Anastrozole Zaphyr Pharmaceuticals 1 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Anastrozole

Available from:

Zaphyr Pharmaceuticals Ireland Limited

ATC code:

L02BG; L02BG03

INN (International Name):

Anastrozole

Dosage:

1 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Aromatase inhibitors; anastrozole

Authorization status:

Marketed

Authorization date:

2009-11-27

Patient Information leaflet

ZAPHYR PHARMACEUTICALS IRELAND LIMITED
DCP NO.:
IE/H/189/001/DC
PA 1914/001/001
ANASTROZOLE ZAPHYR PHARMACEUTICALS 1MG FILM-
COATED TABLETS.
MODULE 1
1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANASTROZOLE ZAPHYR PHARMACEUTICALS 1MG FILM-COATED TABLETS.
Anastrozole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
What
ANASTROZOLE ZAPHYR PHARMACEUTICALS
is and what it is used for
2.
Before you take
ANASTROZOLE ZAPHYR PHARMACEUTICALS
3.
How to take
ANASTROZOLE ZAPHYR PHARMACEUTICALS
4.
Possible side effects
5.
How to store
ANASTROZOLE ZAPHYR PHARMACEUTICALS
tablets.
6.
Further information
1.
WHAT ANASTROZOLE ZAPHYR PHARMACEUTICALS IS AND WHAT IT IS USED
FOR
ANASTROZOLE ZAPHYR PHARMACEUTICALS
contains a substance called anastrozole. This belongs to a
group of medicines called aromatase inhibitors.
ANASTROZOLE ZAPHYR PHARMACEUTICALS
is used to treat breast cancer in women who have gone
through the menopause.
ANASTROZOLE ZAPHYR PHARMACEUTICALS
works by cutting down the amount of hormone called
estrogen that your body makes. It does this by blocking a natural
substance (an enzyme) in your body
calles “aromatase”.
2.
BEFORE YOU TAKE ANASTROZOLE ZAPHYR PHARMACEUTICALS
DO NOT TAKE ANASTROZOLE ZAPHYR PHARMACEUTICALS
-
if you are allergic (hypersensitive) to anastrozole or any of the
other ingredients of
ANASTROZOLE
ZAPHYR PHARMACEUTICALS
(see section 6:Further information)..
-
if you are pregnant or breast feeding (see the sectin called
‘Pregnancy and breast-feeding’).
Do not Take
ANASTROZOLE ZAPHYR PHARMACEUTICALS
if any of the above apply to you. If you are

Summary of Product characteristics

Health Products Regulatory Authority
17 May 2021
CRN00C939
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole Zaphyr Pharmaceuticals 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole
Excipient with known effect:
Each film-coated tablet contains 90.3 mg lactose (as 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. Debossed with ‘1’ on
one side and plain on the reverse side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anastrozole is indicated for the:
- Treatment of hormone receptor-positive advanced breast cancer in
postmenopausal women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Anastrozole for adults including the elderly
is one 1 mg tablet once a day.
_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 should be taken orally.
4.3 CONTRAINDICATIONS
Anastrozole is contraindicated in:
• Pregnant or breast-feeding women
• Patients with known hypersensitivity to anastrozole or to any of
the excipients as referenced in section 6.1.
Health Products Regulatory Authority
17 May 2021
CRN00C939
Page 2 of 10
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General
Anastrozole should not be used in premenopausal women. The menopause
should be defined biochemically
(lutein