Rasagiline Teva 1 mg tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Rasagiline

Saatavilla:

Teva B.V.

ATC-koodi:

N04BD; N04BD02

INN (Kansainvälinen yleisnimi):

Rasagiline

Annos:

1 milligram(s)

Lääkemuoto:

Tablet

Antoreitti:

oral use

Kpl paketissa:

7, 10, 28, 30, 100 or 112 tablets.

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Valmistaja:

Teva Pharmaceuticals Europe B.V

Terapeuttinen ryhmä:

Anti-Parkinson-Drugs, Monoamine oxidase -B inhibitors

Terapeuttinen alue:

Monoamine oxidase B inhibitors; rasagiline

Käyttöaiheet:

Rasagiline Teva 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.

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2015-12-04

Pakkausseloste

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 starting

Valmisteyhteenveto

Health Products Regulatory Authority
20 January 2021
CRN00C0F3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
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 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 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.
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) in