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| Ingredient | ATC Level 1 | ATC Level 2 | Year Of Switch | Country | Status | Additional Information |
|---|---|---|---|---|---|---|
| Fluoride (sodium) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A01. Stomatological preparations | — | UK | OTC | GSL in 2001 with a maximum strength of 0.05% for daily use mouth rinses and with a maximum strength of 0.2% for mouthwashes for other than daily use. Dentifrices with a maximum strength of 0.33% are also GSL. Preparations for the use in prevention of dental caries in the form of tablets or drops 2.2mg maximum daily dose are pharmacy only. |
| Hexetidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A01. Stomatological preparations | — | UK | OTC | GSL if maximum strength 0.1% (external use only). |
| Aluminium hydroxide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | UK | OTC | General sale. |
| Calcium carbonate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | UK | OTC | General sale. |
| Carbenoxolone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1992 | UK | OTC | (Sodium). Pharmacy only if pellet maximum dose 5mg, maximum daily dose 25mg, gel maximum strength 2%, or granules for mouthwash in adults and children over 12 years, maximum dose 20mg, maximum daily dose 80mg and maximum strength 1% and container or package containing maximum 560mg carbenoxolone sodium. No product currently marketed. |
| Cetraxate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | UK | — | No information. |
| Cimetidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1994 | UK | OTC | For the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity and for the prophylaxis of meal-induced heartburn, maximum dose 200mg, maximum daily dose 800mg, maximum treatment period 14 days. For the prophylactic management of nocturnal heartburn, maximum dose 100mg, to be taken as a single dose at night, maximum treatment period 14 days. Pharmacy-only. |
| Famotidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1994 | UK | OTC | Pharmacy only where for the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity, and prevention of these symptoms when associated with food and drink, including nocturnal symptoms. Maximum dose 10mg and maximum daily dose 20mg. For a maximum period of 14 days. General sale since 2000 for the short-term symptomatic relief of heartburn, indigestion, acid indigestion and hyperacidity, maximum dose 10mg, maximum daily dose 20mg and maximum 12 tablets per pack. |
| Lansoprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | UK | Rx | — |
| Nizatidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1996 | UK | OTC | Pharmacy only for the prevention and treatment of the symptoms of food-related heartburn, and meal-induced indigestion. For use in adults and children over 16. Maximum dose 75mg, maximum daily dose 150mg. For a maximum period of 14 days. |
| Omeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2004 | UK | OTC | Pharmacy-only medicine for the relief of reflux-like symptoms such as heartburn in adults aged 18 years and over. Maximum treatment period 2 weeks. Maximum strength 20mg, maximum dose 20mg, maximum daily dose 20mg, maximum pack size 14 tablets. 10mg capsules reclassified to P in 2004. 20mg gastro-resistant capsules reclassified to P in 2013. |
| Pantoprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2009 | UK | OTC | Pantoprazole 20mg was switched to non-prescription status in the entire European Union through a Decision of the European Commission under the centralised procedure dated 12 June 2009. Pantoprazole is available as a pharmacy only medicine, 20mg (one tablet) per day, maximum pack size 14 tablets. For the short-term symptomatic treatment of gastro-oesophageal reflux-like symptoms (e.g. heartburn) in adults aged 18 years and over. |
| Rabeprazole | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 2012 | UK | OTC | March 2012: Rabeprazole sodium 10mg gastro-resistant tablets may be supplied without a prescription (Pharmacy only status) for the short-term symptomatic treatment of gastro-oesophageal reflux-like symptoms (e.g. heartburn) in adults aged 18 and over, for a maximum period of 4 weeks, with a maximum dose of 10mg and a maximum daily dose of 10mg, and in a maximum pack size of 14 tablets (140mg rabeprazole). |
| Ranitidine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | 1994 | UK | OTC | Pharmacy only for the short-term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity or for the prevention of these symptoms when associated with consuming food and drink. Maximum dose 75mg, maximum daily dose 300mg, for a maximum period of 14 days. General sale restricted to maximum pack size of 12 tablets for the symptomatic relief of heartburn, dyspepsia, indigestion, and hyperacidity with a maximum strength of 75mg and maximum daily dose of 150mg. |
