Ropinirole Lambda 5mg film-coated Tablets

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ROPINIROLE

Disponible depuis:

Lambda Therapeutics Limited Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Code ATC:

N04BC04

DCI (Dénomination commune internationale):

ROPINIROLE 5 mg

forme pharmaceutique:

FILM-COATED TABLET

Composition:

ROPINIROLE 5 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

ANTI-PARKINSON DRUGS

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2012-06-14

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ROPINIROLE LAMBDA  
ROPINIROLE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
− 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. Do not pass it on
to others. It may harm them, even if 
their symptoms are the same as yours. 
− If any of the side effects get serious, or
you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 

IN THIS LEAFLET: 
1. What is Ropinirole Lambda Therapeutics 5 mg and what it is used
for 
2. Before you take Ropinirole Lambda Therapeutics 5 mg  
3. How to take Ropinirole Lambda Therapeutics 5 mg  
4. Possible side effects 
5. How to store Ropinirole Lambda Therapeutics 5 mg  
6. Further information 

1. WHAT IS ROPINIROLE LAMBDA THERAPEUTICS 5 MG AND WHAT
IT IS USED 
FOR 

The active substance in Ropinirole Lambda Therapeutics 5 mg 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 Lambda Therapeutics 5 mg 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. 

2. BEFORE YOU TAKE ROPINIROLE LAMBDA THERAPEUTICS 5 MG  

If your doctor has told you that you have sugar intolerance,
speak to him/her before taking this 
medicine. 

DO NOT TAKE ROPINIROLE LAMBDA THERAPEUTICS 5 MG 
  If you are allergic (hypersensitive) to ropinirole, or to any
of the other ingredients of 
Ropinirole Lambda Therapeutics 5 mg ( see Sections 4 and 6) 
  If you have serious kidney disease 
  If you have liver disease 

T

Résumé des caractéristiques du produit

                              Page 1 of 9 

SUMMARY OF PRODUCT CHARACTERISTICS  

1.  
NAME OF THE MEDICINAL PRODUCT 

Ropinirole Lambda 5mg film-coated tablets 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 5 mg Ropinirole (as hydrochloride).  

Excipient (s):   
Each 5 mg film-coated tablet contains 43.30 mg lactose monohydrate. 

For a full list of excipients, see section 6.1. 

3.  
PHARMACEUTICAL FORM 

Film-coated tablet.  
Round biconvex, plain on both sides, blue. 

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).  

Other strengths are available for doses not practicable with this dose strength. 

4.2  
POSOLOGY AND METHOD OF ADMINISTRATION 

Oral use. 

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: 

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