Rasagiline Krka 1mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rasagiline

Available from:

Krka d.d.

ATC code:

N04BD02

INN (International Name):

Rasagiline

Dosage:

1mg

Pharmaceutical form:

tablets

Administration route:

oral use

Units in package:

14, 15, 28, 30 and 112 tablets, in a box

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

KRKA, d.d

Therapeutic group:

anti-parkinson drugs, monoamine oxidase B inhibitors

Therapeutic indications:

Rasagiline Krka 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.

Authorization status:

Authorised

Authorization date:

2015-10-30

Patient Information leaflet

Navodila prepognjena na sredini z vidno prvo stranjo (naslovom);
pharma kodi, ki izhajata iz sredine navodila, morata biti vidni!
 smer vlaken
 smer branja kode
70 mm ± 0,5 mm
70 mm ± 0,5 mm
 smer branja kode
Šifra: 2xxxxx 
Emb. mat.: NA.RASAGILINE KRKA 

IE
Dimenzije: 148 ± 0,5 mm x 420 ± 0,8 mm 
Material: papir tip B
PhC št.: 2xxxx
Merilo: 1:1
Datum: 09.09.2015
Izdelal: K. Savnik
Pregledal: J. Kastelic
_Oddelek za oblikovanje_
_ - PMS-433U-KRKA_
_NA.RASAGILINE KRKA TBL IE_  prva stran
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rasagiline Krka 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 Krka is and what it is used for
2.  What you need to know before you take Rasagiline Krka
3.  How to take Rasagiline Krka
4.  Possible side effects
5.  How to store Rasagiline Krka
6.  Contents of the pack and other information
1. What Rasagiline Krka is and what it is used for
Rasagiline Krka 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 Krka helps to increase
and sustain levels of dopamine in the brain.
2. What you need to know before you take 
Rasagiline Krka
DO NOT TAKE RASAGILINE KRKA:
• if you are allergic to rasagiline or any of the ot

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Krka 1mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as rasagiline hemitartrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to almost white, round, slightly biconvex tablets, 7 mm in diameter, with beveled edges, darker spots may be
visible.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Krka 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 Krka 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
HEALTH PRODUCTS REGULATORY AUTHORITY
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