Zestoretic 20mg/12.5mg Tablets

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

HYDROCHLOROTHIAZIDE, LISINOPRIL DIHYDRATE

Tilgængelig fra:

Atnahs Pharma Netherlands B.V. Copenhagen Towers Ørestads Boulevard 108, 5.tv DK-2300 København S , Denmark

ATC-kode:

C09BA03

INN (International Name):

HYDROCHLOROTHIAZIDE 12.5 mg LISINOPRIL DIHYDRATE 20 mg

Lægemiddelform:

TABLET

Sammensætning:

HYDROCHLOROTHIAZIDE 12.5 mg LISINOPRIL DIHYDRATE 20 mg

Recept type:

POM

Terapeutisk område:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Autorisation status:

Authorised

Autorisation dato:

2006-08-11

Indlægsseddel

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZESTORETIC 10 MG/12.5 MG AND 20 MG/12.5 MG TABLETS
lisinopril, 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 Zestoretic is and what it is used for
2.
What you need to know before you take Zestoretic
3.
How to take Zestoretic
4.
Possible side effects
5.
How to store Zestoretic
6.
Contents of the pack and other information
1. WHAT ZESTORETIC IS AND WHAT IT IS USED FOR
Zestoretic is used to treat high blood pressure (hypertension). It
contains two medicines called
lisinopril and hydrochlorothiazide.
•
Lisinopril belongs to a group of medicines called ACE inhibitors. It
works by making
your blood vessels widen.
•
Hydrochlorothiazide belongs to a group of medicines called diuretics
(water tablets). It
helps your body to get rid of water and salts like sodium in your
urine.
These medicines work together to lower your blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESTORETIC
DO NOT TAKE ZESTORETIC:
•
if you are allergic to lisinopril or hydrochlorothiazide or any of the
other ingredients of
Zestoretic (listed in section 6).
•
if you are allergic to ACE inhibitor or sulphonamide medicines. If you
are not sure if this
applies to you, please ask your doctor.
•
if you have ever had itching, hives, sudden fall in blood pressure,
sudden swelling of the
hands, feet, ankles, face, lips, tongue or throat, especially if this
followed treatment with
an ACE inhibitor. It may also have been difficult to swallow

Produktets egenskaber

1
NAME OF THE MEDICINAL PRODUCT
Zestoretic 20 mg/12.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to anhydrous
lisinopril 20 mg
and hydrochlorothiazide 12.5 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Round, white uncoated tablet with ’20 12.5’ on one side and a
break line on the other side.
The break line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1THERAPEUTIC INDICATIONS
In the management of hypertension
(1)
After appropriate stabilisation of patient on a regimen in which each
of the
active ingredients is administered separately.
(2)
Where the patient is unresponsive to monotherapy with lisinopril 20
mg.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
HYPERTENSION
The usual dosage is one tablet, administered once daily. As with all
other medication taken
once daily, Zestoretic should be taken at approximately the same time
each day.
In general, if the desired therapeutic dose cannot be achieved in a
period of 2 to 4 weeks
at this dose level, the dose can be increased to two tablets
administered once daily.
RENAL IMPAIRMENT
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).
Zestoretic is not to be used as initial therapy in any patient with
renal insufficiency. In
patients with creatinine clearance of >30 and <80 ml/min, Zestoretic
may be used, but
only after titration of the individual components. The recommended
initial dose of
lisinopril, when used alone, in mild renal insufficiency, is 5 to 10
mg.
PRIOR DIURETIC THERAPY
Page 1 of 20
Symptomatic hypotension may occur following the initial dose of
Zestoretic; this is more
likely in patients who are volume and/or salt depleted as a result of
prior diuretic therapy.
The diuretic therapy should be discontinued for 2-3 days prior to
initiation of therapy with
Zestoretic. If this is not possi