Arimidex 1mg film-coated Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

ANASTROZOLE

Tilgængelig fra:

AstraZeneca UK Limited

ATC-kode:

L02BG03

INN (International Name):

ANASTROZOLE

Lægemiddelform:

FILM-COATED TABLET

Sammensætning:

ANASTROZOLE 1 mg

Recept type:

POM

Terapeutisk område:

ENDOCRINE THERAPY

Autorisation status:

Authorised

Autorisation dato:

2005-08-27

Indlægsseddel

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
or nurse.
-
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 or
nurse. This includes any possible
side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Arimidex is and what it is
used for
2. What you need to know before you
take Arimidex
3. How to take Arimidex
4. Possible side effects
5. How to store Arimidex
6. Contents of the pack and other
information
1. WHAT ARIMIDEX IS AND WHAT IT
IS USED FOR
Arimidex contains a substance called
anastrozole. This belongs to a group
of medicines called ‘aromatase
inhibitors’. Arimidex is used to treat
breast cancer in women who have
gone through the menopause.
Arimidex works by cutting down
the amount of the hormone called
estrogen that your body makes.
It does this by blocking a natural
substance (an enzyme) in your body
called ‘aromatase’.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ARIMIDEX
DO NOT TAKE ARIMIDEX
•
if you are allergic to anastrozole or
any of the other ingredients of this
medicine (listed in section 6).
•
if you are pregnant or breast-feeding
(see the section called ‘Pregnancy
and breast-feeding’).
Do not take Arimidex if any of the
above apply to you. If you are
not sure, talk to your doctor or
pharmacist before taking Arimidex.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or
nurse before taking Arimidex
•
if you still have menstrual periods
and have not yet gone through the
menopause.
•
if you are taking a medicine that
contains tamoxifen or medicines
that contain estrogen (see the
section called ‘Other medicines
and Arimidex’).
•
if you have ever had a condition
that affects the st

Produktets egenskaber

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1.
NAME OF THE MEDICINAL PRODUCT
Arimidex
®
1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipients with known effect
Each film-coated tablet contains 93 mg of lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets of about 6.1 mm marked with
‘A’ on one side and ‘Adx1’
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Arimidex is indicated for the:

Treatment of hormone receptor-positive advanced breast cancer in
postmenopausal women.

Adjuvant treatment of hormone receptor-positive early invasive breast
cancer in
postmenopausal women.

Adjuvant treatment of hormone receptor-positive early invasive breast
cancer in
postmenopausal women who have received 2 to 3 years of adjuvant
tamoxifen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Arimidex for adults including the elderly is
one 1 mg tablet once a day.
For postmenopausal women with hormone receptor-positive early invasive
breast cancer, the
recommended duration of adjuvant endocrine treatment is 5 years.
_ _
_Special populations _
_Paediatric population _
Arimidex is not recommended for use in children and adolescents due to
insufficient data on safety and
efficacy (see sections 4.4 and 5.1).
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_Renal impairment _
No dose change is recommended in patients with mild or moderate renal
impairment. In patients with
severe renal impairment, administration of Arimidex should be
performed with caution (see section 4.4
and 5.2).
_Hepatic impairment _
No dose change is recommended in patients with mild hepatic disease.
Caution is advised in patients
with moderate to severe hepatic impairment (see section 4.4).
Method of administration
Arimidex should be taken orally.
4.3
CONTRAINDICATIONS
Arimidex is contraindicated in:

Pregnant or breastfeeding women.

Patients with known hyperse