Acea 0.75% w/w Gel
- Revised
- July 2018
- Source updated
- 27 Jul 2018
- MA number
- PL 20685/0020
- ATC
- D06BX01
- Legal status
- Prescription only medicine
Indications
Concepts (30)
+Allergy to the medicineContraindicated
Known hypersensitivity to metronidazole, parabens or any of the constituents.
Source SmPC ↗+Benzyl alcoholWarning
n 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).
Source SmPC ↗+Dialysis and blood filteringWarning
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).
Source SmPC ↗+Kidney conditionsWarning
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).
Source SmPC ↗+UnclassifiedWarning
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 concent
Source SmPC ↗+AlcoholInteraction
Patients are advised not to take alcohol during systemic metronidazole therapy because of the possibility of a disulfiram-like reaction. Some potentiation of anti-coagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Patients receiving phenobarbitone metabolise metronidazole
Source SmPC ↗+BreastfeedingPregnancy
The safety of topically applied metronidazole in pregnancy and lactation has not been adequately established and should not be used in these circumstances unless the physician considers it essential.
Source SmPC ↗+PregnancyPregnancy
The safety of topically applied metronidazole in pregnancy and lactation has not been adequately established and should not be used in these circumstances unless the physician considers it essential.
Source SmPC ↗+Bleeding riskNot in scanned sections
+Taken with other medicinesNot in scanned sections
+Intolerance to an ingredientNot in scanned sections
+FertilityNot in scanned sections
+Stomach and gutNot in scanned sections
+Blood disordersNot in scanned sections
+Heart rhythm blockNot in scanned sections
+Liver conditionsNot in scanned sections
+Low blood pressureNot in scanned sections
+InfectionNot in scanned sections
+LactoseNot in scanned sections
+CancerNot in scanned sections
+Sodium and potassium contentNot in scanned sections
+BlockageNot in scanned sections
+ChildrenNot in scanned sections
+Sugar alcoholsNot in scanned sections
+PorphyriaNot in scanned sections
+Propylene glycolNot in scanned sections
+Heart rhythm (QT interval)Not in scanned sections
+ShockNot in scanned sections
+Blood vessel conditionsNot in scanned sections
+Wheat starchNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
36 months from the date of manufacture of the unopened container.
8 weeks from the date of opening.
§6.4 — Special precautions for storage
Do not store above 25°C.