Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 5 mg
Alphapharm Pty Ltd
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; povidone; microcrystalline cellulose; sodium lauryl sulfate; poloxamer; colloidal anhydrous silica; lactose; magnesium stearate; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow
Oral
28, 7
(S4) Prescription Only Medicine
Tadalafil Alphapharm 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
Visual Identification: A light yellow, film-coated, round, biconvex tablet debossed with M on one side of the tablet and TL over 2 on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-02-03
TADALAFIL ALPHAPHARM T A D A L A F I L A L P H A P H A R M CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING TADALAFIL ALPHAPHARM? TADALAFIL ALPHAPHARM contains the active ingredient tadalafil. TADALAFIL ALPHAPHARM is used to treat erectile dysfunction and urinary symptoms associated with benign prostatic hyperplasia in adult men. For more information, see Section 1. Why am I using TADALAFIL ALPHAPHARM? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TADALAFIL ALPHAPHARM? Do not use if you have ever had an allergic reaction to TADALAFIL ALPHAPHARM or any of the ingredients listed at the end of the CMI. Do not take TADALAFIL ALPHAPHARM if you are currently taking any nitrates or amyl nitrite. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS SUCH AS HEART PROBLEMS OR IF YOU TAKE ANY OTHER MEDICINES. For more information, see Section 2. What should I know before I use TADALAFIL ALPHAPHARM? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TADALAFIL ALPHAPHARM and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TADALAFIL ALPHAPHARM? • Always take TADALAFIL ALPHAPHARM exactly as your doctor has told you. • Follow all directions given to you by your doctor or pharmacist. More instructions can be found in Section 4. How do I use TADALAFIL ALPHAPHARM? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TADALAFIL ALPHAPHARM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist that you are using TADALAFIL ALPHAPHARM. • If you have emergency treatment for any suspected heart condition, tell the emergency medical or ambulance staff that you are taking TADALAFIL ALPHAPHARM. THINGS YOU SHOULD NOT DO • Do not take TADALAFIL ALPHAPHARM to treat any other complaints. • Do not give your medicine to anyone else, even if they have Perskaitykite visą dokumentą
AUSTRALIAN PRODUCT INFORMATION TADALAFIL ALPHAPHARM _Tadalafil film coated tablets _ 1 NAME OF THE MEDICINE Tadalafil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each TADALAFIL ALPHAPHARM film-coated tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil as the active ingredient. Excipients of known effect: Sugars (as lactose). For the full list of excipients, see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 2.5mg: a light yellow, film-coated, round, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL over 1’ on the other side. 5 mg: a light yellow, film-coated, round, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL over 2’ on the other side. 10 mg: a light yellow, film-coated, round, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL3’ on the other side. 20 mg: a light yellow, film-coated, round, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL4’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TADALAFIL ALPHAPHARM 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 DOSE AND METHOD OF ADMINISTRATION TADALAFIL ALPHAPHARM is for oral use. TADALAFIL ALPHAPHARM can be taken with or without food. ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of TADALAFIL ALPHAPHARM 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 ALPHAPHARM 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 Perskaitykite visą dokumentą