Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, Netherlands
Axsain cream is contra-indicated for use on broken or irritated skin.
Axsain Cream is contra-indicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Not for use under tight bandages.
Keep away from the eyes.
Skin irritation has been reported following application of Axsain. 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 Axsain, 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.
If the condition worsens, seek medical advice.
Benzyl alcohol may cause allergic reactions and mild local irritation.
May cause local skin reactions (e.g. contact dermatitis).
No interaction studies have been performed.
The safety of Axsain during pregnancy or lactation has not been established in either humans or animals. However, in the small amounts absorbed transdermally from Axsain Cream, it is considered unlikely that capsaicin will cause any adverse effects in humans.
Not applicable.
Axsain 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 Axsain 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 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 HPRA Pharmacovigilance, Website: www.hpra.ie.
Not applicable.
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