Rasagiline Teva 1 mg Tablett

Negara: Swedia

Bahasa: Swedia

Sumber: Läkemedelsverket (Medical Products Agency)

Bahan aktif:

rasagilinmesilat

Tersedia dari:

Teva Sweden AB

Kode ATC:

N04BD02

INN (Nama Internasional):

rasagilinmesilat

Dosis:

1 mg

Bentuk farmasi:

Tablett

Komposisi:

rasagilinmesilat 1,56 mg Aktiv substans; mannitol Hjälpämne

Jenis Resep:

Receptbelagt

Ringkasan produk:

Förpacknings: Blister, 7 tabletter; Blister, 10 tabletter; Blister, 30 tabletter; Blister, 100 tabletter; Blister, 112 tabletter; Blister, 28 tabletter; Burk, 30 tabletter; Blister, 10 x 1 tabletter (endos); Blister, 30 x 1 tabletter (endos); Blister, 100 x 1 tabletter (endos)

Status otorisasi:

Godkänd

Tanggal Otorisasi:

2015-12-04

Selebaran informasi

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

Karakteristik produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline Teva 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains rasagiline mesilate equivalent to 1 mg
rasagiline.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevelled tablets of 8 mm diameter,
debossed with “GIL” and “1”
underneath on one side and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline Teva 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
Teva) 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 0). 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 Teva in children and adolescents
have not been established.
There is no relevant use of Rasagiline Teva in the paediatric
population in the indication Parkinson’s
disease.
Method of administration
For oral use.
Rasagiline Teva 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 prescript