Lisinopril 20mg Tablets

País: Reino Unido

Língua: inglês

Origem: myHealthbox

Ingredientes ativos:

Lisinopril dihydrate

Disponível em:

Brown & Burk UK Ltd

Código ATC:

C09AA03

DCI (Denominação Comum Internacional):

Lisinopril dihydrate

Dosagem:

20mg

Forma farmacêutica:

Tablets

Via de administração:

Oral use

Unidades em pacote:

Pack size: 28 tablets.

Tipo de prescrição:

POM - Prescription Only Medicine

Fabricado por:

Brown & Burk UK Ltd

Grupo terapêutico:

ACE Inhibitor

Indicações terapêuticas:

Hypertension: all grades of essential and renovascular hypertension. Lisinopril Tablets may be used alone or with other antihypertensives. Congestive heart failure: Lisinopril may be taken as an additional treatment with nonpotassium-sparing diuretics and, where appropriate digoxin or digitoxin. Commencement of Lisinopril treatment should be under close medical supervision. Severe heart failure should be treated in hospital. Acute myocardial infarction: Lisinopril may be used to treat haemodynamically stable patients (ie who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg). Lisinopril can be given within 24 hours of acute myocardial infarction to prevent left ventricular dysfunction, heart failure, and to increase survival prospects. Patients should also receive the standard recommended treatments for this condition, ie aspirin, a beta-blocker and thrombolytics.

Status de autorização:

Authorised

Data de autorização:

2015-03-25

Folheto informativo - Bula

1) Product
:
MICRO LABS LIMITED
Bangalore, INDIA
Head 
QA (Site)
Head 
QC (Site)
Production
Head (Site)
Packaging 
Development
Code No. :
WA
WOA 
Approved
By
Reason for change
Lisinopril Tablets - BBUK
2) Strength
:
2.5/5/10/20 mg
3) Component
:
Leaflet
4) No of colours
:
1
5) Dimension
:
220 x 360 mm
6) Artwork Code
:
NA
7) Pharma code
:
NA
8) Font type and Size
:
Arial Narrow, 9pt
9) Technical specification :
NA
Revision: 00
Date : 01-04-2015
Contract Giver/
PL holder
Regulatory
Affairs
Sign/
Date
NA
NA
Black
Colours used
Keylines
Colours Not for Printing
360 mm
360 mm
Pharmacode
Pharmacode
LISINOPRIL 2.5 MG, 5 MG, 
10 MG AND 20 MG TABLETS
Lisinopril Dihydrate
5. HOW TO STORE LISINOPRIL TABLETS
6. FURTHER INFORMATION
Do  not  take  this  medicine  after  the  expiry  date  shown  on  the  label. Any  out  of  date 
medicines should be returned to your pharmacist for disposal
Do not store Lisinopril Tablets above 25 °C.
Keep out of the reach and sight of children.
Do not use Lisinopril Tablets after the expiry date which is stated on the label/carton. The 
expiry date refers to the last day of that month.
Do not use Lisinopril Tablets if you notice description of the visible signs of deterioration.
Medicines  should  not  be  disposed  of  via  wastewater  or  household  waste.  Ask  your 
pharmacist how to dispose of medicines no longer required. These measures will help to 
protect the environment.
WHAT LISINOPRIL TABLETS CONTAINS
The active substance is lisinopril dihydrate. Each tablet contains 2.5 mg, 5 mg, 10 mg or   
20 mg of the active ingredient.
The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, pregelatinised 
maize starch, croscarmellose sodium and magnesium stearate. The 10 mg and 20 mg 
tablets also contain red, black and yellow iron oxide colourings (E172).
W

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Lisinopril 20mg Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains Lisinopril 20mg as Lisinopril dihydrate.  

For excipients see section 6.1 

3 PHARMACEUTICAL 
FORM 
Tablet.  
Pink, Circular, biconvex 9mm tablets. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
_Hypertension_: all grades of essential and renovascular
hypertension. Lisinopril 
Tablets may be used alone or with other antihypertensives.  

_Congestive heart failure:_ Lisinopril may be taken as
an additional treatment with non-
potassium-sparing diuretics and, where appropriate digoxin
or digitoxin. 
Commencement of Lisinopril treatment should be under close medical
supervision. 
Severe heart failure should be treated in hospital.  

_Acute myocardial infarction:_ Lisinopril may be used to treat
haemodynamically 
stable patients (ie who are not in cardiogenic shock and who
have a systolic blood 
pressure greater than 100 mmHg). Lisinopril can be given within 24
hours of acute 
myocardial infarction to prevent left ventricular dysfunction, heart
failure, and to 
increase survival prospects. Patients should also receive the
standard recommended 
treatments for this condition, ie aspirin, a beta-blocker and
thrombolytics.  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Lisinopril Tablets are for oral administration only.  

Lisinopril Tablets should be taken as a single daily dose at
approximately the same 
time each day. As absorption of Lisinopril Tablets in unaffected
by food, the tablets 
may be taken before, during or after meals.  

Adults and the elderly  

_Hypertension  _

Blood pressure should be measured just before the next dose
to determine whether or 
not the dosage needs to be titrated.  

_Patients taking diuretics for hypertension_ should have the
diuretic discontinued if 
possi