ANASTROZOLE NICHE 1 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ANASTROZOLE

Available from:

Niche Generics Limited

INN (International Name):

ANASTROZOLE

Dosage:

1 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Authorization status:

Withdrawn

Authorization date:

2014-03-10

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ANASTROZOLE NICHE 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 Niche is and what it is used for 
2. 
Before you take Anastrozole Niche 
3. 
How to take Anastrozole Niche 
4. 
Possible side effects 
5. 
How to store Anastrozole Niche.  
6. Further 
information 

1. 
WHAT ANASTROZOLE NICHE IS AND WHAT IT IS USED FOR 

Anastrozole Niche contains a substance called anastrozole.  This
belongs to a group of medicines 
called ‘aromatase inhibitors’. Anastrozole Niche is used to
treat breast cancer in women who have 
gone through the menopause.   

Anastrozole Niche 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. 
BEFORE YOU TAKE ANASTROZOLE NICHE 

DO NOT TAKE ANASTROZOLE NICHE 
- 
if you are allergic (hypersensitive) to anastrozole or any of the
other ingredients Anastrozole 
Niche (see section 6: Further information).  
- 
if you are pregnant or breast feeding (see the section called
‘Pregnancy and breast-feeding’). 

Do not take Anastrozole Niche if any of the
above apply to you.  If you are not sure, talk to your 
doctor or pharmacist before taking Anastrozole Niche. 

TAKE SPECIAL CARE WITH ANASTROZOLE NICHE 
Before treatment with Anastrozole Niche check with your doctor
or phar

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole Niche 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole as active substance.
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
Treatment of advanced breast cancer in postmenopausal women.
Efficacy has not been demonstrated in oestrogen receptor-negative patients unless they had a previous positive clinical
response to tamoxifen.
Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer.
Adjuvant treatment of early breast cancer in hormone receptor positive 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 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_
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 r