Rasagiline ratiopharm

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

rasagiline

Dostupné z:

Teva B.V.

ATC kód:

N04BD02

INN (Medzinárodný Name):

rasagiline

Terapeutické skupiny:

Anti-Parkinson drugs

Terapeutické oblasti:

Parkinson Disease

Terapeutické indikácie:

Rasagiline ratiopharm 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.

Prehľad produktov:

Revision: 8

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2015-01-12

Príbalový leták

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE RATIOPHARM 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 ratiopharm is and what it is used for
2.
What you need to know before you take Rasagiline ratiopharm
3.
How to take Rasagiline ratiopharm
4.
Possible side effects
5.
How to store Rasagiline ratiopharm
6.
Contents of the pack and other information
1.
WHAT RASAGILINE RATIOPHARM IS AND WHAT IT IS USED FOR
Rasagiline ratiopharm 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
ratiopharm helps to increase and sustain
levels of dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE RATIOPHARM
DO NOT TAKE RASAGILINE RATIOPHARM
-
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
ratiopharm:
-
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 ki

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline ratiopharm 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevelled tablets, debossed with
“GIL” and “1” underneath on one side and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline ratiopharm 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
ratiopharm) 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 ratiopharm in children and
adolescents have not been established.
There is no relevant use of Rasagiline ratiopharm in the paediatric
population in the indication
Parkinson’s disease.
Method of administration
For oral use.
Rasagiline ratiopharm may be taken with or without food.
3
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 witho