Ropinirole Lambda 1mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROPINIROLE

Available from:

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

ATC code:

N04BC04

INN (International Name):

ROPINIROLE 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROPINIROLE 1 mg

Prescription type:

POM

Therapeutic area:

ANTI-PARKINSON DRUGS

Authorization status:

Withdrawn

Authorization date:

2012-06-14

Patient Information leaflet

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

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

The active substance in Ropinirole Lambda Therapeutics 1 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 1 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. 

Ropinirole Lambda Therapeutics 1 mg 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 
descr

Summary of Product characteristics

                               Page 1 of 12 

SUMMARY OF PRODUCT CHARACTERISTICS 

1.  
NAME OF THE MEDICINAL PRODUCT 

Ropinirole Lambda  1mg film-coated tablets 

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 1 mg Ropinirole (as hydrochloride).  

Excipient (s):   
Each 1 mg film-coated tablet contains 47.86 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, green. 

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: 

                               Page 2 of 12 

Week 

1 
2 
3 
4 
Unit dose (mg) of ropinirol