Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Tadalafil 5mg
Sandoz New Zealand Limited
5 mg
Film coated tablet
Active: Tadalafil 5mg Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry yellow 32K520007 Sorbitan stearate
Prescription
Tadalafil Sandoz is indicated for the treatment of: · erectile dysfunction (ED) in adult men. In order for Tadalafil Sandoz to be effective in treating ED, sexual stimulation is required. · moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men · adult men with co-existing ED and LUTS associated with BPH.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al - 28 tablets - 36 months from date of manufacture stored at or below 25°C
2020-12-02
Tadalafil Sandoz ® 1 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. 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 these conditions. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TADALAFIL SANDOZ HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. Tadalafil Sandoz is available only with a doctor's prescription. Tadalafil Sandoz is not int Read the complete document
230320-tadalafilsandoz-ds Page 1 of 21 NEW ZEALAND DATA SHEET TADALAFIL SANDOZ ® (TADALAFIL) 1. PRODUCT NAME Tadalafil Sandoz 5 mg film-coated tablets Tadalafil Sandoz 10 mg film-coated tablets Tadalafil Sandoz 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg, 10 mg or 20 mg tadalafil as the active ingredient. _Excipient(s) with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 5 mg: light yellow, capsule-shaped, biconvex, bevel-edged, film-coated tablet debossed with ‘T 5’ on one side and plain on the other side. 10 mg: light yellow, capsule-shaped, biconvex, bevel-edged, film-coated tablet marked with ‘T 10’ on one side and plain on the other side. 20 mg: yellow, capsule-shaped, biconvex, bevel-edged, film-coated tablet marked with ‘T 20’ 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 men. In order for Tadalafil Sandoz to be effective in treating ED, sexual stimulation is required. • moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult men • adult men with co-existing ED and LUTS associated with BPH. 4.2. D OSE AND METHOD OF ADMINISTRATION Tadalafil Sandoz tablets are for oral use. Tadalafil Sandoz can be taken with or without food. FOR ERECTILE DYSFUNCTION IN ADULT MEN - ON-DEMAND DOSING The maximum recommended dose of Tadalafil Sandoz is 20 mg, taken prior to anticipated sexual activity. The maximum recommended dosing frequency is once per day. Tadalafil Sandoz may be taken between 30 minutes and 36 hours prior to anticipated sexual activity. Patients may initiate sexual activity at varying time points relative to dosing in order to determine their own optimal window of responsiveness. The dose may be lowered to 10 mg based on individual response and tolerability. Tadalafi Read the complete document