PACKAGING AWARD
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NOT ATTRIBUTED IN 2010 |
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"YELLOW CARDS" |
In alphabetical order: |
Exforge HCT°
tablets
Novartis |
amlodipine 5 mg or 10 mg + valsartan 160 mg + hydrochlorothiazide 12.5 mg or 25 mg |
For the similar labelling of the boxes and blister packs of different dose strengths, representing a source of confusion (Rev Prescrire n° 325). |
Resikali° powder for oral or rectal suspension Fresenius Medical Care |
calcium sulfonate polystyrene |
This product is not contained in a box, meaning that the information leaflet may be lost; in addition, the dosing spoon is buried within the powder and is sometimes difficult to find (Rev Prescrire n° 319) |
Sifrol° LP sustained-release tablets
Boehringer Ingelheim |
pramipexole |
For the ambiguous labelling of the blister packs (straddling two blisters), creating a risk of intake of two tablets instead of one (Rev Prescrire n° 323). |
Temeritduo° tablets
Menarini |
nebivolol 5 mg +
hydrochlorothiazide 12.5 mg or 25 mg |
For the near-identical labelling of the boxes, representing a source of confusion between the dose strengths (Rev Prescrire n° 316 and 320). |
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"RED CARDS" |
In alphabetical order: |
Codotussyl toux sèche enfants° and Codotussyl toux sèche adultes° syrups
Genévrier |
pholcodine |
For the fanciful labelling of the boxes and bottles, overshadowing the international nonproprietary name (INN) and representing a source of confusion with other members of this over-the-counter umbrella range; also for the lack of safety cap, creating a risk of overdose in children (pholcodine has neurological adverse effects) (Rev Prescrire n° 317). |
Coveram°
tablets
Servier |
amlodipine 5 mg or 10 mg +
perindopril 5 mg or 10 mg |
For the bulk bottles that create a risk of overdose; and for the similar labelling of the different dose strengths, exposing patients to a risk of hypotension and malaise (Rev Prescrire n° 316).
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Dolirhume aux huiles essentielles° solution for inhalation by
fumigation
Sanofi Aventis |
Peru balm + eucalyptus and styrax
tinctures + thyme and lavender essential oils + levomenthol |
For the failure to mention the ingredients on the bottle, creating a source of medication errors; and for the lack of a safety cap, representing a risk of overdose in children (terpene derivatives can cause hallucinations, drowsiness and confusion) (Rev Prescrire n° 318). |
Ebixa°
oral solution
Lundbeck |
memantine |
For the measuring device based on a primed pump, creating a risk of confusion and overdose and exposing patients to the adverse effects of this psychotropic drug (Rev Prescrire n° 323) (a). |
Instanyl°
nasal solution 50 μg, 100 μg or 200 μg per puff
Nycomed |
fentanyl |
For the unsafe packaging and the lack of a built-in mechanism ensuring a sufficient pause between puffs, thus creating a risk of overdose with this opiate (Prescrire Int n° 110). |
Keppra°
oral solution
100 mg/ml
UCB |
levetiracetam |
For the oral syringe graduated in milliliters of solution, requiring the user to convert the dose (in mg) to a volume (in ml), and representing a source of overdose with this antiepileptic drug used to treat children (Rev Prescrire n° 321 and 327). |
Nurofenfem° 400 mg tablets
Reckitt Benckiser |
ibuprofen
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For the failure of the information leaflet to underline the risk of miscarriage linked to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the first trimester of pregnancy. This exposes pregnant women to an unjustifiable risk with this widely used over-the-counter drug (Rev Prescrire n° 320). |
Sodium valproate Winthrop 20 pour cent° oral solution
(200 mg/ml)
Sanofi Aventis
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valproic acid |
For the differences, relative to the reference product, in the graduation of the oral syringe, and the way in which the concentration is expressed on the box and bottle (b), creating a source of confusion and overdose, and exposing patients to an increased risk of adverse effects with this antiepileptic drug
(Rev Prescrire n° 315) |
VoltarenPlast ° medicated plasters 140 mg
Novartis Santé Familiale |
diclofenac |
For the failure of the labelling and leaflet to underline cardiac and renal risks for the unborn child linked to the use of NSAIDs during the second trimester of pregnancy (Rev Prescrire n° 320). |
a - After the review in Rev Prescrire n° 323, oral Ebixa° was modified.
b - Particularly as Depakine°, the reference product, is also marketed by Sanofi Aventis.
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©Prescrire March 2011
"The 2010 Prescrire Awards" Prescrire Int 2011; 20 (114): 79-82. (Pdf, free)
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