Aremed tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

anastrozole

Available from:

Remedica Ltd

ATC code:

L02BG03 վերարտադրված դեղի առաջին դեղաձև, դեղաչափ

INN (International Name):

anastrozole

Dosage:

1mg (28/2x14/) in blister

Pharmaceutical form:

tablets film-coated

Units in package:

1mg (28/2x14/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-06-30

Patient Information leaflet

P18-0680 RPILEC
000499
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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.
-
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. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Aremed is and what it is used for
2. What you need to know before you take Aremed
3. How to take Aremed
4. Possible side effects
5. How to store Aremed
6. Contents of the pack and other information
1. WHAT AREMED IS AND WHAT IT IS USED FOR
Aremed contains a substance called anastrozole. This
belongs to a group of medicines called ‘aromatase
inhibitors’. Aremed is used to treat breast cancer in
women who have gone through the menopause.
Aremed 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 AREMED
DO NOT TAKE AREMED
•
if you are allergic to anastrozole or any of the other
ingredient of this medicine (listed in section 6).
•
if you are pregnant or breast-feeding (see section
called ‘Pregnancy, breast-feeding and fertility’).
Do not take Aremed if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before taking Aremed.
WARNINGS AND PRECAUTIONS
Talk
to
your
doctor
or
pharmacist
before
taking
Aremed.
•
if you still have menstrual periods and have not gone
through the menopause.
•
if you are taking a medicine that contains tamoxifen
or medicines that contain estrogen (see the section
called ‘Other medicines and Aremed’).
•
if you have ever had a condition that affects the
strength of your bones (oste

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aremed 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
Excipient(s) with known effect
This product contains 65 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, film-coated tablets with a diameter of 6,6 mm
approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aremed 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 Aremed for adults including the elderly in one
1 mg tablet once a day.
_Special populations _
Paediatric population:
Aremed 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 Aremed should be
performed with caution (see
section 4.4 and 5.2).
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_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
Oral administration.
4.3
CONTRAINDICATIONS
Aremed is contra-indicated in:

pregnant or breast-feeding women.

hypersensitivity to the active substance(s) or to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
General
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 patients where there is doubt about menopausal status.
There are no data to support
the use of anastrozole with LHRH analogues.
Co-administra