País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 5 mg
Lupin Australia Pty Limited
Tablet, film coated
Excipient Ingredients: lactose monohydrate; croscarmellose sodium; sodium lauryl sulfate; magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow
Oral
28's, 7's
(S4) Prescription Only Medicine
TADALAFIL GH (tadalafil 5 mg tablets) are indicated for the treatment of: ? erectile dysfunction (ED) in adult males; and ? moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males.
Visual Identification: Yellow coloured, round shaped, biconvex film coated tablets debossed with 'T5' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-06-07
TADALAFIL GH CMI V2 Page 1 of 5 CONSUMER MEDICINE INFORMATION TADALAFIL GH _tadalafil_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TADALAFIL GH. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist, nurse or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.generichealth.com.au. The updated leaflet may contain important information about TADALAFIL GH and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking TADALAFIL GH 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 TADALAFIL GH IS USED FOR TADALAFIL GH 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, TADALAFIL GH 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. TADALAFIL GH 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. • urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is when the prostate gland gets bigger with age. Symptoms include difficulty in starting to pass urine, a feeling of not completely emptying the bladder and a more frequent need to pass urine even at night. TADALAFIL GH improves blood flow to, and relaxes the muscles of Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION – TADALAFIL GH (TADALAFIL) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Tadalafil. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient in Tadalafil GH tablets is tadalafil. Three strengths are available, containing 5 mg, 10 mg and 20 mg of tadalafil. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Tadalafil GH 5 mg tablets are yellow coloured, round shaped, biconvex film-coated tablets debossed with ‘T5’ on one side and plain on other side. Tadalafil GH 10 mg tablets are yellow coloured, round shaped, biconvex film-coated tablets debossed with ‘T10’ on one side and plain on other side. Tadalafil GH 20 mg tablets are yellow coloured, round shaped, biconvex film-coated tablets debossed with ‘T20’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tadalafil GH is indicated for the treatment of: • erectile dysfunction (ED) in adult males; and • moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males. 4.2 DOSE AND METHOD OF ADMINISTRATION Tadalafil GH is for oral use. Tadalafil GH can be taken with or without food. Tadalafil GH does not include 2.5 mg strength. If a patient requires a 2.5 mg dose then other brands of tadalafil are available. FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of Tadalafil GH 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 Tadalafil GH v2 Page 2 of 27 (Tadalafil) film-coated tablets once per day. Tadalafil GH 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not for continuous daily use. 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 poi Llegiu el document complet