Rasagiline Rowex 1 mg tablets

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Rasagiline

Disponible des:

Rowex Ltd

Codi ATC:

N04BD; N04BD02

Designació comuna internacional (DCI):

Rasagiline

Dosis:

1 milligram(s)

formulario farmacéutico:

Tablet

Vía de administración:

oral use

Unidades en paquete:

10, 28, 30, 98, 100, 112 tablets

tipo de receta:

Product subject to prescription which may be renewed (B)

Fabricat per:

Delorbis Pharmaceuticals Ltd

Grupo terapéutico:

anti-parkinson drugs, monoamine oxidase B inhibitors

Área terapéutica:

Monoamine oxidase B inhibitors; rasagiline

indicaciones terapéuticas:

Rasagiline Rowex 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

Estat d'Autorització:

Marketed

Data d'autorització:

2015-11-27

Informació per a l'usuari

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

Fitxa tècnica

Health Products Regulatory Authority
25 May 2022
CRN00CVR2
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Rowex 1 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of rasagiline (as rasagiline tartrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off-white, round, flat, bevelled tablets (6.5 mm).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Rowexis indicated in adults for the treatment of idiopathic
Parkinson’s disease (PD) as monotherapy (without
levodopa) or as adjunct therapy (with levodopa) inpatients with end of
dose fluctuations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of rasagiline is1mg (one tablet of Rasagiline
Rowex) 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 inpatients 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 Rowex in children and
adolescents have not been established. There is no relevant use of
Rasagiline Rowex in the paediatric population in the indication
Parkinson’s disease.
Method of administration
For oral use.
Rasagiline Rowex 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) inhibitors
(including medicinal and natural products without
prescription e.g. St. John's Wort) orpeth