Rasagiline Vancombex Tablets 1mg

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

RASAGILINE

Saatavilla:

Combino Pharma (Malta) Ltd. HF60, Hal Far Industrial Estate, BBG07, Hal Far, Malta

ATC-koodi:

N04BD02

INN (Kansainvälinen yleisnimi):

RASAGILINE 1 mg

Lääkemuoto:

TABLET

Koostumus:

RASAGILINE 1 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTI-PARKINSON DRUGS

Valtuutuksen tilan:

Withdrawn

Valtuutus päivämäärä:

2016-09-06

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE VANCOMBEX 1 MG TABLETS
Rasagiline
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 Rasagiline Vancombex is and what it is used for
2.
What you need to know before you take Rasagiline Vancombex
3.
How to take Rasagiline Vancombex
4.
Possible side effects
5.
How to store Rasagiline Vancombex
6.
Contents of the pack and other information
1.
WHAT RASAGILINE VANCOMBEX IS AND WHAT IT IS USED FOR
Rasagiline Vancombex is used for the treatment of Parkinson’s
disease. It can be used together with
or without Levodopa (another medicine that is used to treat
Parkinson’s disease).
With Parkinson’s disease, there is a loss of cells that produce
dopamine in the brain. Dopamine is a
chemical in the brain involved in movement control. Rasagiline
Vancombex helps to increase and
sustain levels of dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE VANCOMBEX
DO NOT TAKE RASAGILINE VANCOMBEX:
-
if you are allergic (hypersensitive) to rasagiline or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have severe liver problems.
DO NOT TAKE THE FOLLOWING MEDICINES WHILE TAKING RASAGILINE VANCOMBEX
:
-
monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression
or Parkinson’s disease,
or used for any other indication), including medicinal and natural
products without prescription
e.g. St. John's Wort.
-
pethidine (a strong pain killer).
You
must
wait
at
least
14
days
after
stoppingRasagiline
Vancombex

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline Vancombex 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as tartrate).
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline Vancombex is indicated for the treatment of idiopathic
Parkinson's disease (PD) as
monotherapy (without levodopa) or as adjunct therapy (with levodopa)
in patients with end of dose
fluctuations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rasagiline is administered orally, at a dose of 1 mg once daily with
or without levodopa.
It may be taken with or without food.
Elderly: No change in dose is required for elderly patients.
Paediatric
population:
Rasagiline
Vancombex
is
not
recommended
for
use
in
children
and
adolescents due to lack of data on safety and efficacy.
_ _
Patients with hepatic impairment: Rasagiline use in patients with
severe hepatic impairment is
contraindicated (see section 4.3). Rasagiline use in patients with
moderate hepatic impairment
should be avoided. Caution should be used when initiating treatment
with rasagiline in patients with
mild hepatic impairment. In case patients progress from mild to
moderate hepatic impairment
rasagiline should be stopped (see section 4.4).
Patients with renal impairment: No change in dose is required for
renal impairment.
_ _
Page 2 of 10
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Concomitant treatment with other monoamine oxidase (MAO) inhibitors
(including medicinal and
natural products without prescription e.g. St. John's Wort) or
pethidine (see section 4.5). At least 14
days must elapse between discontinuation of rasagiline and initiation
of treatment with MAO
inhibitors or pethidine.
Rasagiline is contraindicated in patients with severe hepatic
impairment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The con