ZANIDIP lercanidipine hydrochloride 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lercanidipine hydrochloride, Quantity: 10 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

14 tablets, 30 tablets, 28 tablets, 7 tablets (sample)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zanidip is indicated for the treatment of hypertension.

Product summary:

Visual Identification: Yellow, circular, biconvex film-coated tablets, scored on one side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2001-05-29

Patient Information leaflet

ZANIDIP
®
Z
A
N
I
D
I
P
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING ZANIDIP?
ZANIDIP contains the active ingredient lercanidipine hydrochloride.
ZANIDIP is used to lower high blood pressure, which doctors call
hypertension.
For more information, see Section 1. Why am I taking ZANIDIP? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ZANIDIP?
Do not take if you have ever had an allergic reaction to lercanidipine
hydrochloride 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
ZANIDIP? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ZANIDIP and affect how it works.
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 ZANIDIP?
•
ZANIDIP should be taken at about the same time each day, at least 15
minutes before a meal.
More instructions can be found in Section 4. How do I take ZANIDIP? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ZANIDIP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
ZANIDIP.
•
Tell your doctor if you become pregnant while you are taking ZANIDIP.
•
If you have an operation, tell the anaesthetist that you are taking
this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not take ZANIDIP with grapefruit or grapefruit juice as these may
increase the effects of this medicine.
DRIVING
OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how ZANIDIP affects you.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol.
LOOKING AFTER
YOUR MEDICINE
•
Keep it in a cool dry place away from sunlight where the temperature
stays belo

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ZANIDIP
®
_Lercanidipine hydrochloride tablets _
1
NAME OF THE MEDICINE
Lercanidipine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lercanidipine hydrochloride is a microcrystalline, odourless, citrine
powder.
Each ZANIDIP 10 mg tablet contains 9.4 mg of lercanidipine (present as
lercanidipine hydrochloride 10 mg)
as the active ingredient.
Each ZANIDIP 20 mg tablet contains 18.8 mg of lercanidipine (present
as lercanidipine hydrochloride 20 mg)
as the active ingredient.
Excipients with known effect: lactose
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ZANIDIP 10 mg tablet is available as a yellow, round, scored,
film-coated tablet.
ZANIDIP 20 mg tablet is available as a pink, circular, biconvex,
film-coated tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZANIDIP is indicated for the treatment of hypertension.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 10 mg once daily, at least 15 minutes before a
meal. The dose may be increased to
20 mg once daily depending on the individual response. Dose titration
should be gradual, as it may take about
2 weeks for the maximal antihypertensive effect to be apparent.
Titration may proceed more rapidly, however,
if clinically warranted, provided the patient is assessed frequently.
Since it is unlikely that increasing the dose
beyond 20 mg will further improve the efficacy, and may be associated
with side effects, doses above 20 mg
are not recommended. Some individuals not adequately controlled on a
single antihypertensive agent may
benefit from the addition of lercanidipine at the same doses used in
monotherapy to the existing regimen with
a beta-blocker, a diuretic or an ACE inhibitor.
Use in elderly, children, hepatic and renal impairment: see Section
4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to any dihydropyridine or any ingredient of ZANIDIP;
•
Left ventricular outflow tract obstruction.
•
Untreated congesti