Anastrozole 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Anastrozole

Available from:

Niche Generics 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

1
ACCORD LOGO
ANASTROZOLE 1MG TABLETS
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.
-
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
The full name of the product is Anastrozole 1mg Film-coated Tablets
but within the leaflet it
will be referred to as Anastrozole tablets.
WHAT IS IN THIS LEAFLET
:
1.
WHAT ANASTROZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
3.
HOW TO TAKE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ANASTROZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Anastrozole tablets contain a substance called anastrozole. This
belongs to a group of medicines
called ‘aromatase inhibitors’. Anastrozole tablets are used to
treat breast cancer in women who
have gone through the menopause.
Anastrozole tablets work 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
DO NOT TAKE
ANASTROZOLE TABLETS IF YOU
-
are
ALLERGIC
to anastrozole or any of the other ingredients of this medicine
(listed in section 6).
-
are
PREGNANT
or
BREAST FEEDING
(see the section called ‘Pregnancy and breast-feeding’).
Do not take Anastrozole tablets if any of the above apply to you. If
you are not sure, talk to your
doctor or pharmacist before taking Anastrozole tablets.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Anastrozole tablets:
-
if you still have menstrual periods and have not yet gone through the
menopause.
-

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Anastrozole 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1mg anastrozole.
Excipient: Each tablet contains 93mg lactose monohydrate (see section
4.4).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White film-coated round biconvex tablets, debossed with “ANA” and
“1” on one
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anastrazole 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 anastrozole for adults including the elderly
is one
1mg 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_
Anastrozole 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
anastrozole 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
Anastrozole Actavis should be taken orally.
4.3
CONTRAINDICATIONS
Anastrozole is contraindicated in:
•
Pregnant or breast-feeding women.
•
Patients with known hypersensitivity to the active substance
anastrozole or to
any of the exc