Rasagiline Accord 1 mg tablets

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Rasagiline

Mevcut itibaren:

Accord Healthcare Ireland Ltd.

ATC kodu:

N04BD; N04BD02

INN (International Adı):

Rasagiline

Doz:

1 milligram(s)

Farmasötik formu:

Tablet

Terapötik alanı:

Monoamine oxidase B inhibitors; rasagiline

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2015-11-27

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE ACCORD 1MG 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 Rasagiline A

Ürün özellikleri

Health Products Regulatory Authority
04 January 2023
CRN00D4GY
Page 1 of 10
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 rasagiline tartrate). For the
full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevelled tablets (6.5 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Accord is indicated in adults for the treatment of
idiopathic Parkinson's disease 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 (one tablet of Rasagiline
Accord)once daily to be taken with or without levodopa.
_Elderly_
No change in dose is required for elderly patients. (see section 5.2).
_Hepaticimpairment_
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 should be
stopped (see sections 4.4 and 5.2).
_Renalimpairment_
No special precautions are required in patients with renal impairment.
_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 Wort) or pe