Rasagiline 1mg Tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: myHealthbox

सक्रिय संघटक:

rasagiline

थमां उपलब्ध:

Caduceus Pharma Ltd

ए.टी.सी कोड:

N04BD02

INN (इंटरनेशनल नाम):

rasagiline

डोज़:

1mg

फार्मास्यूटिकल फॉर्म:

Tablets

प्रशासन का मार्ग:

Oral use

पैकेज में यूनिट:

28 tablets

प्रिस्क्रिप्शन प्रकार:

POM - Prescription Only Medicine

द्वारा बनाया गया:

Actavis ehf

चिकित्सीय समूह:

Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors

चिकित्सीय संकेत:

It 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.

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2015-08-20

सूचना पत्रक

Rasagiline 1mg 28 Tablets PIL - UK
item no: AAAI0886
print proof no: 4
origination date: 24.06.15
originated by: S.Anson
revision date: 26.06.15
revised by: BW
dimensions: 170 x 440  
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 24.06.15
supplier: Actavis Iceland
technically app. date:
min pt size: 9pt
TECHNICAL APPROVAL
RASAGILINE 1MG TABLETS
Rasagiline tartrate
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.
•         The full name of this medicine is Rasagiline 
1mg Tablets but within the leaflet it will be 
referred to as Rasagiline Tablets.
WHAT IS IN THIS LEAFLET
1

    WHAT RASAGILINE TABLETS ARE AND WHAT 
THEY ARE USED FOR
2

    WHAT YOU NEED TO KNOW BEFORE YOU 
TAKE RASAGILINE TABLETS
3

  HOW TO TAKE RASAGILINE TABLETS
4

  POSSIBLE SIDE EFFECTS
5

  HOW TO STORE RASAGILINE TABLETS
6

   CONTENTS OF THE PACK AND OTHER 
INFORMATION
1

    WHAT RASAGILINE TABLETS ARE AND WHAT 
THEY ARE USED FOR
Rasagiline Tablets are 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 Tablets helps to increase and 
sustain levels of d

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Rasagiline 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, debossed with “A486” on one
side and plain on the other 
side. 

4 CLINICAL 
PARTICULARS 
4.1 THERAPEUTIC 
INDICATIONS 

Rasagiline Tablets 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 Tablets 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) o