Olanzapine PharmConsul 10 mg orodispersible tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

PharmConsul s.r.o. Krcmárovská 223/33, Miskovice, Prague 9, 196 00, , Czech Republic

ATC code:

N05AH03

INN (International Name):

OLANZAPINE 10 mg

Pharmaceutical form:

ORODISPERSIBLE TABLET

Composition:

OLANZAPINE 10 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2023-10-25

Patient Information leaflet

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withdrawn.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

Summary of Product characteristics

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