Galantamine

Safety advisory - serious skin reactions

8 December 2014

Consumers and health professionals are advised that Janssen-Cilag, in consultation with the TGA, has updated the Product Information (PI) for galantamine (marketed under the brand name Reminyl, as well as a number of generic brands).

Galantamine is used to treat mild to moderately severe dementia of the Alzheimer type.

The PI update has added a new precaution for serious skin reactions, including Stevens-Johnson syndrome and acute generalised exanthematous pustulosis. Such reactions have been reported in patients receiving galantamine.

Stevens-Johnson syndrome and acute generalised exanthematous pustulosis have also been added to the adverse effects section of the PI as very rare adverse events associated with galantamine treatment.

Information for consumers

Janssen-Cilag has written to health professionals to provide further information about the above issue.

Serious skin reactions associated with galantamine treatment are very rare.

If you, or someone you care for, have been prescribed galantamine, do not stop taking it in the absence of symptoms of serious skin reactions.

However, stop using galantamine at the first sign of skin rash or ulcers and other lesions in the mucous membranes, such as nostrils, lips and eye lids, and seek medical attention.

If you have any questions or concerns about this issue, speak to your health professional.

Information for health professionals

Janssen-Cilag has written to health professionals to provide further information about the above issue. The updated PI is available on the TGA website.

If you are treating patients with galantamine, advise them of this new information, but reassure them that these problems are very rare.

Educate patients and their carers about the signs of serious skin reactions, including Stevens-Johnson syndrome and acute generalised exanthematous pustulosis. Instruct them to discontinue treatment with galantamine at the first sign of skin rash or ulcers and other lesions in the mucous membranes, and then seek medical attention.

If you have any questions or concerns about this issue, phone Jenssen-Cilag on 1800 226 334 or email at medinfo@janau.jnj.com.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.