Rasagiline 1mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Rasagiline

Mevcut itibaren:

Rivopharm (UK

ATC kodu:

N04BD02

INN (International Adı):

Rasagiline

Doz:

1mg

Farmasötik formu:

Tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04090100; GTIN: 5060388650636

Bilgilendirme broşürü

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE RIVOHARM 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 tablets is and what it is used for
2.
What you need to know before you take Rasagiline tablets
3.
How to take Rasagiline tablets
4.
Possible side effects
5.
How to store Rasagiline tablets
6.
Contents of the pack and other information
1.
WHAT RASAGILINE TABLETS IS AND WHAT IT IS USED FOR
The full name of your medicine is "Rasagiline Rivopharm 1 mg tablets".
It is referred
to as "Rasagiline tablets" in the rest of the leaflet.
Rasagiline tablets 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 tablets
helps to increase and sustain levels of dopamine in the brain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE TABLETS
DO NOT TAKE RASAGILINE TABLETS:
-
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 tablets:
-
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 pre

Ürün özellikleri

OBJECT 1
RASAGILINE RIVOPHARM 1 MG TABLET
Summary of Product Characteristics Updated 18-Jan-2018 | Rivopharm UK
Ltd
1. Name of the medicinal product
Rasagiline Rivopharm 1 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 1 mg rasagiline (equivalent to 1.438 mg
rasagiline hemitartrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets
White to off white round, flat tablets with bevelled edges and
engraved with “1” in one side, with a
diameter of 8 mm.
4. Clinical particulars
4.1 Therapeutic indications
Rasagiline Rivopharm 1 mg tablets 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 Rivopharm 1 mg tablets is administered orally, at a dose of
1 mg once daily with or without
levodopa.
_Elderly_
No change in dose is required for elderly patients.
_Paediatric population_
Rasagiline is not recommended for use in children and adolescents due
to lack of data on safety and
efficacy.
_Patients with hepatic impairment_
Rasagiline Rivopharm 1 mg tablets use in patients with severe hepatic
impairment is contraindicated (see
section 4.3). Rasagiline Rivopharm 1 mg tablets use in patients with
moderate hepatic impairment should
be avoided. Caution should be used when initiating treatment with
Rasagiline Rivopharm 1 mg tablets in
patients with mild hepatic impairment. In case patients progress from
mild to moderate hepatic
impairment Rasagiline Rivopharm 1 mg tablets should be stopped (see
section 4.4).
_Patients with renal impairment_
No change in dose is required for renal impairment.
Method of administration
Rasagiline Rivopharm 1 mg tablets is administered orally.
It 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