Xadago 100mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Safinamide methansulfonate

Предлага се от:

Profile Pharma Ltd

АТС код:

N04BD03

INN (Международно Name):

Safinamide methansulfonate

дозиране:

100mg

Лекарствена форма:

Tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 04090100; GTIN: 5060045110121

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XADAGO 50 MG FILM-COATED TABLETS
XADAGO 100 MG FILM-COATED TABLETS
Safinamide
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.
-
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. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xadago is and what it is used for
2.
What you need to know before you take Xadago
3.
How to take Xadago
4.
Possible side effects
5.
How to store Xadago
6.
Contents of the pack and other information
1.
WHAT XADAGO IS AND WHAT IT IS USED FOR
Xadago is a medicine that contains the active substance safinamide. It
acts to increase the level of a
substance called dopamine in the brain, which is involved in the
control of movement and is present in
reduced amounts in the brain of patients with Parkinson’s disease.
Xadago is used for the treatment of
Parkinson’s disease in adults.
In mid- to late-stage patients experiencing sudden switches between
being “ON” and able to move and
being “OFF” and having difficulties moving about, Xadago is added
to a stable dose of the medicine
called levodopa alone or in combination with other medicines for
Parkinson’s disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XADAGO
DO NOT TAKE XADAGO
-
If you are allergic to safinamide or any of the other ingredients of
this medicine (listed in
section 6).
-
If you are taking any of the following medicines:
-
Monoamine oxidase (MAO) inhibitors such

Данни за продукта

OBJECT 1
XADAGO 50MG FILM-COATED TABLETS XADAGO 100MG
FILM-COATED TABLETS
Summary of Product Characteristics Updated 11-Jan-2018 | Profile
Pharma Limited
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
Xadago 50 mg film-coated tablets
Xadago 100 mg film-coated tablets
2. Qualitative and quantitative composition
Xadago 50 mg film-coated tablets
Each film-coated tablet contains safinamide methansulfonate equivalent
to 50 mg safinamide.
Xadago 100 mg film-coated tablets
Each film-coated tablet contains safinamide methansulfonate equivalent
to 100 mg safinamide.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet)
Xadago 50 mg film-coated tablets
Orange to copper, round, biconcave, film-coated tablet of 7 mm
diameter with metallic gloss, embossed
with the strength “50” on one side of the tablet.
Xadago 100 mg film-coated tablets
Orange to copper, round, biconcave, film-coated tablet of 9 mm
diameter with metallic gloss, embossed
with the strength “100” on one side of the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Xadago is indicated for the treatment of adult patients with
idiopathic Parkinson's disease (PD) as add-on
therapy to a stable dose of Levodopa (L-dopa) alone or in combination
with other PD medicinal products
in mid-to late-stage fluctuating patients.
4.2 Posology and method of administration
Posology
Treatment with Xadago should be started at 50 mg per day. This daily
dose may be increased to 100
mg/day on the basis of individual clinical need.
If a dose is missed the next dose should be taken at the usual time
the next day.
_Elderly_
No change in dose is required for elderly patients.
Experience of use of safinamide in patients over 75 years of age is
limited.
_Hepatic impairment_
Xadago use in pat