Table 1 UK licensed medicines that contain DBP, DEP and/or PVAP and respective maximum daily exposures relative to proposed EMA guidelines
Trade Name (generic name) | License holder | Phthalate | Phthalate content (mg) per tablet/capsule | Maximum licensed daily dose of drug | Phthalate (mg) at maximum daily dose | Chronic/Acute | Use in pregnancy |
|---|---|---|---|---|---|---|---|
Phthalate in tablet/capsule/liquid formulation | |||||||
Asacol 800 mg MR Tablets (mesalazine) | Warner Chilcott UK Ltd | DBP | 8.00c | 4.8 mg | 48.00 | Chronic | Benefit>Risk |
Coracten XL 30 mg (Nifedipine) | UCB Pharma Ltd | DBP | 0.14 | 90 mg | 0.42 | Chronic | No |
Coracten XL 60 mg (Nifedipine) | UCB Pharma Ltd | DBP | 0.28 | 90 mg | 0.28 | Chronic | No |
Occlusal (Salicylic acid) | Alliance Pharmaceuticals | DBP | N/A | RTD | RTD | Acute | Benefit>Risk |
Timodine Cream (Nystatin, Dimeticone, Hydrocortisone & Benzalkonium Chloride) | Alliance Pharmaceuticals | DBP | N/A | RTD | RTD | Acute | No |
Vivotif (Salmonella enterica serovar Typhi) | Crucell Italy S.r.l | DBP / DEP | 8.00 / 8.00 | 1 tablet | 8.00 / 8.00 | Acute | Benefit>Risk |
Kenzem 120 mg SR Capsules (Diltiazem hydrochloride) | Kent Pharmaceuticals | DEP | NR | 480 mg | NR | Chronic | No |
Kenzem 90 mg SR Capsules (Diltiazem hydrochloride) | Kent Pharmaceuticals | DEP | NR | 480 mg | NR | Chronic | No |
Kenzem 60 mg SR Capsules (Diltiazem hydrochloride) | Kent Pharmaceuticals | DEP | NR | 480 mg | NR | Chronic | No |
Omeprazole 40 mg Gastro-resistant Capsules, Hard (Omeprazole) | Accord Healthcare Ltd | DEP | 0.15 | 120 mg | 0.45 | Chronicd | Yes |
Omeprazole 20 mg Gastro-resistant Capsules, Hard (Omeprazole) | Accord Healthcare Ltd | DEP | 0.15 | 120 mg | 0.90 | Chronicd | Yes |
Reminyl XL 24 mg Prolonged Release Capsules (Galantamine) | Shire Pharmaceuticals Ltd | DEP | NR | 24 mg | NR | Chronic | Benefit>Risk |
Reminyl XL 16 mg Prolonged Release Capsules (Galantamine) | Shire Pharmaceuticals Ltd | DEP | NR | 24 mg | NR | Chronic | Benefit>Risk |
Reminyl XL 8 mg Prolonged Release Capsules (Galantamine) | Shire Pharmaceuticals Ltd | DEP | NR | 24 mg | NR | Chronic | Benefit>Risk |
Rheumatac Retard 75 mg Tablets (Diclofenac sodium) | Adipharm Mercury Company Ltd | DEP | 0.95 | 150 mg | 1.90 | Acute | No |
Surgical Spirit BP (Virgin castor oil & Methyl salicylate | Thornton & Ross Ltd | DEP | N/A | N/A | UTQ | Acute | Benefit>Risk |
Videx EC 400 mg Gastro-resistant Capsules (Didanosine) | Bristol-Myers Squibb Pharmaceuticals Ltd | DEP | RTD | 400 mg | RTD | Chronic | Benefit>Risk |
Videx EC 250 mg Gastro-resistant Capsules (Didanosine) | Bristol-Myers Squibb Pharmaceuticals Ltd | DEP | RTD | 400 mg | RTD | Chronic | Benefit>Risk |
Videx EC 200 mg Gastro-resistant Capsules (Didanosine) | Bristol-Myers Squibb Pharmaceuticals Ltd | DEP | RTD | 400 mg | RTD | Chronic | Benefit>Risk |
Videx EC 125 mg Gastro-resistant Capsules (Didanosine) | Bristol-Myers Squibb Pharmaceuticals Ltd | DEP | RTD | 400 mg | RTD | Chronic | Benefit>Risk |
Volsaid Retard 100 mg Tablets (Diclofenac Sodium) | Chiesi Ltd | DEP | 1.27 | 100 mg | 1.27 | Acute | No |
Volsaid Retard 75 mg Tablets (Diclofenac Sodium) | Chiesi Ltd | DEP | 0.95 | 150 mg | 1.90 | Acute | No |
Boots Constipation Relief Tablets 40s (Bisacodyl) | Dr. Reddy’s Laboratories (UK) Ltd | DEP | NR | 2 tablets | NR | Acute | No |
Epilim 500 Gastro-resistant Tablets (Sodium valproate) | Sanofi | DEP / PVAP | 2.31 / 23.31 | 2500 mg | 11.55 / 116.55 | Chronic | No |
Epilim 200 Gastro-resistant Tablets (Sodium valproate) | Sanofi | DEP / PVAP | 1.23 / 12.43 | 2500 mg | 14.76 / 149.16 | Chronic | No |
