Ropinirole 5mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Ropinirole hydrochloride

Fáanlegur frá:

DE Pharmaceuticals

ATC númer:

N04BC04

INN (Alþjóðlegt nafn):

Ropinirole hydrochloride

Skammtar:

5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04090100

Upplýsingar fylgiseðill

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
REQUIP
® 5MG TABLETS
(ropinirole hydrochloride)
Your medicine is available using the name Requip 5mg
Tablets, but will be referred to as Requip throughout this
leaflet. This medicine is also available in strengths 0.25mg,
1mg and 2mg.
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 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 Requip is and what it is used for
2.
What you need to know before you take Requip
3.
How to take Requip
4.
Possible side effects
5.
How to store Requip
6.
Contents of the pack and other information
1.
WHAT REQUIP IS AND WHAT IT IS USED FOR
REQUIP IS USED TO TREAT PARKINSON’S DISEASE.
The active ingredient in Requip 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
REQUIP
DO NOT TAKE REQUIP:

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 Requip:

if you are PREGNANT or think you may be pregnant

if you are BREAST-FE

Vara einkenni

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