Raponer XL 4mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-06-2018
Summary of Product characteristics
(SPC)
20-06-2018
Active ingredient:
Ropinirole hydrochloride
Available from:
Accord-UK Ltd
ATC code:
N04BC04
INN (International Name):
Ropinirole hydrochloride
Dosage:
4mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04090100; GTIN: 5012617022806
Patient Information leaflet
_Continued top of next column _
BBBA0933
RAPONER XL 2MG, 4MG AND 8MG
PROLONGED-RELEASE TABLETS
Ropinirole
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 .
•
The full name of this medicine is Raponer XL 2mg, 4mg and
8mg Prolonged-release Tablets but within the leaflet it will be
referred to as Raponer XL tablets.
WHAT IS IN THIS LEAFLET:
1 WHAT RAPONER XL TABLETS ARE AND WHAT THEY ARE
USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAPONER
XL TABLETS
3
HOW TO TAKE RAPONER XL TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RAPONER XL TABLETS
6
CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT RAPONER XL TABLETS ARE AND WHAT THEY ARE
USED FOR
The active ingredient in Raponer XL 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.
Raponer XL prolonged-release tablets are 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 RAPONER
XL TABLETS
DO NOT TAKE RAPONER XL TABLETS IF YOU
• are ALLERGIC to ropinirole or any of the other ingredients of this
medicine (listed in section 6)
• have a SERIOUS KIDNEY disease
• 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 T
Read the complete document
Summary of Product characteristics
OBJECT 1
RAPONER XL 4MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 26-Jan-2018 | Accord-UK Ltd
1. Name of the medicinal product
Raponer XL 4mg Prolonged-release Tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains 4 mg ropinirole (as
hydrochloride).
Excipient with known effect:
Each 4 mg prolonged-release tablet contains 59.12 mg lactose
monohydrate.
Raponer XL 4mg Prolonged-release Tablets contain hydrogenated castor
oil
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged-release tablet.
Raponer XL 4mg prolonged-release tablets:
Brown, mottled, oval tablet, 16.0 x 8.20 mm, with 4x debossed on one
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
Posology
_Adults_
Individual dose titration against efficacy and tolerability is
recommended. Raponer XL prolonged-release
tablets should be taken once a day, at a similar time each day. The
prolonged-release tablets may be taken
with or without food (see section 5.2).
_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 side effects that they cannot tolerate, may benefit from
switching to treatment with ropinirole
film-coated (immediate release) tablets at a lower daily dose, divided
into three equal doses.
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