Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
lercanidipine hydrochloride, Quantity: 10 mg
Viatris Pty Ltd
Lercanidipine hydrochloride
Tablet, film coated
Excipient Ingredients: povidone; magnesium stearate; microcrystalline cellulose; sodium starch glycollate type A; lactose monohydrate; hypromellose; purified talc; titanium dioxide; macrogol 6000; iron oxide yellow
Oral
7 tablets (sample), 14 tablets, 30 tablets, 28 tablets
(S4) Prescription Only Medicine
Lercan is indicated for the treatment of hypertension.
Visual Identification: Yellow homogeneous scored round film-coated tablet; 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
Registered
2010-03-26
LERCAN ® L E R C A N ® 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 LERCAN? LERCAN contains the active ingredient lercanidipine hydrochloride. LERCAN is used to lower high blood pressure, which doctors call hypertension. For more information, see Section 1. Why am I taking LERCAN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE LERCAN? 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 LERCAN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with LERCAN 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 LERCAN? • LERCAN 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 LERCAN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING LERCAN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking LERCAN. • Tell your doctor if you become pregnant while you are taking LERCAN. • If you have an operation, tell the anaesthetist that you are taking this medicine. THINGS YOU SHOULD NOT DO • Do not take LERCAN 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 LERCAN 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 below 30°C. For more Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION LERCAN ® _Lercanidipine hydrochloride tablets _ 1 NAME OF THE MEDICINE Lercanidipine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lercanidipine hydrochloride is a microcrystalline, odourless, citrine powder. Each LERCAN 10 mg tablet contains 9.4 mg of lercanidipine (present as lercanidipine hydrochloride 10 mg) as the active ingredient. Each LERCAN 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 LERCAN 10 mg tablet is available as a yellow, round, scored, film-coated tablet. LERCAN 20 mg tablet is available as a pink, circular, biconvex, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LERCAN 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 LERCAN; • Left ventricular outflow tract obstruction. • Untreated congestive card Прочитајте комплетан документ