EXACCORD 25 FILM COATED TABLET 25 MG

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

Exemestane

Dostupné s:

ACCORD HEALTHCARE PRIVATE LIMITED

ATC kód:

L02BG06

Léková forma:

TABLET, FILM COATED

Složení:

Exemestane 25 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

Intas Pharmaceuticals Limited

Stav Autorizace:

ACTIVE

Datum autorizace:

2020-12-18

Charakteristika produktu

PACKAGE INSERT
(For the use of a Registered Medical Practitioner or a Hospital)
1. NAME OF THE MEDICINAL PRODUCT
EXACCORD 25 (Exemestane Tablets 25 mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains
Exemestane 25 mg
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex film coated tablets debossed with
‘E25’ on one side and
plain on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exemestane is indicated for the adjuvant treatment of postmenopausal
women with oestrogen
receptor positive invasive early breast cancer (EBC), 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
postmenopausal
status
whose
disease
has
progressed
following
anti-oestrogen
therapy. Efficacy has not been demonstrated in patients with oestrogen
receptor negative
status.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adult and elderly patients
The recommended dose of Exemestane is one 25 mg tablet to be taken
once a
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 tumour relapse occurs.
In patients with advanced breast cancer, treatment with Exemestane
should continue until
tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal
insufficiency (see 5.2).
Paediatric population
Not recommended for use in children
4.3
CONTRA-INDICATIONS
Exemestane tablets are contraindicated in patients with a known
hypersensitivity to the active
substance or to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Exemestane should not be administered to women with pre-menopausal
endocrine status.
Therefore, whenever clinically appropriate, the post-menopausal st