Losartan Potassium 25mg Film-Coated Tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Losartan potassium

Boleh didapati daripada:

Wockhardt UK Limited

Kod ATC:

C09CA; C09CA01

INN (Nama Antarabangsa):

Losartan potassium

Dos:

25 milligram(s)

Borang farmaseutikal:

Film-coated tablet

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Angiotensin II antagonists, plain; losartan

Status kebenaran:

Not marketed

Tarikh kebenaran:

2011-10-07

Risalah maklumat

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
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 Tablets are and what
they are used for
2. What you need to know before you take
Losartan Potassium Tablets
3. How to take Losartan Potassium Tablets
4. Possible side effects
5. How to store Losartan Potassium Tablets
6. Contents of the pack and other information
1. WHAT LOSARTAN POTASSIUM TABLETS ARE AND
WHAT THEY ARE 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 blood vessels to relax
which in turn lowers the blood pressure. Losartan
slows the decrease of kidneys function in patients
with high blood pressure and type 2 diabetes.
Losartan Potassium Tablets are used
• to treat patients with high blood pressure
(hypertension) in adults, and in children and
adolescents between 6 - 18 years of age
• to protect the kidneys in hypertensive type 2
diabetic patients with laboratory evidence of
impaired renal function and proteinuria ≥ 0.5g per
day (a condition in which the urine contains an
abnormal amount of protein)
• to treat patients with chronic heart failure when
therapy with specific medicines called
angiot

Ciri produk

Health║Products║Regulatory║Authority
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan║Potassium║25mg║Film-Coated║Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║tablet║contains║25
mg║of║losartan║potassium,║equivalent║to║22.9mg║of║losartan.
Excipient with known effect:
Lactose║(anydrous)║–║15mg║per║tablet.
For║the║full║list║of║excipients,║see║section 6.1.
3 PHARMACEUTICAL FORM
Film║coated║tablets.
White,║oval-shaped,║film-coated║tablets,║plain║on║both║sides.
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║strokein║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
Health║Products║Regulatory║Authority
28║September║2018
CRN008L3N
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