Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 20 mg
Eli Lilly Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hyprolose; sodium lauryl sulfate; magnesium stearate; purified talc; titanium dioxide; hypromellose; triacetin; iron oxide yellow
Oral
2 tablets, 1 tablets, 4 tablets, 8 tablets
(S4) Prescription Only Medicine
CIALIS is indicated for the treatment of: ? erectile dysfunction (ED) in adult males.
Visual Identification: YELLOW, ALMOND SHAPED TABLET, DEBOSSED WITH "C20".; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2002-10-23
CIALIS ® C I A L I S ® 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 CIALIS? CIALIS contains the active ingredient tadalafil. CIALIS 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 CIALIS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CIALIS? Do not use if you have ever had an allergic reaction to CIALIS or any of the ingredients listed at the end of the CMI. Do not take CIALIS 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 TAKE ANY OTHER MEDICINES. For more information, see Section 2. What should I know before I use CIALIS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CIALIS 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 CIALIS? • Always take CIALIS 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 CIALIS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CIALIS? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CIALIS. • If you have emergency treatment for any suspected heart condition tell the emergency medical or ambulance staff that you are taking CIALIS. THINGS YOU SHOULD NOT DO • Do not take CIALIS to treat any other complaints. • Do not give your medicine to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • Be careful driving or operating machinery until you know how CIALIS affects you. DRINKING ALCOHOL • CIALIS can be taken with or without food or alcohol. However, drinking alcohol may affect your a Read the complete document
CIALIS vA14_Jun19 SUPERSEDES: CIALIS-v13_27Oct17 Page 1 of 28 CIALIS ® (TADALAFIL) TABLETS 1. NAME OF THE MEDICINE Tadalafil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tadalafil 2.5 mg, 5 mg, 10mg and 20 mg tablets. For the full list of excipients, see 6.1 LIST OF EXCIPIENTS 3. PHARMACEUTICAL FORM CIALIS 2.5 mg tablets are light orange-yellow, film-coated, almond-shaped tablets for oral administration, marked “C 2 ½” on one side. CIALIS 5 mg tablets are light yellow, film-coated, almond-shaped tablets for oral administration, marked “C 5” on one side. CIALIS 10 mg tablets are light yellow, film-coated, almond-shaped tablets for oral administration, marked “C 10” on one side. CIALIS 20 mg tablets are yellow, film-coated, almond-shaped tablets for oral administration, marked “C 20” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CIALIS 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 CIALIS is for oral use. CIALIS can be taken with or without food. FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of CIALIS 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. CIALIS 10 and 20 mg is intended for use prior to anticipated sexual activity and is not for continuous daily use. CIALIS vA14_Jun19 SUPERSEDES: CIALIS-v13_27Oct17 Page 2 of 28 CIALIS 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 Cialis (i.e. at least twice weekly), a once dail Read the complete document