SIMIPEX pramipexole dihydrochloride monohydrate 1.5 mg tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

pramipexole dihydrochloride monohydrate, Quantity: 1.5 mg

থেকে পাওয়া:

Arrotex Pharmaceuticals Pty Ltd

INN (আন্তর্জাতিক নাম):

pramipexole dihydrochloride monohydrate

ফার্মাসিউটিকাল ফর্ম:

Tablet

রচনা:

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

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

100's

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

The treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa.

পণ্য সারাংশ:

Visual Identification: white, round tablets, marked oon one side with the letter 'E', 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

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2011-10-25

তথ্য লিফলেট

170120 Simipex CMI V1
1
SIMIPEX
Pramipexole hydrochloride
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 hydrochloride.
Pramipexole hydrochloride 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 IF THE PACKAGING IS
TORN OR DAMA

পণ্য বৈশিষ্ট্য

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