Acea 0.75%

Acea 0,75% W / W Gel

Metronidazole 0.75% w / w

For the full list of excipients, see 6.1.

Gel.

Very pale light yellow gel.

Treatment of acute inflammatory exacerbations of rosacea.

For dermal use only.

(I) For adults and the elderly. Apply the gel to the affected area of the skin in a thin film twice a day for 8 weeks. Subsequently, further applications may be required depending on the severity of the condition.

(ii) For Children. Not recommended.

Known hypersensitivity to metronidazole, parabens or any of the constituents.

Warnings: Avoid contact with eyes. In case of contact with the eyes, the gel should be thoroughly washed off with water.

Precautions: The following statements take into account the possibility that metronidazole may be absorbed after topical application. However there is no evidence of significant systemic concentrations of metronidazole after topical applications. Peripheral neuropathy has been reported in association with prolonged use of oral metronidazole. The elimination half-life of the drug remains unchanged in the presence of renal failure. These patients, however, retain the metabolite of metronidazole. The clinical significance of this is not known at present. However, in patients on hemodialysis, metronidazole and its metabolites are effectively eliminated

Contains Methyl Parahydroxybenzoate (E218) and Propyl Parahydroxybenzoate (E216) and Ethyl Parahydroxybenzoate (E214), may cause allergic reactions (possibly delayed).

No adverse effects on the ability to drive or use machines have been reported following topical application of metronidazole.

Dryness or irritation of the skin can be felt after application to unbroken skin. Metronidazole systemic treatment can sometimes cause an unpleasant taste in the mouth, a stuffed tongue, nausea, vomiting, gastrointestinal disorders, urticaria, angioedema and anyphylaxis. Drowsiness, dizziness, headache, ataxia, rash, pruritus and darkening of urine have been reported, but rarely.

Reporting suspected adverse reactions

It is important to report suspected side effects after authorisation of the drug. It allows continuous monitoring of the benefit/risk ratio of the drug. Healthcare professionals are advised to report any suspected side effects via the yellow card system:

Site: www.mhra.gov.uk/yellowcard

Overdose is unlikely. If necessary, remove the medicine by washing it with warm water. In case of accidental ingestion, an appropriate method of gastric emptying can be used if it is considered appropriate.

ATC Code: D06BX01

Metronidazole is a derivative of 5-nitroimidazole with activity against anaerobic protozoa and anaerobic bacteria. It also has a radiosensitizing effect of hypoxic tumor cells. It is believed that its mechanism of action involves interference with DNA by a metabolite in which the nitro group of metronidazole was reduced. The mode of action of topical metronidazole in the treatment of rosacea is not known.

No bioavailability studies have been performed with this formulation.

Glycerol

Hydroxyethylcellulose

Methyl Parahydroxybenzoate (E218) China Manufacturer)

Propyl Parahydroxybenzoate (E216) China Manufacturer)

Ethyl Parahydroxybenzoate (E214) China Manufacturer)

Disodium edetate

Sodium Hydroxide

Potassium Dihydrogen Phosphate

Purified water

Not applicable.

36 months from the date of manufacture of the unopened container.

8 weeks from the opening date.

Do not store above 25°C.

Do not refrigerate or freeze.

Aluminum tube with polypropylene screw cap.

Packages are 5 g, 25 g and 40 g. not all packages can be marketed.

Not applicable.

Ferndale Pharmaceuticals Ltd

Unit 740

Thorp Arch Estate

Wetherby

West Yorkshire

LS23 7FX

Kingdom

PL 20685/0020

27 February 2004 / 17^th September 2007

6^th October 2016