البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 20 mg
Sandoz Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sorbitan stearate; magnesium stearate; titanium dioxide; purified talc; triacetin; iron oxide yellow
Oral
8 tablets, 4 tablets
(S4) Prescription Only Medicine
TADALAFIL SANDOZ is indicated for the treatment of erectile dysfunction (ED) in adult males
Visual Identification: Yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with T 20 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2018-01-15
Version 3 1 2021 TADALAFIL SANDOZ _tadalafil _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tadalafil Sandoz. 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. _ _ All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tadalafil Sandoz 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 SANDOZ IS USED FOR Tadalafil Sandoz 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 Sandoz 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 Sandoz 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 Sandoz improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia. Your doctor may have prescribed you Tadalafil Sandoz to treat either, or both of th اقرأ الوثيقة كاملة
1 v3 AUSTRALIAN PRODUCT INFORMATION – TADALAFIL SANDOZ (TADALAFIL) TABLETS 1 NAME OF THE MEDICINE Tadalafil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tadalafil Sandoz 5 mg, 10 mg, and 20 mg. Excipients with Known effect: Lactose monohydrate For the full list of excipients, see _SECTION 6.1 LIST OF EXCIPIENTS_. 3 PHARMACEUTICAL FORM Tadalafil Sandoz 20 mg tablets are yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with "T 20" on one side and plain on the other side. Tadalafil Sandoz 10 mg tablets are light yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with "T 10" on one side and plain on the other side. . Tadalafil Sandoz 5 mg tablets are light yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with "T 5" on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Tadalafil Sandoz is indicated for the treatment of: • erectile dysfunction (ED) in adult males • moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males 4.2 D OSE AND METHOD OF ADMINISTRATION Note that 2.5 mg tablets can be available from other brand/s. Tadalafil Sandoz can be taken with or without food. Tadalafil Sandoz is for oral use. 2 v3 FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of Tadalafil Sandoz 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. Tadalafil Sandoz 10 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 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 a اقرأ الوثيقة كاملة