Anagrelide 500microgram capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Anagrelide hydrochloride

Prieinama:

Consilient Health Ltd

ATC kodas:

L01XX35

INN (Tarptautinis Pavadinimas):

Anagrelide hydrochloride

Dozė:

500microgram

Vaisto forma:

Capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 09010400; GTIN: 5391512454982

Pakuotės lapelis

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 iT is 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 AnAgrelide
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 using anagrelide:
•
If you have or think you might have a problem with your heart;
•
If you were born with or have family history of prolonged QT interval
(seen on ECG, electrical recording of the heart), or you are taking
other
medicines that result in abnormal ECG changes or if you have low
levels
of electrolytes e.g. potassium, magnesium or calcium (see section
“Other
medicines and Anagrelide”);
•
If you have any problems with your liver or kidneys.
In combination with acetylsalicylic acid (a substance present in many
medicines used to relieve pain and lower fever, as well as to prevent
blood
clotting, also known as aspirin), there is an increased risk of major
haemorrhages (bleeding) (s

Prekės savybės

OBJECT 1
ANAGRELIDE 0.5 MG HARD CAPSULES
Summary of Product Characteristics Updated 17-Jul-2017 | Consilient
Health Ltd
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)
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) 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 109/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 109/l and ideally at levels between 150 x 109/l and
400 x 109/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
starti