Rasagiline 1mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Rasagiline

متاح من:

HBS Healthcare Ltd

ATC رمز:

N04BD02

INN (الاسم الدولي):

Rasagiline

جرعة:

1mg

الشكل الصيدلاني:

Tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 04090100

نشرة المعلومات

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

خصائص المنتج

OBJECT 1
RASAGILINE HBS 1MG TABLETS
Summary of Product Characteristics Updated 19-Apr-2016 | HBS
Healthcare Ltd
1. Name of the medicinal product
Rasagiline HBS 1mg 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
Round, biconvex, white or nearly white. The diameter is 8 mm.
4. Clinical particulars
4.1 Therapeutic indications
Rasagiline HBS 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 HBS 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 of
treatment with MAO inhibitors or pethidine.
Rasagiline is contraindicated in patients with sever