Losartan Teva 100 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

Teva Pharma B.V.

ATC code:

C09CA; C09CA01

INN (International Name):

Losartan potassium

Dosage:

100 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:

2008-06-20

Patient Information leaflet

ZONA SEGURIDAD EN BLANCO 10 MM.
ZONA SEGURIDAD EN BLANCO 10 MM.
ZONA SEGURIDAD EN BLANCO 10 MM.
ZONA SEGURIDAD EN BLANCO 10 MM.
Losartan Teva 50 mg
Film-coated Tablets
Losartan Teva 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.
1. WHAT LOSARTAN TEVA IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
LOSARTAN TEVA
3. HOW TO TAKE LOSARTAN TEVA
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE LOSARTAN TEVA
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT LOSARTAN TEVA IS AND WHAT IT
IS USED FOR
Losartan Teva 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 Teva
prevents the binding of angiotensin-
II
to these
receptors, causing the blood vessels to relax
which in turn lowers the blood pressure.
Losartan Teva slows the decrease of kidney
function in patients with high blood pressure and
type 2 diabetes.
Losartan Teva 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
angiotens

Summary of Product characteristics

Health║Products║Regulatory║Authority
31║October║2019
CRN0098ZH
Page║1║of║14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan║Teva║100║mg║Film-coated║Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║tablet║contains║100║mg║of║losartan║potassium,║equivalent║to║91.6║mg║of║losartan.
_Excipient with known effect:_
Each║tablet║contains║18.0║mg║of║lactose║monohydrate.
For the║full║list║of║excipients,║see║section║6.1.
3 PHARMACEUTICAL FORM
Film-coated║tablet.
White,║oval,║slightly║arched║film-coated║tablets,║debossed║“100”║on║one║side,║scoreline║on║the║other.
The║tablets║can║be║divided║into║equal║doses.
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 POSO