Perxele

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PRAMIPEXOLE DIHYDROCHLORIDE, MONOHYDRATE

Available from:

Pharmaswiss Česká republika s.r.o. Jankovcova 1569/2c, Prague 17000, Czech Republic

ATC code:

N04BC05

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.75 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.75 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Withdrawn

Authorization date:

2014-09-03

Patient Information leaflet

Page 1 of 8 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Perxele 0.26 mg prolonged-release tablets 
Perxele 0.52 mg prolonged-release tablets 
Perxele 1.05 mg prolonged-release tablets 
Perxele 2.1 mg prolonged-release tablets 
Perxele 2.62 mg prolonged-release tablets 
Perxele 3.15 mg prolonged-release tablets 

PRAMIPEXOLE 

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 or
nurse . 
- 
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 or
nurse.

This includes any 
possible side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 
1. 
What Perxele is and what it is used for 
2. 
What you need to know before you take Perxele 
3. 
How to take Perxele 
4. 
Possible side effects 
5. 
How to store Perxele 
6. 
Contents of the pack and other information 

1. 
WHAT PERXELE IS AND WHAT IT IS USED FOR 

Perxele belongs to a group of medicines known as dopamine agonists,
which stimulate dopamine 
receptors in the brain. Stimulation of the dopamine receptors
triggers nerve impulses in the brain 
that help to control body movements. 

Perxele is used to treat the symptoms of primary
Parkinson’s disease in adults. It can be used alone 
or in combination with levodopa (another medicine for Parkinson’s
disease). 

2. 
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERXELE  

DO NOT TAKE PERXELE 
- if you are allergic to pramipexole or any of the other ingredients
of this medicine (listed in section 
6). 

WARNINGS AND PRECAUTIONS 
Talk to your doctor before taking Perxele. Tell your doctor if you
have (had) or develop any 
medical conditions

Summary of Product characteristics

Page 1 of 13

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Perxele 0.26 mg prolonged-release tablets 
Perxele 0.52 mg prolonged-release tablets 
Perxele 1.05 mg prolonged-release tablets 
Perxele 2.1 mg prolonged-release tablets 
Perxele 2.62 mg prolonged-release tablets 
Perxele 3.15 mg prolonged-release tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each prolonged-release tablet contains 0.375 mg pramipexole
dihydrochloride monohydrate 
equivalent to 0.26 mg pramipexole. 
Each prolonged-release tablet contains 0.75 mg pramipexole
dihydrochloride monohydrate 
equivalent to 0.52 mg pramipexole. 
Each prolonged-release tablet contains 1.5 mg pramipexole
dihydrochloride monohydrate 
equivalent to 1.05 mg pramipexole. 
Each prolonged-release tablet contains 3 mg pramipexole
dihydrochloride monohydrate equivalent 
to 2.1 mg pramipexole. 
Each prolonged-release tablet contains 3.75 mg pramipexole
dihydrochloride monohydrate 
equivalent to 2.62 mg pramipexole. 
Each prolonged-release tablet contains 4.5 mg pramipexole
dihydrochloride monohydrate 
equivalent to 3.15 mg pramipexole. 

_Please note: _
Pramipexole doses as published in the literature refer to the salt
form. 
Therefore, doses will be expressed in terms of both pramipexole base
and pramipexole salt (in 
brackets). 
For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Prolonged-release tablet. 

Perxele 0.26 mg prolonged-release tablets: The tablets of 9 mm are
white or nearly white, 
cylindrical, plans, with beveled edges  and marked with 026 on one
side 
Perxele 0.52 mg prolonged-release tablets: The tablets of 10 mm are
white or nearly white, 
cylindrical, biconvex  and marked with 052 on one side 
Perxele 1.05 mg prolonged-release tablets: The tablets of 10 mm are
white or nearly white, 
cylindrical, biconvex , and marked with 105 on one side 
Perxele 2.1 mg prolonged-release tablets: The table