Cosartal Plus 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:

Accord Healthcare Ireland Ltd.

ATC code:

C09DA; C09DA01

INN (International Name):

Hydrochlorothiazide; Losartan potassium

Dosage:

50/12.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Angiotensin II antagonists and diuretics; losartan and diuretics

Authorization status:

Marketed

Authorization date:

2010-06-04

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
COSARTAL PLUS 50 MG/12.5 MG FILM-COATED TABLETS
COSARTAL PLUS 100 MG/12.5 MG FILM-COATED TABLETS
COSARTAL PLUS 100 MG/25 MG FILM-COATED TABLETS
Losartan potassium/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 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 Cosartal Plus is and what it is used for
2.
What you need to know before you take Cosartal Plus
3.
How to take Cosartal Plus
4.
Possible side effects
5.
How to store Cosartal Plus
6.
Contents of the pack and other information
1.
WHAT COSARTAL PLUS IS AND WHAT IT IS USED FOR
Cosartal Plus 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.
Cosartal Plus is indicated for the treatment of essential hypertension
(high blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COSARTAL PLUS
DO NOT TAKE COSARTAL PLUS:
-
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 (hypersensitive) to other sulfonamide-derived
substances (e. g. other
thiazides, some ant

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2022
CRN00CQT9
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cosartal Plus 50 mg/12.5 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg losartan potassium and 12.5 mg
hydrochlorothiazide
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Cosartal Plus 50 mg/12.5 mg film-coated tablets: White to off-white
colored, 8 mm round shaped, biconvex, film-coated
tablets, with breakline on both sides and debossed on one side with
'KK' and '1' on either side of breakline.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cosartal Plus 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 Cosartal Plus is one tablet of Cosartal
Plus 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once
daily. For patients who do not respond adequately to Cosartal Plus 50
mg/12.5 mg, the dosage may be increased to one tablet
of Cosartal Plus 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once
daily. The maximum dose is one tablet of Cosartal Plus
100 mg/25 mg once daily. In general, the antihypertensive effect is
attained within three to four weeks after initiation of
therapy.
Other tablets containing losartan 100 mg/ HCTZ 12.5 mg may be