Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Olanzapine
Rowex Ltd
N05AH; N05AH03
Olanzapine
10 milligram(s)
Orodispersible tablet
Product subject to prescription which may not be renewed (A)
Diazepines, oxazepines, thiazepines and oxepines; olanzapine
Not marketed
2011-09-16
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 your 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 Rolyprexa DisTab is and what it is used for 2. What you need to know before you take Rolyprexa DisTab 3. How to take Rolyprexa DisTab 4. Possible side effects 5. How to store Rolyprexa DisTab 6. Contents of the pack and other information PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ROLYPREXA DISTAB 5 MG ORODISPERSIBLE TABLETS ROLYPREXA DISTAB 10 MG ORODISPERSIBLE TABLETS ROLYPREXA DISTAB 15 MG ORODISPERSIBLE TABLETS ROLYPREXA DISTAB 20 MG ORODISPERSIBLE TABLETS olanzapine Continued on the next page ›› 1 WHAT ROLYPREXA DISTAB IS AND WHAT IT IS USED FOR Rolyprexa DisTab contains the active substance olanzapine. It 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. Rolyprexa DisTab has 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 ROLYPREXA DISTAB DO NOT TAKE ROLYPREXA DISTAB • If you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as Przeczytaj cały dokument
Health Products Regulatory Authority 10 October 2019 CRN0096XW Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rolyprexa DisTab 10 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg of olanzapine. Excipient(s) with known effect Each orodispersible tablet contains 115.1 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. _10 mg orodispersible tablets:_ Yellow, round, flat, approximately 8.2 mm in diameter and 2.4 mm in thickness. 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 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, continue therapy for preventing recurrence 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 inc Przeczytaj cały dokument