Cozaar 100mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Losartan potassium

제공처:

CST Pharma Ltd

ATC 코드:

C09CA01

INN (International Name):

Losartan potassium

복용량:

100mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 02050502; GTIN: 5055946804712

환자 정보 전단

S0221-28-PL-PIL-05.07.2019
PACKAGE LEAFLET: INFORMATION FOR THE
USER
COZAAR® 100MG TABLETS
(losartan potassium)
YOUR MEDICINE IS KNOWN AS ANY OF THE ABOVE BUT
WILL BE REFERRED TO AS COZAAR THROUGHOUT THIS
LEAFLET. Your medicine is available in other strengths.
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,
pharmacist or nurse.

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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Cozaar is and what it is used for
2. What you need to know before you take Cozaar
3. How to take Cozaar
4. Possible side effects
5. How to store Cozaar
6. Contents of the pack and other information
1. WHAT COZAAR IS AND WHAT IT IS USED FOR
Losartan (Cozaar) 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.
Cozaar 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

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
COZAAR 100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
Each COZAAR 100 mg tablet contains 51.0 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
COZAAR 100 mg tablet
White, teardrop-shaped film-coated tablets marked 960 on one side and
plain
on the other.
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 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, 4.5, and
5.1).
Hypertensive type II diabetic patients with proteinuria
≥
0.5