Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
aripiprazole, Quantity: 30 mg
Sandoz Pty Ltd
aripiprazole
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate; hyprolose; maize starch; iron oxide red
Oral
30
(S4) Prescription Only Medicine
Treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.
Visual Identification: Pink coloured, mottled, round shaped tablets, debossed with 'SZ' on one side and '449' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2010-04-18
Aripiprazole Sandoz® 1 ARIPIPRAZOLE 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 ARIPIPRAZOLE SANDOZ? Aripiprazole Sandoz contains the active ingredient aripiprazole. Aripiprazole Sandoz is used to treat symptoms of schizophrenia. For more information, see Section 1. Why am I using Aripiprazole Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE ARIPIPRAZOLE SANDOZ? Do not use if you have ever had an allergic reaction to Aripiprazole Sandoz 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 Aripiprazole? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Aripiprazole 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 ARIPIPRAZOLE SANDOZ? • Unless your doctor gives you other directions, you should take Aripiprazole Sandoz only once a day. • Take Aripiprazole Sandoz at about the same time each day. More instructions can be found in Section 4. How do I use Aripiprazole Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING ARIPIPRAZOLE SANDOZ? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are taking Aripiprazole Sandoz. • If you become pregnant while taking Aripiprazole Sandoz, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not give Aripiprazole Sandoz to anyone else, even if their symptoms seem similar or they have the same condition as you. • Do not stop taking Aripiprazole Sandoz or lower the dosage, even if you are feeling better, without checking with your doctor. DRIVING OR USING MACHINES • Make sure that you know how you react Lesen Sie das vollständige Dokument
210624-Aripiprazole Sandoz-pi Page 1 of 31 AUSTRALIAN PRODUCT INFORMATION ARIPIPRAZOLE SANDOZ ® (ARIPIPRAZOLE) TABLETS 1 NAME OF THE MEDICINE Aripiprazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Aripiprazole Sandoz ® 5 mg tablet contains 5 mg Aripiprazole. Each Aripiprazole Sandoz ® 10 mg tablet contains 10 mg Aripiprazole. Each Aripiprazole Sandoz ® 15 mg tablet contains 15 mg Aripiprazole. Each Aripiprazole Sandoz ® 20 mg tablet contains 20 mg Aripiprazole. Each Aripiprazole Sandoz ® 30 mg tablet contains 30 mg Aripiprazole. _Excipients with known effect: _ Each tablet contains lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. _Not all strengths may be marketed in Australia. _ 3 PHARMACEUTICAL FORM Aripiprazole Sandoz 5 mg tablets are blue, mottled, round shaped tablets, debossed with ‘SZ’ on one side and ‘444’ on the other side. Aripiprazole Sandoz 10 mg tablets are pink, mottled, round shaped tablets, debossed with ‘SZ’ on one side and ‘446’ on the other side. Aripiprazole Sandoz 15 mg tablets are yellow, mottled, round shaped tablets, debossed with ‘SZ’ on one side and ‘447’ on the other side. Aripiprazole Sandoz 20 mg tablets are white, round shaped tablets, debossed with ‘SZ’ on one side and ‘448’ on the other side. Aripiprazole Sandoz 30 mg tablets are pink, mottled, round shaped tablets, debossed with ‘SZ’ on one side and ‘449’ on the other side. _ _ 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Aripiprazole Sandoz is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE _SCHIZOPHRENIA _ _ADULTS _ The recommended starting dose for aripiprazole is 10 or 15 mg/day. Doses in the range of 10 to 30 mg/day have been effective in clinical trials. Daily dosage may be adjusted on the basis 210624-Aripiprazole Sandoz-pi Page 2 of 31 of individual clinical status within the range of 10-30 mg daily. Dosage i Lesen Sie das vollständige Dokument