Pramipexole Aurobindo 0.35mg Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

PRAMIPEXOLE

Disponible desde:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Código ATC:

N04BC05

Designación común internacional (DCI):

PRAMIPEXOLE 0.35 mg

formulario farmacéutico:

TABLET

Composición:

PRAMIPEXOLE 0.35 mg

tipo de receta:

POM

Área terapéutica:

ANTI-PARKINSON DRUGS

Estado de Autorización:

Authorised

Fecha de autorización:

2013-08-07

Información para el usuario

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAMIPEXOLE AUROBINDO 0.088 MG TABLETS
PRAMIPEXOLE AUROBINDO 0.18 MG TABLETS
PRAMIPEXOLE AUROBINDO 0.35 MG TABLETS
PRAMIPEXOLE AUROBINDO 0.7 MG TABLETS
PRAMIPEXOLE AUROBINDO 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 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 Aurobindo is and what it is used for
2.
What you need to know before you take Pramipexole Aurobindo
3.
How to take Pramipexole Aurobindo
4.
Possible side effects
5.
How to store Pramipexole Aurobindo
6.
Contents of the pack and other information
1.
WHAT PRAMIPEXOLE AUROBINDO IS AND WHAT IT IS USED FOR
Pramipexole Aurobindo 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 AUROBINDO 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).
-
treat the symptoms of moderate to severe primary Restless Legs
Syndrome in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAMIPEXOLE AUROBINDO
DO NOT TAKE PRAMIPEXOLE AUROBINDO:
-
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 Aurobindo
.
Tell your doctor if you have (had) o

Ficha técnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pramipexole Aurobindo 0.088 mg Tablets
Pramipexole Aurobindo 0.18 mg Tablets
Pramipexole Aurobindo 0.35 mg Tablets
Pramipexole Aurobindo 0.7 mg Tablets
Pramipexole Aurobindo 1.1 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.125 mg of pramipexole dihydrochloride
monohydrate equivalent to 0.088 mg
pramipexole.
Each tablet contains 0.25 mg of pramipexole dihydrochloride
monohydrate equivalent to 0.18 mg
pramipexole.
Each tablet contains 0.5 mg of pramipexole dihydrochloride monohydrate
equivalent to 0.35 mg
pramipexole.
Each tablet contains 1.0 mg of pramipexole dihydrochloride monohydrate
equivalent to 0.7 mg
pramipexole.
Each tablet contains 1.5 mg of 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 Aurobindo 0.088 mg Tablets: _
White to off-white, round [5.5 mm in diameter], flat, beveled edge,
uncoated tablets, debossed with
‘Y’ on one side ‘41’ on other side.
_Pramipexole Aurobindo 0.18 mg Tablets: _
White to off-white, oval, biconcave, beveled edge, uncoated tablets,
debossed with ‘Y’ and ‘42’
separated by score line on one side and plain with score line on other
side. The size is 6.5 mm X 4.5
mm.
The tablet can be divided into equal doses.
_Pramipexole Aurobindo 0.35 mg Tablets: _
White to off-white, oval, biconcave, beveled edge, uncoated tablets,
debossed with ‘Y’ and ‘43’
separated by score line on one side and plain with score line on other
side. The size is 8.2 mm X 5.8
mm.
The tablet can be divided into equal doses.
_ _
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_Pramipexole Aurobindo 0.7 mg Tablets: _
White to off-white, round [9.3 mm in diameter], flat, beveled edge,
uncoated tablets, debo