Lotanos 50mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

Rowex Ltd

ATC code:

C09CA; C09CA01

INN (International Name):

Losartan potassium

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists, plain; losartan

Authorization status:

Marketed

Authorization date:

2006-09-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LOTANOS 50MG 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 Lotanos is and what it is used for
2. What you need to know before you take Lotanos
3. How to take Lotanos
4. Possible side effects
5. How to store Lotanos
6. Contents of the pack and other information.
1 WHAT LOTANOS 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.
Lotanos 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 when therapy with
specific medicines called angiotensin-
converting-enzyme inhibitors (ACE inhibitors, medicine used to lower
high blood pressure) is not
considered suitable by your doctor. If your heart failure

Summary of Product characteristics

Health Products Regulatory Authority
30 January 2019
CRN008QH7
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lotanos 50mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50mg losartan potassium.
Excipients with known effect:
Each tablet contains 2.16 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
White, oval film-coated tablet with one notch on each side and
embossed with a ‘3’
on one side.
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 ≥ 0.5g/day as part of an antihypertensive
treatment.
Treatment of chronic heart failure in adults , when treatment with
Angiotensin-converting enzyme (ACE) inhibitors is not considered
suitable due to
incompatibility, especially cough or contraindication. .Patients with
heart failure who
are stable on 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
Health Products Regulatory Authority
30 January 2019
CRN008QH7
Page 2 of 23
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 may be administered with other antihypertensive agents,
especially with
diuretics (e.g. hydrochlorothiazide) (see sections 4.3, 4.4,