Country: Малта
Језик: Енглески
Извор: Medicines Authority
OLANZAPINE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N05AH03
OLANZAPINE 10 mg
ORODISPERSIBLE TABLET
OLANZAPINE 10 mg
POM
PSYCHOLEPTICS
Authorised
2013-02-19
PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE AUROBINDO 5 MG ORODISPERSIBLE TABLETS OLANZAPINE AUROBINDO 10 MG ORODISPERSIBLE TABLETS OLANZAPINE AUROBINDO 15 MG ORODISPERSIBLE TABLETS OLANZAPINE AUROBINDO 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 WHAT IS IN THIS LEAFLET : 1. What Olanzapine Aurobindo is and what it is used for 2. What you need to know before you take Olanzapine Aurobindo 3. How to take Olanzapine Aurobindo 4. Possible side effects 5. How to store Olanzapine Aurobindo 6. Contents of the pack and other information 1. WHAT OLANZAPINE AUROBINDO IS AND WHAT IT IS USED FOR Olanzapine Aurobindo 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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. Olanzapine 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 OLANZAPINE AUROBINDO DO NOT TAKE OLANZAPINE AUROBINDO • If you are allergic 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 Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olanzapine Aurobindo 5 mg orodispersible tablets Olanzapine Aurobindo 10 mg orodispersible tablets Olanzapine Aurobindo 15 mg orodispersible tablets Olanzapine Aurobindo 20 mg orodispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 5 mg olanzapine. Each orodispersible tablet contains 10 mg olanzapine. Each orodispersible tablet contains 15 mg olanzapine. Each orodispersible tablet contains 20 mg olanzapine. EXCIPIENTS WITH KNOWN EFFECT: _5 mg _ Each orodispersible tablet contains 0.50 mg aspartame. _10 mg _ Each orodispersible tablet contains 1 .00 mg aspartame. _15 mg _ Each orodispersible tablet contains 1 .50 mg aspartame. _20 mg _ Each orodispersible tablet contains 2 .00 mg aspartame. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet. _Olanzapine Aurobindo 5 mg orodispersible _ _tablets _ Yellow coloured, circular [diameter 5.7 mm], flat faced beveled edge tablets debossed with ‘C’ on one side and ‘51’ on the other side. _Olanzapine Aurobindo 10 mg orodispersible _ _tablets _ Yellow coloured, circular [diameter 7 mm], flat faced beveled edge tablets debossed with ‘C’ on one side and ‘52’ on the other side. _Olanzapine Aurobindo 15 mg orodispersible _ _tablets _ Yellow coloured, circular [diameter 8.2 mm], flat faced beveled edge tablets debossed with ‘C’ on one side and ‘53’ on the other side. _Olanzapine Aurobindo 20 mg orodispersible _ _tablets _ Yellow coloured, circular [diameter 9 mm], flat faced beveled edge tablets debossed with ‘C’ on one side and ‘54’ on the other side. 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 episod Прочитајте комплетан документ