Pramipexole Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pramipexole dihydrochloride monohydrate

Available from:

Teva Pharma B.V.

ATC code:

N04BC05

INN (International Name):

pramipexole

Therapeutic group:

Anti-Parkinson drugs

Therapeutic area:

Parkinson Disease

Therapeutic indications:

Pramipexole Teva is indicated 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).Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).

Product summary:

Revision: 22

Authorization status:

Authorised

Authorization date:

2008-12-18

Patient Information leaflet

43
B. PACKAGE LEAFLET
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAMIPEXOLE TEVA 0.088 MG TABLETS
PRAMIPEXOLE TEVA 0.18 MG TABLETS
PRAMIPEXOLE TEVA 0.35 MG TABLETS
PRAMIPEXOLE TEVA 0.7 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 of the 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 Teva is and what it is used for
2.
What you need to know before you take Pramipexole Teva
3.
How to take Pramipexole Teva
4.
Possible side effects
5.
How to store Pramipexole Teva
6.
Contents of the pack and other information
1.
WHAT PRAMIPEXOLE TEVA IS AND WHAT IT IS USED FOR
Pramipexole Teva 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 Teva 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 TEVA
DO NOT TAKE PRAMIPEXOLE TEVA
•
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 Teva. Tell your doctor
if you have (had) or develop any
medical conditions or symptoms, especially any of the foll

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
Pramipexole Teva 0.088 mg tablets
Pramipexole Teva 0.18 mg tablets
Pramipexole Teva 0.35 mg tablets
Pramipexole Teva 0.7 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pramipexole Teva 0.088 mg tablets
Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate
equivalent to 0.088 mg
pramipexole.
Pramipexole Teva 0.18 mg tablets
Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate
equivalent to 0.18 mg
pramipexole.
Pramipexole Teva 0.35 mg tablets
Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate
equivalent to 0.35 mg
pramipexole.
Pramipexole Teva 0.7 mg tablets
Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate
equivalent to 0.7 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 Teva 0.088 mg tablets
White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed
with “93” on one side and “P1”
on the other side.
Pramipexole Teva 0.18 mg tablets
White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed
with "P2" over "P2" on the
scored side and "93" on the other side. The tablet can be divided into
equal halves.
Pramipexole Teva 0.35 mg tablets
White to off-white, oval, biconvex tablets, engraved with 9 vertical
scoreline 3 on the scored side, and
8023 on the other side. The tablet can be divided into equal halves.
Pramipexole Teva 0.7 mg tablets
White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed
with "8024" over "8024" on the
scored side and "93" on the other side. The tablet can be divided into
equal halves.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pramipexole Teva is indicated in adults for treatment of the signs and
symptoms of idiopathic
Parkinson’s disease