Tenox Tablets 10 mg

Pays: Singapour

Langue: anglais

Source: HSA (Health Sciences Authority)

Ingrédients actifs:

Amlodipine besilate 13.88 mg equivalent to Amlodipine

Disponible depuis:

SINGAPORE PHARMACEUTICAL PRIVATE LIMITED

Code ATC:

C08CA01

Dosage:

10mg

forme pharmaceutique:

TABLET

Composition:

Amlodipine besilate 13.88 mg equivalent to Amlodipine 10mg

Mode d'administration:

ORAL

Type d'ordonnance:

Prescription Only

Fabriqué par:

Krka, d.d., Novo mesto

Statut de autorisation:

ACTIVE

Date de l'autorisation:

2014-05-19

Résumé des caractéristiques du produit

SmPCPIL146145_3
10.03.2020 – Updated: 03.03.2022
Page 1 of 10
TENOX TABLETS 5 MG P I
TENOX TABLETS 10 MG P I
1.
NAME OF THE MEDICINAL PRODUCT
Tenox 5 mg tablets
Tenox 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenox 5 mg tablets:
Each tablet contains 5 mg amlodipine (as amlodipine besilate).
Tenox 10 mg tablets:
Each tablet contains 10 mg amlodipine (as amlodipine besilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Tenox 5 mg:
The tablets are white, round (diameter 8 mm), slightly biconvex
tablets with bevelled-edges, scored on
one side. The tablet can be divided into equal halves.
Tenox 10 mg:
The tablets are white, round (diameter 10.5 mm), slightly biconvex
tablets with bevelled-edges.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypertension
Amlodipine is indicated for the first-line treatment of hypertension
and can be used as the sole agent to
control blood pressure in the majority of patients. Patients not
adequately controlled on a single
antihypertensive agent may benefit from the addition of amlodipine,
which has been used in
combination with a thiazide diuretic, alpha blockers, beta
adrenoceptor blocking agent, or an
angiotensin-converting enzyme (ACE) inhibitor.
Coronary Artery Disease
_Chronic Stable Angina _
Amlodipine is indicated for the symptomatic treatment of chronic
stable angina. Amlodipine may be
used alone or in combination with other antianginal drugs.
_Vasospastic Angina (Prinzmetal’s or Variant Angina) _
Amlodipine is indicated for the treatment of confirmed or suspected
vasospastic angina. Amlodipine
may be used as monotherapy, or in combination with other antianginal
drugs.
_Angiographically Documented Coronary Artery Disease _
In patients with recently documented coronary artery disease (CAD) by
angiography and without heart
SmPCPIL146145_3
10.03.2020 – Updated: 03.03.2022
Page 2 of 10
failure or an ejection fraction <40%, amlodipine is indicated to
reduce the risk of hospitalization due
to angina and to reduce the