Azoren 40 mg10 mg film-coated tablets

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

OLMESARTAN MEDOXOMIL; AMLODIPINE BESILATE

Beschikbaar vanaf:

PFIZER (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

OLMESARTAN MEDOXOMIL; AMLODIPINE BESILATE

Eenheden in pakket:

30tablet Tablets

Geproduceerd door:

DAIICHI SANKYO EUROPE GMBH

Bijsluiter

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AZOREN
® FILM COATED TABLETS
Olmesartan Medoxomil and Amlodipine (20 mg/5 mg, 40 mg/5 mg, 40 mg/10
mg)
1
WHAT IS IN THIS LEAFLET
1.
What Azoren is used for
2.
How Azoren works
3.
Before you use Azoren
4.
How to use Azoren
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Azoren
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT AZOREN IS USED FOR
Azoren is used for the treatment of
high blood pressure in patients whose
blood pressure is not controlled enough
with either olmesartan medoxomil or
amlodipine alone.
HOW AZOREN WORKS
Azoren contains two substances called
olmesartan medoxomil and amlodipine
(as amlodipine besylate).
•
Olmesartan medoxomil belongs to a
group of medicines called
“angiotensin-II receptor antagonists”
which lower blood pressure by
relaxing the blood vessels.
•
Amlodipine belongs to a group of
substances called “calcium channel
blockers”. It stops calcium from
moving into the blood vessel wall
which stops the blood vessels from
tightening.
BEFORE YOU USE AZOREN
-
_When you must not use it _
Do not take Azoren if you:
_ _
•
are allergic to olmesartan
medoxomil or to amlodipine or
dihydropyridines, or any of the
other ingredients of Azoren
•
are in the second or third trimester
of pregnancy
•
have severe liver problems
•
have bile ducts blockage
•
have very low blood pressure
•
are suffering from insufficient
blood supply to your tissues
(including insufficient blood
supply due to heart problems)
•
if the blood flow from your heart
is obstructed (e.g., because of the
narrowing of the artery).
•
suffer from low heart output after
a heart attack.
•
if you have diabetes mellitus or
renal impairment and are taking
aliskiren containing products
_Pregnancy and lactation _
Do not take Azoren if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Azoren if you are breast-
feeding as aml

Productkenmerken

1
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 6.94 mg).
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 6.94 mg).
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 13.89 mg).
Excipients:
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
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 adult patients whose blood pressure is not
adequately controlled on
olmesartan medoxomil or amlodipine monotherapy (see sections 4.2 and
5.1).
Treatment should not be initiated with fixed-dose combination.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should not be initiated with this combination.
2
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