| Sucralfate | A Alimentary tract and metabolism. Alimentary tract and metabolism | A02. Drugs for acid related disorders | — | UK | Rx | — |
| Dicyclomine (Dicycloverine) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | UK | OTC | Pharmacy only. Maximum dose 10mg, maximum daily dose 60mg. |
| Dimeticone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | UK | OTC | Activated Dimeticone is available with General Sale status for the relief of wind, trapped gas and bloating. Liquid formulations are available for babies and children and solid formulations for adults and children. In addition, Dimeticone since 2009 may be supplied on general sale for the eradication of headlice infestations in adults and children aged 6 months and over. Maximum strength 4%, maximum pack size 100ml. |
| Domperidone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | UK | Rx | Back-switched (from pharmacy-only status to prescription-only medicine) in September 2014 due to small increased risk of serious cardiac effects (need for patients to have a medical assessment before taking domperidone). |
| Hyoscine butylbromide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | 1991 | UK | OTC | Pharmacy-only status: 1/ By inhaler - 2/ Otherwise than by inhaler: maximum dose 20mg, maximum daily dose 80mg, maximum pack size 240mg. For the symptomatic relief of irritable bowel syndrome. General Sale status (from 2004): Tablets for the relief of gastrointestinal tract spasm associated with medically confirmed irritable bowel syndrome (IBS) in adults and children aged 12 years and over. Maximum strength 10mg, maximum dose 20mg, maximum daily dose 80mg, maximum pack size 40 tablets. |
| Mebeverine | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | 1997 | UK | OTC | Pharmacy only status. For the symptomatic treatment of irritable bowel syndrome, maximum dose 135mg, maximum daily dose 405mg. For other uses: maximum dose 100mg, maximum daily dose 300mg. |
| Metoclopramide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | UK | Rx | — |
| Propantheline | A Alimentary tract and metabolism. Alimentary tract and metabolism | A03. Drugs for functional gastrointestinal disorders | — | UK | OTC | (Bromide). Pharmacy only status if maximum dose 15mg, maximum daily dose 45mg. However there is no marketed OTC product. |
| Dimenhydrinate (diphenhydramine and 8-chlorotheophylline) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A04. Antiemetics and antinauseants | — | UK | OTC | Pharmacy-only status. |
| Hyoscine (Scopolamine) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A04. Antiemetics and antinauseants | 1992 | UK | OTC | Hyoscine hydrobromide. Pharmacy only status when maximum dose 300 micrograms, maximum daily dose 900 micrograms. External (except ophthalmic) / internal (otherwise than by inhaler) routes. Hyoscine patches became available as a pharmacy-only product in 2004 for the prevention of travel sickness symptoms. For use in adults and children aged 10 years or over. Maximum strength: 1.5mg per patch, maximum pack size: 2 patches. Other preparations for internal use: maximum strength: 0.15%. |
| Hymecromone | A Alimentary tract and metabolism. Alimentary tract and metabolism | A05. Bile and liver therapy | — | UK | N.R. | Not registered or not marketed. |
| Bisacodyl | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | UK | OTC | Bisacodyl is pharmacy only unless the following conditions are met: maximum dose 10mg for general sale to adults and children over 10 years (maximum pack size 60 tablets, maximum strength 5mg). |
| Lactitol | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | UK | OTC | No product currently marketed. Pharmacy only. |
| Lactulose | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | UK | OTC | Pharmacy only status. |
| Macrogol (Polyethylene glycol 3350) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | — | UK | OTC | Pharmacy only status but not actively marketed to the public. Almost always prescribed by a health professional. |
| Picosulfate (sodium) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A06. Laxatives | 1997 | UK | OTC | General sale if for adults and children over 10 years. Maximum strength 0.1%, maximum dose 15mg, maximum daily dose 15mg, maximum pack size 60ml. In 2004, the conditions for GSL supply were extended to include liquid-filled capsules with a maximum strength of 2.5mg and maximum pack size of 24 capsules. |
| Loperamide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents | 1997 | UK | OTC | General sale for the symptomatic treatment of acute diarrhoea in adults and children over 12 years. For the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over following initial diagnosis by a doctor. Maximum strength 2mg, maximum dose 4mg, maximum daily dose 12mg, maximum pack size 6 caps or tabs. Pharmacy only for treatment of acute diarrhoea. |
