Apo-Cilazapril

Country: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Cilazapril monohydrate 5.213mg equivalent to 5 mg cilazapril

থেকে পাওয়া:

Apotex NZ Ltd

INN (International Name):

Cilazapril monohydrate 5.213 mg (equivalent to 5 mg cilazapril)

ডোজ:

5 mg

ফার্মাসিউটিকাল ফর্ম:

Film coated tablet

রচনা:

Active: Cilazapril monohydrate 5.213mg equivalent to 5 mg cilazapril Excipient: Hyprolose Hypromellose Iron oxide red Macrogol 8000 Maize starch Microcrystalline cellulose Purified water Sodium stearyl fumarate

প্যাকেজ ইউনিট:

Bottle, plastic, 75 mL HDPE, 200 tablets

শ্রেণী:

Prescription

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Hetero Labs Limited

থেরাপিউটিক ইঙ্গিত:

APO-CILAZAPRIL is indicated in the treatment of all grades of essential hypertension and renovascular hypertension.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Bottle, plastic, 75 mL HDPE - 200 tablets - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

অনুমোদন তারিখ:

2007-10-24

তথ্য লিফলেট

New Zealand Consumer Medicine Information
APO-CILAZAPRIL
_CILAZAPRIL _
2.5mg & 5mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Cilazapril.
This leaflet answers some common questions about Apo-Cilazapril. 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 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 IS USED FOR
Apo-Cilazapril contains the active ingredient cilazapril. It belongs
to a group of
medicines called angiotensin converting enzyme (ACE) inhibitors.
Apo-Cilazapril is used to treat
•
high blood pressure (hypertension)
•
heart failure
HIGH BLOOD PRESSURE (HYPERTENSION)
Apo-Cilazapril is used to lower high blood pressure (hypertension).
Everyone has
blood pressure. This pressure helps get your blood all around your
body. Your blood
pressure may be different at different times of the day, depending on
how busy or
worried you are. You have hypertension (high blood pressure) when your
blood
pressure stays higher than is needed, even when you are calm and
relaxed. There
are usually no symptoms of hypertension. The only way of knowing that
you have
hypertension is to have your blood pressure checked on a regular
basis. If high blood
pressure is not treated it can lead to serious health problems,
including stroke, heart
disease and kidney failure.
HEART FAILURE
Heart failure means that the heart muscle is weak and cannot pump
blood strongly
enough to supply all the blood needed throughout the body. Heart
failure is not the
same as heart attack and does not mean that the heart stops. Heart
failure may start
off with no symptoms, but as the condition progresses, patients may
feel short of
breath or may get tired easily af

পণ্য বৈশিষ্ট্য

NEW ZEALAND DATA SHEET
APO-CILAZAPRIL
1. APO-CILAZAPRIL (1MG, 2.5MG & 5MG FILM COATED TABLETS)
APO-CILAZAPRIL 1mg film coated tablets
APO-CILAZAPRIL 2.5mg film coated tablets
APO-CILAZAPRIL 5mg film coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Cilazapril monohydrate 1.0425mg (equivalent to Cilazapril 1mg)
Cilazapril monohydrate 2.606mg (equivalent to Cilazapril 2.5mg)
Cilazapril monohydrate 5.213mg (equivalent to Cilazapril 5mg)
Chemical Structure:
Molecular Formula:
C
22
H
31
N
3
O
5
.H
2
O
Molecular Mass:
435.50
Excipient(s) with known effect
APO-CILAZAPRIL contains corn starch.
APO-CILAZAPRIL is gluten free and lactose free
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
1mg APO-CILAZAPRIL Yellow, oval, biconvex, film coated tablet.
Engraved “CZ” over
European bisect “1” on one side, “APO” on the other side. Each
tablet typically weighs
82mg
2.5mg APO-CILAZAPRIL Dusty rose, oval, biconvex, film coated tablet.
Engraved “CZ”
over European bisect “2.5” on one side, ’APO” on the other
side. Each tablet typically
weighs 82mg.
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 14
APO-CILAZAPRIL
5mg APO-CILAZAPRIL Reddish-brown, oval, biconvex, film coated tablet.
Engraved “CZ”
over European bisect “5” on one side, “APO” on the other side.
Each tablet typically
weighs 82mg.
The tablet can be divided into equal doses
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
APO-CILAZAPRIL is indicated in the treatment of all grades of
essential hypertension
and renovascular hypertension.
•
APO-CILAZAPRIL is also indicated in the treatment of congestive heart
failure as an
adjunctive therapy with digitalis and/or diuretics.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
STANDARD DOSAGE
APO-CILAZAPRIL should be administered once daily. As food intake has
no clinically
significant influence on absorption, APO-CILAZAPRIL can be
administered before or after
a meal. The dose should always be taken at about the sa