Cozaar 100mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Losartan potassium

Dostopno od:

Sigma Pharmaceuticals Plc

Koda artikla:

C09CA01

INN (mednarodno ime):

Losartan potassium

Odmerek:

100mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02050502

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COZAAR
® COMP 100MG/25MG TABLETS
(losartan potassium and hydrochlorothiazide)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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.
The name of your medicine is Cozaar Comp 100mg/25mg tablets but will
be referred to as Cozaar Comp throughout this leaflet. Please note
that
the leaflet also contains information about other strengths Cozaar
Comp
50mg/12.5mg and 100mg/12.5mg tablets.
WHAT IS IN THIS LEAFLET
1.
What Cozaar Comp is and what it is used for
2.
What you need to know before you take Cozaar Comp
3.
How to take Cozaar Comp
4.
Possible side effects
5.
How to store Cozaar Comp
6.
Contents of the pack and other information
1.
WHAT COZAAR COMP IS AND WHAT IT IS USED FOR
Cozaar Comp is a combination of an angiotensin II receptor antagonist
(losartan) and a diuretic (hydrochlorothiazide). 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. Hydrochlorothiazide works by making the kidneys pass
more water and salt. This also helps to reduce blood pressure.
Cozaar Comp is indicated for the treatment of essential hypertension
(high blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COZAAR COMP
DO NOT TAKE COZAAR COMP

if you are allergic to losartan, hydrochlorothiazide or to any of the
other ingredients of this medi

Lastnosti izdelka

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