OLMETEC PLUS 4012.5MG FILM-COATED TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Unit dalam pakej:

30 mcg/mL

Dikeluarkan oleh:

DAIICHI SANKYO EUROPE GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
OLMETEC PLUS
®
TABLET
Olmesartan Medoxomil and Hydrochlorothiazide (20 mg/12.5 mg, 40
mg/12.5 mg)
WHAT IS IN THIS LEAFLET
1.
What Olmetec Plus is used for
2.
How Olmetec Plus works
3.
Before you use Olmetec Plus
4.
How to use Olmetec Plus
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Olmetec
Plus
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT OLMETEC PLUS IS USED FOR
Olmetec Plus is used to treat high
blood pressure in patients whose blood
pressure is not adequately controlled
with olmesartan medoxomil or
hydrochlorothiazide alone.
HOW OLMETEC PLUS WORKS
Olmetec Plus contains two active
substances, olmesartan medoxomil
and hydrochlorothiazide.
-
Olmesartan medoxomil belongs to a
group of medicines called
angiotensin II-receptor antagonists.
It lowers blood pressure by relaxing
the blood vessels.
-
Hydrochlorothiazide belongs to a
group of medicines called thiazide
diuretics (“water tablets”). It lowers
blood pressure by helping the body
to get rid of extra fluid by making
your kidneys produce more urine.
BEFORE YOU USE OLMETEC PLUS
-
_When you must not use it_
Do not take Olmetec Plus if you:
- are allergic to olmesartan
medoxomil or hydrochlorothiazide
or sulphonamides, or any of the
other ingredients of Olmetec Plus
- are in the second and third
trimesters of pregnancy
- have severe kidney problems
- suffer from low potassium, low
sodium, high calcium or high uric
acid levels in the blood
- have severe liver problems or have
problems with drainage of the bile
from the gallbladder or liver
(biliary obstruction and
cholestasis)
_Pregnancy and lactation_
Do not take Olmetec Plus if you are
pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Olmetec Plus if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it_
Before you take Olmetec Plus, tell
your doctor if you:
- have diarrhea,

Ciri produk

1
OLMETEC PLUS

(Olmesartan medoxomil and hydrochlorothiazide combination)
1.
NAME OF THE MEDICINAL PRODUCT
Olmetec Plus 20 mg/12.5 mg film-coated tablets
Olmetec Plus 40 mg/12.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olmetec Plus 20 mg/12.5 mg film-coated tablet:
Each
film-coated
tablet
contains
20
mg
olmesartan
medoxomil
and
12.5
mg
hydrochlorothiazide.
Olmetec Plus 40 mg/12.5 mg film-coated tablet:
Each
film-coated
tablet
contains
40
mg
olmesartan
medoxomil
and
12.5
mg
hydrochlorothiazide.
Excipients:
Olmetec Plus tablet contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Olmetec Plus 20 mg/12.5 mg film-coated tablet: Reddish-yellow, round,
film-coated tablet
with C22 debossed on one side.
Olmetec Plus 40 mg/12.5 mg film-coated tablet: Reddish-yellow, oval,
film-coated tablet
with C23 debossed on one side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of essential hypertension.
Olmetec Plus fixed dose combination is indicated in patients whose
blood pressure is not
adequately controlled on olmesartan medoxomil or hydrochlorothiazide
alone.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
_ADULTS_
Olmetec Plus is used in patients whose blood pressure is not
adequately controlled by
olmesartan medoxomil or hydrochlorothiazide alone.
Olmetec Plus is administered once
daily, with or without food.
When clinically appropriate, direct change from monotherapy to the
fixed combination
may be considered, taking into account that the antihypertensive
effect of olmesartan
medoxomil is maximal by about 8 weeks after initiating therapy (see
section 5.1). Dose
titration of the individual components is recommended:
2
Olmetec Plus 20 mg/12.5 mg may be administered in patients whose blood
pressure is
not adequately controlled by the optimal monotherapy olmesartan
medoxomil 20 mg
alone.
Olmetec Plus 40 mg/12.5 mg may be administered in patients whose blood
pressure is
not adequately controlled by olmesartan medoxomil