Ropinirole 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ropinirole hydrochloride

Available from:

Wockhardt UK Ltd

ATC code:

N04BC04

INN (International Name):

Ropinirole hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04090100; GTIN: 5012727906560

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ropinirole 5mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5.7mg ropinirole hydrochloride,
equivalent to
5mg ropinirole.
Excipient(s) with known effect
Lactose monohydrate – 113.2mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, irregular hexagonal shape film-coated tablets, debossed with
‘W’ on one side
and ‘177’ 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
Posology 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 of ropinirole should be 0.25
mg three
times daily for one week. Thereafter, the dose of ropinirole can be
increased in
0.25mg three times daily increments, according to the following
regimen:_ _
Week
3
Unit dose (mg) of
ropinirole
0.
7
5
Total daily dose (mg)_ _of
ropinirole
2.
2
5
_THERAPEUTIC REGIMEN_: After the initial titration, weekly increments
of 0.5 to
1mg three times daily (1.5 to 3mg/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
24mg/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
titra