Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OLANZAPINE
SYNERRV SDN BHD
OLANZAPINE
28tablet Tablets
Jubilant Generics Limited
Consumer Medication Information Leaflet (RiMUP) JUBREXA ODT Olanzapine Ph. Eur. 5mg Orodispersable Tablet; Olanzapine Ph. Eur, 10mg Orodispersable Tablet 1 WHAT IS IN THIS LEAFLET 1. What Jubrexa ODT Tablet is used for 2. How Jubrexa ODT Tablet works 3. Before you take Jubrexa ODT Tablet 4. How to take Jubrexa ODT Tablet 5. While you are using Jubrexa ODT Tablet 6. Side Effects 7. Storage and Disposal of Jubrexa ODT Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 1. WHAT JUBREXA ODT TABLET IS USED FOR Jubrexa ODT is used for acute and maintenance treatment for schizophrenia, a mental illness with symptoms such as hearing, seeing, or sensing things which are not there, mistaken beliefs, unusual suspiciousness and becoming withdrawn. 2. HOW JUBREXA ODT TABLET WORKS Jubrexa ODT is an antipsychotic, antimanic, and mood stabilising agent which helps to correct chemical imbalances in the brain which may cause mental illness. 3. BEFORE YOU TAKE JUBREXA ODT TABLETS _WHEN YOU MUST NOT USE IT _ - if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of Jubrexa ODT. An allergic reaction may be recognized 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 _ Tell your doctor if you have or have had any medical conditions or illnesses especially as following: • Prostate problem ( which cause difficulty in urination) • Diabetes mellitus • Hyperglycaemia( excess glucose in bloodstream, often associated with diabetes mellitus) • Liver or kidney disease • Blocked intestine (paralytic ileus) • Blood disorder • Seizures • Parkinson’s disease • Stroke or mini stroke (temporary symptoms of stroke) • Heart disease • Dementia Pregnancy and breastfeeding • Tell your doctor if you are pregnant or breastfeeding, thin Přečtěte si celý dokument
XXXXXXXXXX Last modified: 2. September 2020, 5:21 PM REASON FOR ARTWORK: NEW ITEM CODE: XXXXXXXXXX SUBSTRATE: 40 GSM BIBLE PAPER WITH FOLDING SIZE- 62 X 30 MM SITE PACKAGING DEVELOPMENT SIGN AND DATE PRODUCTION SIGN AND DATE QA SIGN AND DATE DIMENSION: 420 X 240 MM SUPERSEDED ITEM CODE: XXXXXXXXXX FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A LABORATORY ONLY JUBREXA ODT (Olanzapine Orodispersible tablets 5 mg) JUBREXA ODT (Olanzapine Orodispersible tablets 10 mg) PRODUCT NAME: JUBREXA ODT (Olanzapine Orodispersible tablets 5 mg) JUBREXA ODT (Olanzapine Orodispersible tablets 10 mg) NAME AND STRENGTH OF ACTIVE INGREDIENT: EACH ORODISPERSIBLE TABLET CONTAINS Olanzapine Ph.Eur. 5 mg Olanzapine Ph.Eur. 10 mg PRODUCT DESCRIPTION FOR 5 MG Yellow coloured, round, flat face beveled edge tablets with characteristic flavour, debossed with “D5” on one side and “CO” on other side FOR 10 MG Yellow coloured, round, flat face beveled edge tablets with characteristic flavour, debossed with “D10” on one side and “CO” on other side PHARMACODYNAMICS / PHARMACOKINETICS PHARMACODYNAMICS: _Pharmacotherapeutic group: _Diazepines, oxazepines and thiazepines. _ATCcode: _N05A H03. Olanzapine is an antipsychotic, antimanic, and mood stabilising agent that demonstrates a broad pharmacologic profile across a number of receptor systems. PHARMACOKINETICS Olanzapine is well absorbed from the gastrointestinal tract after oral doses but undergoes considerable firstpass metabolism. Peak plasma concentrations are achieved about 5 to 8 hours after oral doses and about 15 to 45 minutes after an intramuscular dose. Olanzapine is about 93% bound to plasma proteins. It is extensively metabolised in the liver, primarily by direct glucuronidation and by oxidation mediated through the cytochrome P450 isoenzymes CYP1A2, and, to a lesser extent, CYP2D6. The 2 major metabolites 10-N-glucuronide and 4′-N-desmethyl olanzapine appear to be inactive. About 57% of a dose is excreted in the urine, mainly as metabolites, and a Přečtěte si celý dokument