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.
36 months from the date of manufacture of the unopened container.
8 weeks from the opening date.
Known hypersensitivity to metronidazole, parabens or any of the constituents.
Not applicable.
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
Gel.
Very pale light yellow gel.
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
There are no prescriber-relevant preclinical data in addition to those already included in other sections of the CPP.
Treatment of acute inflammatory exacerbations of rosacea.
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.
6th October 2016
Acea 0,75% W / W Gel
Ferndale Pharmaceuticals Ltd
Unit 740
Thorp Arch Estate
Wetherby
West Yorkshire
LS23 7FX
Kingdom
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.
PL 20685/0020
Metronidazole 0.75% w / w
For the full list of excipients, see 6.1.
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.
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.
Not applicable.
27 February 2004 / 17th September 2007
