Sevikar Plus 40mg/5mg/12.5mg film coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Olmesartan medoxomil; Amlodipine besilate; Hydrochlorothiazide

Available from:

Daiichi Sankyo Ireland Ltd

ATC code:

C09DB; C09DB02

INN (International Name):

Olmesartan medoxomil; Amlodipine besilate; Hydrochlorothiazide

Dosage:

40 mg/5 mg/12.5 milligram(s)

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:

Not marketed

Authorization date:

2011-02-25

Patient Information leaflet

1
1.3.1.3 TEXT PROPOSED FOR THE PACKAGE LEAFLET
SEVIKAR PLUS 20 MG/5 MG/12.5 MG, 40 MG/5 MG/12.5 MG, 40 MG/10 MG/
12.5 MG, 40 MG/5 MG/25 MG, 40 MG/10 MG/25 MG
FILM-COATED TABLETS
VARIATION APPLICATION:
NL/H/1858/001-005/IA/045
Attached please find:
PROPOSED IE PIL- PROPOSED CLEAN
2
Package leaflet: Information for the user
SEVIKAR PLUS 20 MG/5 MG/12.5 MG FILM-COATED TABLETS
SEVIKAR PLUS 40 MG/5 MG/12.5 MG FILM-COATED TABLETS
SEVIKAR PLUS 40 MG/10 MG/12.5 MG FILM-COATED TABLETS
SEVIKAR PLUS 40 MG/5 MG/25 MG FILM-COATED TABLETS
SEVIKAR PLUS 40 MG/10 MG/25 MG FILM-COATED TABLETS
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE
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 Sevikar Plus is and what it is used for
2.
What you need to know before you take Sevikar Plus
3.
How to take Sevikar Plus
4.
Possible side effects
5.
How to store Sevikar Plus
6.
Contents of the pack and other information
1.
WHAT SEVIKAR PLUS IS AND WHAT IT IS USED FOR
Sevikar
Plus
contains
three
active
substances
called
olmesartan
medoxomil,
amlodipine (as amlodipine besilate) and hydrochlorothiazide. All three
substances
help to control high blood pressure.
•
Olmesartan medoxomil belongs to a group of medicines called
“angiotensin-II
receptor antagonists”, which lowers blood pressure by relaxing the
blood
vessels.
•
Amlodipine
belongs
to
a
group
of
substances
called
“calcium
channel
blockers”. Amlodipine also lowers blood pressure by relaxing blood
vessels.
•
Hydrochlorothiazide is one of a group of me

Summary of Product characteristics

Health Products Regulatory Authority
09 August 2022
CRN00D0G1
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sevikar Plus 40mg/5mg/12.5mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg olmesartan medoxomil, 5 mg
amlodipine (as amlodipine besilate) and 12.5 mg
hydrochlorothiazide.
Excipients with known effect
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, round, film-coated tablet of 9.5 mm debossed C53 on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
_ADD-ON THERAPY _
Sevikar Plus is indicated in adult patients whose blood pressure is
not adequately controlled on the combination of olmesartan
medoxomil and amlodipine taken as dual-component formulation.
_SUBSTITUTION THERAPY_
Sevikar Plus is indicated as substitution therapy in adult patients
whose blood pressure is adequately controlled on the
combination of olmesartan medoxomil, amlodipine and
hydrochlorothiazide, taken as a dual-component (olmesartan
medoxomil and amlodipine or olmesartan medoxomil and
hydrochlorothiazide) and a single-component formulation
(hydrochlorothiazide or amlodipine).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
The recommended dose of Sevikar Plus is 1 tablet per day.
_ADD-ON THERAPY_
Sevikar Plus 40 mg/5 mg/12.5 mg may be administered in patients whose
blood pressure is not adequately controlled on
olmesartan medoxomil 40 mg and amlodipine 5 mg taken as dual-component
combination or in patients whose blood
pressure is not adequately controlled on Sevikar Plus 20 mg/5 mg/12.5
mg.
A step-wise titration of the dosage of the individual components is
recommended before changing to the triple-component
combination. When clinically appropriate, direct change from
dual-component combination to the triple-component
combination may be considered.
_SUBSTITUTION THERAPY_
Patients controlled on stable doses of olmesartan medoxomil,
amlodip