PIPEXUS 3.15 Milligram Tablet Prolonged Release

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Available from:

DB Ashbourne Ltd

ATC code:

N04BC05

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Dosage:

3.15 Milligram

Pharmaceutical form:

Tablet Prolonged Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dopamine agonists

Authorization status:

Authorised

Authorization date:

2016-09-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Pipexus 0.26 mg prolonged-release tablets
Pipexus 0.52 mg prolonged-release tablets
Pipexus 1.05 mg prolonged-release tablets
Pipexus 1.57 mg prolonged-release tablets
Pipexus 2.1 mg prolonged-release tablets
Pipexus 2.62 mg prolonged-release tablets
Pipexus 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, 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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Pipexus is and what it is used for
2.
What you need to know before you take Pipexus
3.
How to take Pipexus
4.
Possible side effects
5.
How to store Pipexus
6.
Contents of the pack and other information
1.
WHAT PIPEXUS
IS AND WHAT IT IS USED FOR
Pipexus contains the active substance pramipexole and 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.
Pipexus 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 PIPEXUS
DO NOT TAKE PIPEXUS
-
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 before taking Pipexus. Tell your doctor if you
have (had) or develop any medical
conditions or symptoms, especially any of the following:
-
Kidney disease.
-
Hallucinations (seeing, he

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pipexus 3.15 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
The round tablets of 11 mm diameter are white or nearly white, have a
flat surface with bevelled edges and are marked
with 315 on one side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pipexus 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
Pipexus 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.
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 that the
incidence of somnolence is increased at doses higher than 1.05 mg of
base (1.5 mg of salt) per day (see section 4.8).
Patients already taking pramipexole tablets may be switched to Pipexus
prolonged-release tablets overnight, at the same
daily dose. Aft