Ropinirole 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ropinirole hydrochloride

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

N04BC04

INN (International Name):

Ropinirole hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100

Patient Information leaflet

ROPINIROLE 2MG FILM-COATED TABLETS
Your medicine is called Ropinirole 2 mg film-coated tablets but will
be
reffered to as Ropinirole throughout this leaflet. _Please note that
this leaflet_
_also contains information about other strengths of this medicine
Ropinirole _
_0.25mg, 0.5mg and 1mg film coated tablets_
WHAT IS IN THIS LEAFLET:
What Ropinirole is and what it is used for
What you need to know before you take Ropinirole
How to take Ropinirole
Possible side effects
How to store Ropinirole
Contents of the pack and other information
WHAT ROPINIROLE IS AND WHAT IT IS USED FOR
The active substance in Ropinirole Film-coated Tablets is ropinirole,
which
belongs to a group of medicines called dopamine agonists. Dopamine
agonists affect the brain in a similar way to a natural substance
called
dopamine.
Ropinirole is used to treat Parkinson’s disease.
People with Parkinson’s disease have low levels of dopamine in some
parts
of their brain. Ropinirole has effects similar to those of natural
dopamine, so
it helps to reduce the symptoms of Parkinson’s disease.
Ropinirole is also used to treat the symptoms of moderate to severe
idiopathic Restless Legs Syndrome.
Moderate to severe Restless Legs Syndrome is typically represented by
patients who have difficulty sleeping or severe discomfort in their
legs
or arms.
Restless Legs Syndrome is a condition characterised by an irresistible
urge
to move the legs and occasionally the arms, usually accompanied by
uncomfortable sensations such as tingling, burning or prickling. These
feelings occur during periods of rest or inactivity such as sitting or
lying
down, especially in bed, and are worse in the evening or at night.
Usually the only relief is obtained by walking about or moving the
affected
limbs, which often leads to problems sleeping.
Ropinirole relieves the discomfort and reduces the urge to move the
limbs
that disrupts night time sleep.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROPINIROLE
DO NOT TAKE ROPINIROLE:
*
if you are ALLERGIC to Ropinirole or any of the other i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ropinirole 2 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg of ropinirole (as
hydrochloride).
Excipient with known effect:
Each film-coated tablet contains 54.25 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Ropinirole 2 mg: Light pink, capsule shaped biconvex, film-coated
tablets with break-
line on both sides.
The tablet can be divided into equal halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of Parkinson’s disease_ _under the following
conditions:
-
Initial treatment as monotherapy, in order to delay the introduction
of levodopa
-
In combination with levodopa, over the course of the disease, when the
effect of
levodopa wears off or becomes inconsistent and fluctuations in the
therapeutic
effect occur ("end of dose" or "on-off" type fluctuations)
-
for the symptomatic treatment of moderate to severe idiopathic
Restless Legs
Syndrome (see section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individual dose titration is recommended, based on efficacy and
tolerability.
Parkinson’s disease
Ropinirole should be taken three times daily, preferably with meals to
improve gastrointestinal tolerance.
_Treatment initiation_
The initial dose should be 0.25 mg Ropinirole three times daily for
one week.
Thereafter, the dose can be increased upwards in 0.25 mg increments
three times
daily according to the
following regimen:
Week
1
2
3
4
Unit dose (mg) of ropinirole
0.25
0.5
0.75
1.0
Total daily dose (mg) of ropinirole
0.75
1.5
2.25
3.0
_Therapeutic regimen _
Following initial dose titration, the Ropinirole dose may be increased
by weekly
increments of 0.5 to 1 mg three times daily (1.5 to 3 mg/day).
A therapeutic response may be seen between 3 and 9 mg/day of
ropinirole. If
sufficient symptomatic control is not achieved, or maintained after
the initial
titration as described above, the dose of ropinirole