Emadine

emedastine

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Emadine?

Emadine is a clear eye drop solution. It contains the active substance emedastine (0.5 mg/ml). Emadine is available in a bottle and in single-dose containers.

What is Emadine used for?

Emadine is used to treat the symptoms of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hayfever). These symptoms include itching, redness and swelling.

Emadine is used in adults and children aged three years and older.

The medicine can only be obtained with a prescription.

How is Emadine used?

Emadine is given as one drop in the affected eye(s) twice a day. Its effects have not been studied beyond six weeks. If more than one type of eye drop is being used, each one should be given at least 10 minutes apart.

Emadine is not recommended for patients older than 65 years or in patients who have problems with their liver or kidneys.

How does Emadine work?

The active substance in Emadine, emedastine, is an antihistamine. It works by blocking the receptors that histamine normally attaches to. Histamine is a substance in the body that causes allergic symptoms. When the receptors are blocked, histamine cannot have its effect, which leads to a decrease in the symptoms of allergy.

How has Emadine been studied?

Emadine has been compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis aged four years and over. The main measure of effectiveness was the reduction in itching and redness, measured on a nine-point scale over up to six weeks.

The company also presented the results of studies in which patients received Emadine, levocabastine or placebo (a dummy treatment) before being subjected to an 'allergen challenge'. This is a test where patients with an allergy who are not currently showing any allergic symptoms receive a defined dose of an allergen (the substance that they are allergic to) to trigger an allergic reaction.

What benefit has Emadine shown during the studies?

Emadine was as effective as levocabastine in reducing symptoms of seasonal conjunctivitis. In both groups of patients, itching scores fell from around 5.1 at the start of the study, to around 3.8 after five minutes and around 2.7 after two hours. Similar reductions in redness scores were seen, falling from 4.5 to 3.7 after five minutes and 2.7 after two hours. In the long term, the itching scores fell from an average of around 3.9 on the first day, falling to 0.8 for Emadine and 2.0 for levocabastine after six weeks. For redness, the scores fell from around 2.7 to 0.5 for Emadine and to 1.1 for levocabastine.

Similar results were seen in adults and in children.

The results of the allergen challenge tests supported these results.

What is the risk associated with Emadine?

The most common side effects with Emadine (seen in between 1 and 10 patients in 100) are headache, eye pain, eye irritation, blurred vision, eye pruritus (itchy eye), dry eye, staining of the cornea (the transparent layer in front of the pupil) and conjunctival hyperaemia (increased blood flow to the eye, leading to redness). For the full list of all side effects reported with Emadine, see the Package Leaflet.

Emadine should not be used in people who may be hypersensitive (allergic) to emedastine or any of the other ingredients. The bottle form of Emadine contains benzalkonium chloride, which is known to discolour soft contact lenses. Therefore, care should be taken by people who wear soft contact lenses.

Why has Emadine been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Emadine’s benefits are greater than its risks for the symptomatic treatment of seasonal allergic conjunctivitis. The Committee recommended that Emadine be given marketing authorisation.

Other information about Emadine:

The European Commission granted a marketing authorisation valid throughout the European Union for Emadine to Alcon Laboratories (UK) Ltd. on 27 January 1999. The marketing authorisation was renewed on 27 January 2004 and on 27 January 2009.

This EPAR was last updated on 08/12/2010 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

30/11/2010  Emadine -EMEA/H/C/000223 -N/0027

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Symptomatic treatment of seasonal allergic conjunctivitis.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents