Olmetec Plus 40 12.5 mg

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Hydrochlorothiazide; Olmesartan medoxomil

Fáanlegur frá:

PFIZER PRIVATE LIMITED

Skammtar:

12.50 mg

Lyfjaform:

TABLET, FILM COATED

Samsetning:

Hydrochlorothiazide 12.50 mg; Olmesartan medoxomil 40.00mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Daiichi Sankyo Europe GmbH

Leyfisstaða:

ACTIVE

Leyfisdagur:

2007-05-22

Upplýsingar fylgiseðill

Page 1 of 18 

OLMETEC 
PLUS
TM

(OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) 

1. TRADENAME OF THE MEDICINAL PRODUCT 

Olmetec Plus
TM
 20/12.5 mg 
Olmetec Plus
TM
 40/12.5 mg 
Olmetec Plus
TM
 40/25 mg 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Olmetec Plus
TM
 20/12.5 mg tablet contains 20 mg of olmesartan medoxomil and
12.5 mg of 
hydrochlorothiazide. 

Olmetec Plus
TM
 40/12.5 mg tablet contains 40 mg of olmesartan medoxomil and
12.5 mg of 
hydrochlorothiazide. 

Olmetec Plus
TM
 40/25 mg tablet contains 40 mg of olmesartan medoxomil
and 25 mg of 
hydrochlorothiazide. 

For excipients, see 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablets. 

Olmetec Plus
TM
 20 mg/12.5 mg: reddish-yellow, circular, film-coated
tablets, approximately 
8.5 mm in diameter, with "C22" debossed on one side. 

Olmetec Plus
TM
 40 mg/12.5 mg: reddish-yellow, oval, film-coated
tablets, approximately 
15 x 7 mm, with "C23" debossed on one side. 

Olmetec Plus
TM
 40 mg/25 mg: pink, oval, film-coated
tablets, approximately 15 x 7 mm, with 
"C25" debossed on one side. 

4. CLINICAL PARTICULARS 

Olmetec Plus
TM
 (olmesartan medoxomil-hydrochlorothiazide) is a combination
of an angiotensin II 
receptor antagonist (AT1 subtype), olmesartan medoxomil, and a
thiazide diuretic, 
hydrochlorothiazide (HCTZ). 

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan
during absorption from the 
gastrointestinal tract. 

Olmesartan medoxomil
is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[_p_-(o-
1_H _tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. 

USE IN PREGNANCY 

WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD
TRIMESTERS, DRUGS THAT ACT DIRECTLY ON THE 
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE
DEVELOPING FETUS. When pregnancy is 
detected, Olmesartan medoxomil

Vara einkenni

OLMETEC PLUS
TM
(OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE)
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, DRUGS
THAT ACT
DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN
DEATH TO THE
DEVELOPING FETUS. When pregnancy is detected, olmesartan medoxomil and
hydrochlorothiazide should be discontinued as soon as possible (see
WARNINGS,
FETAL/NEONATAL MORBIDITY AND MORTALITY).
1. TRADE NAME OF THE MEDICINAL PRODUCT
Olmetec Plus
TM
20/12.5 mg
Olmetec Plus
TM
40/12.5 mg
Olmetec Plus
TM
40/25 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmetec Plus
TM
20/12.5 mg tablet contains 20 mg of olmesartan medoxomil and
12.5 mg of hydrochlorothiazide.
Olmetec Plus
TM
40/12.5 mg tablet contains 40 mg of olmesartan medoxomil and
12.5 mg of hydrochlorothiazide.
Olmetec Plus
TM
40/25 mg tablet contains 40 mg of olmesartan medoxomil and 25 mg
of hydrochlorothiazide.
For excipients, see 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Olmetec Plus
TM
20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets,
approximately 8.5 mm in diameter, with "C22" debossed on one side.
Olmetec Plus
TM
40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets,
approximately 15 x 7 mm, with "C23" debossed on one side.
Olmetec Plus
TM
40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7
mm, with "C25" debossed on one side.
4. CLINICAL PARTICULARS
Olmetec Plus
TM
(olmesartan medoxomil-hydrochlorothiazide) is a combination of an
angiotensin II receptor antagonist (AT
1
subtype), olmesartan medoxomil, and a
thiazide diuretic, hydrochlorothiazide (HCTZ).
Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during
absorption
from the gastrointestinal tract.
Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl
4-(1-hydroxy-1-methylethyl)-2-
propyl-1-[_p_-(o-1_H
_tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-
carbonate.
Its empirical formula is C
29
H
30
N
6
O
6
and its structural formula is:
Olmesartan medoxomil is a white to light yellowish-white powder or
crystall