Pramipexole 88microgram tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Pramipexole dihydrochloride monohydrate

Tilgjengelig fra:

Milpharm Ltd

ATC-kode:

N04BC05

INN (International Name):

Pramipexole dihydrochloride monohydrate

Dosering :

88microgram

Legemiddelform:

Tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04090100

Informasjon til brukeren

Number of tablets
Total daily dose (mg)
ST
1 WEEK
1 tablet Pramipexole 0.088 mg three times a day
0.264
Number of tablets
ND
2 WEEK
1 tablet Pramipexole
0.18 mg three times a day
OR
2 tablets Pramipexole
0.088 mg three times a day
1 tablet Pramipexole
0.35 mg three times a day
OR
2 tablets Pramipexole
0.18 mg three times a day
RD
3 WEEK
Total daily dose (mg)
0.54
1.1
PRAMIPEXOLE 0.088 MG TABLETS
PRAMIPEXOLE 0.18 MG TABLETS
PRAMIPEXOLE 0.7 MG TABLETS
Pramipexole
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 is and what it is used for
2.
What you need to know before you take Pramipexole
3.
How to take Pramipexole
4.
Possible side effects
5.
How to store Pramipexole
6.
Contents of the pack and other information
Pramipexole 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 IS USED TO:
-
treat the symptoms of primary Parkinson’s disease. It can be used
alone or
in combination with levodopa (another medicine for Parkinson’s
disease).
Pramipexole may also be authorised to treat other conditions which are
not
mentioned in this leaflet. Ask your doctor or pharmacist if you have
further
questions.
DO NOT TAKE PRAMIPEXOLE
-
if you are allergic to pramipexole or to any of the other ingredients
of this
medicine (listed in

Preparatomtale

OBJECT 1
PRAMIPEXOLE 0.088MG TABLETS
Summary of Product Characteristics Updated 08-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Pramipexole 0.088 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 0.125 mg of pramipexole dihydrochloride
monohydrate equivalent to 0.088 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
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.
4. Clinical particulars
4.1 Therapeutic indications
Pramipexole 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 doses 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.
Ascending – 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
3
3 x 0.35
1.1
3 x 0.5
1.50
If a further dose increase is necessary the daily dose should be
increased by 0.54 mg of base (0.75 mg of
salt) at weekly intervals up to a maximum dose of 3.3 mg of base (4.5
mg of s