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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amlodipine (as amlodipine besilate ph. eur.); Olmesartan medoxomil

Available from:

Accord Healthcare Limited

ATC code:

C09DB; C09DB02

INN (International Name):

Amlodipine (as amlodipine besilate ph. eur.); Olmesartan medoxomil

Dosage:

40/5 mg/mg

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2018-01-05

Patient Information leaflet

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
pharmacis.
- 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
bloo

Summary of Product characteristics

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 40 mg/5 mg may be administered in
patients whose blood pressure is not
adequately controlled by Olmesartan medoxomil/Amlodipine 20 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 component
doses.
Olmesartan medoxomil/Amlodipine can be taken with or without food.
Older people (age 65 years or over)
No adjustment of the recommended dose is generally required for older
people but increase of the dosage should take
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