Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OLANZAPINE
DCH AURIGA (MALAYSIA) SDN. BHD.
OLANZAPINE
28 Tablets
Actavis Ltd.
Consumer Medication Information Leaflet (RiMUP) ONZAPIN ORODISPERSIBLE TABLETS Olanzapine orodispersible (5mg,10mg) _ _ _ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Onzapin is used for 2. How Onzapin works 3. Before you use Onzapin 4. How to take Onzapin 5. While you are using Onzapin 6. Side Effects 7. Storage and Disposal of Onzapin 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ONZAPIN IS USED FOR Olanzapine belongs to a group of medicines called antipsycotics 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 has been shown to prevent recurrence of these symptoms in patients with bipolar disorder whose manic episode has responded to olanzapine treatment. HOW ONZAPIN WORKS Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain. BEFORE YOU USE ONZAPIN _-When you must not take it _ Do not take olanzapine: -If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine. 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 doctor -If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye). _-Before you start to take it _ Talk to your doctor or pharmacist before you take olanzapine: -The use of olanzapine in elderly patients with dementia is not recommended as it may have serious side effects. -Medicines of this type may cause unusual movements mainly of the face or tongue. If this happens after you have been given olanzapine tell your doctor. -Very rarely Lestu allt skjalið
ONZAPIN ORODISPERSIBLE TABLETS DESCRIPTION 5mg: Yellow tablets, 6 mm round, biconvex. Markings O 10mg: Yellow tablets, 8 mm round, biconvex. Markings O1 COMPOSITION Each Onzapin Orodispersible tablets 5mg contains 5mg olanzapine. Each Onzapin Orodispersible tablets 10mg contains 10mg olanzapine. PHARMACOLOGY Olanzapine is an antipsychotic, antimanic, and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems. In preclinical studies, olanzapine exhibited a range of receptor affinities (K i <100nM) for serotonin 5HT 2A/2C , 5HT 3 , 5HT 6 ; dopamine D 1 , D 2 , D 3 , D 4 , D 5 ; cholinergic muscarinic receptors M 1 -M 5 ; α 1 adrenergic; and histamine H 1 receptors. Animal behavioral studies with olanzapine indicated 5HT, dopamine, and cholinergic antagonism, consistent with the receptor-binding profile. Olanzapine demonstrated a greater _in vitro_ affinity for serotonin 5HT 2 than dopamine D 2 receptors and greater 5HT 2 than D 2 activity in _in vivo_ models. Electrophysiological studies demonstrated that olanzapine selectively reduced the firing of mesolimbic (A10) dopaminergic neurons, while having little effect on the striatal (A9) pathways involved in motor function. Olanzapine reduced a conditioned avoidance response, a test indicative of antipsychotic activity, at doses below those producing catalepsy, an effect indicative of motor side effects. Unlike some other antipsychotic agents, olanzapine increases responding in an ‘anxiolytic’ test. PHARMACOKINETICS _Absorption_ Olanzapine is well absorbed after oral administration, reaching peak plasma concentrations within 5 to 8 hours. The absorption is not affected by food. Absolute oral bioavailability relative to intravenous administration has not been determined. Olanzapine orodispersible tablet is bioequivalent to olanzapine coated tablets, with a similar rate and extent of absorption. Olanzapine orodispersible tablets may be used as an alternative to olanzapine coated tablets. _Biotransformation_ Olanza Lestu allt skjalið