Labelling of medicines

 

Strength indication of FDCs

 

 

 

 

Look at theese three packages. They all have the same strength!

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 


 

 

 

 

 

 

 

 

 

 

Strength indication for medicines with more than one active ingredient (Fixed Dose Combinations, FDCs) is a very dangerous mess. Within one country you can find FDCs with:

 

* No strength indication at all in the product name, e.g. 'Sinemet Mite'.

* Strength indicated for only one of the active ingredients, e.g. 'Sinemet 100'.

* Strength indicated as the sum of milligrams for two different substances (adding ants to elephants?),

    e.g. 'Sinemet 110'.

* Strength indicated with numbers separated by a slash/solidus, e.g. 'Sinemet 10/100'. (This is the way I recommend)

 

 

Sinemet and many other FDCs are extensively parallel imported from low cost to high cost European countries, thus creating many dangerous situations for the patients.

 

I have written an article about the problem (2001) in Pharmaceutical Journal. Word format here.

I have also written a letter (2006) in Pharmaceutical Journal. Word format here

I urge all pharmacists and regulatory people to promote a better practice and a better standard in this matter. I consider USA and the European Union to be the most important areas. Please contact me if you can contribute.

 

My recommendation:

 

For FDCs with fantasy name and two or three active ingredients, as a minimum the numerical strength should be indicated in the product name.

If denotations (mg, Units) are omitted, the values should be separated by a dash (solidus) or '+'.

For FDCs with four or more active ingredients the term 'multi ingredient' should be printed directly beneath the product name.

 

Examples:

Paralgin Forte 30/400 or Paralgin Forte 30+400 or Paralgin Forte 30mg + 400mg

(codeine phosphate 30mg, paracetamol 400mg)

Paralgin Major 60/800

Rifater 50/120/300

 

Amedine 8/250 or Amedine 250/8

(bromhexine 8mg, amoxicilline 250mg)

Which is first is not important.

It is important to give signal about the medicine containing more than one active ingredient.

Amedine 500/8 or Amedine Forte 500/8