATER COMPOSITION corresponding to ; ANAGRELIDE

Forma lieku:

Capsule, hard

Zloženie:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171),

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Anagrelide

Prehľad produktov:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); LACTOSE 0-WATER; LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); POVIDON K 30 (E 1201); TITAANDIOXIDE (E 171);

Dátum Autorizácia:

2017-10-24

Príbalový leták

1.3.1
Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAGRELIDE ZENTIVA 0,5 MG, HARDE 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 any 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 Zentiva is and what it is used for
2.
What you need to know before you take Anagrelide Zentiva
3.
How to take Anagrelide Zentiva
4.
Possible side effects
5.
How to store Anagrelide Zentiva
6.
Contents of the pack and other information
1
WHAT ANAGRELIDE ZENTIVA IS AND WHAT IT IS USED FOR
Anagrelide Zentiva 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 ANAGRELIDE ZENTIVA
DO NOT TAKE ANAGRELIDE ZENTIVA:

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
Ta

Súhrn charakteristických

1.3.1
Summary of Product Characteristics
1.
NAME OF THE MEDICINAL PRODUCT
Anagrelide Zentiva 0,5 mg, harde capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg anagrelide (as anagrelide
hydrochloride monohydrate)
Excipient(s) with known effect:
Each hard capsule contains lactose monohydrate (28.0 mg) and lactose
(32.9 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
A hard capsule (size 4, 14.3 x 5.3 mm) with an opaque white body and
cap.
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 platelet counts sho