País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 20 mg
Cipla Australia Pty Ltd
Tadalafil
Tablet
Excipient Ingredients: lactose monohydrate; sodium lauryl sulfate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow
Oral
1, 2, 8, 4
(S4) Prescription Only Medicine
TADACIP 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: Yellow coloured, capsule shaped, biconvex film coated tablet with "T 20" debossed on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-03-27
TADACIP* 1 TADACIP* 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 TADACIP? TADACIP contains the active ingredient tadalafil. TADACIP is used to treat erectile dysfunction and urinary symptoms associated with benign prostatic hyperplasia For more information, see Section 1. Why am I using TADACIP? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TADACIP? Do not use if you have ever had an allergic reaction to tadalafil or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use TADACIP? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TADACIP 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 TADACIP? • For erectile dysfunction: can be taken as either on‐ demand dosing or once‐a‐day dosing. TADACIP on‐demand (10 mg and 20 mg) is intended for use prior to anticipated sexual activity and is not for continuous daily use. TADACIP once‐a‐day (5 mg) is for patients who anticipate frequent use of TADACIP (i.e. at least twice weekly). • For urinary symptoms associated with benign prostate hyperplasia: TADACIP once‐a‐day (5mg) is taken daily. More instructions can be found in Section 4. How do I use TADACIP? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TADACIP? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using TADACIP. • If you have emergency treatment for any suspected heart condition tell the emergency medical or ambulance staff that you are taking TADACIP. THINGS YOU SHOULD NOT DO • Do not take TADACIP to treat any other complaints unless your doctor tells you Llegiu el document complet
AUSTRALIAN PRODUCT INFORMATION - TADACIP (TADALAFIL) 1 NAME OF THE MEDICINE Tadalafil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tadacip 2.5 contains 2.5 mg of tadalafil. Tadacip 5 contains 5 mg of tadalafil. Tadacip 10 contains 10 mg of tadalafil. Tadacip 20 contains 20 mg of tadalafil. List of excipients with known effect: Contains sugar as lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TADACIP 20 film-coated tablets are yellow coloured, capsule shaped, biconvex film coated tablets with “T 20” debossed on one side and plain on other side. TADACIP 10 film-coated tablets are yellow coloured, capsule shaped, biconvex film coated tablets with “T 10” debossed on one side and plain on other side. TADACIP 5 film-coated tablets are cream coloured, circular, biconvex film coated tablets with “T 5” debossed on one side and plain on other side. TADACIP 2.5 film-coated tablets are cream coloured, circular, biconvex film coated tablets with “T 2.5” debossed on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TADACIP 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 TADACIP is for oral use. TADACIP can be taken with or without food. FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of TADACIP 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. TADACIP 10 and 20 mg is intended for use prior to anticipated sexual activity and is not for continuous daily use. TADACIP 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 optim Llegiu el document complet