1. Name of the medicinal product
Acea 0.Seventy five% w/w Gel
2. Qualitative and quantitative composition
Metronidazole zero.75% w/w
For complete list of excipients see 6.1.
3. Pharmaceutical form
Gel.
Clear very faded yellow gel.
4. Clinical particulars
Four.1 Therapeutic indicators
The treatment of acute inflammatory exacerbations of rosacea.
4.2 Posology and technique of administration
For cutaneous use handiest.
(i) For adults and the aged. Apply the gel to the affected place of the skin in a skinny movie twice every day for 8 weeks. Thereafter in addition applications may be essential depending on the severity of the condition.
(ii) For Children. Not recommended.
4.3 Contraindications
Known hypersensitivity to metronidazole, parabens or any of the ingredients.
4.4 Special warnings and precautions for use
Warnings: Avoid touch with the eyes. If touch with the eyes happens the gel must be washed out carefully with water.
Precautions: The following statements take into account the opportunity that metronidazole can be absorbed after topical utility. However there may be no evidence of any vast systemic concentrations of metronidazole following topical programs. Peripheral neuropathy has been mentioned in affiliation with extended use of oral metronidazole. The removal half of-existence of metronidazole remains unchanged inside the presence of renal failure. Such sufferers, however, maintain the metabolite of metronidazole. The medical importance of this is not acknowledged at gift. However in patients present process haemodialysis, metronidazole and its metabolites are successfully removed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and ethyl parahydroxybenzoate (E214), may also motive allergic reactions (probably not on time).
4.5 Interaction with other medicinal products and different forms of interaction
Patients are recommended not to take alcohol in the course of systemic metronidazole remedy due to the opportunity of a disulfiram-like reaction.
Some potentiation of anti-coagulant remedy has been stated while metronidazole has been used with the warfarin kind oral anticoagulants.
Patients receiving phenobarbitone metabolise metronidazole at a much quicker fee than everyday, reducing the 1/2-existence to three hours.
4.6 Pregnancy and lactation
The safety of topically carried out metronidazole in pregnancy and lactation has now not been effectively installed and must now not be used in those situations unless the health practitioner considers it essential.
Four.7 Effects on ability to pressure and use machines
No negative results at the potential to force or use machines has been stated following the topical utility of metronidazole.
4.8 Undesirable consequences
Dryness or irritation of the pores and skin may be skilled after application to unbroken skin. Systemic metronidazole therapy may additionally every so often motive an ugly 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, however hardly ever.
Reporting of suspected unfavorable reactions
Reporting suspected damaging reactions after authorisation of the medicinal product is vital. It allows persisted tracking of the benefit/threat stability of the medicinal product. Healthcare specialists are requested to report any suspected destructive reactions through the Yellow Card Scheme: Website: www.Mhra.Gov.United kingdom/yellowcard or look for MHRA Yellow Card in the Google Play or Apple App Store.
Four.Nine Overdose
Overdose is unlikely. If important dispose of the medication via washing with heat water. If unintentional ingestion happens, an appropriate method of gastric emptying may be used if taken into consideration appropriate.
5. Pharmacological properties
Five.1 Pharmacodynamic homes
ATC Code: D06BX01
Metronidazole is a 5-nitroimidazole spinoff with hobby in opposition to anaerobic protozoa and anaerobic micro organism. It also has a radiosensitising effect of hypoxic tumour cells. Its mechanism of action is idea to involve interference with DNA by a metabolite in which the nitro organization of metronidazole has been reduced. The mode of action of topical metronidazole within the treatment of rosacea is not recognized.
5.2 Pharmacokinetic properties
No bioavailability studies had been completed with this method.
Five.3 Preclinical protection records
There are not any preclinical data of relevance to the prescriber, that have additional to the ones already covered in other sections of the SmPC.
6. Pharmaceutical particulars
6.1 List of excipients
Glycerol
Hydroxyethylcellulose
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Ethyl parahydroxybenzoate (E214)
Disodium edetate
Sodium hydroxide
Potassium dihydrogen phosphate
Purified water
6.2 Incompatibilities
Not relevant.
6.3 Shelf life
36 months from the date of manufacture of the unopened box.
8 weeks from the date of establishing.
6.4 Special precautions for garage
Do no longer shop above 25°C.
6.5 Nature and contents of box
Aluminium tube with a polypropylene screw cap.
The percent sizes are five g, 25 g and forty g. Not all p.C. Sizes can be advertised.
6.6 Special precautions for disposal and different managing
Not relevant.
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Labels :
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Acea 0.Seventy five% w/w Gel
2. Qualitative and quantitative composition
Metronidazole zero.75% w/w
For complete list of excipients see 6.1.
3. Pharmaceutical form
Gel.
Clear very faded yellow gel.
