OLANZAPINE RANBAXY 20 Milligram Orodispersible Tablet
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
29-05-2024
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Viambatanisho vya kazi:
OLANZAPINE
Inapatikana kutoka:
Ranbaxy Ireland Limited
INN (Jina la Kimataifa):
OLANZAPINE
Kipimo:
20 Milligram
Dawa fomu:
Orodispersible Tablet
Dawa ya aina:
Product subject to prescription which may not be renewed (A)
Idhini hali ya:
Withdrawn
Idhini ya tarehe:
2013-01-31
Tabia za bidhaa
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Olanzapine Ranbaxy 20mg orodispersible tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet conatins 20mg olanzapine
Excipient with known effect: Each orodispersible also contains 6.0mg aspartame
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible tablet.
Light yellow to yellow colored, slightly mottled, round tablets debossed with ‘OV4’ on one side and plain on 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 episode.
In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of
recurrence in patients with bipolar disorder (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
Schizophrenia: The recommended starting dose for olanzapine is 10mg/day.
Manic episode: The starting dose is 15mg as a single daily dose in monotherapy or 10mg daily in combination therapy
(see section 5.1).
Preventing recurrence in bipolar disorder: The recommended starting dose is 10mg/day. For patients who have been
receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a
new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as
needed), with supplementary therapy to treat mood symptoms, as clinically indicated.
During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder,
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