Zentiva 500 mg Gastro-resistant Tablets (Sodium valproate) | Winthrop Pharmaceuticals UK Ltd | DEP / PVAP | 2.31 / 23.31 | 2500 mg | 11.55 / 116.55 | Chronic | No |
Zentiva 200 mg Gastro-resistant Tablets (Sodium valproate) | Winthrop Pharmaceuticals UK Ltd | DEP / PVAP | 1.23 / 12.43 | 2500 mg | 14.76 / 149.16 | Chronic | No |
Boots Alternatives Laxative Tablets (Senna, Aloin, Cascara bark extract) | G.R. Lane Health Products Ltd | PVAP | 2.10 | 2 tablets | 4.20 | Acute | No |
Boots Period Pain Relief 250 mg Gastro-resistant Tablets (Naproxen) | Teva UK Ltd | PVAP | NR | 500 mg | NR | Acute | No |
Deltacortril 2.5 mg Gastro-resistant Tablets (Prednisolone) | Alliance Pharmaceuticals | PVAP | RTD | 60 mg | RTD | Chronicd | Benefit>Risk |
Deltacortril 5 mg Gastro-resistant Tablets (Prednisolone) | Alliance Pharmaceuticals | PVAP | RTD | 60 mg | RTD | Chronicd | Benefit>Risk |
Disipal 50 mg Tablets (Orphenadrine hydrochloride) | Astellas Pharma Ltd | PVAP | 17.30 | 400 mg | 138.40 | Chronic | Benefit>Risk |
Feminax Ultra 250 mg Gastro-resistant Tablets (Naproxen) | Teva UK Ltd | PVAP | NR | 750 mg | NR | Acute | No |
Ferrous Gluconate 300 mg Tablets (Ferrous gluconate) | Kent Pharmaceuticals | PVAP | NR | 1800 mg | NR | Chronicd | Yes |
Nardil 15 mg Tablets (Phenelzine) | Archimedes Pharma UK Ltd | PVAP | 1.42 | 90 mg | 8.52 | Chronic | No |
Prednisolone 5 mg Gastro-resistant Tablets (Prednisolone) | Actavis UK Ltd | PVAP | 12.00 | 60 mg | 144.00 | Chronicd | Benefit>Risk |
Prednisolone 2.5 mg Gastro-resistant Tablets (Prednisolone) | Actavis UK Ltd | PVAP | 12.00 | 60 mg | 288.00 | Chronicd | Benefit>Risk |
Pancrex Granules (Pancreatin) | Essential Pharmaceuticals Ltd | PVAP | RTD | variablea | RTD | Chronic | Benefit>Risk |
Pancrex V Tablets (Pancreatin) | Essential Pharmaceuticals Ltd | PVAP | RTD | variablea | RTD | Chronic | Benefit>Risk |
Pancrex V Forte Tablets (Pancreatin) | Essential Pharmaceuticals Ltd | PVAP | RTD | variablea | RTD | Chronic | Benefit>Risk |
Phthalate in tablet/capsule logo ink | |||||||
Aloxi 500 μg Soft Capsules (Palonosetron) | Sinclair IS Pharma | PVAP | UTQ | 500 μg | UTQ | Acute | No |
Amitiza 24 μg Soft Capsules (Lubiprostone) | Sucampo Pharma Europe Ltd | PVAP | 0.21 | 48 μg | 0.42 | Acute | No |
Anadin Ultra Double Strength/LiquiFast 400 mg Capsules (Aspirin) | Pfizer Consumer Healthcare | PVAP | <0.01 | 1200 mg | 0.03 | Acute | No |
Anadin Ultra/LiquiFast 200 mg Capsules (Aspirin) | Pfizer Consumer Healthcare | PVAP | <0.01 | 1200 mg | 0.05 | Acute | No |
Aptivus 250 mg soft Capsules (Tipranavir) | Boehringer Ingelheim Ltd | PVAP | UTQ | 1000 mg | UTQ | Chronic | Benefit>Risk |
Benadryl Allergy Liquid Release 10 mg Capsules (Certirizine dihydrochloride) | McNeil Products Ltd | PVAP | 1.00 | 10 mg | 1 | Chronicd | Benefit>Risk |
Nurofen Express 200 mg Liquid Capsules (Ibuprofen) | Reckitt Benckiser Healthcare (UK) Ltd | PVAP | NR | 1200 mg | NR | Acute | No |
Nurofen Express 400 mg Liquid Capsules (Ibuprofen) | Reckitt Benckiser Healthcare (UK) Ltd | PVAP | NR | 1200 mg | NR | Acute | No |
Targretin 75 mg Capsules (Bexarotene) | Eisai Ltd | PVAP | UTQ | 21 capsulesb | UTQ | Acute | No |
Xtandi 40 mg Soft Capsules (Enzalutamide) | Astellas Pharma Ltd | PVAP | UTQ | 160 mg | UTQ | Acute | No |
Zemplar Soft Capsules 2 μg (Paricalcitol) | AbbVie Ltd | PVAP | 0.86 | 32 μg | 13.76 | Chronic | Benefit>Risk |
Zemplar Soft Capsules 1 μg (Paricalcitol) | AbbVie Ltd | PVAP | 0.86 | 32 μg | 27.52 | Chronic | Benefit>Risk |