Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
lercanidipine hydrochloride, Quantity: 20 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; povidone; magnesium stearate; hypromellose; purified talc; titanium dioxide; macrogol 6000; iron oxide red
Oral
14 tablets, 7 tablets, 28 tablets, 30 tablets
(S4) Prescription Only Medicine
Zircol 10 is indicated for the treatment of hypertension.
Visual Identification: Pink, Circular, Biconvex, film-coated tablets; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2017-12-06
ZIRCOL 10 AND ZIRCOL 20 Z I R C O L 1 0 a n d Z I R C O L 2 0 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 Lesen Sie das vollständige Dokument
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 Lesen Sie das vollständige Dokument