Rasagiline Krka 1 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rasagiline

Available from:

KRKA, d.d., Novo mesto

ATC code:

N04BD; N04BD02

INN (International Name):

Rasagiline

Dosage:

1 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Monoamine oxidase B inhibitors; rasagiline

Authorization status:

Marketed

Authorization date:

2015-10-30

Patient Information leaflet

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 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 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 other ingredients of
this medicine (listed in section
6).
-
if you have severe liver problems.
Do not take the following medicines while taking Rasagiline Krka:
-
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 Krka
treatment and start

Summary of Product characteristics

Health Products Regulatory Authority
17 June 2021
CRN00CD31
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Krka 1 mg 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 in adults 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
The recommended dose of rasagiline is 1 mg (one tablet of Rasagiline
Krka) once daily, 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 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 Krka in children and adolescents
have not been established. There is no relevant use of
Rasagiline Krka in the paediatric population in the indication
Parkinson’s disease.
Method of administration
For oral use.
Rasagiline Krka 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.
Health Products Regulatory Authority
17 June 2021
CRN00CD31
Page 2 of 10
Concomitant treatment