Pramipexole Accord
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
11-03-2024
Produktets egenskaber
(SPC)
11-03-2024
Offentlige vurderingsrapport
(PAR)
27-09-2016
Aktiv bestanddel:
pramipexole dihydrochloride monohydrate
Tilgængelig fra:
Accord Healthcare S.L.U.
ATC-kode:
N04BC05
INN (International Name):
pramipexole
Terapeutisk gruppe:
Anti-Parkinson drugs
Terapeutisk område:
Parkinson Disease; Restless Legs Syndrome
Terapeutiske indikationer:
Pramipexole Accord 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).
Produkt oversigt:
Revision: 10
Autorisation status:
Authorised
Autorisation dato:
2011-09-29
Indlægsseddel
36
B. PACKAGE LEAFLET
Medicinal product no longer authorised
37 PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAMIPEXOLE ACCORD 0.088 MG TABLETS
PRAMIPEXOLE ACCORD 0.18 MG TABLETS
PRAMIPEXOLE ACCORD 0.35 MG TABLETS
PRAMIPEXOLE ACCORD 0.7 MG TABLETS
PRAMIPEXOLE ACCORD 1.1 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 of the 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 Accord is and what it is used for
2. What you need to know before you take Pramipexole Accord
3. How to take Pramipexole Accord
4. Possible side effects
5. How to store Pramipexole Accord
6. Contents of the pack and other information
1.
WHAT PRAMIPEXOLE ACCORD IS AND WHAT IT IS USED FOR
Pramipexole Accord 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 ACCORD 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 ACCORD
DO NOT TAKE PRAMIPEXOLE ACCORD:
•
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 Accord. Tell your doctor
if you have (had) or develop
any medical conditions or symptoms, especially any
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Pramipexole Accord 0.088 mg tablets
Pramipexole Accord 0.18 mg tablets
Pramipexole Accord 0.35 mg tablets
Pramipexole Accord 0.7 mg tablets
Pramipexole Accord 1.1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pramipexole Accord 0.088 mg tablet
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate
equivalent to 0.088 mg
pramipexole.
Pramipexole Accord 0.18 mg tablet
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate
equivalent to 0.18 mg
pramipexole.
Pramipexole Accord 0.35 mg tablet
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate
equivalent to 0.35 mg
pramipexole.
Pramipexole Accord 0.7 mg tablet
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate
equivalent to 0.7 mg
pramipexole.
Pramipexole Accord 1.1 mg tablet
Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate
equivalent to 1.1 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
Tablet.
Pramipexole Accord 0.088 mg tablet
The tablets are white to off-white, round, flat faced, bevel edged,
with inscription ‘I1’ on one side and
plain on the other side.
Pramipexole Accord 0.18 mg tablet
The tablets are white to off-white, round, flat faced, bevel edged,
with inscription ‘I’ and ‘2’ on either
side of the breakline on one side and breakline on the other side.
The tablet can be divided into two equal doses.
Pramipexole Accord 0.35 mg tablet
The tablets are white to off-white, round, flat faced, bevel edged,
with inscription ‘I’ and ‘3’ on either
side of the breakline on one side and breakline on the other side.
Medicinal product no longer authorised
3
The tablet can be divided into two equal doses.
Pramipexole
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