Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
tadalafil, Quantity: 10 mg
Arrotex Pharmaceuticals Pty Ltd
Tadalafil
Tablet, film coated
Excipient Ingredients: hyprolose; magnesium stearate; silicon dioxide; croscarmellose sodium; lactose monohydrate; sodium lauryl sulfate; povidone; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000
Oral
4, 2, 8
(S4) Prescription Only Medicine
CIDALA 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 to light yellow, round shaped, beveled edge, coated tablets debossed with 338 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-05-26
CIDALA – Consumer Medicine Information Page 1 of 5 CIDALA tadalafil CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CIDALA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking CIDALA 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 CIDALA IS USED FOR CIDALA 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, CIDALA 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. CIDALA 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. CIDALA 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 CIDALA to treat either, or both of these conditions. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CIDALA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. CIDALA is available only with a doctor's prescription. CIDALA is not intended for use by women or by children under the age of 18 years. The active ingredient in Lestu allt skjalið
1 AUSTRALIAN PRODUCT INFORMATION – CIDALA (TADALAFIL) TABLETS 1 NAME OF THE MEDICINE Tadalafil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tadalafil tablets contain 2.5 mg, 5 mg, 10mg and 20 mg of tadalafil. Excipient with known effect: Sugars as lactose. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CIDALA, tadalafil 20 mg tablets are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L 339’ on one side and plain on other side. CIDALA, tadalafil 10 mg tablets are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side. CIDALA, tadalafil 5 mg tablets are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side. CIDALA, tadalafil 2.5mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS CIDALA 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 2 4.2 D OSE AND METHOD OF ADMINISTRATION CIDALA is for oral use. CIDALA can be taken with or without food. FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING The recommended dose of CIDALA 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. CIDALA 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 Lestu allt skjalið