Country: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Olanzapine
Consilient Health Ltd
N05AH03
Olanzapine
2.5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5391512451592
PACKAGE LEAFLET: INFORMATION FOR THE USER ZALASTA 2.5 MG TABLETS ZALASTA 5 MG TABLETS ZALASTA 7.5 MG TABLETS ZALASTA 10 MG TABLETS ZALASTA 15 MG TABLETS ZALASTA 20 MG 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 doctor. - If you have been previously diagnosed with eye সম্পূর্ণ নথি পড়ুন
OBJECT 1 ZALASTA 2.5MG TABLETS Summary of Product Characteristics Updated 13-Jun-2016 | Consilient Health Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Zalasta 2.5 mg tablets 2. Qualitative and quantitative composition Each tablet contains 2.5 mg olanzapine. Excipient with known effect: Each tablet contains 40.4 mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet. Tablets are round, slightly biconvex, slightly yellow tablets with possible individual yellow 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 recu সম্পূর্ণ নথি পড়ুন