Pramipexole Bluefish 0.7 mg tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Pramipexole dihydrochloride monohydrate

Disponibil de la:

Bluefish Pharmaceuticals AB

Codul ATC:

N04BC; N04BC05

INN (nume internaţional):

Pramipexole dihydrochloride monohydrate

Dozare:

0.7 milligram(s)

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

Dopamine agonists; pramipexole

Statutul autorizaţiei:

Marketed

Data de autorizare:

2010-07-16

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER PRAMIPEXOLE BLUEFISH 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 Pramipexole Bluefish is and what it is used for
2. What you need to know before you take Pramipexole Bluefish
3. How to take Pramipexole Bluefish
4. Possible side effects
5. How to store Pramipexole Bluefish
6. Contents of the pack and other information
1.
WHAT PRAMIPEXOLE BLUEFISH IS AND WHAT IT IS USED FOR
Pramipexole Bluefish 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.
PRAMIPEXOLE BLUEFISH 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 PRAMIPEXOLE BLUEFISH
DO NOT TAKE PRAMIPEXOLE BLUEFISH:

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 Pramipexole Bluefish. 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,
uncontrolled
movemen

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pramipexole Bluefish 0.7 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pramipexole Bluefish 0.7 mg tablets contain 0.7 mg of pramipexole base
(as 1.0 mg pramipexole dihydrochloride
monohydrate).
_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
Tablet
White, circular, 9.5 mm diameter, uncoated tablets with score line and
embossed with “PA” in the both halves in one side and the
other side plain.
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pramipexole Bluefish 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 dose should be
titrated to achieve a maximal therapeutic effect.
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
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