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Components:
Erythromycin, Tretinoin
Method of action:
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.10.20

Qualitative and quantitative composition

Erythromycin; Tretinoin

Therapeutic indications

The information provided in Therapeutic indications of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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For the treatment of all forms of acne, both non-inflammatory forms with comedones and inflammatory forms with papules and pustules particularly those associated with a very oily skin.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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For application to the skin.

To be applied to the affected areas once or twice daily. Treatment should continue for 9-12 weeks according to the condition of the skin. It should be noted that therapeutic improvement may not be observed for several weeks after starting treatment.

Consistent application makes a significant contribution to the success of the therapy.

Excess application of Acneout should be avoided since it may result in marked erythema, drying and discomfort of the treated areas.

The dosage is the same for all ages.

The applicator allows direct administration to the skin. The patient should press the top of the screw cap on the foam pad before each use and should feel a 'click' which indicates that the applicator will close again automatically.

Contraindications

The information provided in Contraindications of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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- A family history of cutaneous epithelioma.

- In acute eczemas, rosacea and acute inflammatory conditions of the skin, especially around the mouth.

- When underlying sunburn is present

- concomitant use with other skin medications particularly those containing keratolytic agents..

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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Photosensitivity may occur during treatment with Acneout. Exposure to sunlight should be minimised and use of sun lamps or sun beds avoided during treatment. Patients with sunburn should not use this product until recovered because of the increased susceptibility to sunlight whilst using tretinoin. Wind and rain may be unusually irritating to patients under treatment.

Accumulation of the product in skin folds or in the angles of the nose should be avoided.

The product should not be allowed to come into contact with the eyes or eyelids - if this occurs, thorough rinsing with water is recommended.

As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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No effects.

Undesirable effects

The information provided in Undesirable effects of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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The following frequency categories are used for the evaluation of undesirable effects:

Very common

(>1/10)

Common

(>1/100 to <1/10)

Uncommon

(>1/1,000 to <1/100)

Rare

(>1/10,000 to <1/1,000)

Very rare

(<1/10,000)

Not known

(frequency cannot be estimated from the available data)

Skin and subcutaneous tissue disorders:

There may be rare cases of skin irritation in the form of erythema, burning, drying or peeling of the skin may be observed. In very rare cases the above symptoms may also be an expression of a hypersensitivity reaction (allergic contact eczema).There may be an apparent deterioration in acne with an increase in inflammatory symptoms at the commencement of treatment; this is a sign that the medicine is beginning to act and is usually transitory. If the above occurs, treatment should not be interrupted but the frequency of application reduced.

Rarely, a temporary hypopigmentation or hyperpigmentation has been reported in individuals treated with tretinoin. Temporary depigmentation in non-caucasians is possible.

Not known: acute generalised exanthematous pustulosis (AGEP).

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, Website: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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Acneout is for topical use only. Overdosage will not occur since the amount of erythromycin and tretinoin applied is too small to induce systemic toxicity. If the product is accidentally taken orally, unless the amount is small, gastric lavage should be performed as soon as possible.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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Erythromycin is a macrolide antibiotic with bacteriostatic action on all pathogens involved in the development of acne. When applied topically it also effects a reduction in the concentration of skin surface lipids and shows a direct anti-inflammatory effect.

The retinoid tretinoin acts topically as keratolytic agent by markedly increasing cell turnover in the cornified epithelium including the epithelium of the follicular ducts and comedones. In the first instance, skin irritation, erythema and increased vascularization occur followed by thickening and desquamation of the epithelium. The renewal time of the cornified epithelium is therefore shortened.

The alcohol base dissolves sebum.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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Percutaneous absorption or erythromycin is negligible following topical application of Acneout solution for several weeks to large areas of skin.

After topical application, up to 6% of the applied dose of tretinoin is recovered in the urine within 50-60 hours, indicating some absorption. The ratio of renal to biliary excretion is approximately 1:3, therefore the maximum likely total absorption is 24%.

Preclinical safety data

The information provided in Preclinical safety data of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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(Pregnancy and lactation).

Incompatibilities

The information provided in Incompatibilities of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acneout is based on data of another medicine with exactly the same composition as the Acneout of the medicine (Erythromycin, Tretinoin). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acneout directly from the package or from the pharmacist at the pharmacy.
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Any medicine remaining after completion of treatment should be disposed of in accordance with local requirements.

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