Rasagilin Accord Healthcare 1 mg Tablett

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

rasagilintartrat

Dostępny od:

Accord Healthcare B.V.

Kod ATC:

N04BD02

INN (International Nazwa):

rasagilintartrat

Dawkowanie:

1 mg

Forma farmaceutyczna:

Tablett

Skład:

rasagilintartrat 1,44 mg Aktiv substans

Typ recepty:

Receptbelagt

Podsumowanie produktu:

Förpacknings: Blister, 10 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 100 tabletter; Burk, 30 tabletter; Burk, 100 tabletter; Burk, 112 tabletter

Status autoryzacji:

Avregistrerad

Data autoryzacji:

2015-12-16

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILIN ACCORD HEALTHCARE 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 /…/ is and what it is used for
2.
What you need to know before you take /…/
3.
How to take /…/
4.
Possible side effects
5.
How to store /…/
6.
Contents of the pack and other information
1.
WHAT /…/ IS AND WHAT IT IS USED FOR
/.../ 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. /.../ helps to
increase and sustain levels of
dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE /…/
DO NOT TAKE /…/
-
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 /.../:
-
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 /.../ treatment and
starting treatment with MAO
inhibitors or pethidine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or ph

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rasagilin Accord Healthcare 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as tartrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White, round bevel edge, 7 mm, debossed with “A486” on one side
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
/.../ is indicated for the treatment in adults 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 recommened dose of Rasagiline is1 mg (1 tablet of /…/) once
daily administered orally, 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 use 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 /.../ in children and adolescents have not
been established. There is no
relevant use of /…/ in the paediatric population in the indication
Parkinson’s disease
Method of administration
For oral use.
/…/may be taken with or without food.
2
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