Cozaar Comp 50 mg/12.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hydrochlorothiazide; Losartan potassium

Available from:

PCO Manufacturing Ltd.

ATC code:

C09DA; C09DA01

INN (International Name):

Hydrochlorothiazide; Losartan potassium

Dosage:

50 mg/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Angiotensin II antagonists and diuretics; losartan and diuretics

Authorization status:

Authorised

Authorization date:

2004-01-09

Patient Information leaflet

_ _
_ _
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 thiazides, som

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2023
CRN00DNW6
Page 1 of 2
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
hydrochlorothiazide (HCTZ) as the active ingredients.
Excipient(s) with known effect: Each tablet contains lactose
monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy and Poland:_
Yellow oval-shaped, film-coated tablet marked '717' on one side and a
single score line on the other.
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
As per PA23198/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Hydroxypropylcellulose (E463)
Hypromellose (E464)
Lactose monohydrate
Magnesium stearate (E572)
Microcrystalline cellulose (E460)
Pregelatinised maize starch
Titanium dioxide (E171)
Quinoline Yellow aluminium lake (E104)
Carnauba wax (E903)
Contains 4.24 mg (0.108 mmol) of potassium
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
04 July 2023
CRN00DNW6
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C.
Store in the original package in order to protect from light and
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 14 tablets in an outer carton. Pack size 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/109/001
9 DATE OF FIRST