Cozaar 50mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Losartan potassium

Fáanlegur frá:

Organon Pharma (UK) Ltd

ATC númer:

C09CA01

INN (Alþjóðlegt nafn):

Losartan potassium

Skammtar:

50mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02050502; GTIN: 5013945183511

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
COZAAR® 12.5 MG FILM-COATED TABLETS
COZAAR® 25 MG FILM-COATED TABLETS
COZAAR® 50 MG FILM-COATED TABLETS
COZAAR® 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, 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 medicines called
angiotensin-converting-enzyme inhibito

Vara einkenni

OBJECT 1
COZAAR 12.5 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 09-Apr-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Cozaar® 12.5 mg film-coated tablets
Cozaar® 25 mg film-coated tablets
Cozaar® 50 mg film-coated tablets
Cozaar® 100 mg film-coated tablets
2. Qualitative and quantitative composition
Each COZAAR 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each COZAAR 25 mg tablet contains 25 mg of losartan potassium.
Each COZAAR 50 mg tablet contains 50 mg of losartan potassium.
Each COZAAR 100 mg tablet contains 100 mg of losartan potassium.
Each COZAAR 12.5 mg tablet contains 25.25 mg lactose monohydrate.
Each COZAAR 25 mg tablet contains 12.75 mg lactose monohydrate.
Each COZAAR 50 mg tablet contains 25.5 mg lactose monohydrate.
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 12.5 mg tablet
Blue, oval film-coated tablets marked 11 on one side and plain on the
other.
COZAAR 25 mg tablet
White, oval unscored film-coated tablets marked 951 on one side and
plain on the other.
COZAAR 50 mg tablet
White, oval film-coated tablets marked 952 on one side and scored on
the other.
The score line is not intended for breaking the tablet.
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 be