Losartan Potassium Pinewood 50 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

Pinewood Laboratories 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:

2007-10-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 when therapy with
specific medicine

Summary of Product characteristics

Health║Products║Regulatory║Authority
28║September║2022
CRN00CVXW
Page║1║of║15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan║Potassium║Pinewood║50║mg║film-coated║tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Losartan║Potassium║Pinewood║contains║50║mg║of║the║active║ingredient║losartan║potassium.
Excipient(s)║with║known║effect:
Lactose║monohydrate║25.50║mg║and║other║excipients.
For║the║full║list║of║excipients,║see║section║6.1.║
3 PHARMACEUTICAL FORM
Film-coated║tablets.
Round,║white,║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║Angiotensin-converting║enzyme║(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