Zineryt 40/12 mg Lotion

Moderate to severe forms of acne vulgaris, for which topical therapy without antibiotics has produced insufficient results or is not tolerated. In severe forms of acne, the treatment with Zineryt u00ae may be combined with, for instance, topical application of vitamin A or benzoyl peroxide or oral administration of tetracycline.

Posology: Zineryt u00ae lotion should be applied to the affected skin twice daily, usually for a period of 10 - 12 weeks. If no or insufficient improvement or even a worsening has occurred after a period of 12 weeks, the patient should consult his/her doctor.

Method of administration: Zineryt u00ae lotion should be applied liberally into the skin of the entire face or onto other affected parts (not only onto the lesion itself), until the entire area to be treated is covered (about 0,5 ml is needed each time). Zineryt u00ae lotion is applied by tilting the bottle downward and rubbing the applicator top over the skin while gently applying pressure. The rate of flow of Zineryt u00ae may be controlled by increasing the pressure against the skin.

Zineryt u00ae is contra-indicated in persons who have shown hypersensitivity to erythromycin or other macrolide antibiotics, or to zinc, di-isopropyl sebacate or ethanol.

Zineryt u00ae is for topical treatment of the skin only and should be kept away from the eyes and mucous membranes of the nose or mouth. It will cause a burning and irritating sensation in these areas. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, especially with the use of abrasive agents. Cross resistance may occur with other antibiotics of the group of macrolides and with lincomycin and clindamycin, which could result in overgrowth of antibiotic resistant organisms on the skin. Mutual cross allergy between macrolides may occur. As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. Should this occur, administration of the preparation should be discontinued and appropriate measures taken. Prolonged use of an anti-infective may result in superinfection due to microorganisms resistant to the anti-infective. If there is no response within 10 to 12 weeks alternative measures should be considered. Prolonged use is not recommended. A course should not usually exceed six months. Hypersensitivity. Zineryt u00ae contains ethanol it may cause burning sensation on damaged skin.

Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur, especially with the use of abrasive agents. Although use with other therapies such as benzoyl peroxide has shown an additive effect, the use of Zineryt u00ae with other topical treatment should only be carried out with caution in view of possible cumulative local adverse effects.

Safety in pregnancy and lactation has not been established.

Pregnancy: Human experience with oral erythromycin suggests that erythromycin can cause congenital malformations, such as cardiovascular malformations and pyloric stenosis, when administered during pregnancy. Zineryt u00ae should not be used during pregnancy.

Breastfeeding: There is no contra-indication to the use of Zineryt u00ae in lactation. It is recommended that the preparation should be used with caution in lactating women who are breast feeding, and on areas away from the chest.

Fertility: No data is available.

No information available.

Tabulated summary of adverse reactions The following frequency rating is used since there is no clinical trial data: Frequent, less frequent and frequency unknown (cannot be estimated from available data).

MedDRA System Organ Class Frequency and description Immune system disorders Less frequent: Hypersensitivity Skin and subcutaneous tissue disorders Less frequent: Pruritus, skin irritation, skin exfoliation, but they have disappeared on withdrawal of the preparation, erythema, burning sensation, dry skin Frequency not known: Acute generalised exanthematous pustulosis (AGEP)

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. For reporting of side effects directly to the HCR, contact +27 11 635 0134 or email [email protected].

It is not expected that overdosage would occur in normal use. Patients showing idiosyncratic hypersensitivity should wash the treated area with copious water and simple soap. Swallowing the entire contents of a single pack of Zineryt u00ae would mainly lead to symptoms associated with alcohol intake. Treatment is symptomatic and supportive.