APO-PRAMIPEXOLE pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

pramipexole dihydrochloride monohydrate, Quantity: 0.125 mg

Tilgængelig fra:

Southern Cross Pharma Pty Ltd

INN (International Name):

pramipexole dihydrochloride monohydrate

Lægemiddelform:

Tablet

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

30's

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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 oversigt:

Visual Identification: white, round tablets marked on one side with the letter 'A', with no defects and dimensions 6 mm in diameter and 3 mm in 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

Autorisation status:

Licence status A

Autorisation dato:

2015-11-17

Indlægsseddel

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C: Products/APO-Pramipexole/CMI 15Mar18
Page
1 of 4
APO-PRAMIPEXOLE
_Pramipexole hydrochloride _
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
1.
WHAT APO-PRAMIPEXOLE IS
USED FOR
2. BEFORE YOU TAKE APO-
PRAMIPEXOLE
a)
When you must not take
APO-PRAMIPEXOLE
b)
Before you start to take APO-
PRAMIPEXOLE
c)
Pregnancy
d)
Breastfeeding
e)
Children
3. TAKING APO-PRAMIPEXOLE
a)
How to take APO-
PRAMIPEXOLE
b)
If you forget to take a dose
c)
If you have taken too much
APO-PRAMIPEXOLE
(overdose)
4. WHILE YOU ARE TAKING APO-
PRAMIPEXOLE
a)
Things you must do
b)
Things to be careful of 5. SIDE EFFECTS
6. AFTER TAKING APO-
PRAMIPEXOLE
a)
Storage
b)
Disposal
7. PRODUCT DESCRIPTION
a)
What is APO-
PRAMIPEXOLE
b)
Ingredients
c)
Manufacturer
This leaflet answers some common
questions about APO-
PRAMIPEXOLE. It does not contain
all available information, nor does it
take the place of talking to your doctor
or pharmacist.
KEEP THIS INFORMATION WITH YOUR
APO-PRAMIPEXOLE.
You may need to read it again later.
TO FIND OUT MORE ABOUT APO-
PRAMIPEXOLE
YOU SHOULD ASK YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY QUESTIONS
ABOUT APO-PRAMIPEXOLE OR IF
YOU HAVE ANY TROUBLE BEFORE, DURING
OR AFTER USING APO-
PRAMIPEXOLE.
1. What APO-
PRAMIPEXOLE is
used for
APO-PRAMIPEXOLE 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. APO-
PRAMIPEXOLE works by having a
similar effect as dopamine in the brain.
APO-PRAMIPEXOLE 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

Produktets egenskaber

1
AUSTRALIAN PI – APO-PRAMIPEXOLE TABLETS (PRAMIPEXOLE)
1
NAME OF THE MEDICINE
Pramipexole Hydrochloride monohydrate
2
AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each tablet contains pramipexole hydrochloride monohydrate, as the
active ingredient.
Pramipexole hydrochloride monohydrate is a white to off white
crystalline powder. Freely soluble in
water, soluble in methanol, sparingly soluble to slightly soluble in
ethanol (96%) and practically
insoluble in methylene chloride.
In addition to pramipexole, each tablet contains the following
inactive ingredients: Mannitol,
pregelatinised maize starch, microcrystalline cellulose, Povidone,
purified talc and magnesium
stearate.
APO-PRAMIPEXOLE tablets are round and white for each strength.
0.125 MG TABLETS:
APO-PRAMIPEXOLE 0.125 mg tablets contain 0.125 mg pramipexole
hydrochloride monohydrate
and are marked with an “A” on one side of the tablet.
0.25 MG TABLETS:
APO-PRAMIPEXOLE 0.25 mg tablets contain 0.25 mg pramipexole
hydrochloride monohydrate
and are marked with a “B” on one side of the tablet.
1 MG TABLETS:
APO-PRAMIPEXOLE 1 mg tablets contain 1 mg pramipexole hydrochloride
monohydrate and are
marked with a “D” on one side of the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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
DOSE 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.
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.
2
PRAMIPEXOLE HYDROCHLORIDE TABLE 1
Ascending dosage schedule of pramipexol