Rasagiline 1mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Rasagiline

Pieejams no:

A A H Pharmaceuticals Ltd

ATĶ kods:

N04BD02

SNN (starptautisko nepatentēto nosaukumu):

Rasagiline

Deva:

1mg

Zāļu forma:

Tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04090100

Lietošanas instrukcija

70 mm ± 0,5 mm
smer branja kode
smer vlaken
70 mm ± 0,5 mm
smer branja kode
_NA.RASAGILINE TBL 1MG GB_
prva stran
Šifra: 2xxxxx
Emb. mat.: NA.RASAGILINE TBL 1MG
GB
Dimenzije: 148 ± 0,5 mm x 297 ± 0,5 mm
Material: papir tip B
PhC št.: xxx
Merilo: 1:1
Datum: 05.02.2018
Izdelal: A. Mohorič
Pregledal: N. Regina
_Oddelek za oblikovanje_
_ - PMS-433U-KRKA_
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Rasagiline 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 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 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

Produkta apraksts

1.
NAME OF THE MEDICINAL PRODUCT
Rasagiline 1mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as rasagiline hemitartrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to almost white, round, slightly biconvex tablets, 7 mm in
diameter, with beveled
edges, darker spots may be visible.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rasagiline 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 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
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) 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 severe hepatic
impairment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE