AKNEMYCIN PLUS Cutaneous solution (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Aknemycin Plus 4.0% w/w and 0.025% w/w cutaneous solution.

2. Qualitative and quantitative composition

Each gram of cutaneous solution contains 40 mg of erythromycin and 0.25 mg of tretinoin. Excipients with known effect: 1 ml of solution contains 752 mg of alcohol (ethanol). For the full list of ...

3. Pharmaceutical form

Cutaneous solution. Aknemycin Plus is a clear solution for topical administration.

4.1. Therapeutic indications

Aknemycin Plus is indicated 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 ...

4.2. Posology and method of administration

Posology 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 ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. A family history of cutaneous epithelioma. In acute eczemas, rosacea and acute inflammatory conditions of the ...

4.4. Special warnings and precautions for use

Photosensitivity may occur during treatment with Aknemycin Plus. Exposure to sunlight should be minimised and use of sun lamps or sun beds avoided during treatment. Patients with sunburn should not use ...

4.5. Interaction with other medicinal products and other forms of interaction

Skin irritation may be enhanced by UV rays (natural sunlight, sun lamps, sun beds), X-rays or by bathing in chlorinated or salt water. Any sunburn should be allowed to heal before the start of treatment ...

4.6. Pregnancy and lactation

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result ...

4.7. Effects on ability to drive and use machines

Aknemycin Plus has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

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 ...

4.9. Overdose

Aknemycin Plus 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, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antiinfectives for treatment of acne, erythromycin in combination with tretinoin ATC code: D10AF52 Erythromycin is a macrolide antibiotic with bacteriostatic action ...

5.2. Pharmacokinetic properties

Percutaneous absorption or erythromycin is negligible following topical application of Aknemycin Plus solution for several weeks to large areas of skin. After topical application, up to 6% of the applied ...

5.3. Preclinical safety data

High oral doses of tretinoin are teratogenic in animals and there is evidence of embryotoxicity from studies where tretinoin is applied dermally. Aknemycin Plus should not therefore be used in pregnancy ...

6.1. List of excipients

Ethanol Glycerol Copolyvidone

6.2. Incompatibilities

None known.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store below 30°C. Keep bottle in outer carton to protect from direct sunlight.

6.5. Nature and contents of container

Amber glass bottle, with white screw cap, containing 25ml Aknemycin Plus. The bottle has a polyethylene stopper which holds a foam pad with a nylon gauze covering. Pack sizes 25ml, 50ml (2 25ml).

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Aknemycin is an alcohol-based product and is flammable.

7. Marketing authorization holder

Almirall Hermal GmbH, Scholtzstrasse 3, D-21465, Reinbek, Germany

8. Marketing authorization number(s)

PL 33016/0007

9. Date of first authorization / renewal of the authorization

31 July 1998

10. Date of revision of the text

13 May 2020

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