Arimidex 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Anastrozole

Available from:

Lexon (UK) 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

ARIMIDEX 1MG FILM-COATED TABLETS
(anastrozole)
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Arimidex 1mg Film-coated Tablets but will be
referred
to as Arimidex throughout the leaflet.
WHAT IS IN THIS LEAFLET
What Arimidex is and what it is used for
What you need to know before you take Arimidex
How to take Arimidex
Possible side effects
How to store Arimidex
Contents of the pack and other information
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’.
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 contain

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