País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
aripiprazole, Quantity: 15 mg
Arrotex Pharmaceuticals Pty Ltd
aripiprazole
Tablet, uncoated
Excipient Ingredients: microcrystalline cellulose; iron oxide yellow; croscarmellose sodium; tartaric acid; magnesium stearate
Oral
30 and 100
(S4) Prescription Only Medicine
Aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.,Acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate;,Maintenance treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.
Visual Identification: Yellow, round, slightly biconvex tablets, engraved "ARI" over "15" on one side, "APO" on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-07-09
APO- ARIPIPRAZOLE TABLETS 1 APO- ARIPIPRAZOLE TABLETS _Aripiprazole _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about aripiprazole. 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 using this medicine 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 YOUR MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR This medicine contains the active ingredient aripiprazole. Aripiprazole belongs to a group of medicines called antipsychotic agents. It is used to treat schizophrenia. 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. There is no evidence that this medicine is addictive. This medicine is not recommended for use in children under the age of 18, as safety and efficacy have not been established in this age group. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • aripiprazole • any of the ingredients listed at the end of this leaflet • Always check the ingredients to make sure you can use this medicine. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT BREASTFEED IF YOU ARE TAKING THIS MEDICINE. Aripiprazole passes into breast milk. and there is a possibility that your baby may be affected. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. Llegiu el document complet
1 AUSTRALIAN PRODUCT INFORMATION - APO- ARIPIPRAZOLE (ARIPIPRAZOLE) TABLETS 1 NAME OF THE MEDICINE Aripiprazole. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg, 5mg, 10mg, 15mg, 20mg and 30mg aripiprazole as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 2 MG TABLETS Green, rectangular, slightly biconvex tablets, engraved “2” on one side, “A” on the other side. 5 MG TABLETS Blue, rectangular, slightly biconvex tablets, engraved “5” on one side, “A” on the other side. 10 MG TABLETS Pink, rectangular, slightly biconvex tablets, engraved “10” on one side, “A” on the other side. 15 MG TABLETS Yellow, round, slightly biconvex tablets, engraved “ARI” over “15” on one side, “APO” on the other side. 20 MG TABLETS White to off-white, round, slightly biconvex tablets, engraved “ARI” over “20” on one side, “APO” on the other side. 30 MG TABLETS Pink, round, slightly biconvex tablets, engraved “ARI” over “30” on one side, “APO” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. Although this document refers to the results of studies of aripiprazole in conditions other than schizophrenia, the APO- Aripiprazole tablets are not indicated for use in the treatment of conditions other than schizophrenia. 2 4.2 DOSE AND METHOD OF ADMINISTRATION Aripiprazole tablets are intended for oral administration. DOSAGE ADULTS Recommended Dosage – Schizophrenia The recommended starting dose for aripiprazole is 10 or 15 mg/day administered on a once-a- day schedule without regard to meals. In clinical trial, doses in the range of 10 to 30 mg/day have been effective. Daily dosage may be adjusted with regard to individual clinical status within the range of 10-30 mg daily. Dosage increases should not be made prior to the time needed to achieve ste Llegiu el document complet