Losartan Potassium 100mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium

Available from:

Wockhardt UK Limited

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:

Not marketed

Authorization date:

2011-10-07

Patient Information leaflet

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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan║Potassium║100mg║Film-Coated║Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║tablet║contains║100
mg║of║losartan║potassium,║equivalent║to║91.6mg║of║losartan.
Excipient with known effect:
Lactose║(anydrous) ║60mg║per║tablet.
For║the║full║list║of║excipients,║see║section 6.1.
3 PHARMACEUTICAL FORM
Film║coated║tablets.
White,║almond-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
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