Rasagiline 1mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Rasagiline

Saadav alates:

Milpharm Ltd

ATC kood:

N04BD02

INN (Rahvusvaheline Nimetus):

Rasagiline

Annus:

1mg

Ravimvorm:

Tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04090100

Infovoldik

Package leaflet: Information for the user
RASAGILINE 1 MG TABLETS
Rasagiline
111111.1.1
Laetus XXX
The Leaflet can be printed in both sides
111111.1.1
Laetus XXX
back side
The Leaflet can be printed in both sides
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 is and what it is used for
2.
What you need to know before you take
Rasagiline
3.
How to take Rasagiline
4.
Possible side effects
5.
How to store Rasagiline
6.
Contents of the pack and other information 1 WHAT RASAGILINE IS AND WHAT IT IS USED FOR
Rasagiline is used for the treatment of
Parkinson’s disease. 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 helps to increase and sustain
levels of dopamine in the brain.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RASAGILINE
DO NOT TAKE RASAGILINE
-
if you are ALLERGIC (HYPERSENSITIVE) 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: 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

Toote omadused

OBJECT 1
RASAGILINE MILPHARM 1 MG TABLETS
Summary of Product Characteristics Updated 16-Nov-2015 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Rasagiline Milpharm 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 to off-white, oblong (approximately 11.5 mm x 6 mm), biconvex
tablets, debossed with 'R9SE' on
one side and '1' on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Rasagiline Milpharm 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.
4.2 Posology and method of administration
Posology
Rasagiline is administered orally, at a dose of 1 mg once daily with
or without levodopa.
It may be taken with or without food.
_Elderly_
No change in dose is required for elderly patients.
_Paediatric population_
Rasagiline Milpharm is not recommended for use in children and
adolescents due to lack of data on safety
and efficacy.
_Patients with hepatic impairment _
Rasagiline use in patients with severe hepatic impairment is
contraindicated (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).
_Patients with renal impairment_
No change in dose is required for renal impairment.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
(see 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 discontinuation of rasagiline and initiation