Anagrelide STADA 0,5 mg, harde capsules

Country: Netherlands

Language: Dutch

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

Active ingredient:

ANAGRELIDEHYDROCHLORIDE 1-WATER 0,6 mg/stuk SAMENSTELLING overeenkomend met ; ANAGRELIDE 0,5 mg/stuk

Available from:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC code:

L01XX35

INN (International Name):

ANAGRELIDEHYDROCHLORIDE 1-WATER 0,6 mg/stuk SAMENSTELLING overeenkomend met ; ANAGRELIDE 0,5 mg/stuk

Pharmaceutical form:

Capsule, hard

Composition:

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

Administration route:

Oraal gebruik

Therapeutic area:

Anagrelide

Product summary:

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);

Authorization date:

1900-01-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANAGRELIDE STADA 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 STADA 0,5 mg, harde capsules is and what it is used
for
2. What you need to know before you take Anagrelide STADA 0,5 mg,
harde capsules
3. How to take Anagrelide STADA 0,5 mg, harde capsules
4. Possible side effects
5. How to store Anagrelide STADA 0,5 mg, harde capsules
6. Contents of the pack and other information
1. WHAT ANAGRELIDE STADA 0,5 MG, HARDE CAPSULES IS AND WHAT IT IS USED
FOR
Anagrelide STADA 0,5 mg, harde capsules 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 STADA 0,5 MG,
HARDE CAPSULES
DO NOT TAKE ANAGRELIDE STADA 0,5 MG, HARDE CAPSULES:
•
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 sh

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Anagrelide STADA 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. The capsule is
filled with white to off-white 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 > 1 000 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 startin