NEBIVOLOL STELLA TABLET 5MG

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Nebivolol Hydrochloride eqv Nebivolol

Предлага се от:

AUXILTO IMPEX PTE. LTD.

АТС код:

C07AB12

Лекарствена форма:

TABLET

Композиция:

Nebivolol Hydrochloride eqv Nebivolol 5 mg

Начин на приложение:

ORAL

Вид предписание :

Prescription Only

Произведено от:

STELLAPHARM J.V. CO., LTD. - BRANCH 1

Статус Оторизация:

ACTIVE

Дата Оторизация:

2022-05-04

Данни за продукта

_RX PRESCRIPTION ONLY_
NEBIVOLOL STELLA TABLET 5MG
1.
NAME OF THE MEDICINAL PRODUCT
NEBIVOLOL STELLA TABLET 5MG
2.
SPECIAL NOTICE AND RECOMMENDATION
Keep out of reach of children
Read the package insert carefully before use
3.
COMPOSITION
_Each tablet contains: _
_Active ingredient: _
Nebivolol (as nebivolol hydrochloride)
................................. 5 mg
_Excipients: _
Lactose
monohydrate,
pregelatinized
starch,
povidone
K30,
croscarmellose sodium, crospovidone, magnesium stearate and
colloidal anhydrous silica.
4.
PHARMACEUTICAL FORM
Tablet
White, round, biconvex tablet with cross score.
The tablet can be subdivided into equal doses.
5.
INDICATIONS
Hypertension
Treatment of essential hypertension.
Chronic heart failure (CHF)
Treatment of stable mild and moderate chronic heart failure in
addition to standard therapies in elderly patients of ≥ 70 years.
6.
ADMINISTRATION AND DOSAGE
_ADMINISTRATION _
Oral use.
The tablet can be taken with or without food.
_DOSAGE _
Hypertension
_Adults _
The dose is 5 mg daily, preferably at the same time of the day.
The blood pressure lowering effect becomes evident after 1-2
weeks of treatment. Occasionally, the optimal effect is reached
only after 4 weeks.
_Combination with other antihypertensive agents _
Beta-blockers can be used alone or concomitantly with other
antihypertensive agents. To date, an additional antihypertensive
effect has been observed only when nebivolol is combined with
hydrochlorothiazide 12.5-25 mg.
_Patients with renal insufficiency _
In patients with renal insufficiency, the recommended starting
dose is 2.5 mg daily. If needed, the daily dose may be increased
to 5 mg.
_Patients with hepatic insufficiency _
Data
in
patients
with
hepatic
insufficiency
or
impaired
liver
function are limited. Therefore, the use of nebivolol in these
patients is contraindicated.
_Elderly _
In patients over 65 years, the recommended starting dose is 2.5
mg daily. If needed, the daily dose may be increased to 5 mg.
However, in view of the limited experience in patients a