Arimidex 1mg Film-coated Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Anastrozole

Inapatikana kutoka:

Laboratoires Juvise Pharmaceuticals

ATC kanuni:

L02BG; L02BG03

INN (Jina la Kimataifa):

Anastrozole

Kipimo:

1 milligram(s)

Dawa fomu:

Film-coated tablet

Eneo la matibabu:

Aromatase inhibitors; anastrozole

Idhini hali ya:

Marketed

Idhini ya tarehe:

2000-08-11

Taarifa za kipeperushi

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIMIDEX AND ASSOCIATED NAMES 1 MG FILM-COATED TABLETS
[TO BE COMPLETED NATIONALLY]
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 Arimidex is and what it is used for
2.
What you need to know before you take Arimidex
3.
How to take Arimidex
4.
Possible side effects
5.
How to store Arimidex
6.
Contents of the pack and other information
1.
WHAT ARIMIDEX IS AND WHAT IT IS USED FOR
Arimidex contains a substance called anastrozole. This belongs to a
group of medicines called ‘aromatase
inhibitors’. Arimidex is used to treat breast cancer in women who
have gone through the menopause.
Arimidex 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 ARIMIDEX
DO NOT TAKE ARIMIDEX
-
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 Arimidex if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist
before taking Arimidex.
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before taking Arimidex
-
if you still have menstrual periods and have not yet gone through the
menopause.
-
if you are taking a medicine that contains tamoxifen or med

Tabia za bidhaa

Health Products Regulatory Authority
09 June 2021
CRN00C8WD
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arimidex 1mg 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 93 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, biconvex film-coated tablets of about 6.1 mm marked with
‘A’ on one side and ‘Adx1’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arimidex 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 Arimidex 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 _
Arimidex 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 Arimidex 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
Arimidex should be taken orally.
Health Products Regulatory Authority
09 June 2021
CRN0