Ropilynz XL 8mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ropinirole hydrochloride

זמין מ:

Lupin Healthcare (UK) Ltd

קוד ATC:

N04BC04

INN (שם בינלאומי):

Ropinirole hydrochloride

כמות:

8mg

טופס פרצבטיות:

Modified-release tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04090100; GTIN: 5060346430287

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPILYNZ XL 2 MG PROLONGED-RELEASE TABLETS
ROPILYNZ XL 4 MG PROLONGED-RELEASE TABLETS
ROPILYNZ XL 8 MG PROLONGED-RELEASE TABLETS
Ropinirole
READ
ALL
OF
THIS
LEAFLET
CAREFULLY
BEFORE
YOU START
TAKING
TH
IS 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 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 Ropilynz XL is and what it is used for
2.
What you need to know before you take Ropilynz XL
3.
How to take Ropilynz XL
4.
Possible side effects
5.
How to store Ropilynz XL
6.
Contents of the pack and other information
1. WHAT ROPILYNZ XL IS AND WHAT IT IS USED FOR
The active ingredient
in Ropilynz XL 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.
ROPILYNZ XL IS USED TO TREAT PARKINSON’S DISEASE.
People
with
Parkinson’s
disease
have
low levels
of
dopamine in some parts of
their brains.
Ropinirole has
effects similar to those of natural dopamine, so it helps to
reduce the symptoms of Parkinson’s disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROPILYNZ XL
DO NOT TAKE ROPILYNZ XL
•
if
you are allergic to ropinirole or
any of
the other
ingredients of this medicine (listed in section 6)
•
if you have serious kidney disease
•
if you have liver disease
Tell your doctor if you think any of these may apply to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Ropilynz
XL.
Tell
your doctor if
you or your family/carer notices that
you are developing urges or cravings to behave in ways
that are unusual for you and you

מאפייני מוצר

OBJECT 1
ROPILYNZ XL 8 MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 04-Dec-2015 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Ropilynz XL 8 mg prolonged-release tablets
2. Qualitative and quantitative composition
Each tablet contains 8 mg ropinirole (as ropinirole hydrochloride).
Excipients with known effect:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
Red, oval biconvex tablets 19.2 x 10.2 ± 0.2 mm in diameter and 5.2
± 0.2mm in thickness.
4. Clinical particulars
4.1 Therapeutic indications
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).
4.2 Posology and method of administration
Posology
_Adults_
Individual dose titration against efficacy and tolerability is
recommended.
_Initial titration_
The starting dose of ropinirole prolonged-release tablets is 2 mg once
daily for the first week; this should
be increased to 4 mg once daily from the second week of treatment. A
therapeutic response may be seen
at a dose of 4 mg once daily of ropinirole prolonged-release tablets.
Patients who initiate treatment with a dose of 2 mg/day of ropinirole
prolonged-release tablets and who
experience undesirable effects that they cannot tolerate, may benefit
from switching to treatment with
ropinirole immediate-release tablets at a lower daily dose, divided
into three equal doses.
_Therapeutic regimen_
Patients should be maintained on the lowest dose of ropinirole
prolonged-release tablets that achieve
symptomatic control.
If sufficient symptomatic control is not achieved or maintained at a
dose of 4 mg once daily of ropinirole
prolonged-release tablets, the daily dose may be increased by 2 mg at
weekly or longer