Stalevo 150 mg/37.5 mg/200 mg film-coated tablets

The following are the major changes:

Section 2: What you need to know before you take Stalevo

Added the words ‘and sodium’ into ‘Stalevo contains sucrose’ header, and added the following words underneath;

• • This medicine contains 2.6 mg sodium (main component of cooking/table salt) in each tablet. The maximum recommended daily dose (10 tablets) contains 26 mg of sodium. This is equivalent to 1.3% of the recommended maximum daily dietary intake of sodium for an adult.

The following are the major changes:

Section 2: Qualitative And Quantitative Composition

• To 150 mg/37.5 mg/200 mg under Excipients with known effect, added the words “…and 2.6 mg sodium as a constituent of an excipient.”

Section 4.4: Special warnings and precautions for use

Added following paragraphs:

• Stalevo 150 mg/37.5 mg/200 mg contains 2.6 mg sodium per tablet. The maximum recommended daily dose (10 tablets) contains 26 mg sodium, equivalent to 1.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 175 mg/43.75 mg/200 mg and 200 mg/50 mg/200 mg film-coated tablets contain less than 1 mmol (23 mg) sodium per maximum recommended daily dose, that is to say essentially ‘sodium-free’.

Additional site of manufacture added to section 6 of the leaflet.

Date of revision of text updated, no other updates.

Representative offices contact details for Malta and Bulgaria updated

The package leaflet has been updated with information relating to what patients and their families should do if addiction-like symptoms are developed and what the side-effects of this may be.

The Summary of product characteristics for Stalevo has been updated to include information on Dopamine Dysregulation Syndrome (DDS):

Section 4.4 is updated to state: Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/levodopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS.

Section 4.8 is updated to state: Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias.