Cozaar-Comp 50mg/12.5mg

Land: Malta

Tungumál: enska

Heimild: Malta Medicines Authority

Virkt innihaldsefni:

HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM

Fáanlegur frá:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC númer:

C09CA01

INN (Alþjóðlegt nafn):

HYDROCHLOROTHIAZIDE 12.5 mg LOSARTAN POTASSIUM 50 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

HYDROCHLOROTHIAZIDE 12.5 mg LOSARTAN POTASSIUM 50 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Leyfisstaða:

Withdrawn

Leyfisdagur:

2005-06-30

Upplýsingar fylgiseðill

Page 1 of 10
PACKAGE LEAFLET
Page 2 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
COZAAR COMP 50MG/12.5MG FILM-COATED TABLETS
COZAAR COMP 100MG/12.5MG FILM-COATED TABLETS
COZAAR COMP 100MG/25MG FILM-COATED 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.
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
medicine (listed in section 6),

if you are allergic to other sulfonamide-derived substances (e.g.
other thiazides

Vara einkenni

Page
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SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
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21
1.
NAME OF THE MEDICINAL PRODUCT
COZAAR Comp 50 mg/12.5 mg film-coated tablets
COZAAR Comp 100 mg/12.5 mg film-coated tablets
COZAAR Comp 100 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cozaar Comp 50 mg/12.5 mg
Each tablet contains 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide (HCTZ).
Cozaar Comp 100 mg/12.5 mg
Each tablet contains 100 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide (HCTZ).
Cozaar Comp 100 mg/25 mg
Each tablet contains 100 mg of losartan potassium and 25 mg of
hydrochlorothiazide (HCTZ).
Cozaar Comp 50 mg/12.5 mg: each tablet contains 63.13 mg lactose
monohydrate.
Cozaar Comp 100 mg/12.5 mg: each tablet contains 88.40 mg lactose
monohydrate.
Cozaar Comp 100 mg/25 mg: each tablet contains 126.26 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet
Cozaar Comp 50 mg/12.5 mg
Yellow, oval film-coated tablets marked 717 on one side and plain or
scored on the other.
The score line is not intended for breaking the tablet.
Cozaar Comp 100 mg/12.5 mg
White, oval film-coated tablets marked 745 on one side and plain on
the other.
Cozaar Comp 100 mg/25 mg
Light yellow, oval film-coated tablets marked 747 on one side and
plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cozaar Comp is indicated for the treatment of essential hypertension
in patients whose blood
pressure is not adequately controlled on losartan or
hydrochlorothiazide alone.
Page
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
Losartan and hydrochlorothiazide is not for use as initial therapy,
but in patients whose blood
pressure is not adequately controlled by losartan potassium or
hydrochlorothiazide alone.
Dose titration with the individual components (losartan and
hydrochlorothiazide) is recommended.
When clinically appropriate direct change from monotherapy to the
fixed combination may be
considered in patients who