Zestoretic 20 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydrochlorothiazide; Lisinopril

Available from:

Atnahs Pharma UK Ltd

ATC code:

C09BA03

INN (International Name):

Hydrochlorothiazide; Lisinopril

Dosage:

12.5mg ; 20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5000455005518

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZESTORETIC
®
20 TABLETS
(Lisinopril/hydrochlorothiazide)
Your medicine is known as the above but will be referred to as
Zestoretic throughout the
remainder of this leaflet.
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 sudden swelling of the hands, feet, ankles, face,
lips, tongue or throat,
especially if this followed treatment with an ACE inhibitor. It may
also

Summary of Product characteristics

OBJECT 1
ZESTORETIC 20
Summary of Product Characteristics Updated 21-May-2018 | AstraZeneca
UK Limited
1. Name of the medicinal product
Zestoretic 20.
2. Qualitative and quantitative composition
Each tablet contains lisinopril dihydrate (equivalent to 20 mg
anhydrous lisinopril) 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 score line is not intended for breaking the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Zestoretic is indicated in the management of mild to moderate
hypertension in patients who have been
stabilised on the individual components given in the same proportions.
4.2 Posology and method of administration
PRIMARY 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 effect 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 dose of
lisinopril, when used alone, in mild
renal insufficiency, is 5 to 10 mg.
PRIOR DIURETIC THERAPY
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