Anastrozole Bluefish 1 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Anastrozole

Saadav alates:

Bluefish Pharmaceuticals AB

ATC kood:

L02BG; L02BG03

INN (Rahvusvaheline Nimetus):

Anastrozole

Annus:

1 milligram(s)

Ravimvorm:

Film-coated tablet

Retsepti tüüp:

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

Terapeutiline ala:

Aromatase inhibitors; anastrozole

Volitamisolek:

Marketed

Loa andmise kuupäev:

2011-03-25

Infovoldik

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANASTROZOLE BLUEFISH 1 MG FILM-COATED 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.
WHAT IS IN THIS LEAFLET
:
1.
What Anastrozole Bluefish is and what it is used for
2.
What you need to know before you take Anastrozole Bluefish
3.
How to take Anastrozole Bluefish
4.
Possible side effects
5.
How to store Anastrozole Bluefish
6.
Contents of the pack and other information
1.
WHAT ANASTROZOLE BLUEFISH IS AND WHAT IT IS USED FOR
Anastrozole Bluefish contains a substance called anastrozole. This
belongs to a group of medicines called
‘aromatase inhibitors’. Anastrozole Bluefish is used to treat
breast cancer in women who have gone through
the menopause.
Anastrozole Bluefish 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’.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANASTROZOLE BLUEFISH
DO NOT TAKE ANASTROZOLE BLUEFISH
-
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 Anastrozole Bluefish if any of the above apply to you. If
you are not sure, talk to your doctor or
pharmacist before taking Anastrozole Bluefish.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse before

Toote omadused

Health Products Regulatory Authority
02 July 2021
CRN00CD2Z
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anastrozole Bluefish 1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg anastrozole
Excipient with known effect:
Each tablet contains 93 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex tablet of diameter 6.0 - 6.2mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anastrozole Bluefish 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 Bluefish for adults including the
elderly is 1 mg tablet once a day.
Special population
Paediatric population
Anastrozole Bluefish 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 and moderate renal
impairment. In patients with severe renal
impairment, administration of Anastrozole Bluefish 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 Bluefish is contraindicated in:
- pregnant or breast-feeding women,
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General
Health Products Regulatory Authority
02 July 2021
CRN00CD2Z
Page 2 of 9
Anastrozole should not be used in premenopausal women. The menopause
should be defined biochemically
(luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or
estradiol levels) in any patient where there is doub