Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Tadalafil 10mg;
Viatris Limited
Tadalafil 10 mg
10 mg
Film coated tablet
Active: Tadalafil 10mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Lactose Magnesium stearate Microcrystalline cellulose Opadry yellow 32K520043 Poloxamer Povidone Purified water Sodium laurilsulfate
Prescription
Mylan Laboratories Limited
· Erectile dysfunction (ED) in adult men. In order for Cilatil 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/Aclar/Al or PVC/PE/PVDC/Al - 2 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al or PVC/PE/PVDC/Al - 4 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Aclar/Al or PVC/PE/PVDC/Al - 8 tablets - 36 months from date of manufacture stored at or below 25°C
2012-12-13
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION CILATIL ® _TADALAFIL FILM COATED TABLET 5 MG, 10 MG & 20 MG_ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Cilatil. This leaflet answers some common questions about Cilatil. 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 Cilatil against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CILATIL IS USED FOR Cilatil is used to treat: • erectile dysfunction (ED) in adult men • lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) • co-existing ED and LUTS associated with BPH. Cilatil contains the active ingredient tadalafil. It belongs to a group of medicines called phosphodiesterase type 5 inhibitors It works by helping the blood vessels in the penis to relax, allowing the flow of blood into the penis, resulting in improved erectile function. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CILATIL _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE CILATIL IF YOU ARE • allergic any medicine containing tadalafil • allergic any of the ingredients listed at the end of this leaflet • currently taking any nitrates, medicines used to treat angina (chest pain) or other heart conditions. Cilatil has been shown to increase the effects of these medicines • using recreational drugs called “poppers” or “amyl” like amyl nitrite and butyl nitrite that are normally taken through inhalation • using guanylate cyclase stimulators such as riociguat to treat pulmonary arterial hypertension • having h Διαβάστε το πλήρες έγγραφο
Page 1 of 18 NEW ZEALAND DATA SHEET CILATIL ® 1. PRODUCT NAME Cilatil 2.5 mg film coated tablets. Cilatil 5 mg film coated tablets. Cilatil 10 mg film coated tablets. Cilatil 20 mg film coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of tadalafil as the active ingredient. Excipient with known effect: Cilatil tablets contain lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 2.5 mg: A yellow-orange film-coated, almond shaped, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL5’ on the other side. 5 mg: A yellow film-coated, almond shaped, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL6’ on the other side. 10 mg: A yellow film-coated, almond shaped, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL7’ on the other side. 20 mg: A yellow film-coated, almond shaped, biconvex tablet debossed with ‘M’ on one side of the tablet and ‘TL8’ on the other side. 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Cilatil is indicated for the treatment of: erectile dysfunction (ED) in adult men. In order for Cilatil 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 _ _DOSE AND METHOD OF ADMINISTRATION _ Cilatil film coated tablets are for oral use. Cilatil can be taken with or without food. FOR ERECTILE DYSFUNCTION IN ADULT MEN - ON-DEMAND DOSING The maximum recommended dose of Cilatil is 20 mg, taken prior to anticipated sexual activity. The maximum recommended dosing frequency is once per day. Cilatil may be taken between 30 minutes and 36 hours prior to anticipated sexual activity. Patients may initiate sexual activity at varying time Page 2 of 18 points relative to dosing in order to determine their own optimal window of res Διαβάστε το πλήρες έγγραφο