Anastrozole Pharmacare tablets film-coated

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

anastrozole

थमां उपलब्ध:

Pharmacare Premium Limited

ए.टी.सी कोड:

L02BG03

INN (इंटरनेशनल नाम):

anastrozole

डोज़:

1mg: (30/3x10/) in blister

फार्मास्यूटिकल फॉर्म:

tablets film-coated

पैकेज में यूनिट:

1mg: (30/3x10/) in blister

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2022-09-23

सूचना पत्रक

ANASTROZOLE PHARMACARE 1MG FILM-COATED TABLETS
Anastrozole 1mg
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,
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,
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 Pharmacare is and what it is used
for
2.
What you need to know before you take Anastrozole
Pharmacare
3.
How to take Anastrozole Pharmacare
4.
Possible side effects
5.
How to store Anastrozole Pharmacare
6.
Contents of the pack and other information
1.
WHAT ANASTROZOLE PHARMACARE IS AND WHAT IT IS USED
FOR
Anastrozole Pharmacare contains a medicine called
Anastrozole. Anastrozole belongs to a group of medicines
called ‘aromatase inhibitors’. Anastrozole Pharmacare is
used to treat breast cancer in post-menopausal women.
Anastrozole Pharmacare 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANASTROZOLE
PHARMACARE
DO NOT TAKE ANASTROZOLE PHARMACARE:
-
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 section
called “Pregnancy and breast-feeding”).
Do not take Anastrozole Pharmacare if any of the above
applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Anastrozole Pharmacare.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking
Anastrozole Pharmacare:
-
if you still have menstrual periods and have not yet
gone through the menop

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anastrozole Pharmacare 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 91 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 and biconvex tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anastrozole Pharmacare is indicated for:

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 Pharmacare 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 Pharmacare 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 Pharmacare
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 Pharmacare should be taken orally.
4.3
CONTRAINDICATIONS
Anastrozole Pharmacare is contraindicated in:

Pregnant or breast-feeding women.

Patients with known