ZAN-EXTRA 10/20 lercanidipine hydrochloride 10mg and enalapril maleate 20mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lercanidipine hydrochloride, Quantity: 10 mg; enalapril maleate, Quantity: 20 mg

Available from:

Viatris Pty Ltd

INN (International Name):

enalapril maleate,Lercanidipine hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; sodium bicarbonate; purified talc; quinoline yellow aluminium lake; sodium starch glycollate type A; iron oxide yellow; magnesium stearate; microcrystalline cellulose; hypromellose; titanium dioxide; povidone; macrogol 6000

Administration route:

Oral

Units in package:

35 tablets, 30 tablets, 7 tablets, 28 tablets, 50 tablets, 56 tablets, 10 tablets, 60 tablets, 14 tablets, 98 tablets, 100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of hypertension. Treatment should not be initiated with these fixed dose combinations. (See DOSAGE AND ADMINISTRATION).

Product summary:

Visual Identification: Yellow, circular, biconvex film coated tablet.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-02-14

Patient Information leaflet

ZAN-EXTRA
®
Z
A
N
-
E
X
T
R
A
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING ZAN-EXTRA?
ZAN-EXTRA contains the active ingredients lercanidipine hydrochloride
and enalapril maleate. ZAN-EXTRA is used to lower high
blood pressure. For more information, see Section 1. Why am I taking
ZAN-EXTRA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ZAN-EXTRA?
Do not take ZAN-EXTRA if you have ever had an allergic reaction to
lercanidipine, enalapril, any medicines closely related to
lercanidipine or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I take
ZAN-EXTRA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines and ZAN-EXTRA may interfere with each other and affect
how they work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE ZAN-EXTRA?
•
The usual dose is one tablet taken once daily.
•
Take ZAN-EXTRA at about the same time each day, at least 15 minutes
before a meal. Swallow ZAN-EXTRA whole with a
glass of water.
More instructions can be found in Section 4. How do I take ZAN-EXTRA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ZAN-EXTRA?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
ZAN-EXTRA.
•
Tell your doctor if you become pregnant while you are taking
ZAN-EXTRA.
•
Tell the anaesthetist that you are taking ZAN-EXTRA if you have an
operation.
THINGS YOU SHOULD
NOT DO
•
Do not give ZAN-EXTRA to anyone else, even if they have the same
condition as you.
•
Do not use ZAN-EXTRA to treat any other complaints unless your doctor
tells you to.
DRIVING OR USING
MACHINES
•
Be careful before you drive or

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ZAN-EXTRA

_Lercanidipine hydrochloride and Enalapril maleate film-coated tablets
_
1
NAME OF THE MEDICINE
Lercanidipine hydrochloride and Enalapril maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ZAN-EXTRA film-coated tablets are immediate release film-coated
tablets for oral use.
Each ZAN-EXTRA 10/10 film-coated tablets contains 10 mg of
lercanidipine hydrochloride and enalapril
maleate 10 mg as the active ingredients.
Each ZAN-EXTRA 10/20 film-coated tablets contains 10 mg of
lercanidipine hydrochloride and enalapril
maleate 20 mg as the active ingredients.
Excipients with known effect:
ZAN-EXTRA 10/10 - sugars as lactose
ZAN-EXTRA 10/20 - lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ZAN-EXTRA is available as tablets of two separate strengths, ZAN-EXTRA
10/10 and ZAN-EXTRA 10/20
both containing lercanidipine hydrochloride 10 mg and enalapril
maleate either 10 mg or 20 mg respectively.
ZAN-EXTRA 10/10 tablets are white, circular, biconvex, film-coated
tablets.
ZAN-EXTRA 10/20 tablets are yellow, circular, biconvex, film-coated
tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
Treatment should not be initiated with these fixed dose combinations
(see Section 4.2 DOSE AND METHOD
OF ADMINISTRATION).
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dosage for ZAN-EXTRA tablets is one tablet once daily
taken orally at least 15 minutes
before meals.
The 10 mg/10 mg strength tablets may be administered to patients whose
blood pressure is not adequately
controlled on lercanidipine 10 mg alone.
The 10 mg/20 mg strength tablets may be administered to patients whose
blood pressure is not adequately
controlled on enalapril 20 mg alone.
The administration of the 10 mg/20 mg tablets to patients whose blood
pressure was not controlled by 10
mg/10 mg has proved to be well tolerated. No randomised study has
compared the efficacy of the two strengths
or 10mg/10mg tablets versus enalapril 10mg alone.