Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
lercanidipine hydrochloride, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Lercanidipine hydrochloride
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; iron oxide yellow; polyvinyl alcohol; purified talc; macrogol 3350; titanium dioxide; magnesium stearate; sodium starch glycollate; povidone
Oral
30 tablets, 7 tablets (sample), 28 tablets
(S4) Prescription Only Medicine
Treatment of hypertension.
Visual Identification: round biconvex yellow coated tablets, scored on one side, marked "L" on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-07-14
LERCANIDIPINE APOTEX TABLETS 1 LERCANIDIPINE APOTEX TABLETS _Contains the active ingredient lercanidipine (as hydrochloride) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some of the common questions about lercanidipine. It does not contain all the available information. It does not replace seeking advice from your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. All medicines have risks and benefits. Your doctor has weighed the risks of you taking lercanidipine against the benefits this medicine is expected to have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with the medicine. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Lercanidipine APOTEX. It contains the active ingredient lercanidipine (as hydrochloride). Lercanidipine belongs to a group of medicines called dihydropyridine calcium channel blockers. Lercanidipine helps lower high blood pressure, otherwise known as hypertension. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ This medicine works by relaxing some of the blood vessels in the body and reducing resistance to the flow of blood through the blood vessels. Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. If your blood pressure stays higher than is needed, even when you are calm and relaxed, you have hypertension (high blood pressure). There are usually no symptoms of Baca dokumen lengkapnya
1 AUSTRALIAN PRODUCT INFORMATION LERCANIDIPINE APOTEX (LERCANIDIPINE HYDROCHLORIDE) 1 NAME OF THE MEDICINE Lercanidipine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg or 20 mg lercanidipine hydrochloride as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT: lactose monohydrate. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 10 mg: round biconvex yellow film coated tablets, scored on one side, marked “L” on the other side. 20 mg: round biconvex pink film coated tablets, scored on one side, marked “L” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lercanidipine is indicated for the treatment of hypertension. 4.2 DOSE AND METHOD OF ADMINISTRATION Lercanidipine tablets are intended for oral administration. DOSAGE 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 two 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 THE 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 in this medicine (see Section 6.1 List of Excipients) ▪ Left ventricular outflow tract obstruction ▪ Untreated congestive cardiac failure 2 ▪ Unstable angina pectoris or recent (within 1 month) my Baca dokumen lengkapnya