Ropinirole 5mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ropinirole hydrochloride

זמין מ:

Mawdsley-Brooks & Company Ltd

קוד ATC:

N04BC04

INN (שם בינלאומי):

Ropinirole hydrochloride

כמות:

5mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04090100

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPINIROLE 5MG FILM-COATED TABLETS
ROPINIROLE HYDROCHLORIDE
(Referred to as Ropinirole Tablets in remainder of the leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAIN
IMPORTANT INFORMATION FOR YOU.
− Keep this leaflet. You may need to read it again.
− If you have any further questions, please 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 side effects
not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET:
1. What Ropinirole Tablets are and what they are used for
2. What you need to know before you take Ropinirole Tablets
3. How to take Ropinirole Tablets
4. Possible side effects
5. How to store Ropinirole Tablets
6. Contents of the pack and other information
1. WHAT ROPINIROLE TABLETS ARE AND WHAT THEY ARE USED FOR
Ropinirole Tablets are used to treat Parkinson’s disease.
The active ingredient in Ropinirole 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.
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 ROPINIROLE TABLETS
DO NOT TAKE ROPINIROLE TABLETS:
• if you are allergic to ropinirole or to any of the other
ingredients of this medicine (listed in
section 6)
• if you have a serious kidney disease
• if you have a 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 Ropinirole Tablets:
• if you are pregnant or think you may be pregnant
• if you are breas

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ropinirole 5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ropinirole hydrochloride equivalent
to 5.0 mg of ropinirole.
Ropinirole 5 mg film-coated tablets:
Each film-coated tablet contains ropinirole hydrochloride equivalent
to 5 mg of ropinirole
Excipient with known effect: 67.55 mg lactose (as lactose monohydrate
and lactose anhydrous).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
5.0 mg
Blue, circular, bevelled edged, biconvex film coated tablets with
‘259’ debossed on one
side and ‘G’ on the other side.
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
Oral use.
Parkinson’s disease:
Adults
Individual dose titration against efficacy and tolerability is
recommended.
Ropinirole 0.25 mg film-coated tablets should be taken three times a
day, preferably with meals to
improve gastrointestinal tolerance.
Treatment initiation
The initial dose of ropinirole should be 0.25 mg three times daily for
1 week. Thereafter, the dose of
ropinirole can be increased in 0.25 mg three times daily increments,
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
After the initial titration, weekly increments of 0.5 to 1 mg three
times daily (1.5 to 3 mg/day) of
ropinirole may be given.
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 titr