OLMESARTAN MEDOXOMIL/AMLODIPINE TEVA 20/5 mg/mg Film Coated Tablet

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE

Доступна з:

Teva B.V.

Код атс:

C09DB02

ІПН (Міжнародна Ім'я):

OLMESARTAN MEDOXOMIL, AMLODIPINE BESILATE

Дозування:

20/5 mg/mg

Фармацевтична форма:

Film Coated Tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Angiotensin II antagonists and calcium channel blockers

Статус Авторизація:

Authorised

Дата Авторизація:

2017-12-15

інформаційний буклет

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

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olmesartan medoxomil/amlodipine Teva 20 mg/5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of Olmesartan medoxomil/amlodipine Teva
contains 20 mg of olmesartan medoxomil and 5 mg
of amlodipine (as amlodipine besilate).
For the full list of excipients, see section 6.1.
Excipient with known effect:
Each 20 mg/5 mg tablet contains 12.30 mg lactose monohydrate
3 PHARMACEUTICAL FORM
Film-coated tablet
White, round standard convex, film coated tablets, debossed with "5"
on one side, the other side of the tablet is scored
and debossed with "2" on the left side of the score and "0" on the
rightside.
The score line is only to facilitate breaking
for ease of swallowing and not to divide 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 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 medoxomil/amlodipine Teva tablets containing the same
component doses.
Olmesartan medoxomil/amlodipine Teva can be taken with or without
food.
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