Stalevo 175 mg/43.75 mg/200 mg film-coated tablets

The following are the major changes:

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

Under ‘Stalevo contains sucrose’ added

“This medicine contains less than 1 mmol (23 mg) sodium per maximum recommended daily dose, that is to say essentially ‘sodium-free’.”

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’.

Date of revision of text updated, no other updates.

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

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.