LODOZ 5 MG TABLET

Country: Малезија

Језик: Енглески

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

Активни састојак:

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Доступно од:

MERCK SDN. BHD.

INN (Међународно име):

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Јединице у пакету:

100 Tablets; 30 Tablets; 90 Tablets; 50 Tablets; 60 Tablets

Произведен од:

Merck Healthcare KGaA

Информативни летак

Consumer Medication Information Leaflet (RiMUP)
1
LODOZ TABLET
Lodoz 2.5 mg / 6.25 mg:2.5 mg bisoprolol fumarate & 6.25 mg
hydrochlorothiazide
Lodoz 5 mg / 6.25 mg:5 mg bisoprolol fumarate & 6.25 mg
hydrochlorothiazide
What is in this leaflet
1.
What Lodoz is used for
2.
How Lodoz works
3.
Before you use Lodoz
4.
How to take Lodoz
5.
While you are using Lodoz
6.
Side Effects
7.
Storage and Disposal of Lodoz
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial number
What Lodoz is used for
The active substances are bisoprolol
and hydrochlorothiazide. This
medicine is recommended in the
treatment of high blood pressure in
patients whose blood pressure is not
sufficiently controlled by bisoprolol or
hydrochlorothiazide alone.
How does Lodoz works
Bisoprolol belongs to the family of
medicines called beta-blockers and it
is used to decrease blood pressure.
Bisoprolol slows down the heart rate
and makes the heart more efficient at
pumping blood around the body
Hydrochlorothiazide belongs to the
family of medicines called thiazide
diuretics (also known as “water
tablets”). Hydrochlorothiazide helps to
lower blood pressure by increasing the
elimination of urine.
Before you take Lodoz
-
When you must not take it
If you,
 are allergic to bisoprolol,
hydrochlorothiazide, other
thiazides, sulphonamides
(substances chemically related to
hydrochlorothiazide) or any of
the other ingredients of this
medicine.
 suffer from acute weakness of the
heart muscle (acute heart failure) or
if your heart muscle weakness is not
under control (decompensated heart
failure)
 suffer from shock due to a heart
attack (cardiogenic shock)
 have major disturbances of heart
rhythm (2nd and 3rd degree AV
block, sick sinus syndrome, sino-
atrial block)
 have a severely slowed heart rate
 suffer from severe forms of asthma
or any other breathing problems
such as chronic respiratory disorders
 have severe circulatory disorders
affecting the limbs (such as
Raynaud’s syndrome tha

Карактеристике производа

Lodoz® 2.5 mg/6.25 mg, film-coated tablet
Lodoz® 5 mg/6.25 mg, film-coated tablet
Bisoprolol fumarate
Hydrochlorothiazide
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lodoz 2.5 mg/6.25 mg, film-coated tablet:
Bisoprolol fumarate 2.5 mg
Hydrochlorothiazide 6.25 mg
Lodoz 5 mg/6.25 mg, film-coated tablet:
Bisoprolol fumarate 5 mg
Hydrochlorothiazide 6.25 mg
PHARMACEUTICAL FORM
Lodoz 2.5 mg/6.25 mg, film-coated tablet:
Film coated tablet
Yellow, round, biconvex upper side embossed heart, downside embossed
2.5.
Lodoz 5 mg/6.25 mg, film-coated tablet:
Film coated tablet
Pastel-pink, round, biconvex, upper side embossed heart, downside
embossed 5.
ROUTE OF ADMINISTRATION
Oral
CLINICAL PARTICULARS
Therapeutic indications
Mild to moderate hypertension.
Posology and method of administration
For individual therapy Lodoz is available in the strengths:
Lodoz 2.5/6.25 mg, film-coated tablets
Lodoz 5/6.25 mg, film-coated tablets
The initial dosage is one tablet containing bisoprolol 2.5 mg +
hydrochlorothiazide 6.25 mg once daily.
If inadequate response to treatment is obtained, the dosage should be
increased to one tablet containing
bisoprolol 5 mg + hydrochlorothiazide 6.25 mg in a once daily dose. If
latter proves to be insufficiently
effective, the dosage may be increased to bisoprolol 10 mg +
hydrochlorothiazide 6.25 mg once daily.
If discontinuation is necessary, gradual discontinuation of bisoprolol
treatment is recommended, since
abrupt withdrawal of bisoprolol may lead to an acute deterioration of
the patient‘s condition, in
particular in patients with ischaemic heart disease.
Lodoz should be swallowed in the morning and can be taken with food.
The film-coated tablets should be
swallowed with some liquid and not be chewed.
No dose adjustment is necessary in patients with mild-to-moderate
hepatic impairment or mild-to
moderate renal impairment (creatinine clearance > 30 mL/min).
Elderly: No dose adjustment is normally required
Paediatric population
Experience with Lodoz in paediatric patients is limited, therefore its
u