TELMISARTAN SANDOZ TABLETS 80MG

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Telmisartan

Dostupné z:

SANDOZ SINGAPORE PTE. LTD.

ATC kód:

C09CA07

Dávkovanie:

80mg

Forma lieku:

TABLET

Zloženie:

Telmisartan 80mg

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

Lek Pharmaceuticals d.d.

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2014-07-08

Súhrn charakteristických

TELMISARTAN SANDOZ
® TABLETS 40MG/ 80MG
Page
1
of
12
1.
NAME OF THE MEDICINAL PRODUCT
Telmisartan Sandoz Tablets 40 mg
Telmisartan Sandoz Tablets 80 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telmisartan Sandoz Tablets 40 mg
Each tablet contains 40 mg telmisartan.
Telmisartan Sandoz Tablets 80 mg
Each tablet contains 80 mg telmisartan.
_For a full list of excipients, see section 6.1. _
3.
PHARMACEUTICAL FORM
Tablet.
Telmisartan Sandoz Tablets 40 mg
White, oblong, plain tablet, scored on one side and debossed with
‘40’ on the other side.
Telmisartan Sandoz Tablets 80 mg
White, oblong, plain tablet, scored on one side and debossed with
‘80’ on the other side.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults.
Reduction of the risk of non-fatal stroke or non-fatal myocardial
infarction in adults 55 years or older at high
risk of developing major cardiovascular events who cannot tolerate an
angiotensin converting enzyme
inhibitor (ACEI).
High risk of cardiovascular events includes evidence of coronary
artery disease, peripheral arterial disease,
stroke, transient ischemic attack, or diabetes mellitus with evidence
of end-organ damage.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Treatment of essential hypertension
The recommended dose is 40 mg once daily. Some patients may already
benefit at a daily dose of 20 mg. In
cases where the target blood pressure is not achieved, telmisartan
dose can be increased to a maximum of 80
mg once daily. When considering raising the dose, it must be borne in
mind that the maximum
antihypertensive effect is generally attained four to eight weeks
after the start of treatment. Alternatively,
telmisartan may be used in combination with thiazide-type diuretics
such as hydrochlorothiazide or calcium-
channel-blockers such as amlodipine, which has been shown to have an
additive blood pressure lowering
effect with telmisartan.
In patients with severe hypertension treatment with telmi