ROPINIROLE 0.5 Milligram Film Coated Tablet

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

ROPINIROLE HYDROCHLORIDE

Tersedia dari:

Accord Healthcare Limited

INN (Nama Internasional):

ROPINIROLE HYDROCHLORIDE

Dosis:

0.5 Milligram

Bentuk farmasi:

Film Coated Tablet

Jenis Resep:

Product subject to prescription which may be renewed (B)

Status otorisasi:

Authorised

Tanggal Otorisasi:

0000-00-00

Selebaran informasi

PACKAGE LEAFLET: INFORMATION FOR THE USER 
INVENTED NAME 
ROPINIROLE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS 
IMPORATANT INFORMATION FOR YOU. 
− Keep this leaflet. You may need to read it again. 
− If you have any further questions, please ask your doctor,
pharmacist or nurse. 
− 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, pharmacist
or nurse. This includes any possible side 
effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET: 
1. What is Ropinirole Accord and what it is used for 
2. What you need to know before you take Ropinirole Accord  
3. How to take Ropinirole Accord  
4. Possible side effects 
5. How to store Ropinirole Accord  
6. Contents of the pack and other information 

1. WHAT IS ROPINIROLE ACCORD AND WHAT IT IS USED FOR 

The active substance in Ropinirole Accord 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 
dopamine. 

Ropinirole Accord is used to treat Parkinson's disease. 
People with Parkinson's disease have low concentrations of dopamine in
some parts of their brains. 
Ropinirole has similar effects to those of natural dopamine,  so
it helps to reduce the symptoms of 
Parkinson’s disease. 

Ropinirole Accord is used to treat the symptoms of moderate to
severe Restless Legs Syndrome. 
Patients with moderate to severe Restless Legs Syndrome
generally complain of trouble sleeping or 
severe discomfort in the legs or arms. 
Patients with Restless Legs Syndrome have an irresistible urge to
move their legs,and sometimes their 
arms and other parts of their body. They usually have an
uncomfortable feeling in the legs (sometimes 
described as pins and needles, burnin

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ropinirole 0.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.50 mg Ropinirole (as hydrochloride).
Excipient (s) with known effect: Each 0.50 mg film-coated tablet contains 48.43 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round biconvex, plain on both sides, yellow.
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).
Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
PARKINSON’S DISEASE
Adults
Individual dose titration against efficacy and tolerability is recommended.
Ropinirole 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:
_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.
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
IRISH MEDICINES BOARD
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