Riik: Malta
keel: inglise
Allikas: Medicines Authority
PharmConsul s.r.o. Krcmárovská 223/33, Miskovice, Prague 9, 196 00, , Czech Republic
N05AH03
OLANZAPINE 15 mg
ORODISPERSIBLE TABLET
OLANZAPINE 15 mg
POM
PSYCHOLEPTICS
Authorised
2023-10-25
PACKAGE LEAFLET: INFORMATION FOR THE USER OLANZAPINE PHARMCONSUL 5 MG ORODISPERSIBLE TABLETS OLANZAPINE PHARMCONSUL 10 MG ORODISPERSIBLE TABLETS OLANZAPINE PHARMCONSUL 15 MG ORODISPERSIBLE TABLETS OLANZAPINE PHARMCONSUL 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 PharmConsul is and what it is used for 2. What you need to know before you take Olanzapine PharmConsul 3. How to take Olanzapine PharmConsul 4. Possible side effects 5. How to store Olanzapine PharmConsul 6. Contents of the pack and other information 1. WHAT OLANZAPINE PHARMCONSUL IS AND WHAT IT IS USED FOR Olanzapine PharmConsul 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 PHARMCONSUL DO NOT TAKE OLANZAPINE PHARMCONSUL • 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 swol Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Olanzapine PharmConsul 5 mg orodispersible tablets Olanzapine PharmConsul 10 mg orodispersible tablets Olanzapine PharmConsul 15 mg orodispersible tablets Olanzapine PharmConsul 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 PharmConsul 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 PharmConsul 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 PharmConsul 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 PharmConsul 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 sev Lugege kogu dokumenti