Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
pirfenidone, Quantity: 267 mg
Sandoz Pty Ltd
Tablet
Excipient Ingredients: hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; pregelatinised starch; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
90, 270
(S4) Prescription Only Medicine
PIRFENIDONE SANDOZ is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)
Visual Identification: Yellow, oval, biconvex, film-coated tablet, debossed SD267 on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2022-03-16
PIRFENIDONE SANDOZ® 1 PIRFENIDONE SANDOZ® 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 PIRFENIDONE SANDOZ? PIRFENIDONE SANDOZ contains the active ingredient pirfenidone. PIRFENIDONE SANDOZ is used to treat Idiopathic Pulmonary Fibrosis (IPF). For more information, see Section 1. Why am I using PIRFENIDONE SANDOZ? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PIRFENIDONE SANDOZ? Do not use PIRFENIDONE SANDOZ if you have ever had an allergic reaction to pirfenidone 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 PIRFENIDONE SANDOZ? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PIRFENIDONE SANDOZ 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 PIRFENIDONE SANDOZ? • The recommended dose of PIRFENIDONE SANDOZ is: DAYS 1 TO 7: one 267 mg tablet, three times a day with food DAYS 8 TO 14: two 267 mg tablets or one 534 mg tablet, three times a day with food DAY 15 ONWARD: three 267 mg tablets or one 801 mg tablet, three times a day with food More instructions can be found in Section 4. How do I use PIRFENIDONE SANDOZ? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PIRFENIDONE SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using PIRFENIDONE SANDOZ. • PIRFENIDONE SANDOZ can cause low sodium levels in the blood. Tell your doctor if you experience nausea, headache or dizziness. Your doctor may monitor your sodium levels while you are taking PIRFENIDONE SANDOZ. THINGS YOU SHOULD NOT DO • Do not stop using this medicine or lower the dosage without checking wi Baca dokumen lengkap
230504-pirfenidone-pi Page 1 of 15 AUSTRALIAN PRODUCT INFORMATION PIRFENIDONE SANDOZ ® (PIRFENIDONE) 1. NAME OF THE MEDICINE Pirfenidone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PIRFENIDONE SANDOZ 267 mg film coated tablets contain 267 mg pirfenidone. PIRFENIDONE SANDOZ 801 mg film coated tablets contain 801 mg pirfenidone. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM PIRFENIDONE SANDOZ 267 mg tablets are yellow, oval, biconvex, film-coated tablets, debossed SD267 on one side. PIRFENIDONE SANDOZ 801 mg tablets are dark pink, oval, biconvex, film-coated tablets, debossed SD801 on one side. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS PIRFENIDONE SANDOZ is indicated for the treatment of idiopathic pulmonary fibrosis (IPF) 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE Treatment with PIRFENIDONE SANDOZ should be initiated by physicians experienced in the diagnosis and treatment of IPF. ADULTS The recommended daily dose of PIRFENIDONE SANDOZ for patients with IPF is 801 mg three times a day with food, for a total of 2403 mg/day. It is recommended that dose titration occur with the 267 mg tablets. Upon initiating treatment, the dose should be titrated to the recommended daily dose of 2403 mg/ day over a 14 day period as follows: • Days 1 to 7: a dose of 267 mg administered three times a day (801 mg/day) • Days 8 to 14: a dose of 534 mg administered three times a day (1602 mg/day) • Day 15 onward: a dose of 801 mg administered three times a day (2403 mg/day) Doses above 2403 mg/day are not recommended for any patient (see section 4.9 Overdose). 230504-pirfenidone-pi Page 2 of 15 MISSED DOSES Patients who miss 14 consecutive days or more of PIRFENIDONE SANDOZ treatment should re-initiate therapy by undergoing the initial 2 week titration regimen up to the recommended daily dose. For treatment interruption of less than 14 consecutive days, the dose can be resumed at the previous recommended daily dose without titration. DOSE ADJUSTMENTS AND OTHER CONSIDERA Baca dokumen lengkap