Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Clonmel Healthcare Ltd

ATC code:

C09DA01

INN (International Name):

Losartan potassium; Hydrochlorothiazide

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

losartan and diuretics

Authorization status:

Not marketed

Authorization date:

2023-01-27

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL 50 MG/12.5 MG FILM-COATED TABLETS
LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL 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, 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 Losartan/Hydrochlorothiazide Clonmel is and what it is used for
2.
What you need to know before you take Losartan/Hydrochlorothiazide
Clonmel
3.
How to take Losartan/Hydrochlorothiazide Clonmel
4.
Possible side effects
5.
How to store Losartan/Hydrochlorothiazide Clonmel
6.
Contents of the pack and other information
1.
WHAT LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL IS AND WHAT IT IS USED FOR
Losartan/Hydrochlorothiazide Clonmel 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.
Losartan/Hydrochlorothiazide Clonmel is indicated for the treatment of
essential hypertension (high
blood pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE
CLONMEL
DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE CLONMEL
_• _
If

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2023
CRN00CHQK
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of losartan potassium and 25
mg of hydrochlorothiazide.
Excipient with known effect
Each film-coated tablet contains 157.9 mg of lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round, pale yellow film-coated tablet of around 10.5 mm in diameter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan/Hydrochlorothiazide Clonmel 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 Clonmel is
one tablet of Losartan/Hydrochlorothiazide Clonmel
50 mg/12.5 mg (losartan potassium 50 mg/hydrochlorothiazide 12.5 mg)
once daily. For patients who do not respond
adequately to Losartan/Hydrochlorothiazide Clonmel 50 mg/12.5 mg, the
dosage may be increased to one tablet of
Losartan/Hydrochlorothiazide Clonmel 100 mg/25 mg (losartan potassium
100 mg/hydrochlorothiazide 25 mg) once daily. The
maximum dose is one tablet of Losartan/Hydrochlorothiazide Clonmel 100
mg/25 mg once daily. In general, the
antihypertensive effect is attained within three to four weeks after
initiation of therapy. Lo