Apo-Cilazapril/Hydrochlorothiazide

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Cilazapril monohydrate 5.22mg equivalent to 5 mg cilazapril base; Hydrochlorothiazide 12.5mg

Available from:

Apotex NZ Ltd

INN (International Name):

Cilazapril monohydrate 5.22 mg (equivalent to 5 mg cilazapril base)

Dosage:

5 mg/12.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Cilazapril monohydrate 5.22mg equivalent to 5 mg cilazapril base Hydrochlorothiazide 12.5mg Excipient: Hyprolose Hypromellose Iron oxide red Macrogol 8000 Maize starch Microcrystalline cellulose Sodium stearyl fumarate Titanium dioxide

Units in package:

Bottle, plastic, HDPE with polypropylene cap, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hetero Labs Limited

Therapeutic indications:

APO-CILAZAPRIL/HCTZ is indicated for the treatment of patients with hypertension who are not adequately controlled on monotherapy.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with polypropylene cap - 100 tablets - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2007-10-24

Patient Information leaflet

New Zealand Consumer Medicine Information
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE
_CILAZAPRIL 5MG + HYDROCHLOROTHIAZIDE 12.5MG _
_FILM COATED TABLETS_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Cilazapril/Hydrochlorothiazide.
This leaflet answers some common questions about
Apo-Cilazapril/Hydrochlorothiazide. It
does not contain all the available information. It does not take the
place of talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using Apo-
Cilazapril/Hydrochlorothiazide against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE IS USED FOR
Apo-Cilazapril/Hydrochlorothiazide
contains
two
active
ingredients,
cilazapril
and
hydrochlorothiazide.
Cilazapril belongs to a group of medicines known as ACE (Angiotensin
Converting Enzyme)
inhibitors. Hydrochlorothiazide belongs to a group of medicines known
as thiazide diuretics.
Cilazapril and hydrochlorothiazide are both used to treat raised blood
pressure. When used
in combination they are more effective at lowering blood pressure than
either medicine used
alone.
Cilazapril works by inhibiting (blocking) natural chemicals produced
by the body which
increase blood pressure. This inhibition leads to a reduction of blood
pressure. When given
together with diuretics (fluid tablets) this helps to reduce the blood
pressure further.
Your doctor may have prescribed Apo-Cilazapril/Hydrochlorothiazide for
another reason.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
APO-
CILAZAPRIL/HYDROCHLOROTHIAZIDE HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with a doctor's prescription.
1
BEFORE YOU USE APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Apo-Cilazapril/Hydrochlorothiazide if:
•
YOU ARE ALLERGIC TO CILAZAPRIL OR OTHER BLOOD PRESSUR

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 22
1. PRODUCT NAME
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE
–
cilazapril
5mg
and
hydrochlorothiazide
12.5mg film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cilazapril
monohydrate
5.22mg
(equivalent
to
Cilazapril
5mg)
and
Hydrochlorothiazide
12.5mg
EXCIPIENT(S) WITH KNOWN EFFECT
HYDROCHLOROTHIAZIDE contains sulphur.
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is lactose free and gluten free.
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE contains Red Ferric Oxide (orange
shade #
34690).
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE are pink, oval biconvex film-coated
tablets.
Each tablet is engraved “APO” on one side and “5” bisect
“12.5” on the other side. Each
tablet typically weighs 92mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is indicated for the treatment of
patients with
hypertension who are not adequately controlled on monotherapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
The dosage of APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is one tablet
administered
once daily. As food intake has no clinically significant influence on
absorption,
APO-
CILAZAPRIL/HYDROCHLOROTHIAZIDE can be administered before or after
meals. The
dose should always be taken at about the same time of day.
SPECIAL POPULATIONS
RENAL INSUFFICIENCY
When concomitant diuretic therapy is required in patients with severe
renal impairment, a
loop
diuretic
rather
than
a
thiazide
diuretic
is
preferred
for
use
with
cilazapril/hydrochlorothiazide; therefore, for patients with severe
renal dysfunction (creatinine
APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 2 of 22
clearance <10ml/min), APO-CILAZAPRIL/HYDROCHLOROTHIAZIDE is not
recommended.
(See section 4.4 Special warnings and precautions for use,
haemodialys