Cozatan Comp 100 mg/25 mg film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Losartan potassium; Hydrochlorothiazide

Dostopno od:

Clonmel Healthcare Ltd

Koda artikla:

C09DA; C09DA01

INN (mednarodno ime):

Losartan potassium; Hydrochlorothiazide

Odmerek:

100 mg/25 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Terapevtsko območje:

Angiotensin II antagonists and diuretics; losartan and diuretics

Status dovoljenje:

Marketed

Datum dovoljenje:

2009-01-23

Navodilo za uporabo

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
COZATAN COMP 50MG/12.5MG FILM-COATED TABLETS
COZATAN COMP 100MG/25MG 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 or your pharmacist.

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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Cozatan Comp is and what it is used for
2. What you need to know before you take Cozatan Comp
3. How to take Cozatan Comp
4. Possible side effects
5. How to store Cozatan Comp
6. Contents of the pack and other information
1. WHAT COZATAN COMP IS AND WHAT IT IS USED FOR
Cozatan 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.
Cozatan Comp is indicated for the treatment of essential hypertension
(high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COZATAN COMP
DO NOT TAKE COZATAN COMP

if you are allergic to losartan, hydrochlorothiazide or 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, some antibacterial
drugs such as co-trimoxazole, ask your doctor if y

Lastnosti izdelka

Health Products Regulatory Authority
20 January 2022
CRN00CQDT
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cozatan Comp 100 mg/25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of losartan potassium equivalent to 91.52
mg losartan and 25 mg hydrochlorothiazide.
_Cozatan Comp 100 mg/25 mg film-coated tablets_
_Each tablet contains 100 mg of losartan potassium, equivalent to
91.52 mg losartan and 25 mg of hydrochlorothiazide._
Excipient with known effect:
_Each tablet contains 231.60 mg lactose monohydrate._
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, oblong tablets with a score line. The tablet can be divided
into two equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cozatan 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 losartan/hydrochlorothiazide is one
tablet of 50 mg/12.5 mg once daily. For patients who do
not respond adequately to losartan/hydrochlorothiazide 50 mg/12.5 mg,
the dosage may be increased to one tablet of
losartan/hydrochlorothiazide 100 mg/25 mg once daily. The maximum dose
is one tablet of losartan/hydrochlorothiazide
100 mg/25 mg once daily.
In general, the antihypertensive effect is attained within three to
four weeks after initiation of therapy.
Losartan/hydrochlorothiazide 100/12.5 mg is ava