Olanzapine Mylan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
14-07-2023
Charakterystyka produktu
(SPC)
14-07-2023
Sprawozdanie z oceny publicznego
(PAR)
16-10-2008
Składnik aktywny:
olanzapine
Dostępny od:
Mylan Pharmaceuticals Limited
Kod ATC:
N05AH03
INN (International Nazwa):
olanzapine
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Schizophrenia; Bipolar Disorder
Wskazania:
AdultsOlanzapine 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 recurrence in patients with bipolar disorder.
Podsumowanie produktu:
Revision: 19
Status autoryzacji:
Authorised
Data autoryzacji:
2008-10-06
Ulotka dla pacjenta
84
B. PACKAGE LEAFLET
85
PACKAGE LEAFLET: INFORMATION FOR THE USER
OLANZAPINE MYLAN 2.5 MG FILM-COATED TABLETS
OLANZAPINE MYLAN 5 MG FILM-COATED TABLETS
OLANZAPINE MYLAN 7.5 MG FILM-COATED TABLETS
OLANZAPINE MYLAN 10 MG FILM-COATED TABLETS
OLANZAPINE MYLAN 15 MG FILM-COATED TABLETS
OLANZAPINE MYLAN 20 MG FILM-COATED 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 Mylan is and what it is used for
2.
What you need to know before you take Olanzapine Mylan
3.
How to take Olanzapine Mylan
4.
Possible side effects
5.
How to store Olanzapine Mylan
6.
Contents of the pack and other information
_ _
1.
WHAT OLANZAPINE MYLAN IS AND WHAT IT IS USED FOR
Olanzapine Mylan contains the active substance olanzapine. Olanzapine
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 Mylan 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 MYLAN
DO NOT TAKE OLANZAPINE MYLAN
•
if you are allergic (hypersensitive) to olanzapine, peanut or soya or
any
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Olanzapine Mylan 2.5 mg film-coated tablets
Olanzapine Mylan 5 mg film-coated tablets
Olanzapine Mylan 7.5 mg film-coated tablets
Olanzapine Mylan 10 mg film-coated tablets
Olanzapine Mylan 15 mg film-coated tablets
Olanzapine Mylan 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Olanzapine Mylan 2.5 mg film-coated tablets
Each film-coated tablet contains 2.5 mg olanzapine.
Excipients with known effect
Each film-coated tablet contains 76 mg lactose (as monohydrate).
The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin.
Olanzapine Mylan 5 mg film-coated tablets
Each film-coated tablet contains 5 mg olanzapine.
Excipients with known effect
Each film-coated tablet contains 152 mg lactose (as monohydrate).
The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin.
Olanzapine Mylan 7.5 mg film-coated tablets
Each film-coated tablet contains 7.5 mg olanzapine.
Excipients with known effect
Each film-coated tablet contains 228 mg lactose (as monohydrate).
The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin.
Olanzapine Mylan 10 mg film-coated tablets
Each film-coated tablet contains 10 mg olanzapine.
Excipients with known effect
Each film-coated tablet contains 304 mg lactose (as monohydrate).
The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin.
Olanzapine Mylan 15 mg film-coated tablets
Each film-coated tablet contains 15 mg olanzapine.
Excipients with known effect
Each film-coated tablet contains 183 mg lactose (as monohydrate).
The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin.
Olanzapine Mylan 20 mg film-coated tablets
Each film-coated tablet contains 20 mg olanzapine.
Excipients with known effect
Each film-coated tablet contains 244 mg lactose (as monohydrate).
The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Olanzap
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