Ocaliva 10mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Obeticholic acid

Disponible desde:

Intercept Pharma UK & Ireland Ltd

Código ATC:

A05AA04

Designación común internacional (DCI):

Obeticholic acid

Dosis:

10mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01090100; GTIN: 00369516000042

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
OCALIVA 5 MG FILM-COATED TABLETS
OCALIVA 10 MG FILM-COATED TABLETS
obeticholic acid
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OCALIVA is and what it is used for
2.
What you need to know before you take OCALIVA
3.
How to take OCALIVA
4.
Possible side effects
5.
How to store OCALIVA
6.
Contents of the pack and other information
1.
WHAT OCALIVA IS AND WHAT IT IS USED FOR
OCALIVA contains the active substance obeticholic acid (farnesoid
X-receptor agonist) which helps
to improve how your liver works by reducing the production and build
up of bile in the liver and also
reducing inflammation.
This medicine is used to treat adult patients with a type of liver
disease known as primary biliary
cholangitis (also known as primary biliary cirrhosis), either by
itself or together with another
medicine, ursodeoxycholic acid.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OCALIVA
_ _
DO NOT TAKE OCALIVA:
-
if you are allergic to obeticholic acid or any of the other
ingredients of this medicine (listed in
section 6).
-
if you have a complete blockage of the biliary tract (liver, gall
bladder and bile ducts).
_ _
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking OCALIVA.
If you experience itching that is d

Ficha técnica

OBJECT 1
OCALIVA 5MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 17-Apr-2018 | Intercept
Pharma UK & Ireland
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
OCALIVA 5 mg film-coated tablets
OCALIVA 10 mg film-coated tablets
2. Qualitative and quantitative composition
OCALIVA 5 mg film
-
coated tablets
Each film-coated tablet contains 5 mg of obeticholic acid.
OCALIVA 10 mg film
-
coated tablets
Each film-coated tablet contains 10 mg of obeticholic acid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
OCALIVA 5 mg film-coated tablets
Yellow, 8 mm round tablet debossed with 'INT' on one side and '5' on
the other side.
OCALIVA 10 mg film-coated tablets
Yellow, 7.6 mm X 7.4 mm triangular tablet debossed with 'INT' on one
side and '10' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
OCALIVA is indicated for the treatment of primary biliary cholangitis
(also known as primary biliary
cirrhosis) in combination with ursodeoxycholic acid (UDCA) in adults
with an inadequate response to
UDCA or as monotherapy in adults unable to tolerate UDCA.
4.2 Posology and method of administration
Posology
Prior to initiation of treatment with obeticholic acid the patient's
hepatic status must be known.
The starting dose and dosage titration by PBC patient population is
shown in Table 1.
Table 1: Dosage Regimen by PBC Patient Population
STAGING/CLASSIFICATION
NON-CIRRHOTIC OR CHILD-PUGH
CLASS A
CHILD-PUGH CLASS B OR C OR
DECOMPENSATED CIRRHOTIC
STARTING DOSAGE
5 MG ONCE DAILY
5 MG ONCE WEEKLY
DOSAGE TITRATION
For patients who have not achieved
an adequate reduction in alkaline
phosphatase (ALP) and/or total
bilirubin after 6 MONTHS of treatment
and the patient is tolerating
obeticholic acid, titrate up to 10 MG
ONCE D