Method of action:
Antialcoholic, Antibiotics And Chemotherapeutics For Dermatological Use, Antiprotozoal, Antiulcer, Bactericidal
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Name of the medicinal product

Acea 0.75% w/w Gel

Qualitative and quantitative composition

Metronidazole 0.75% w/w

For full list of excipients see 6.1.

Pharmaceutical form


Clear very pale yellow gel.

Therapeutic indications

The treatment of acute inflammatory exacerbations of rosacea.

Dosage (Posology) and method of administration

For cutaneous use only.

(i) For adults and the elderly. Apply the gel to the affected area of the skin in a thin film twice daily for 8 weeks. Thereafter further applications may be necessary depending on the severity of the condition.

(ii) For Children. Not recommended.


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

Special warnings and precautions for use

Warnings: Avoid contact with the eyes. If contact with the eyes occurs the gel should be washed out carefully 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 any significant systemic concentrations of metronidazole following topical applications. Peripheral neuropathy has been reported in association with prolonged use of oral metronidazole. The elimination half-life of metronidazole remains unchanged in the presence of renal failure. Such patients, however, retain the metabolite of metronidazole. The clinical significance of this is not known at present. However in patients undergoing haemodialysis, metronidazole and its metabolites are efficiently removed.

Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and ethyl parahydroxybenzoate (E214), may cause allergic reactions (possibly delayed).

Effects on ability to drive and use machines

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

Undesirable effects

Dryness or irritation of the skin may be experienced after application to unbroken skin. Systemic metronidazole therapy may occasionally cause an unpleasant taste in the mouth, furred tongue, nausea, vomiting, gastro-intestinal disturbance, urticaria, angioedema and anyphylaxis. Drowsiness, dizziness, headache, ataxia, skin rash, pruritis and darkening of urine has been reported, but rarely.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:



Overdose is unlikely. If necessary remove the medication by washing with warm water. If accidental ingestion occurs, an appropriate method of gastric emptying may be used if considered appropriate.

Pharmacodynamic properties

ATC Code: D06BX01

Metronidazole is a 5-nitroimidazole derivative with activity against anaerobic protozoa and anaerobic bacteria. It also has a radiosensitising effect of hypoxic tumour cells. Its mechanism of action is thought to involve interference with DNA by a metabolite in which the nitro group of metronidazole has been reduced. The mode of action of topical metronidazole in the treatment of rosacea is not known.

Pharmacokinetic properties

No bioavailability studies have been carried out with this formulation.

Preclinical safety data

There are no preclinical data of relevance to the prescriber, which have additional to those already included in other sections of the SmPC.

List of excipients



Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Ethyl parahydroxybenzoate (E214)

Disodium edetate

Sodium hydroxide

Potassium dihydrogen phosphate

Purified water


Not applicable.

Shelf life

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

8 weeks from the date of opening.

Special precautions for storage

Do not store above 25°C.

Do not refrigerate or freeze.

Nature and contents of container

Aluminium tube with a polypropylene screw cap.

The pack sizes are 5 g, 25 g and 40 g. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Not applicable.

Marketing authorisation holder

Ferndale Pharmaceuticals Ltd

Unit 740

Thorp Arch Estate


West Yorkshire

LS23 7FX

United Kingdom

Marketing authorisation number(s)

PL 20685/0020

Date of first authorisation/renewal of the authorisation

27 February 2004 / 17th September 2007

Date of revision of the text

6th October 2016