AROMASTAN F.C. TABLET 25MG

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Exemestane

Доступно од:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

АТЦ код:

L02BG06

Фармацеутски облик:

TABLET, FILM COATED

Састав:

Exemestane 25 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

S.C. SINDAN-PHARMA S.R.L.

Статус ауторизације:

ACTIVE

Датум одобрења:

2017-05-11

Карактеристике производа

1. NAME OF THE MEDICINAL PRODUCT
AROMASTAN F.C. TABLET 25MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg exemestane.
For List of Excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablets
White, round, biconvex film-coated tablets, with uniform appearance
and intact edges.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Exemestane is indicated for the adjuvant treatment of post-
menopausal women with estrogen-receptor positive invasive early
breast cancer, following 2-3 years of initial adjuvant tamoxifen
therapy.
Exemestane is indicated for the treatment of advanced breast
cancer in women with natural or induced post-menopausal status
whose disease has progressed following anti- estrogen therapy.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Adult and Elderly Patients
The recommended dose of exemestane is one 25 mg tablet to be
taken once daily, preferably after a meal.
In patients with early breast cancer, treatment with exemestane
should continue until completion of five years of combined
sequential adjuvant hormonal therapy (tamoxifen followed by
exemestane), or earlier if tumor relapse occurs.
In patients with advanced breast cancer, treatment with
exemestane should continue until tumor progression is evident.
Hepatic or Renal Insufficiency
No dose adjustments are required for patients with hepatic or renal
insufficiency.
Children
Not recommended for use in children.
4.3. CONTRAINDICATIONS
Exemestane is contraindicated in patients with a known
hypersensitivity to the drug or to any of the excipients.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Because of its mode of action, exemestane should not be
administered to women with pre-menopausal endocrine status.
Therefore, whenever clinically appropriate, the post-menopausal
status should be ascertained by assessment of LH, FSH and
estradiol levels.
Exemestane should not be co-administered with estrogen-
containing products as these would negate its pharmacological
action.
Exemestane should be used with caution in patien