Olmesartan medoxomil/Amlodipine 40 mg/5 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Olmesartan medoxomil; Amlodipine

제공처:

Accord Healthcare Ireland Ltd.

ATC 코드:

C09DB; C09DB02

INN (국제 이름):

Olmesartan medoxomil; Amlodipine

복용량:

40/5 mg/mg

약제 형태:

Film-coated tablet

치료 영역:

Angiotensin II antagonists and calcium channel blockers; olmesartan medoxomil and amlodipine

승인 상태:

Marketed

승인 날짜:

2018-01-05

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLMESARTAN MEDOXOMIL/AMLODIPINE 20 MG/5 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE 40 MG/5 MG FILM-COATED TABLETS OLMESARTAN MEDOXOMIL/AMLODIPINE 40 MG/10 MG FILM-COATED TABLETS
Olmesartan medoxomil/Amlodipine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Olmesartan medoxomil/Amlodipine is and what it is used for
2.
What you need to know before you take Olmesartan medoxomil/Amlodipine
3.
How to take Olmesartan medoxomil/Amlodipine
4.
Possible side effects
5.
How to store Olmesartan medoxomil/Amlodipine
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE IS AND WHAT IT IS USED FOR
Olmesartan medoxomil/Amlodipine contains two substances called
olmesartan medoxomil and
amlodipine (as amlodipine besilate). Both of these substances help to
control high blood pressure.
•
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”. Amlodipine
stops calcium from moving into the blood vessel wall which stops the
blood vessels from
tightening thereby also reducing blood pressure.
The actions of both these substances contribute to stopping the
tightening of blood vessels, so that
blood vessels relax and blood pressure decreases.
Olmesartan medoxomil/Amlodipine is used for the treatment of high
blood pressure in patients whose
blo

제품 특성 요약

Health Products Regulatory Authority
02 March 2023
CRN00DF5Q
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/Amlodipine 40 mg/5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil and 5 mg
amlodipine (as amlodipine besilate).
Excipients- with known effect:
Each 40 mg/5 mg film-coated tablet contains 10 mg of lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, round, film-coated tablets debossed with “OA3”
on one side and plain on other side.
Dimension: Diameter 8.10 mm ± 0.20 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan medoxomil/Amlodipine is indicated in adult patients whose
blood pressure is not adequately controlled on
olmesartan medoxomil or amlodipine monotherapy (see section 4.2 and
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended dosage of Olmesartan medoxomil/Amlodipine is 1 tablet
per day.
Olmesartan medoxomil/Amlodipine 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.
Olmesartan medoxomil/Amlodipine 40 mg/5 mg may be administered in
patients whose blood pressure is not adequately
controlled by Olmesartan medoxomil/Amlodipine 20 mg/5 mg.
Olmesartan medoxomil/Amlodipine 40 mg/10 mg may be administered in
patients whose blood pressure is not adequately
controlled by Olmesartan medoxomil/Amlodipine 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 may be considered.
For convenience, patients receiving olmesartan medoxomil and
amlodipine from separate tablets may be switched to
Olmesartan medoxomil/Amlodipine tablets containing the same com