Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Olanzapine
Accord Healthcare Ireland Ltd.
N05AH; N05AH03
Olanzapine
2.5 milligram(s)
Film-coated tablet
Diazepines, oxazepines, thiazepines and oxepines; olanzapine
Marketed
2009-12-18
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLANZAPINE 2.5 MG FILM-COATED TABLETS OLANZAPINE 5 MG FILM-COATED TABLETS OLANZAPINE 7.5 MG FILM-COATED TABLETS OLANZAPINE 10 MG FILM-COATED TABLETS OLANZAPINE 15 MG FILM-COATED TABLETS Olanzapine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Olanzapine tablets are and what they are used for 2. What you need to know before you take Olanzapine tablets 3. How to take Olanzapine tablets 4. Possible side effects 5. How to store Olanzapine tablets 6. Contents of the pack and other information 1. WHAT OLANZAPINE TABLETS ARE AND WHAT THEY ARE USED FOR Olanzapine tablets belongs to a group of medicines called antipsychotics and is used to treat the following conditions: Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense. Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria. Olanzapine tablets have been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINE TABLETS DO NOT TAKE OLANZAPINE TABLETS - if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, a swoll Soma hati kamili
Health Products Regulatory Authority 07 April 2020 CRN009PGR Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine 2.5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg olanzapine. Excipient(s) with known effect: 2.5 mg film-coated tablet contains 58.3 mg lactose anhydrous and 0.064 mg lecithin soya (E322). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round, biconvex, white film-coated tablet 6 mm in diameter, marked with “O” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults_ Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day. Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1). Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, therapy for preventing recurrence should be continued at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated. During treatment for schizophrenia, manic episode and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An Soma hati kamili