SIMIPEX pramipexole dihydrochloride monohydrate 1 mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

pramipexole dihydrochloride monohydrate, Quantity: 1 mg

Tilgjengelig fra:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Legemiddelform:

Tablet

Sammensetning:

Excipient Ingredients: pregelatinised maize starch; mannitol; microcrystalline cellulose; povidone; purified talc; magnesium stearate

Administreringsrute:

Oral

Enheter i pakken:

100's

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

The treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa.,The symptomatic treatment of primary Restless Legs Syndrome.

Produkt oppsummering:

Visual Identification: white, round tablets, marked on one side with the letter 'D', scored on the other side, with no defects and dimensions 6 mm diameter and 3 mm thickness; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2011-10-25

Informasjon til brukeren

Simipex CMI
1
SIMIPEX
Pramipexole dihydrochloride monohydrate
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SIMIPEX. It does
not contain all the information and
does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risk of you taking SIMIPEX
against the benefits they expect it
will have for you.
TALK TO YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SIMIPEX IS USED FOR
SIMIPEX is used in the treatment of
Parkinson's disease.
Parkinson's disease is a disease of
the brain that affects body
movement.
The symptoms of Parkinson's
disease are caused by a lack of
dopamine, a naturally occurring
chemical produced by certain brain
cells. Dopamine relays messages in
the part of the brain that controls
movement. When too little
dopamine is produced, this results
in Parkinson's disease. SIMIPEX
works by having a similar effect as
dopamine in the brain.
SIMIPEX contains the active
ingredient Pramipexole
dihydrochloride monohydrate.
Pramipexole dihydrochloride
monohydrate belongs to a group of
medicines known as "dopamine
agonists".
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SIMIPEX HAS
BEEN PRESCRIBED FOR YOU. Your
doctor may have prescribed
SIMIPEX for another reason.
BEFORE YOU TAKE SIMIPEX_ _
_WHEN YOU MUST NOT TAKE IT _
ONLY USE SIMIPEX IF IT HAS BEEN
PRESCRIBED FOR YOU BY A DOCTOR.
NEVER GIVE IT TO SOMEONE ELSE EVEN
IF THEIR SYMPTOMS SEEM TO BE THE
SAME AS YOURS.
DO NOT TAKE SIMIPEX IF YOU ARE
ALLERGIC TO PRAMIPEXOLE OR ANY OF
THE OTHER INGREDIENTS LISTED AT THE
END OF THIS LEAFLET.
IF YOU ARE NOT SURE IF YOU HAVE
THESE ALLERGIES, YOU SHOULD RAISE
THOSE CONCERNS WITH YOUR DOCTOR.
Signs of an allergic reaction may
include itching of skin, shortness of
breath and swelling of the tongue or
face.
YOU SHOULD NOT USE SIMIPEX AFTER
THE EXPIRY DATE ON THE CARTON OR
BLISTER STRIPS, OR

Preparatomtale

1
AUSTRALIAN PI – SIMIPEX (PRAMIPEXOLE DIHYDROCHLORIDE
MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Pramipexole dihydrochloride monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SIMIPEX tablets are round and white for each strength.
SIMIPEX 0.125 mg tablets are marked with an “A” on one side of the
tablet.
SIMIPEX 0.25 mg tablets are marked with a “B” on one side of the
tablet.
SIMIPEX 1 mg tablets are marked with a “D” on one side of the
tablet.
SIMIPEX tablets 0.5 (marked with a “C” on one side of the tablet)
and 1.5 mg tablets (marked with an
“E” on one side of the tablet) are not currently marketed in
Australia.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
The
treatment
of
signs
and
symptoms
of
idiopathic
Parkinson's
disease.
It
may
be
used
as
monotherapy or in combination with levodopa.
4.2
D
OSE AND METHOD OF ADMINISTRATION
PARKINSON'S DISEASE:
The tablets should be taken orally, swallowed with water. Pramipexole
hydrochloride can be taken
either with or without food.
THE DAILY DOSAGE IS ADMINISTERED IN EQUALLY DIVIDED DOSES THREE
TIMES/DAY.
2
INITIAL TREATMENT
Dosages should be increased gradually from a starting dose of
pramipexole hydrochloride 0.375
mg/day and then increased every five to seven days. Providing patients
do not experience intolerable
side effects, the dosage should be titrated to achieve a maximal
therapeutic effect.
PRAMIPEXOLE HYDROCHLORIDE
TABLE 1
Ascending dosage schedule of pramipexole hydrochloride for
Parkinson’s disease:
Week
Pramipexole hydrochloride
Dosage
Total Daily Dose of
Pramipexole hydrochloride
1
0.125 mg three times a day
0.375 mg
2
0.25 mg three times a day
0.75 mg
3
0.5 mg three times a day
1.5mg
If a further dose increase is necessary, the daily dose should be
increased by 0.75 mg at weekly
intervals up to a maximum dose of 4.5 mg/day.
MAINTENANCE TREATMENT. The individual dose should be in the range of
0.375 mg to a maximum of
pramipexole hydr