Rasagiline Accord 1mg tablets

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

RASAGILINE

Mevcut itibaren:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC kodu:

N04BD02

INN (International Adı):

RASAGILINE 1 mg

Farmasötik formu:

TABLET

Kompozisyon:

RASAGILINE 1 mg

Reçete türü:

POM

Terapötik alanı:

ANTI-PARKINSON DRUGS

Yetkilendirme durumu:

Withdrawn

Yetkilendirme tarihi:

2016-02-01

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Rasagiline Accord
3.
How to take Rasagiline Accord
4.
Possible side effects
5.
How to store Rasagiline Accord
6.
Contents of the pack and other information
1.
WHAT RASAGILINE ACCORD IS AND WHAT IT IS USED FOR
Rasagiline Accord contains the active substance rasagiline 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 Accord
helps to increase and
sustain levels of dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE ACCORD
DO NOT TAKE RASAGILINE ACCORD
-
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 Accord:
-
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

Ürün özellikleri

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline Accord 1 mg 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 Accord 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 recommened dose of Rasagiline is1 mg (1 tablet of Rasagiline
Accord) 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.
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_Paediatric population _
The safety and efficacy of Rasagiline Accord in children and
adolescents have not been established.
There is no relevant use of Rasagiline Accord in the paediatric
population in the indication
Parkinson’s disease
Method of administration
For oral use.
Rasagiline Accord may be taken with or without food.
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