Latuda 18.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lurasidone hydrochloride

Available from:

Sunovion Pharmaceuticals Europe Ltd

ATC code:

N05AE05

INN (International Name):

Lurasidone hydrochloride

Dosage:

18.5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5060475950090

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LATUDA 18.5 MG FILM-COATED TABLETS
LATUDA 37 MG FILM-COATED TABLETS
LATUDA 74 MG FILM-COATED TABLETS
lurasidone
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Latuda is and what it is used for
2.
What you need to know before you take Latuda
3.
How to take Latuda
4.
Possible side effects
5.
How to store Latuda
6.
Contents of the pack and other information
1.
WHAT LATUDA IS AND WHAT IT IS USED FOR
Latuda contains the active substance lurasidone and belongs to a group
of medicines called
antipsychotics. It is used to treat symptoms of schizophrenia in
adults aged 18 years or over.
Lurasidone works by blocking receptors in the brain to which the
substances dopamine and serotonin
attach. Dopamine and serotonin are neurotransmitters (substances that
allow nerve cells to
communicate with each other) that are involved in the symptoms of
schizophrenia. By blocking their
receptors, lurasidone helps to normalise the activity of the brain,
reducing the symptoms of
schizophrenia.
Schizophrenia is a disorder with symptoms such as hearing things,
seeing or sensing things that are not
there, mistaken beliefs, unusual suspiciousness, becoming withdrawn,
incoherent speech and
behaviour and emotional flatness. People with this disorder may als

Summary of Product characteristics

OBJECT 1
LATUDA 18.5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Apr-2018 | Sunovion
Pharmaceuticals Europe Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Latuda 18.5 mg film-coated tablets
Latuda 37 mg film-coated tablets
Latuda 74 mg film-coated tablets
2. Qualitative and quantitative composition
Each 18.5mg film-coated tablet contains lurasidone hydrochloride
equivalent to18.6 mg lurasidone
Each 37mg film-coated tablet contains lurasidone hydrochloride
equivalent to 37.2 mg lurasidone
Each 74mg film-coated tablet contains lurasidone hydrochloride
equivalent to 74.5 mg lurasidone
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets
Latuda 18.5 mg film-coated tablets: white to off-white, film-coated
round tablets of 6 mm debossed with
'LA'
Latuda 37 mg: film-coated tablets: white to off-white, film-coated
round tablets of 8 mm debossed with
'LB'
Latuda 74 mg film-coated tablets: pale green, film-coated oval tablets
of 12 mm x 7 mm debossed with
'LD'
4. Clinical particulars
4.1 Therapeutic indications
Latuda is indicated for the treatment of schizophrenia in adults aged
18 years and over.
4.2 Posology and method of administration
Posology
The recommended starting dose of lurasidone is 37 mg once daily. No
initial dose titration is required. It
is effective in a dose range of 37 to 148 mg once daily. Dose increase
should be based on physician
judgement and observed clinical response. The maximum daily dose
should not exceed 148 mg.
Patients on doses higher than 111 mg once daily who discontinue their
treatment for longer than 3 days
should be restarted on 111 mg once daily and up-titrated to their
optimal dose. For all other doses patients
can be restarted on their previous dose without need for up-titration.
_