ZACIN Cream Ref.[49894] Active ingredients: Capsaicin

Skin irritation has been reported following application of Zacin. The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should be washed 30 minutes after application

Contact with eyes and mucous membranes should be avoided.

Patients should avoid taking a hot bath or shower just before or after applying Zacin, as it can enhance the burning sensation.

Patients and carers should avoid inhalation of vapours from the cream, as transient irritation of the mucous membranes of the eyes and respiratory tract (including exacerbation of asthma) has been reported.

Keep Zacin away from the eyes.

Medical advice should be sought if the condition worsens, or clears up then recurs.

Tight bandages should not be applied on top of Zacin cream.

Excipients

Benzyl alcohol may cause mild local irritation.

Cetyl alcohol May cause local skin reactions (e.g. contact dermatitis).

No interaction studies have been performed.

The safety of Zacin during pregnancy and lactation has not been established, in either humans or animals. However, in the small amounts absorbed transdermally from Zacin Cream, it is considered unlikely that capsaicin will cause any adverse effects in humans.

Not applicable.

Zacin may cause skin irritation or transient burning on application. This burning is observed more frequently when application schedules of more than 4 times daily are utilised. The burning can be enhanced if too much cream is used and if it is applied just before or after a bath or shower.

Irritation of the mucous membranes of the eyes and respiratory tract (such as nasal and throat irritation) on application of Zacin cream has been reported rarely, resulting in symptoms such as coughing, sneezing and runny eyes. These events are usually mild and self-limiting. There have been a few reports of dyspnoea, wheezing and exacerbation of asthma.

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.