Presartan H 5012.5mg Film Coated Tablet

מדינה: מלזיה

שפה: אנגלית

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

מרכיב פעיל:

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

זמין מ:

THE ZYFAS MEDICAL CO.,

INN (שם בינלאומי):

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

יחידות באריזה:

28 Tablets; 28 Tablets

תוצרת:

IPCA LABORATORIES LIMITED

עלון מידע

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_PRESARTAN H 50/12.5MG FILM COATED TABLET _
Losartan Potassium, 50mg & Hydrochlorothiazide Tablets, 12.5mg
1
WHAT IS IN THIS LEAFLET:
1. What Presartan H 50 is used for
2. How Presartan H 50 works
3. Before you take Presartan H 50
4. How to take Presartan H 50
5. While you are using Presartan H 50
6. Side effects
7. After using Presartan H 50
8. Product Description
9. Manufacturer & Product
Registration Holder
WHAT PRESARTAN H 50 IS USED FOR
Presartan H 50 is indicated for the
treatment of essential hypertension
(high blood pressure). Presartan H 50
is a combination of an angiotensin II
receptor antagonist (losartan) and a
diuretic (hydrochlorothiazide).
HOW PRESARTAN H 50 WORKS
It is a medicine used to treat high
blood pressure. Losartan relaxes your
blood vessels and thus lowers your
blood pressure, whereas
hydrochlorothiazide works by making
your kidneys pass more water and
salt.
BEFORE YOU TAKE PRESARTAN H 50
_When you must not take it _
You should not take this medicine
when:
•
you are allergic
(hypersensitive) to losartan,
hydrochlorothiazide or to
any of the other ingredients
in this medicine
•
you are allergic
(hypersensitive) to other
sulfonamide-derived
substances (e.g. other
thiazides, some antibacterial
drugs such as co-
trimoxazole, ask your doctor
if you are not sure)
•
you are, think you may be or
are planning to become
pregnant
•
your kidneys are not
producing any urine
Inform your healthcare providers
before taking Presartan H 50 if
you have had skin cancer or if
you develop an unexpected skin
lesion during the treatment.
Treatment with
hydrochlorothiazide, particularly
long term use with high doses,
may increase the risk of some
types of skin and lip cancer
cancer (non-melanoma skin
cancer). Protect your skin from
sun exposure and UV rays while
taking Presartan H 50
_Before you start to take it _
Check with your doctor before
you take losartan and
hydrochlorothiazide tablets:
•
if you are diabetic
•
if you have had gout
•
if you ha

מאפייני מוצר

_PRESARTAN H 50/12.5 _
Losartan Potassium & Hydrochlorothiazide
50 mg / 12.5 mg Film-Coated Tablets
COMPOSITION
Each film-coated tablet contains:
Losartan potassium 50 mg
Hydrochlorothiazide 12.5 mg
PRODUCT DESCRIPTION
Yellow coloured, oval, biconvex, film coated tablet.
INDICATIONS
Presartan H 50/12.5 Film Coated Tablets is indicated for the
treatment of hypertension, for patients in whom combination therapy
is appropriate.
In hypertensive patients with left ventricular hypertrophy, a reduced
risk of stroke was demonstrated with losartan administered usually in
combination with hydrochlorothiazide.
DOSAGE AND METHOD OF ADMINISTRATION
Presartan H may be administered with other antihypertensive
agents. Presartan H may be administered with or without food.
Fixed dose combination is not indicated for initial therapy.
HYPERTENSION
The usual starting and maintenance dose of Presartan H 50/12.5 is
one tablet of Presartan H 50/12.5 (losartan potassium 50
mg/hydrochlorothiazide 12.5 mg) once daily. For patients who do not
respond adequately to Presartan H 50/12.5, the dosage may be
increased to one tablet of Presartan H 50/12.5 (losartan potassium
100mg/hydrochlorothiazide
25mg) once daily or two tablets of
Presartan H 50/12.5 once daily. The maximum dose is one tablet of
Presartan H 50/12.5 once daily or two tablets of Presartan H 50/12.5
once daily. In general, the antihypertensive effect is attained within
three weeks after initiation of therapy. Presartan H 50/12.5 (losartan
potassium 100 mg/hydrochlorothiazide 12.5 mg) is available for
those patients titrated to 100 mg of Losartan who require additional
blood pressure control.
Losartan Potassium should not be initiated in patients who are
intravascularly volume- depleted (e.g., those treated with high-dose
diuretics).
Losartan Potassium is not recommended for patients with severe
renal impairment (creatinine clearance ≤30 mL/min) or for patients
with hepatic impairment.
No initial dosage adjustment of Presartan H 50/12.5 is necessary for
elderly patients. Presarta