Rasagiline Mylan
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
25-05-2020
Valmisteyhteenveto
(SPC)
25-05-2020
Julkisesta arviointikertomuksesta
(PAR)
29-04-2016
Aktiivinen ainesosa:
rasagiline tartrate
Saatavilla:
Mylan S.A.S.
ATC-koodi:
N04BD02
INN (Kansainvälinen yleisnimi):
rasagiline
Terapeuttinen ryhmä:
Anti-Parkinson drugs
Terapeuttinen alue:
Parkinson Disease
Käyttöaiheet:
Rasagiline Mylan 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.
Tuoteyhteenveto:
Revision: 3
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2016-04-04
Pakkausseloste
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RASAGILINE MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Rasagiline Mylan
3.
How to take Rasagiline Mylan
4.
Possible side effects
5.
How to store Rasagiline Mylan
6.
Contents of the pack and other information
1.
WHAT RASAGILINE MYLAN IS AND WHAT IT IS USED FOR
Rasagiline Mylan 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 Mylan
helps to increase and sustain
levels of dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE MYLAN
_ _
DO NOT TAKE RASAGILINE MYLAN:
-
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 Rasagaline Mylan:
-
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 Mylan
treatment and starting treatment wi
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline Mylan 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains rasagiline tartrate corresponding to 1 mg
rasagiline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Tablet
White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex
tablets, debossed with ‘R9SE’
on one side and ‘1’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline Mylan 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.
_Elderly _
No change in dose is required for elderly patients.
_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).
_Renal impairment _
No change in dose is required for renal impairment.
_ _
_Paediatric population _
Rasagiline is not recommended for use in children and adolescents due
to lack of data on safety and
efficacy.
Method of administration
For oral use.
Rasagiline 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 without prescription e.g. St. John's Wort) or
pethidine (see section 4.5). At least
14 days must elapse between discontinuation of rasagiline and
initiation of treatment with MAO
inhibitors or
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