Země: Singapur
Jazyk: angličtina
Zdroj: HSA (Health Sciences Authority)
Amlodipine besilate 13.88 mg equivalent to Amlodipine
SINGAPORE PHARMACEUTICAL PRIVATE LIMITED
C08CA01
10mg
TABLET
Amlodipine besilate 13.88 mg equivalent to Amlodipine 10mg
ORAL
Prescription Only
Krka, d.d., Novo mesto
ACTIVE
2014-05-19
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 Přečtěte si celý dokument