Azilect

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

rasagiline

Available from:

Teva B.V.

ATC code:

N04BD02

INN (International Name):

rasagiline

Therapeutic group:

Anti-Parkinson drugs

Therapeutic area:

Parkinson Disease

Therapeutic indications:

Azilect 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.

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2005-02-21

Patient Information leaflet

25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZILECT 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 AZILECT is and what it is used for
2.
What you need to know before you take AZILECT
3.
How to take AZILECT
4.
Possible side effects
5.
How to store AZILECT
6.
Contents of the pack and other information
1.
WHAT AZILECT IS AND WHAT IT IS USED FOR
AZILECT 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. AZILECT helps to
increase and sustain levels of
dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZILECT
DO NOT TAKE AZILECT
-
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 AZILECT:
-
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 AZILECT treatment and
starting treatment with MAO
inhibitors or pethidine.
WARNINGS AND PRECAUTIONS
T

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AZILECT 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
AZILECT 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 AZILECT)
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 AZILECT in children and adolescents have
not been established. There is
no relevant use of AZILECT in the paediatric population in the
indication Parkinson’s disease.
Method of administration
For oral use.
AZILECT 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
1