Losartan/Hydrochlorothiazide Teva 50mg/12.5mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Losartan potassium; Hydrochlorothiazide

Available from:

Teva Pharma B.V.

ATC code:

C09DA; C09DA01

INN (International Name):

Losartan potassium; Hydrochlorothiazide

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:

Marketed

Authorization date:

2008-01-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOSARTAN/HYDROCHLOROTHIAZIDE TEVA 50 MG/12.5 MG FILM-COATED TABLETS
LOSARTAN/HYDROCHLOROTHIAZIDE TEVA 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 Losartan/Hydrochlorothiazide Teva tablets are and what they are
used for
2. What you need to know before you take Losartan/Hydrochlorothiazide
Teva tablets
3. How to take Losartan/Hydrochlorothiazide Teva tablets
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide Teva tablets
6. Contents of the pack and other information
1.
WHAT LOSARTAN/HYDROCHLOROTHIAZIDE TEVA TABLETS ARE AND WHAT THEY ARE
USED FOR
Losartan and Hydrochlorothiazide 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 Teva is indicated for the treatment of
essential hypertension (high blood
pressure).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN/HYDROCHLOROTHIAZIDE
TEVA TABLETS
DO NOT TAKE LOSARTAN/HYDROCHLOROTHIAZIDE TEVA TABLETS
•
i

Summary of Product characteristics

Health Products Regulatory Authority
09 February 2024
CRN00DXFS
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan/Hydrochlorothiazide Teva 50mg/12.5mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg losartan potassium and 12.5 mg
hydrochlorothiazide.
Excipient with known effect:
Each tablet contains 135 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
50/12.5MG:
Yellow, oval, bi-convex tablets marked with 5 and 0 on one side and a
score line on both sides.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Losartan Hydrochlorothiazide 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 Losartan Hydrochlorothiazide 50 mg/12.5 mg
(losartan 50 mg/HCTZ 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 (losartan 100
mg/HCTZ 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.
_ _
_Use in patients with renal impairment and haemodialysis patie