Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
OLANZAPINE
McDermott Laboratories Ltd t/a Gerard Laboratories
N05AH03
OLANZAPINE
10 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Antipsychotics
Authorised
2012-05-18
PAGE 1 OF 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OLANZAPINE MYLAN 5 MG ORODISPERSIBLE TABLETS OLANZAPINE MYLAN 10 MG ORODISPERSIBLE TABLETS OLANZAPINE MYLAN 15 MG ORODISPERSIBLE TABLETS OLANZAPINE MYLAN 20 MG ORODISPERSIBLE 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 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 your pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Olanzapine Mylan is and what it is used for 2. What you need to know before you take Olanzapine Mylan 3. How to take Olanzapine Mylan 4. Possible side effects 5. How to store Olanzapine Mylan 6. Contents of the pack and other information 1. WHAT OLANZAPINE MYLAN IS AND WHAT IT IS USED FOR Olanzapine Mylan contains the active substance olanzapine and belongs to a group of medicines called antipsychotics. Olanzapine Mylan is used to treat 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. Olanzapine Mylan is used to treat moderate to severe manic episodes, a condition with symptoms such as feeling "high", having excessive amounts of energy, n read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 10mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg olanzapine Excipient with known effect: Each 10 mg orodispersible tablet contains 3.950 mg aspartame For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet Light yellow to yellow coloured, plain to mottled, round, flat faced, beveled edged tablets debossed with “M” on one side and “OE2” on other 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, 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. IRISH MEDICINES BOARD ____________________ read_full_document