OLMESARTAN MEDOXOMIL/AMLODIPINE TEVA 40/10 Film Coated Tablet

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE

Dostupné z:

Teva B.V.

ATC kód:

C09DB02

INN (Medzinárodný Name):

OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE

Dávkovanie:

40/10

Forma lieku:

Film Coated Tablet

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Angiotensin II antagonists and calcium channel blockers

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2017-12-15

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
OLMESARTAN MEDOXOMIL/AMLODIPINE TEVA 20 MG/5 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE TEVA 40 MG/5 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE TEVA 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 Teva is and what it is used for
2.
What you need to know before you take Olmesartan medoxomil/amlodipine
Teva
3.
How to take Olmesartan medoxomil/amlodipine Teva
4.
Possible side effects
5.
How to store Olmesartan medoxomil/amlodipine Teva
6.
Contents of the pack and other information
1.
WHAT OLMESARTAN MEDOXOMIL/AMLODIPINE TEVA IS AND WHAT IT IS USED FOR
Olmesartan medoxomil/amlodipine Teva 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 Teva is used for the treatme

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/amlodipine Teva 40 mg/10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmesartan medoxomil/amlodipine Teva 40 mg/10 mg film-coated tablets:
Each film-coated tablet of Olmesartan medoxomil/amlodipine Teva
contains 40 mg of olmesartan medoxomil and 10
mg of amlodipine (as amlodipine besilate).
For the full list of excipients, see section 6.1.
Excipient with known effect:
Each 40 mg/10 mg tablet contains 24.60mg lactose monohydrate
3 PHARMACEUTICAL FORM
Film-coated tablet
Brownish red, round standard convex, film coated tablets, debossed
with "10" on one side, the other side of the tablet is
scored and debossed with "4" on the left side of the score and "0" on
the right side. The tablet can be divided into equal
doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmesartan medoxomil/amlodipine Teva 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 Teva is 1
tablet per day.
Olmesartan medoxomil/amlodipine Teva 40 mg/10 mg may be administered
in patients whose blood pressure is not
adequately controlled by Olmesartan medoxomil/amlodipine Teva 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 Teva tablets containing the same
component doses.
Olmesartan medoxomil/amlodipine Teva can be taken with or without
food.
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