Rasagiline Actavis 1mg tablets

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Rasagiline tartrate

Dostupné s:

Actavis Group PTC ehf

ATC kód:

N04BD; N04BD02

INN (Mezinárodní Name):

Rasagiline tartrate

Dávkování:

1 milligram(s)

Léková forma:

Tablet

Druh předpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Monoamine oxidase B inhibitors; rasagiline

Stav Autorizace:

Not marketed

Datum autorizace:

2016-01-08

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 ACTAVIS IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RASAGILINE ACTAVIS
3
HOW TO TAKE RASAGILINE ACTAVIS
4 POSSIBLE SIDE EFFECTS
5
HOW TO STORE RASAGILINE ACTAVIS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT RASAGILINE ACTAVIS IS AND WHAT IT IS USED FOR
Rasagiline Actavis 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 Actavis helps to increase and sustain
levels of dopamine in the brain.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RASAGILINE ACTAVIS
DO NOT TAKE RASAGILINE ACTAVIS
•
if you are allergic 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 Actavis:
•
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 stopping
Rasagiline Actavis treatment and starting treatment
with MAO inhibitors or pethidine.
WARNINGS A

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Actavis 1mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as tartrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, round bevel edge, 7 mm, debossed with “A486” on one side
and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Actavis 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 Actavis 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.
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
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