País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Olanzapine
Consilient Health Ltd
N05AH03
Olanzapine
20mg
Orodispersible tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: ; GTIN: 5391512451684
PACKAGE LEAFLET: INFORMATION FOR THE USER ZALASTA 5 MG ORODISPERSIBLE TABLETS ZALASTA 7.5 MG ORODISPERSIBLE TABLETS ZALASTA 10 MG ORODISPERSIBLE TABLETS ZALASTA 15 MG ORODISPERSIBLE TABLETS ZALASTA 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 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. IN THIS LEAFLET : 1. What Zalasta is and what it is used for 2. What you need to know before you take Zalasta 3. How to take Zalasta 4. Possible side effects 5. How to store Zalasta 6. Contents of the pack and other information 1. WHAT ZALASTA IS AND WHAT IT IS USED FOR Zalasta contains the active substance olanzapine. Zalasta 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. Zalasta 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 ZALASTA DO NOT TAKE ZALASTA - 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 swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doct Llegiu el document complet
OBJECT 1 ZALASTA 20 MG ORODISPERSIBLE TABLETS Summary of Product Characteristics Updated 13-Jun-2016 | Consilient Health Ltd 1. Name of the medicinal product Zalasta 20 mg orodispersible tablets 2. Qualitative and quantitative composition Each orodispersible tablet contains 20 mg olanzapine. Excipient with known effect: Each orodispersible tablet contains 2.00 mg aspartame. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Orodispersible tablet. Tablets are round, slightly biconvex, yellow marbled tablets with possible individual spots. 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 increase to a dose greater than the reco Llegiu el document complet