Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Perforation of the ear drum or inflammation of the ear.
If pain or inflammation is experienced, treatment should be discontinued.
None known.
There is no evidence to suggest that Waxsol Ear Drops should not be used during pregnancy and lactation.
None known.
Immune system disorders: Hypersensitivity/allergic reactions.
Skin disorders: Contact dermatitis and allergic skin reactions.
General disorders: Application site reactions rarely including transient stinging or irritation may occur. Injuries or inflammation in the auditory canal may result in painful symptoms.
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.
None known.
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