Zalasta 7.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Olanzapine

Available from:

Consilient Health Ltd

ATC code:

N05AH03

INN (International Name):

Olanzapine

Dosage:

7.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5391512451615

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZALASTA 2.5 MG TABLETS
ZALASTA 5 MG TABLETS
ZALASTA 7.5 MG TABLETS
ZALASTA 10 MG TABLETS
ZALASTA 15 MG TABLETS
ZALASTA 20 MG 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.
IN THIS LEAFLET
:
1.
What Zalasta is and what it is used for
2.
What you need to know before you take Zalasta
3.
How to take Zalasta
4.
Possible side effects
5.
How to store Zalasta
6.
Contents of the pack and other information
1.
WHAT ZALASTA IS AND WHAT IT IS USED FOR
Zalasta contains the active substance olanzapine. Zalasta 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withdrawn.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.
Zalasta 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 ZALASTA
DO NOT TAKE ZALASTA
-
If you are allergic (hypersensitive) 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 shortness of breath. If this has happened to you, tell
your doctor.
-
If you have been previously diagnosed with eye

Summary of Product characteristics

OBJECT 1
ZALASTA 7.5 MG TABLETS
Summary of Product Characteristics Updated 14-Jun-2016 | Consilient
Health Ltd
1. Name of the medicinal product
Zalasta 7.5 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 7.5 mg olanzapine.
Excipient with known effect:
Each tablet contains 121.3 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
Tablets are round, slightly biconvex, slightly yellow tablets with
possible individual yellow spots and an
inscription “7.5“.
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 10
mg/day.
Manic episode: The starting dose is 15 mg as a single daily dose in
monotherapy or 10 mg daily in
combination therapy (see section 5.1).
Preventing recurrence in bipolar disorder: The recommended starting
dose is 10 mg/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, daily
dosage may subsequently be adjusted on the basis of individual
clinical status within the range 5-20
mg/day. An increase to a dose greater than the recommended starting
dose is advised only