Cozaar Comp 50 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Organon Pharma (Ireland) Limited

ATC code:

C09DA; C09DA01

INN (International Name):

Losartan potassium; Hydrochlorothiazide

Dosage:

50mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists and diuretics; losartan and diuretics

Authorization status:

Marketed

Authorization date:

1997-02-07

Patient Information leaflet

[Organon] Proprietary
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
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 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 thiazid

Summary of Product characteristics

Health Products Regulatory Authority
01 July 2022
CRN00CR0V
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozaar Comp 50 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide (HCTZ).
Each tablet contains 63.13 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets (tablets)
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.
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.
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 whose
blood pressure is not adequately controlled.
The usual maintenance dose of Cozaar Comp is one tablet of Cozaar Comp
50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg)
once daily. For patients who do not respond adequately to Cozaar Comp
50 mg/12.5 mg, the dosage may be increased to one
tablet of Cozaar Comp 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once
daily. The maximum dose is one tablet of Cozaar
Comp 100 mg/25 mg once daily. In general, the antihypertensive effect
is attained within three to four weeks after initiation of
therapy. Cozaar Comp 100/12.5 (losartan 100 mg/ HCTZ 12.5 mg) is
available for those patients titrated to 100 mg of Cozaar
who require additional blood pressure control.
Use in patients with renal impairment an