ZIRCOL 20 lercanidipine hydrochloride 20mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lercanidipine hydrochloride, Quantity: 20 mg

Available from:

Alphapharm Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

14 tablets, 7 tablets, 28 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zircol 10 is indicated for the treatment of hypertension.

Product summary:

Visual Identification: Pink, Circular, Biconvex, film-coated tablets; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2017-12-06

Patient Information leaflet

ZIRCOL 10 AND ZIRCOL 20
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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 ZIRCOL?
ZIRCOL contains the active ingredient lercanidipine hydrochloride.
ZIRCOL is used to lower high blood pressure, which doctors call
hypertension.
For more information, see Section 1. Why am I taking ZIRCOL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ZIRCOL?
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
ZIRCOL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ZIRCOL 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 ZIRCOL?
•
ZIRCOL 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 ZIRCOL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ZIRCOL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
ZIRCOL.
•
Tell your doctor if you become pregnant while you are taking ZIRCOL.
•
If you have an operation, tell the anaesthetist that you are taking
this medicine.
THINGS YOU
SHOULD NOT DO
•
Do not take ZIRCOL 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 ZIRCOL 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 tem

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ZIRCOL 10 AND ZIRCOL 20
_Lercanidipine hydrochloride film coated tablets _
1
NAME OF THE MEDICINE
Lercanidipine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 10 mg or 20 mg of lercanidipine
hydrochloride 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
ZIRCOL 10
:
10 mg film coated tablets are yellow, round, scored, containing
lercanidipine 9.4 mg
(present as lercanidipine hydrochloride 10 mg)
ZIRCOL 20
:
20 mg film coated tablets are pink, circular, biconvex, containing
lercanidipine 18.8 mg
(present as lercanidipine hydrochloride 20 mg)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZIRCOL 10 and ZIRCOL 20 are 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.
See
SECTION
4.4
SPECIAL
WARNINGS
AND
PRECAUTIONS FOR USE (USE IN ELDERLY, CHILDREN, HEPATIC AND RENAL
IMPAIRMENT)
.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to any dihydropyridine or any ingredient of ZIRCOL 10
and ZIRCOL 20
•
Left ventricular outflow tract obstruction
•
Untreated congestive cardiac failure
•
Unstable angina pectoris or rec