AKNEMYCIN PLUS Cutaneous solution Ref.[28072] Active ingredients: Erythromycin Tretinoin

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 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.

This medicine contains 752 mg of alcohol (ethanol) in each ml. It may cause burning sensation on damaged skin.

Do not light a cigarette or expose yourself to flame until the medicine has dried completely.

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 with Aknemycin Plus.

Aknemycin Plus should not be used concomitantly with other skin medications particularly those containing keratolytic agents (see section 4.3), as this may exacerbate any skin irritation that is present.

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 into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

Pregnancy

Aknemycin Plus is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy.

If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.

Breast-feeding

It is known that orally administered retinoids and their metabolites are secreted in breast milk. As a precaution therefore, Aknemycin Plus should be avoided in women who are breast feeding.

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.