LOSARTAN TEVA 12.5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LOSARTAN POTASSIUM

Available from:

Teva Pharma B.V.

INN (International Name):

LOSARTAN POTASSIUM

Dosage:

12.5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Withdrawn

Authorization date:

2013-06-19

Patient Information leaflet

PRODUCT:
AMENDS:
APPROVAL:
SENIOR ARTWORK CO-ORDINATOR
• SUBJECT TO REG. AGENCY APPROVAL
• APPROVED BY REG. DEPT. FOR PRINT 
DESIGN DEPARTMENT 
Harlow
Signed
Signed
27102
LOSARTAN TEVA FC TABS 
12.5/25/50/100MG ALL TEI V4 
(TPW)
15-2-13
160x420
2
7-6-13
MW
MW
Leafl et
CUTTER GUIDE
PMS PROCESS BLACK
PMS GREEN
INDESIGN CS6
Last amend:
X
SUPPLIER INSTRUCTIONS Artwork, text and content must NOT be altered.
The only exceptions to this are: bleeds, 
chokes, spreads or other adjustments required for print reproduction
purposes only. If you have any diffi culties 
please contact the Teva Artwork Team. We must receive a copy of the
3rd Party Vendors Proof before fi nal 
approval can be made. 
Body: Univers 55 Roman/ 
65 Bold/ 55 Oblique 8.1pts
Subhead: Univers 65 Bld 11pts
Header: Univers 65 Bld 13pts
LOSARTAN TEVA 12.5 MG 
FILM-COATED TABLETS
LOSARTAN TEVA 25 MG  FILM-
COATED TABLETS
LOSARTAN TEVA 50 MG  FILM-
COATED TABLETS
LOSARTAN TEVA 100 MG 
FILM-COATED TABLETS 
LOSARTAN POTASSIUM
PACKAGE LEAFLET: INFORMATION FOR THE 
USER 
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START 
TAKING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU.
•  Keep this leafl et. 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 leafl et.
IN THIS LEAFLET:
1.  WHAT LOSARTAN TEVA IS AND WHAT IT IS USED FOR
2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
LOSARTAN TEVA
3.  HOW TO TAKE LOSARTAN TEVA
4.  POSSIBLE SIDE EFFECTS
5.  HOW TO STORE LOSARTAN TEVA
6.  CONTENTS OF THE PACK AND OTHER INFORMATION
1
  WHAT LOSARTAN TEVA IS AND 
WHAT IT IS USED FOR
Losartan belongs to a group of medicines known 
as angiotensin-II receptor antagonists.�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Teva 12.5mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.5 mg of losartan potassium, equivalent to 11.44 mg of losartan.
_Excipients:_
Each tablet contains 2.250 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, slightly arched film-coated tablets, debossed “L” on one side, plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria
0.5 g/day as
part of an antihypertensive treatment
Treatment of chronic heart failure (in patients
60 years), when treatment with ACE inhibitors is not considered
suitable due to incompatibility, especially cough, or contraindication. Patients with heart failure who have been
stabilised with an ACE inhibitor should not be switched to losartan. The patients should have a left ventricular ejection
fraction
40% and should be stabilised under the treatment of the chronic heart failure.
Reduction in the risk of stroke in hypertensive patients with left ventricular hypertrophy documented by ECG (see
section 5.1 LIFE study, Race).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Losartan tablets should be swallowed with a glass of water
Losartan tablets may be administered with or without food.
Posology
Hypertension
The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is
attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to
100 mg once daily (in the morning). Losartan m