Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
aripiprazole, Quantity: 30 mg
Generic Health Pty Ltd
aripiprazole
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; maize starch; hyprolose; magnesium stearate
Oral
30 (3 Blisters each containing 10 tablets)
(S4) Prescription Only Medicine
Aripiprazole GH 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: White, round, biconvex bevelled edged uncoated tablets, plain on both sides; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2011-11-18
Aripiprazole GH CMI v4.0 Page 1 of 4 CONSUMER MEDICINE INFORMATION ARIPIPRAZOLE GH _aripiprazole _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Aripiprazole GH. It does not contain all the available information. Some of the information contained in this leaflet may not apply to you. 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 Aripiprazole GH against the benefits it is expected to have for you. IF YOU HAVE CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine as you may need to read it again. WHAT IS ARIPIPRAZOLE GH? Aripiprazole (Ari-pip-rah-zol) belongs to a group of medicines called antipsychotic agents. Aripiprazole GH is used to treat symptoms of Schizophrenia. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. Ask your doctor if you have any questions about why this medicine has been prescribed for you. There is no evidence that Aripiprazole GH is addictive. This medicine is available only with a doctor’s prescription. Aripiprazole GH is not recommended for use in children under the age of 18, as safety and efficacy has not been established in this age group. BEFORE TAKING ARIPIPRAZOLE GH _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ARIPIPRAZOLE GH IF YOU HAVE AN ALLERGY TO: • aripiprazole; • any ingredients listed at the end of this leaflet. Symptoms of an allergic reaction include: • rash, itching, or hives on the skin; • shortness of breath, wheezing or difficulty breathing; • swelling of the face, lips, tongue, throat or other parts of the body. Do not take Aripiprazole GH after the expiry date printed on the pack as it may not work as well. Do not take Aripiprazole GH if the packaging is torn or show signs of tampering. If this is the case, return it to your pharmacist. If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist. _ Lestu allt skjalið
AUSTRALIAN PRODUCT INFORMATION – ARIPIPRAZOLE GH (ARIPIPRAZOLE) TABLET, UNCOATED 1 NAME OF THE MEDICINE Aripiprazole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg aripiprazole. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Aripiprazole GH is available in the following forms: Aripiprazole GH 5 mg tablets: White, round, biconvex bevelled edged uncoated tablets plain on both sides. Aripiprazole GH 10 mg tablets: White, oval-shaped, biconvex bevelled edged uncoated tablets plain on both sides. Aripiprazole GH 15 mg tablets: White, round, biconvex bevelled edged uncoated tablets plain on both sides. Aripiprazole GH 20 mg tablets: White, round, biconvex uncoated tablets plain on both sides. Aripiprazole GH 30 mg tablets: White, round, biconvex bevelled edged uncoated tablets plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aripiprazole GH is indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy. 4.2 DOSE AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE Aripiprazole GH v5 Page 2 of 29 (aripiprazole) tablet, uncoated SCHIZOPHRENIA Adults The recommended starting dose for aripiprazole tablets is 10 or 15 mg/day administered on a once-a- day schedule without regard to meals. Doses in the range of 10 to 30 mg/day have been effective in clinical trials. Daily dosage may be adjusted on the basis of individual clinical status within the range of 10-30 mg daily. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state. There is no evidence that doses higher than 15 mg/day are more effective than the recommended starting dose of 10-15 mg. The maintenance dose for aripiprazole is 15 mg/day. RENAL IMPAIRMENT No dosage adjustment is required for adult patients with renal impairment. HEPATIC IMPAIRMENT No dosage adjustment is required for adult patients wi Lestu allt skjalið