PRAPEXIN 0.7 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PRAMIPEXOLE

Available from:

Rowex Ltd

ATC code:

N04BC05

INN (International Name):

PRAMIPEXOLE

Dosage:

0.7 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopamine agonists

Authorization status:

Authorised

Authorization date:

2010-02-26

Patient Information leaflet

1.1.1 
1.3.1.3 PATIENT INFORMATION LEAFLET 

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

PRAPEXIN 0.088 MG TABLETS 
PRAPEXIN 0.18 MG TABLETS 
PRAPEXIN 0.7 MG 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. 
  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 Prapexin is and what it is used for 
2. What you need to know before you take Prapexin 
3. How to take Prapexin 
4. Possible side effects 
5. How to store Prapexin 
6. Contents of the pack and other information 

1.  WHAT PRAPEXIN IS AND WHAT IT IS USED FOR 

Prapexin 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. 
Prapexin 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 PRAPEXIN 

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

WARNINGS AND PRECAUTIONS 
Talk to your doctor or pharmacist before
taking Prapexin if you have (had) or develop any medical 
conditions or symptoms, especially any of the following: 
  kidney disease 
  hallucin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prapexin 0.7 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.7 mg pramipexole (as 1.0 mg pramipexole dihydrochloride monohydrate).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off- white, uncoated, round shaped tablet with scoreline on both the sides.
The tablets can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prapexin is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson’s disease, alone
(without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the
effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on
off” fluctuations).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Parkinson’s disease
The daily dose is administered in equally divided doses 3 times a day.
_Initial treatment:_
Doses should be increased gradually from a starting-dose of 0.264 mg of base (0.375 mg of salt) per day and then
increased every 5 - 7 days. Providing patients do not experience intolerable undesirable effects, the dosage should be
titrated to achieve a maximal therapeutic effect.
Ascending – Dose Schedule of Pramipexole
Week
Dose (mg of base)
Total Daily Dose (mg of base)
Dose
(mg of salt)
Total Daily Dose
(mg of salt)
1
3 x 0.088
0.264
3 x 0.125
0.375
2
3 x 0.18
0.54
3 x 0.25
0.75
3
3 x 0.35
1.1
3 x 0.5
1.50
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 13/01/2015_
_CRN 2152842_
_page number: 1_
If a further dose increase is necessary the daily dose should be