ReQuip 2mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Ropinirole hydrochloride

Disponible depuis:

GlaxoSmithKline UK Ltd

Code ATC:

N04BC04

DCI (Dénomination commune internationale):

Ropinirole hydrochloride

Dosage:

2mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 04090100; GTIN: 5000483614003

Notice patient

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
REQUIP
® 2MG TABLETS
(ropinirole hydrochloride)
Your medicine is available using the name Requip 2mg
Tablets, but will be referred to as Requip throughout this
leaflet. This medicine is also available in strengths 0.25mg,
1mg and 5mg.
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

Résumé des caractéristiques du produit

OBJECT 1
REQUIP 2 MG TABLETS
Summary of Product Characteristics Updated 14-Nov-2017 |
GlaxoSmithKline UK
1. Name of the medicinal product
Requip
2. Qualitative and quantitative composition
Each film-coated tablet contains 2mg of ropinirole as ropinirole
hydrochloride.
Excipient: 44.6 mg lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pink, pentagonal-shaped, bevelled edge marked “SB” one on side and
“4893 on the other.
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.
Adults
Individual dose titration against efficacy and tolerability is
recommended.
Ropinirole should be taken three times a day, preferably with meals to
improve gastrointestinal tolerance.
_TREATMENT INITIATION: _The initial dose 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 titration as
described above, the dose of ropinirole
may be increased up to 24 mg/day.
Doses of ropinirole above 24 mg/day have not been studied.
If treatment is interrupted for one day or more re-initiation by dose
titration should be considered (see
above).
When ropinirol