Olmesartan /Amlodipine Mylan 20 mg/ 5 mg film coated tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Olmesartan medoxomil; Amlodpine besilate

Saatavilla:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-koodi:

C09DB; C09DB02

INN (Kansainvälinen yleisnimi):

Olmesartan medoxomil; Amlodpine besilate

Annos:

20mg/5 milligram(s)

Lääkemuoto:

Film-coated tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

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

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2018-05-18

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Olmesartan /Amlodipine Mylan 20 mg/5 mg film-coated tablets
Olmesartan /Amlodipine Mylan 40 mg/5 mg film-coated tablets
Olmesartan /Amlodipine Mylan 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 /Amlodipine Mylan is and what it is used for
2.
What you need to know before you take Olmesartan /Amlodipine Mylan
3.
How to take Olmesartan /Amlodipine Mylan
4.
Possible side effects
5.
How to store Olmesartan /Amlodipine Mylan
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN /AMLODIPINE MYLAN IS AND WHAT IT IS USED FOR
Olmesartan /Amlodipine Mylan 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 /Amlodipine Mylan is used for the treatment of high blood
pressure in patients whose blood pressure is
not controlled enough with e

Valmisteyhteenveto

Health Products Regulatory Authority
14 March 2024
CRN00F6HG
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan /Amlodipine Mylan 20 mg/ 5 mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5
mg of amlodipine (as amlodipine besilate).
Excipients with known effects
Each Olmesartan /Amlodipine Mylan 20 mg/5 mg film-coated tablet
contains 1.0 mg (0.04 mmol) of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
white, round, biconvex, film-coated tablet, approximately 7.4 mm
diameter and debossed with ‘M’ on one side and ‘OA1’ on
the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan /Amlodipine Mylan 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).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
The recommended dosage of Olmesartan /Amlodipine Mylan is 1 tablet per
day.
Olmesartan /Amlodipine Mylan 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.
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 /Amlodipine Mylan tablets containing the same component
doses.
Olmesartan /Amlodipine Mylan can be taken with or without food.
Elderly (age 65 years or over)
No adjustment of the recommended dose is generally required for
elderly people but increase of the dosage should take place
with care (see sections 4.4 and 5.2).
If up-titration to the maximum dose of 40 mg olmesartan medoxomi