Rasagiline Clonmel 1 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rasagiline

Available from:

Clonmel Healthcare Ltd

ATC code:

N04BD; N04BD02

INN (International Name):

Rasagiline

Dosage:

1 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Monoamine oxidase B inhibitors; rasagiline

Authorization status:

Marketed

Authorization date:

2016-02-26

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
RASAGILINE CLONMEL 1MG 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 Clonmel is and what it is used for
2. What you need to know before you take Rasagiline Clonmel
3. How to take Rasagiline Clonmel
4. Possible side effects
5. How to store Rasagiline Clonmel
6. Contents of the pack and other information
1. WHAT RASAGILINE CLONMEL IS AND WHAT IT IS USED FOR
Rasagiline Clonmel 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 the cells that produce
dopamine in the brain. Dopamine is a
chemical in the brain involved in movement control. Rasagiline Clonmel
helps to increase and sustain
levels of dopamine in the brain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RASAGILINE CLONMEL
DO NOT TAKE RASAGILINE CLONMEL

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 Clonmel:

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 af

Summary of Product characteristics

Health Products Regulatory Authority
19 June 2020
CRN009QQR
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rasagiline Clonmel 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, round, biplane tablets with a diameter of 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rasagiline Clonmelis 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.
Older people: No change in dose is required for older people.
Paediatric population: Rasagiline Clonmel 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
impai