Rasagiline Evopharm Tablets 1mg

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

RASAGILINE

Fáanlegur frá:

Evopharm s.r.o Vyšehradská 12 Bratislava, 851 06, Slovakia

ATC númer:

N04BD02

INN (Alþjóðlegt nafn):

RASAGILINE 1 mg

Lyfjaform:

TABLET

Samsetning:

RASAGILINE 1 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTI-PARKINSON DRUGS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2016-08-22

Upplýsingar fylgiseðill

Page
1
of
5
PACKAGE LEAFLET: INFORMATION FOR THE
USER
RASAGILINE EVOPHARM 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. 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 Evopharm is and what it is used for
2.
What you need to know before you take Rasagiline Evopharm
3.
How to take Rasagiline Evopharm
4.
Possible side effects
5.
How to store Rasagiline Evopharm
6.
Contents of the pack and other information
1.
WHAT RASAGILINE EVOPHARM IS AND WHAT IT IS USED FOR
Rasagiline Evopharm 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
Evopharm helps to
increase and sustain levels of dopamine in the brain.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
RASAGILINE
EVOPHARM
DO NOT TAKE RASAGILINE EVOPHARM
-
if you are allergic (hypersensitive) to rasagiline or any of the other
ingredients of
Rasagiline Evopharm .
-
if you have severe liver problems.
DO NOT TAKE THE FOLLOWING MEDICINES WHILE TAKING RASAGILINE EVOPHARM :
-
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 Evopharm
treatment and startin

Vara einkenni

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline Evopharm 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as hemitartrate).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round, white or almost white tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline Evopharm 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 Evopharm 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) or pethidine (see
section 4.5). At least 14 days must
elapse between discontinuation of rasagiline and initiation of
treatment with MAO inhibitors or pethidine.
Page 2 of 9
Rasagiline is contraindicated in patients with severe hepatic
impairment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The concomitant use of rasa