Arimidex 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Anastrozole

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

L02BG03

INN (International Name):

Anastrozole

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08030401

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER ARIMIDEX
® 1MG TABLETS
(anastrozole)
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.
The name of your medicine is Arimidex
1mg Tablets but will be referred to as
Arimidex throughout this leaflet.
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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).
_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 hy