| Nifuroxazide | A Alimentary tract and metabolism. Alimentary tract and metabolism | A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents | — | UK | N.R. | Not registered or not marketed. |
| Orlistat | A Alimentary tract and metabolism. Alimentary tract and metabolism | A08. Antiobesity preparations | 2009 | UK | OTC | Orlistat 60mg was switched to non-prescription status under the centralised procedure in the entire European Union through a European Commission Decision dated 12 January 2009. The switch was also implemented in Croatia, Norway and Switzerland. Available as a pharmacy only medicine for weight loss in adults who are overweight (body mass index, BMI, ≥28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet. |
| Vitamin A (Retinol) | A Alimentary tract and metabolism. Alimentary tract and metabolism | A11. Vitamins | — | UK | OTC | General sale. Maximum daily dose 7500iu (2250 micrograms Retinol equivalent). |
| Selenium | A Alimentary tract and metabolism. Alimentary tract and metabolism | A12. Mineral supplements | — | UK | OTC | Available in combination in multivitamin and mineral products in both pharmacy only products and food supplements. Selenium sulphide classified as pharmacy only. |
| Tranexamic acid | B Blood and blood forming organs. Blood and blood forming organs | B02. Antihemorrhagics | 2010 | UK | OTC | Tranexamic acid 500mg tablets were switched to non-prescription (pharmacy-only) status in 2010 for the reduction of heavy menstrual bleeding (menorrhagia) over several cycles in women aged 18 to 45 years with regular, 21-35 days cycles with no more than 3 days individual variability in cycle duration. Maximum dose 1g, maximum daily dose 4g, maximum treatment period 4 days, maximum pack size 18 tablets. |
| Adenosine | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | 2003 | UK | OTC | For oral administration at a maximum daily dose of 750 micrograms. Product should not be taken for longer than 12 weeks without medical advice. Not for children under 14 years of age. Pharmacy only status. |
| Nitro-glycerine | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | UK | OTC | Pharmacy only status. |
| Ubidecarenone | C Cardiovascular system. Cardiovascular system | C01. Cardiac therapy | — | UK | N.R. | Not registered or not marketed. |
| Lovastatin | C Cardiovascular system. Cardiovascular system | C10. Lipid modifying agents | — | UK | Rx | — |
| Simvastatin | C Cardiovascular system. Cardiovascular system | C10. Lipid modifying agents | 2004 | UK | OTC | Simvastatin 10mg switched to pharmacy status for use in conjunction with necessary lifestyle changes to reduce the risk of a first major coronary event in people likely to be at a moderate risk (approximately 10-15% 10-year risk of a first major event) of coronary heart disease (CHD)). Maximum strength 10mg, maximum daily dose 10mg, maximum pack size 28 tablets. Not currently marketed under OTC. |
| Amorolfine (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 2006 | UK | OTC | Amorolfine hydrochloride nail lacquer was switched to pharmacy (P) status on 15 September 2006 for the treatment of mild cases of distal and lateral subungual onychomycoses caused by dermatophytes, yeasts and moulds limited up to 2 nails. Dosage: a once-weekly administration. Maximum strength: 5% amorolfine (as the base). Maximum pack size: 3ml (equivalent to approximately 3 months' treatment). |
| Bifonazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | UK | OTC | Pharmacy only status unless a cream for the treatment of athlete's foot when it will be General Sale (GSL). Maximum strength 1%, maximum pack size 30g of product for GSL products. |
| Butenafine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | UK | N.R. | Not registered or not marketed. |
| Ciclopirox Olamine | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | UK | N.R. | Not registered or not marketed. |
| Clotrimazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | UK | OTC | Maximum strength 1%. For external use for prevention of (2001) or as an adjunct to the treatment of tinea pedis. Maximum 500mg in an individual container or package (General sale in 1995). |
| Croconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | UK | N.R. | Not registered or not marketed. |
| Econazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | — | UK | — | No information. |
| Fenticonazole (topical) | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 2001 | UK | OTC | Pharmacy only status when for external use only for the treatment of vaginal candidiasis. |
| Fluconazole | D Dermatologicals. Dermatologicals | D01. Antifungals for dermatological use | 1995 | UK | OTC | No topical products available. Pharmacy only when for oral administration for the treatment of vaginal candidiasis or associated candidal balanitis in adults (16-60 years). Maximum dose 150mg, maximum pack size 150mg. |
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