Arrow - Losartan potassium & Hydrochlorothiazide

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Hydrochlorothiazide 12.5mg; Losartan potassium 50mg;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Hydrochlorothiazide 12.5 mg

Dosage:

50mg/12.5mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Hydrochlorothiazide 12.5mg Losartan potassium 50mg   Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Purified water   Quinoline yellow Starch Titanium dioxide

Units in package:

Blister pack, white opaque PVDC coated PVC blister /Al foil closure, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Ipca Laboratories Limited

Therapeutic indications:

for the treatment of hypertension, for patients in whom combination therapy is appropriate

Product summary:

Package - Contents - Shelf Life: Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 14 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 50 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 80 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 84 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 90 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 98 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, white opaque PVDC coated PVC blister /Al foil closure - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2009-04-07

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
ARROW – LOSARTAN POTASSIUM & HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM 50 MG AND HYDROCHLOROTHIAZIDE 12.5 MG TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using ARROW –
LOSARTAN POTASSIUM
& HYDROCHLOROTHIAZIDE.
This leaflet answers some common questions about ARROW – LOSARTAN
POTASSIUM &
HYDROCHLOROTHIAZIDE. It does not contain all of the available
information. It does not
take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of you using
ARROW – LOSARTAN POTASSIUM & HYDROCHLOROTHIAZIDE against the
benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine. You may need to read it again.
WHAT ARROW – LOSARTAN POTASSIUM &
HYDROCHLOROTHIAZIDE IS USED FOR
ARROW – LOSARTAN POTASSIUM & HYDROCHLOROTHIAZIDE is a combination of
an
angiotensin II receptor antagonist (losartan) and a diuretic
(hydrochlorothiazide). Losartan
and hydrochlorothiazide work together to lower high blood pressure.
Losartan lowers blood
pressure by specifically blocking a substance called angiotensin II.
Angiotensin II normally
tightens your blood vessels. The losartan ingredient in ARROW –
LOSARTAN POTASSIUM
& HYDROCHLOROTHIAZIDE allows them to relax. Hydrochlorothiazide works
by making
your kidneys pass more water and salt.
ARROW – LOSARTAN POTASSIUM & HYDROCHLOROTHIAZIDE lowers high blood
pressure, which doctors call hypertension. It may be used alone or in
combination with other
medicines. In patients with high blood pressure and a thickening of
the left ventricle, losartan,
often in combination with hydrochlorothiazide, reduces the risk of
stroke and heart attack and
helps patients live longer.
Everyone has blood pressure. This pressure helps get your blood all
around your body. Your
blood pressure may be different at different times of the day,
depending on how busy or
worried you

Summary of Product characteristics

Version 2.3
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Arrow-Losartan potassium & Hydrochlorothiazide, film-coated tablets 50
mg/12.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains losartan potassium 50 mg and hydrochlorothiazide
12.5 mg.
Excipient with known effect:
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Yellow coloured, oval shaped, biconvex, film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPERTENSION
Arrow-Losartan potassium and Hydrochlorothiazide is indicated for the
treatment of hypertension, for
patients in whom combination therapy is appropriate.
REDUCTION IN THE RISK OF CARDIOVASCULAR MORBIDITY AND MORTALITY IN
HYPERTENSIVE PATIENTS WITH
LEFT VENTRICULAR HYPERTROPHY
Arrow-Losartan
potassium
and
Hydrochlorothiazide
is
a
combination
of
losartan
and
hydrochlorothiazide. In patients with hypertension and left
ventricular hypertrophy, losartan, often in
combination with hydrochlorothiazide, reduces the risk of
cardiovascular morbidity and mortality as
measured by the combined incidence of cardiovascular death, stroke,
and myocardial infarction in
hypertensive patients with left ventricular hypertrophy (see section
4.4
SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE, _RACE_
).
4.2
DOSE AND METHOD OF ADMINISTRATION
Dose
HYPERTENSION
The usual starting and maintenance dose of Arrow-Losartan potassium
and Hydrochlorothiazide is one
tablet once daily. For patients who do not respond adequately to one
tablet, the dosage may be increased
to two tablets once daily. The maximum dose is two tablets once daily.
In general the antihypertensive
effect is attained within three weeks after initiation of therapy.
Arrow-Losartan potassium and Hydrochlorothiazide should not be
initiated in patients who are
intravascularly volume-depleted (e.g. those treated with high-dose
diuretics).
REDUCTION IN THE RISK OF CARDIOVASCULAR MORBIDITY AND MORTALITY IN
HYPERTENSIVE PATIENTS WITH
LEFT VENTRICULAR HYPERTROPHY
The usual starting dose is 50 mg of losarta