4. Clinical particulars
Four.1 Therapeutic indicators
The treatment of acute inflammatory exacerbations of rosacea.
4.2 Posology and technique of administration
For cutaneous use handiest.
(i) For adults and the aged. Apply the gel to the affected place of the skin in a skinny movie twice every day for 8 weeks. Thereafter in addition applications may be essential depending on the severity of the condition.
(ii) For Children. Not recommended.
4.3 Contraindications
Known hypersensitivity to metronidazole, parabens or any of the ingredients.
4.4 Special warnings and precautions for use
Warnings: Avoid touch with the eyes. If touch with the eyes happens the gel must be washed out carefully with water.
Precautions: The following statements take into account the opportunity that metronidazole can be absorbed after topical utility. However there may be no evidence of any vast systemic concentrations of metronidazole following topical programs. Peripheral neuropathy has been mentioned in affiliation with extended use of oral metronidazole. The removal half of-existence of metronidazole remains unchanged inside the presence of renal failure. Such sufferers, however, maintain the metabolite of metronidazole. The medical importance of this is not acknowledged at gift. However in patients present process haemodialysis, metronidazole and its metabolites are successfully removed.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and ethyl parahydroxybenzoate (E214), may also motive allergic reactions (probably not on time).
4.5 Interaction with other medicinal products and different forms of interaction
Patients are recommended not to take alcohol in the course of systemic metronidazole remedy due to the opportunity of a disulfiram-like reaction.
Some potentiation of anti-coagulant remedy has been stated while metronidazole has been used with the warfarin kind oral anticoagulants.
Patients receiving phenobarbitone metabolise metronidazole at a much quicker fee than everyday, reducing the 1/2-existence to three hours.
4.6 Pregnancy and lactation
The safety of topically carried out metronidazole in pregnancy and lactation has now not been effectively installed and must now not be used in those situations unless the health practitioner considers it essential.
Four.7 Effects on ability to pressure and use machines
No negative results at the potential to force or use machines has been stated following the topical utility of metronidazole.
4.8 Undesirable consequences
Dryness or irritation of the pores and skin may be skilled after application to unbroken skin. Systemic metronidazole therapy may additionally every so often motive an ugly 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, however hardly ever.
Reporting of suspected unfavorable reactions
Reporting suspected damaging reactions after authorisation of the medicinal product is vital. It allows persisted tracking of the benefit/threat stability of the medicinal product. Healthcare specialists are requested to report any suspected destructive reactions through the Yellow Card Scheme: Website: www.Mhra.Gov.United kingdom/yellowcard or look for MHRA Yellow Card in the Google Play or Apple App Store.
Four.Nine Overdose
Overdose is unlikely. If important dispose of the medication via washing with heat water. If unintentional ingestion happens, an appropriate method of gastric emptying may be used if taken into consideration appropriate.
5. Pharmacological properties
Five.1 Pharmacodynamic homes
ATC Code: D06BX01
Metronidazole is a 5-nitroimidazole spinoff with hobby in opposition to anaerobic protozoa and anaerobic micro organism. It also has a radiosensitising effect of hypoxic tumour cells. Its mechanism of action is idea to involve interference with DNA by a metabolite in which the nitro organization of metronidazole has been reduced. The mode of action of topical metronidazole within the treatment of rosacea is not recognized.
5.2 Pharmacokinetic properties
No bioavailability studies had been completed with this method.
Five.3 Preclinical protection records
There are not any preclinical data of relevance to the prescriber, that have additional to the ones already covered in other sections of the SmPC.
6. Pharmaceutical particulars
6.1 List of excipients
Glycerol
Hydroxyethylcellulose
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Ethyl parahydroxybenzoate (E214)
Disodium edetate
Sodium hydroxide
Potassium dihydrogen phosphate
Purified water
6.2 Incompatibilities
Not relevant.
6.3 Shelf life
36 months from the date of manufacture of the unopened box.
8 weeks from the date of establishing.
6.4 Special precautions for garage
Do no longer shop above 25°C.
6.5 Nature and contents of box
Aluminium tube with a polypropylene screw cap.
The percent sizes are five g, 25 g and forty g. Not all p.C. Sizes can be advertised.
6.6 Special precautions for disposal and different managing
Not relevant.
-------------------------------------------------------------------------------------
Labels :
new lds area seventies 2018 . s mark paler area seventy . area seventy Robert Gordon . area seventy excommunicated . area seventy leaves church . area seventy presidency . area seventies Arizona . area seventy 2018 . area seventy called . era seventies California . area seventies lds . seventy three north face . seventy cat face dress . seventy numinous double face . area seventies . area seventies released October 2018 . area seventies called 2018 . area seventies Europe . new area seventies 2019 . new area seventies . new area seventies 2017 .
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