Lisinopril/Hydrochlorothiazide 20 mg/12.5 mg Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Lisinopril (as dihydrate); Hydrochlorothiazide

Disponível em:

McDermott Laboratories Ltd t/a Gerard Laboratories

Código ATC:

C09BA03

DCI (Denominação Comum Internacional):

Lisinopril (as dihydrate); Hydrochlorothiazide

Dosagem:

20/12.5 milligram(s)

Forma farmacêutica:

Tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

lisinopril and diuretics

Status de autorização:

Not marketed

Data de autorização:

2012-07-13

Folheto informativo - Bula

PAGE 1 OF 11
PACKAGE LEAFLET
PAGE 2 OF 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
LISINOPRIL/HYDROCHLOROTHIAZIDE 10 MG/12.5 MG TABLETS
LISINOPRIL/HYDROCHLOROTHIAZIDE 20 MG/12.5 MG TABLETS
Lisinopril and 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.
WHAT IS IN THIS LEAFLET:
1.
What Lisinopril/Hydrochlorothiazide is and what it is used for
2.
What you need to know before you take Lisinopril/Hydrochlorothiazide
3.
How to take Lisinopril/Hydrochlorothiazide
4.
Possible side effects
5.
How to store Lisinopril/Hydrochlorothiazide
6.
Contents of the pack and other information
1.
WHAT LISINOPRIL/HYDROCHLOROTHIAZIDE IS AND WHAT IT IS USED FOR
Lisinopril/Hydrochlorothiazide is used to treat high blood pressure
(hypertension). It contains two
medicines called lisinopril and hydrochlorothiazide which act together
to lower your blood pressure.
Lisinopril belongs to a group of medicines called Angiotensin
Converting Enzyme (ACE) inhibitors.
ACE inhibitors lower blood pressure by widening your blood vessels.
This allows the blood to flow
more easily and reduces the effort needed to pump blood around the
body.
Hydrochlorothiazide belongs to the group of medicines called thiazide
diuretics (water tablets). The
medicine works by helping your body to get rid of water and salts
(like sodium) by increasing the
amount of urine made by your kidneys.
Lisinopril/Hydrochlorothiazide is used to treat patients whose blood
pressure is not adequately
controlled by lisinopril alone or hydrochlorothiazide alone.
If high blood pressure

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lisinopril/Hydrochlorothiazide 20 mg/12.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of
hydrochlorothiazide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
A white, 10.5 mm, round, biconvex, bevelled edge tablet debossed with
LH2 over M on one side of the tablet and a
score line on the other side.
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
Treatment of essential hypertension.
Lisinopril/Hydrochlorothiazide Tablets fixed dose combination is
indicated for the treatment of hypertension in patients
whose blood pressure is not adequately controlled by lisinopril alone
(or hydrochlorothiazide alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Essential Hypertension_
The selection of a suitable antihypertensive dose of lisinopril and
hydrochlorothiazide will depend upon the clinical
evaluation of the patient.
The recommended dose is one tablet administered once daily. As with
other medicines that are taken once daily,
Lisinopril/Hydrochlorothiazide should be taken at about the same time
each day.
The administration of the fixed combination lisinopril and
hydrochlorothiazide is usually recommended after dosage
titration with the individual components.
When clinically appropriate a direct change from monotherapy to fixed
combination may be considered.
20 mg/12.5 mg tablets may be administered in patients whose blood
pressure is not adequately controlled by 20 mg
lisinopril alone.
A maximum daily dose of 40 mg lisinopril/ 25 mg hydrochlorothiazide
should not be exceeded.
_Renal Insufficiency_
Thiazides may not be appropriate diuretics for use in patients with
renal impairment and are ineffective at creatinine
clearance values of 30 ml/min or below (i.e. moderate or severe renal
insufficiency).
Lisinopril and hydrochlorothiazide combinat