Losartan Potassium Pinewood 12.5 mg film-coated tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Losartan potassium

Verfügbar ab:

Pinewood Laboratories Ltd,

ATC-Code:

C09CA; C09CA01

INN (Internationale Bezeichnung):

Losartan potassium

Dosierung:

12.5 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Angiotensin II antagonists, plain; losartan

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2007-10-12

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN POTASSIUM PINEWOOD 12.5 MG
LOSARTAN POTASSIUM PINEWOOD 50 MG
LOSARTAN POTASSIUM PINEWOOD 100 MG
FILM-COATED TABLETS
LOSARTAN POTASSIUM
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 Losartan Potassium Pinewood is and what it is used for
2.
What you need to know before you take Losartan Potassium Pinewood
3.
How to take Losartan Potassium Pinewood
4.
Possible side effects
5.
How to store Losartan Potassium Pinewood
6.
Contents of the pack and other information
1. WHAT LOSARTAN POTASSIUM PINEWOOD IS AND WHAT IT IS USED FOR
Losartan belongs to a group of medicines known as angiotensin-II
receptor antagonists. Angiotensin-II is a
substance produced in the body which binds to receptors in blood
vessels, causing them to tighten. This
results in an increase in blood pressure. Losartan prevents the
binding of angiotensin-II to these receptors,
causing the blood vessels to relax which in turn lowers the blood
pressure. Losartan slows the decrease of
kidney function in patients with high blood pressure and type 2
diabetes
Losartan Potassium Pinewood is used

to treat patients with high blood pressure (hypertension) in adults
and in children and adolescents 6
– 18 years of age.

to protect the kidney in hypertensive type 2 diabetic patients with
laboratory evidence of impaired
renal function and proteinuria > 0.5 g per day (a condition in which
urine contains an abnormal
amount of protein).

to treat patients with chronic heart failure

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium Pinewood 12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Losartan Potassium Pinewood contains 12.5 mg of the active ingredient
losartan potassium.
Excipient(s) with known effects:
Lactose monohydrate 25.27 mg and other excipients.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Round, blue, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension in adults and in children and
adolescents 6 – 18 years of age.
Treatment of renal disease in adult patients with hypertension and
type 2 diabetes mellitus with proteinuria > 0.5
g/day as part of an antihypertensive treatment (see sections 4.3, 4.4,
4.5, and 5.1).
Treatment of chronic heart failure in adult patients, when treatment
with ACE inhibitors is not considered
suitable due to incompatibility, especially cough, or
contraindication. Patients with heart failure who have been
stabilised with an ACE inhibitor should not be switched to losartan.
The patients should have a left ventricular
ejection fraction < 40% and should be clinically stable and on an
established treatment regimen for chronic heart
failure.
Reduction in the risk of stroke in adult hypertensive patients with
left ventricular hypertrophy documented by
ECG (see section 5.1 LIFE study, Race).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most
patients. The maximal antihypertensive effect is
attained 3-6 weeks after initiation of therapy. Some patients may
receive an additional benefit by increasing the dose to
100 mg once daily (in the morning).
Losartan Potassium Pinewood may be administered with other
antihypertensive agents,
especially with diuretics (e.g.
hydrochlorothiazide) (see sections 4.3, 4.4, 4.5 and 5.1).
Hypertensive type II diabetic patients with proteinuria > 0.5 g/day
The usual starting dose is 50 mg once