Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
vardenafil hydrochloride trihydrate, Quantity: 5.926 mg (Equivalent: vardenafil, Qty 5 mg)
Bayer Australia Ltd
Tablet, film coated
Excipient Ingredients: crospovidone; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; macrogol 400; hypromellose; titanium dioxide; iron oxide yellow; iron oxide red
Oral
4 tablets, 1 tablet (sample), 6 tablets, 8 tablets, 2 tablets, 12 tablets
(S4) Prescription Only Medicine
LEVITRA is indicated for the treatment of erectile dysfunction in adult males (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). LEVITRA is not indicated for use by women.
Visual Identification: Orange (light orange to grey-orange), round film coated tablet with Bayer cross on one side and "5" on the other.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2003-04-08
Levitra 5 10 & 20 CMI 1 LEVITRA ® 5 (LA·VEE·TRAH) LEVITRA ® 10 (LA·VEE·TRAH) LEVITRA ® 20 (LA·VEE·TRAH) _vardenafil _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Levitra. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Levitra against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LEVITRA IS USED FOR This medicine is used to treat erectile dysfunction. Erectile dysfunction, also known as impotence in adult males, is the inability to obtain and/or maintain a hard erect penis sufficient for sexual activity. Levitra tablet contains the active ingredient VARDENAFIL which works by relaxing the blood vessels in the penis when you are sexually aroused. This allows blood to flow into the penis, allowing you to get an erection. Levitra will only work if you are sexually aroused. It will not increase your sex drive. Levitra is not addictive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE LEVITRA _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE LEVITRA IF YOU HAVE AN ALLERGY TO: • any medicine containing vardenafil hydrochloride trihydrate • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE LEVITRA IF YOU ARE TAKING NITRATE MEDICINES WHICH INCLUDE : • glyceryl trinitrate (also called nitroglycerine) • nicorandil • sodium nitroprusside • isosorbide mononitrate • isosorbide dinitrate Read the complete document
200221 LEVITRA 5, 10 & 20 PI 1 AUSTRALIAN PRODUCT INFORMATION LEVITRA ® 5, 10 AND 20 (VARDENAFIL) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Vardenafil (as hydrochloride trihydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LEVITRA 5 film-coated tablets contain 5 mg vardenafil (as 5.926 mg of vardenafil hydrochloride trihydrate). LEVITRA 10 film-coated tablets contain 10 mg vardenafil (as 11.852 mg of vardenafil hydrochloride trihydrate). LEVITRA 20 film-coated tablets contain 20 mg vardenafil (as 23.705 mg of vardenafil hydrochloride trihydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM LEVITRA 5, 10 and 20 tablets are orange film-coated round tablets marked with the BAYER cross on one side and the dose strength (“5”, “10” or “20”) on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS LEVITRA is indicated for the treatment of erectile dysfunction in adult males (inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). LEVITRA is not indicated for use by women. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) The recommended starting dose of LEVITRA is 10 mg, taken orally 25 to 60 minutes before sexual activity. Sexual activity can be initiated as soon as 15 minutes and as long as 4 – 5 hours after taking LEVITRA. Depending on co-morbidities and concomitant medications, it may be necessary to commence on a lower dose of 5 mg film-coated tablet. The maximum recommended dose frequency is once daily. 200221 LEVITRA 5, 10 & 20 PI 2 METHOD OF ADMINISTRATION LEVITRA can be taken with or without food. Sexual stimulation is required for a natural response to treatment. DOSAGE ADJUSTMENT Based on efficacy and tolerability, the LEVITRA dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg once daily. RENAL IMPAIRMENT No dose adjustment is needed in patients with mild (CL cr > 50-80 mL/min), moderate (CL cr > 30-50 mL/min) or severe (CL cr < 30 mL/m Read the complete document