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Table 1 UK licensed medicines that contain DBP, DEP and/or PVAP and respective maximum daily exposures relative to proposed EMA guidelines

From: Review: UK medicines likely to be affected by the proposed European Medicines Agency’s guidelines on phthalates

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
  1. All calculations are based on the maximum licensed dose. If a drug has multiple indications, the indication with the highest dose was used for the calculation. For drugs that cannot be given at the maximum dose due to their dose increment, (i.e. sodium valproate 200 mg – max dose 2500 mg), the maximum achievable dose within the product license was used
  2. UTQ denotes unable to quantify, RTD denotes licence holder refused to declare, NR denotes no response
  3. a Dosing regime of Pancrex is dependent on frequency of meals/snacks
  4. b Based on a dose of 650 mg/m2/day for a person with a body surface area of 2.38–2.62 m2
  5. c Information in the public domain [26, 27], license holder refused to confirm
  6. d These medications are also used in acute settings
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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