Prapexin 0.26 mg prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pramipexole

Available from:

Rowex Ltd

ATC code:

N04BC; N04BC05

INN (International Name):

Pramipexole

Dosage:

0.26 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopamine agonists; pramipexole

Authorization status:

Not marketed

Authorization date:

2014-08-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAPEXIN 0.26 MG PROLONGED-RELEASE TABLETS
PRAPEXIN 0.52 MG PROLONGED-RELEASE TABLETS
PRAPEXIN 1.05 MG PROLONGED-RELEASE TABLETS
PRAPEXIN 2.1 MG PROLONGED-RELEASE TABLETS
PRAPEXIN 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 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 any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor BEFORE TAKING Prapexin. Tell your doctor IF YOU
HAVE (HAD) OR DEVELOP ANY MEDICAL
CONDITIONS OR SYMPTOMS, especially any of the following:
- kidney disease
- hallucinations (seeing, hearing or feeling things that are not
there). Most hallucinations are visual.
- dyskinesia (e.g. abnormal, uncontr

Summary of Product characteristics

Health Products Regulatory Authority
06 July 2020
CRN008NCJ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prapexin 0.26 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.
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.
Prapexin 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.
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
Prapexin prolonged-release tablets are a once-a-day oral formulation
of pramipexole.
_Initial treatment_
Doses should be increased gradually from a starting dose of 0.26 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 dose should be titrated to achieve a
maximal therapeutic effect.
Ascending dose schedule of Prapexin
prolonged-release tablets
Week Daily dose (mg of base)
Daily dose (mg of salt)
1
0.26
0.375
2
0.52
0.75
3
1.05
1.5
If a further dose increase is necessary the daily dose should be
increased by 0.52 mg of base (0.75 mg of salt) at weekly
intervals up to a maximum dose of 3.15 mg of base (4.5 mg of salt) per
day. However, it should be noted th