Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 10 mg
AdiraMedica Pty Ltd
Tablet, film coated
Excipient Ingredients: copovidone; croscarmellose sodium; sodium lauryl sulfate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; triacetin; iron oxide yellow
Oral
8, 4, 2
(S4) Prescription Only Medicine
Tadalafil is indicated for the treatment of erectile dysfunction (ED) in adult males
Visual Identification: Yellow coloured oval shaped tablets marked with "10" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2020-05-12
ADIRA TADALAFIL _tadalafil_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Adira Tadalafil. 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 Adira Tadalafil against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ADIRA TADALAFIL IS USED FOR Adira Tadalafil is used to treat: • erectile dysfunction, also known as impotence, in men. This is when a man cannot get, or maintain, a hard erect penis suitable for sexual activity. Following sexual stimulation, Adira Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Adira Tadalafil will only treat erectile dysfunction if you are sexually aroused. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction. Y o u r d o c t o r may have prescribed you Adira Tadalafil to treat this condition. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ADIRA TADALAFIL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Adira Tadalafil is available only with a doctor's prescription. Adira Tadalafil is not intended for use by women, or by children under the age of 18 years. The active ingredient in Adira Tadalafil tablets, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 inhibitors. BEFORE YOU TAKE ADIRA TADALAFIL_ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ADIRA TADALAFIL IF YOU ARE CURRENTLY TAKING ANY NITRATES OR AMYL NITRITE. Nitrates are medicines used for the treatment of angina ("chest pain") or other heart conditions. Adira Tadalafil has been shown to increase the effects of Olvassa el a teljes dokumentumot
Adira Tadalafil tablets Version 1.0 Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION ADIRA TADALAFIL (TADALAFIL) 1. NAME OF THE MEDICINE Tadalafil. 2. QUALITATIVE AND QUATITATIVE COMPOSITION Each tablet contains 10 mg or 20 mg tadalafil as the active ingredient. Excipient with known effect: ADIRA TADALAFIL tablets contain lactose monohydrate. For the full list of excipients, see 6.1 List of excipients. 3. PHARMACEUTICAL FORM ADIRA TADALAFIL 20 mg tablets are Yellow coloured, ‘Oval’ shaped, tablets, marked with “20’’ on one side and plain on other side. ADIRA TADALAFIL 10 mg tablets are yellow coloured, ‘Oval’ shaped, tablets, marked with “10’’on one side and plain on other side. ADIRA TADALAFIL is unavailable in 2.5 mg or 5 mg tablet strengths. For patients requiring treatment with lower strengths, other brands are available. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADIRA TADALAFIL is indicated for the treatment of: • erectile dysfunction (ED) in adult males 4.2 DOSE AND METHOD OF ADMINISTRATION ADIRA TADALAFIL is for oral use. ADIRA TADALAFIL can be taken with or without food. FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of ADIRA TADALAFIL is either 10 mg or 20 mg, taken prior to anticipated sexual activity. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. ADIRA TADALAFIL 10 and 20 mg is intended for use prior to anticipated sexual activity and is not for continuous daily use. ADIRA TADALAFIL has been proven effective up to 36 hours after dosing and, in some patients, as early as 16 minutes after dosing. Patients may initiate sexual activity at varying time points relative to dosing in order to determine their own optimal window of responsiveness. FOR ERECTILE DYSFUNCTION IN ADULT MALES - ONCE-A-DAY DOSING In patients who anticipate a frequent use of ADIRA Tadalafil (i.e. at least twice weekly), a once daily regimen with the lowest dose of ADIRA TADALAFIL might be considered suitable, based on patient c Olvassa el a teljes dokumentumot