Rasagiline Actavis 1mg tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Rasagiline tartrate

Доступно од:

Accord Healthcare Ireland Ltd.

АТЦ код:

N04BD; N04BD02

INN (Међународно име):

Rasagiline tartrate

Дозирање:

1 milligram(s)

Фармацеутски облик:

Tablet

Терапеутска област:

Monoamine oxidase B inhibitors; rasagiline

Статус ауторизације:

Not marketed

Датум одобрења:

2016-01-08

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE ACTAVIS 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 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 contains the active substance rasagaline and it is
used for the treatment of
Parkinson’s disease in adults. 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 Ras

Карактеристике производа

Health Products Regulatory Authority
01 August 2019
CRN008J2F
Page 1 of 11
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 in adults 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
The recommended dose of Rasagiline is 1 mg (1 tablet of Rasagiline
Actavis) once daily administered orally, to be taken with or
without levodopa.
_Elderly_
No change in dose is required for elderly patients (see section 5.2).
_Hepatic impairment_
Rasagiline is contraindicated in patients with severe hepatic
impairment (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 use should be
stopped (see section 4.4 and 5.2).
_Renal impairment_
No special precautions are required in patients with renal impairment.
_Paediatric population_
The safety and efficacy of Rasagiline Actavis in children and
adolescents have not been established. There is no relevant use of
Rasagiline Actavis in the paediatric population in the indication
Parkinson's disease
Method of administration
For oral use.
Rasagiline Actavis may be taken with or without food.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
01 August 2019
CRN008J2F
Page 2 of 11
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Concomitant treatment wit