País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Aripiprazole 15mg
Sandoz New Zealand Limited
Aripiprazole 15 mg
15 mg
Tablet
Active: Aripiprazole 15mg Excipient: Hyprolose Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose
Prescription
Sandoz Private Limited
Indicated for the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.
Package - Contents - Shelf Life: Blister pack, Alu-Alu blisters in cardboard carton - 30 tablets - 24 months from date of manufacture stored at or below 30°C
2017-05-05
ARIPIPRAZOLE SANDOZ ® 1 ARIPIPRAZOLE SANDOZ ® _Aripiprazole tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aripiprazole Sandoz. 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 risk of you taking Aripiprazole Sandoz against the benefits it is expected to 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 want to read it again. WHAT ARIPIPRAZOLE SANDOZ IS USED FOR _WHAT IT DOES _ Aripiprazole Sandoz belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness. Aripiprazole Sandoz is used to treat symptoms of schizophrenia. Aripiprazole Sandoz may be given to treat acute episodes of sustained upward mood swings (mania) in adult patients with Bipolar 1 Disorder. During mania, patients experience episodes of overactivity, elation or irritability. Schizophrenia is a mental illness with disturbances in thinking, feelings and behaviour. Bipolar disorder is a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that this medicine is addictive. This medicine is available only with a doctor's prescription. Aripiprazole Sandoz 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 ARIPIPRAZOLE SANDOZ _WHEN YOU MUST NOT TAKE _ _ARIPIPRAZOLE SANDOZ _ Do not take Aripiprazole Sandoz if you have an allergy to: • aripiprazole the active ingredient or to any of the ingredients listed Leia o documento completo
230320-aripiprazole sandoz-ds Page 1 of 31 NEW ZEALAND DATA SHEET ARIPIPRAZOLE SANDOZ ® (ARIPIPRAZOLE) 1. PRODUCT NAME Aripiprazole Sandoz 5 mg, 10 mg, 15 mg, 20 mg & 30 mg tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Aripiprazole Sandoz tablet contains 5 mg, 10 mg, 15 mg, 20 mg or 30 mg aripiprazole. _Excipients with known effect:_ Lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tablet, uncoated 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. • for acute and maintenance treatment of manic and mixed episodes with Bipolar I Disorder with or without psychotic features. • as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features. 4.2. D OSE AND METHOD OF ADMINISTRATION _ RECOMMENDED DOSAGE _ Schizophrenia _Adults_ : The recommended starting dose for Aripiprazole Sandoz 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 230320-aripiprazole sandoz-ds Page 2 of 31 mg/day have been effective in clinical trials. Dail Leia o documento completo