Azoren Film-Coated Tablet 40mg5mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Amlodipine besylate 6.944mg equivalent to amlodipine; Olmesartan medoxomil

Available from:

PFIZER PRIVATE LIMITED

ATC code:

C09DB02

Dosage:

5mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Amlodipine besylate 6.944mg equivalent to amlodipine 5mg; Olmesartan medoxomil 40mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Daiichi Sankyo Europe GmbH

Authorization status:

ACTIVE

Authorization date:

2011-06-06

Patient Information leaflet

 
1 
NAME OF THE MEDICINAL PRODUCT 
Azoren 20 mg/5 mg film-coated tablets. 
Azoren 40 mg/5 mg film-coated tablets. 
Azoren 40 mg/10 mg film-coated tablets. 
2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Azoren 20 mg/5 mg film-coated tablets: 
Each film-coated tablet of Azoren contains 20 mg of olmesartan
medoxomil and 5 mg 
of amlodipine (as amlodipine besylate). 
Azoren 40 mg/5 mg film-coated tablets: 
Each film-coated tablet of Azoren contains 40 mg of olmesartan
medoxomil and 5 mg 
of amlodipine (as amlodipine besylate). 
Azoren 40 mg/10 mg film-coated tablets: 
Each film-coated tablet of Azoren contains 40 mg of olmesartan
medoxomil and 
10 mg of amlodipine (as amlodipine besylate). 
For a full list of excipients (see section 6.1). 
3 
PHARMACEUTICAL FORM 
Film-coated tablet. 
Azoren 20 mg/5 mg film-coated tablets: 
White, round, film-coated tablet with C73 debossed on one side. 
Azoren 40 mg/5 mg film-coated tablets: 
Cream, round, film-coated tablet with C75 debossed on one side. 
Azoren 40 mg/10 mg film-coated tablets: 
Brownish-red, round, film-coated tablet with C77 debossed on
one side. 
4 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
Treatment of essential hypertension. 
Azoren is indicated in patients whose blood
pressure is not adequately controlled on 
olmesartan medoxomil or amlodipine monotherapy (see sections 4.2
and 5.1). 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
_Adults _
The recommended dosage of Azoren is 1 tablet per day. 
Azoren 20 mg/5 mg may be administered in patients whose blood
pressure is not 
adequately controlled by 20 mg olmesartan
medoxomil or 5 mg amlodipine alone. 
Azoren 40 mg/5 mg may be administered in patients whose blood
pressure is not 
adequately controlled by Azoren 20 mg/5 mg. 

Azoren 40 mg/10 mg may be administered in
patien

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Azoren 20 mg/5 mg film-coated tablets.
Azoren 40 mg/5 mg film-coated tablets.
Azoren 40 mg/10 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azoren 20 mg/5 mg film-coated tablets:
Each film-coated tablet of Azoren contains 20 mg of olmesartan
medoxomil and 5 mg of
amlodipine (as amlodipine besylate).
Azoren 40 mg/5 mg film-coated tablets:
Each film-coated tablet of Azoren contains 40 mg of olmesartan
medoxomil and 5 mg of
amlodipine (as amlodipine besylate).
Azoren 40 mg/10 mg film-coated tablets:
Each film-coated tablet of Azoren contains 40 mg of olmesartan
medoxomil and 10 mg of
amlodipine (as amlodipine besylate).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Azoren 20 mg/5 mg film-coated tablets:
White, round, film-coated tablet with C73 debossed on one side.
Azoren 40 mg/5 mg film-coated tablets:
Cream, round, film-coated tablet with C75 debossed on one side.
Azoren 40 mg/10 mg film-coated tablets:
Brownish-red, round, film-coated tablet with C77 debossed on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Azoren is indicated in patients whose blood pressure is not adequately
controlled on
olmesartan medoxomil or amlodipine monotherapy (see sections 4.2 and
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
The recommended dosage of Azoren is 1 tablet per day.
Azoren 20 mg/5 mg may be administered in patients whose blood pressure
is not adequately
controlled by 20 mg olmesartan medoxomil or 5 mg amlodipine alone.
Azoren 40 mg/5 mg may be administered in patients whose blood pressure
is not adequately
controlled by Azoren 20 mg/5 mg.
Azoren 40 mg/10 mg may be administered in patients whose blood
pressure is not adequately
controlled by Azoren 40 mg/5 mg.
A step-wise titration of the dosage of the individual components is
recommended before
changing to the fixed combination. When clinically appropriate, direct
change from
monotherapy to the fixed combination ma