Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Olanzapine Micronized
ZUELLIG PHARMA SDN BHD
Olanzapine Micronized
28Tablet Tablets
Catalent UK Swindon Zydis Limited
ZYPREXA TABLET /ZYPREXA ZYDIS ORODISPERSIBLE TABLET Olanzapine (5 mg, 10 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Zyprexa is used for 2. How Zyprexa works 3. Before you use Zyprexa 4. How to use Zyprexa 5. While you are using it 6. Side effects 7. Storage and Disposal of Zyprexa 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT ZYPREXA IS USED FOR Zyprexa is used to treat the following conditions: • Schizophrenia, a mental 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. _ _ • Short-term treatment of acute manic episode associated with Bipolar Disorder. _ _ Zyprexa has been shown to prevent recurrence of manic, depressive or mixed episodes in Bipolar Disorder. _ _ HOW ZYPREXA WORKS Zyprexa is an antipsychotic, antimanic and mood stabilising agent. Zyprexa contains the active ingredient olanzapine. Zyprexa belongs to a group of medicines called antipsychotics. It helps to correct chemical imbalances in the brain which may cause mental illness. BEFORE YOU USE ZYPREXA _- When you must not use it _ • If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). 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 Parkinson’s disease. • If you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye). • The use if Zyprexa in elderly with dementia (symptoms that may include memory loss and difficulties with thinking, problem-solving or language) is not recommended as it may have serious side effects. _- Before you start to use it_ Talk to your doctor or pharmacist before you take Zy Baca dokumen lengkapnya
Zyprexa_Zyprexa Zydis PI_EUSPC19Nov2020_28 Dec 2020 1. NAME OF THE MEDICINAL PRODUCT ZYPREXA/ZYPREXA ZYDIS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ZYPREXA 5 mg coated tablets Each coated tablet contains 5 mg olanzapine. Excipient with known effect: Each coated tablet contains 156 mg lactose monohydrate. ZYPREXA 10 mg coated tablets Each coated tablet contains 10 mg olanzapine. Excipient with known effect: Each coated tablet contains 312 mg lactose monohydrate. ZYPREXA ZYDIS 5 mg orodispersible tablets Each orodispersible tablet contains 5 mg olanzapine. Excipients with known effect: Each orodispersible tablet contains 0.60 mg aspartame (E951), 0.1125 mg sodium methyl parahydroxybenzoate (E219), 0.0375 mg sodium propyl parahydroxybenzoate (E217). ZYPREXA ZYDIS 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg olanzapine. Excipients with known effect: Each orodispersible tablet contains 0.80 mg aspartame (E951), 0.15 mg sodium methyl parahydroxybenzoate (E219), 0.05 mg sodium propyl parahydroxybenzoate (E217). For excipients, see section 6.1. 3. PHARMACEUTICAL FORM COATED TABLETS ZYPREXA 5 mg Tablets are round, white, coated tablets imprinted with "LILLY" and a numeric identicode “4115”. ZYPREXA 10 mg Tablets are round, white, coated tablets imprinted with "LILLY" and a numeric identicode “4117”. ORODISPERSIBLE TABLET ZYPREXA ZYDIS 5 mg and 10 mg Orodispersible Tablet is a yellow, round, freeze dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration. Zyprexa_Zyprexa Zydis PI_EUSPC19Nov2020_28 Dec 2020 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuing therapy in patients who have shown initial treatment response. Olanzapine is indicated for short-term treatment of acute manic episode associated with Bipolar I Disorder. Olanzapine is indicated for Baca dokumen lengkapnya