APO-Perindopril Arginine/Amlodipine 10/5 perindopril arginine 10 mg and amlodipine (as besilate) 5 mg uncoated tablet blister pack

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

amlodipine besilate, Quantity: 6.94 mg; perindopril arginine, Quantity: 10 mg

Dostupné z:

Arrotex Pharmaceuticals Pty Ltd

INN (Medzinárodný Name):

amlodipine besilate,perindopril arginine

Forma lieku:

Tablet

Zloženie:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate

Spôsob podávania:

Oral

Počet v balení:

30

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.

Prehľad produktov:

Visual Identification: White to off-white coloured, triangular-shaped biconvex tablets engraved with 'APO' on one side and '10/5' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

2016-01-12

Súhrn charakteristických

1
AUSTRALIAN PRODUCT INFORMATION
APO-PERINDOPRIL ARGININE/AMLODIPINE
(PERINDOPRIL ARGININE AND AMLODIPINE (AS
BESILATE)) TABLETS
1
NAME OF THE MEDICINE
Perindopril arginine and amlodipine besilate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril arginine and amlodipine (as besilate) combination tablets
contains the following
amount of perindopril arginine and amlodipine (as besilate
1
) respectively: 5 mg/5 mg, 5 mg/10
mg, 10 mg/5 mg & 10 mg/10 mg.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
5 MG/5 MG TABLET
White to off-white coloured, oval-shaped biconvex tablets engraved
with “APO” on one side
and “5/5” on the other side.
5 MG/10 MG TABLET
White to off-white coloured, square-shaped biconvex tablets engraved
with “APO” on one side
and “5/10” on the other side.
10 MG/5 MG TABLET
White to off-white coloured, triangular-shaped biconvex tablets
engraved with “APO” on one
side and “10/5” on the other side.
10 MG/10 MG TABLET
White to off-white coloured, round-shaped biconvex tablets engraved
with “APO” on one side
and “10/10” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Perindopril arginine and amlodipine combination tablets are indicated
as substitution therapy
for the treatment of hypertension and/or stable coronary heart disease
in patients already
controlled with separate doses of perindopril and amlodipine, given
concurrently at the same
dose level. Treatment should not be initiated with this combination.
4.2
DOSE AND METHOD OF ADMINISTRATION
Perindopril Arginine/Amlodipine tablets are intended for oral
administration.
1
Amlodipine doses are given as the active base.
2
Perindopril arginine and amlodipine (as besilate) combination tablet
is available in strengths of
5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg as substitution
therapy for patients
already controlled with separate doses of perindopril (5 mg or 10 mg)
and amlodipine (5 mg
or 10 mg), given concurrently at the dose level as indicated in