ANAGRID 0.5

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ANAGRELIDE AS HYDROCHLORIDE

MAH:

RAFA LABORATORIES LTD

ATC_code:

L01XX35

pharmaceutical_form:

CAPSULES

composition:

ANAGRELIDE AS HYDROCHLORIDE 0.5 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

RAFA LABORATORIES LTD, JERUSALEM

therapeutic_group:

ANAGRELIDE

therapeutic_area:

ANAGRELIDE

therapeutic_indication:

Indicated for the treatment of patients with Essential Thrombocythemia to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms.

authorization_date:

2017-08-31

PIL

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
ANAGRID 0.5
CAPSULES
ACTIVE INGREDIENT:
Each capsule of Anagrid 0.5 contains:
0.5 mg of Anagrelide (as HCl)
For the list of the additional ingredients, see section 6. See also
‘Important information about
some of the medicine’s ingredients’ in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for treatment of patients with essential
thrombocythemia in order to
reduce the high blood platelet count and the risk of thrombosis, and
to improve the associated
symptoms.
Essential thrombocythemia is a condition where the bone marrow
produces too many platelets
(type of blood cells). A high level of platelets in the blood can
cause serious problems in the blood
circulation and clotting.
THERAPEUTIC GROUP:
Thrombolytic medicines
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional ingredients the
medicine contains (for the list of the additional ingredients, see
section 6). An allergic reaction is
characterized amongst others by the appearance of a rash, itching,
swelling of the face, lips or
shortness of breath.
•
You suffer from moderate or severe liver problems.
•
You suffer from moderate or severe kidney problems (creatinine
clearance below 50 ml/min).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:
BEFORE (AND DURING) TREATMENT WITH ANAGRID, TELL YOUR DOCTOR IF:
•
You have or think you might have a heart problem.
•
You suffer from a congenital disorder of prolonged QT interval (is
seen o

SPC

1
Anagrid_0.5_May 2022-03
1.
NAME OF THE MEDICINAL PRODUCT
Anagrid 0.5
Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg anagrelide (as anagrelide hydrochloride).
Excipient(s) with known effect
Each capsule contains lactose monohydrate (about 123 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule.
An off-white capsule.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indicated for the treatment of patients with Essential Thrombocythemia
to reduce the elevated platelet
count and the risk of thrombosis and to ameliorate associated
symptoms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with
Anagrid
should be initiated by a clinician with experience in the management
of essential
thrombocythaemia.
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 should be performed every
two days during the first week of
treatment and at least weekly thereafter until a stable maintenance
dose is reached. Typically, a fall in the
platelet count will be observed within 14 to 21 days of starting
treatment and in most patients an adequate
therapeutic response will be observed and maintained at a dose of 1 to
3 mg/day (for further information
on the clinical effects refer to section 5.1).
_Older people_
The observed pharmacokinetic