Emadine - emedastine

What is Emadine?

Emadine is a clear solution to use as eye drops, containing the active ingredient emedastine (0.5 mg / ml). Emadine is available in a bottle and in single-dose containers.

What is Emadine used for?

Emadine is indicated in the treatment of seasonal allergic conjunctivitis (inflammation of the eyes caused by pollen in patients with hay fever), including itching, redness and swelling. Emadine is used in adults and children over the age of three years. The medicine can only be obtained with a prescription.

How is Emadine used?

The dose is one drop in the eye or in the affected eyes twice a day. Its effects have not been studied beyond six weeks. If more than one type of drop is used, each of them should be administered at least ten minutes after the previous one.

Emadine is not recommended in patients over the age of 65 or in patients with kidney or liver disorders.

How does Emadine work?

The active substance in Emadine, emedastine, is an antihistamine. Emedastine works by blocking the receptors on which histamine, a substance present in the body that causes allergic symptoms, is usually fixed. Once the receptors are blocked, histamine cannot produce its effects and a decrease in allergy symptoms is observed.

What studies have been carried out on Emadine?

Ematine was compared with levocabastine (another antihistamine) in one main study involving 222 patients with seasonal conjunctivitis and aged 4 years or older. The main measure of effectiveness was the reduction of itching and redness, measured on a nine-point scale over a maximum of six weeks. The manufacturer also presented the results of studies involving the administration of Emadine, levocabastine or placebo (a dummy treatment) before subjecting patients to an "allergenic provocation test". The provocation test is an exam in which allergic patients, in the absence of allergy symptoms, receive a certain dose of allergen (the substance to which they are allergic) to trigger the allergic reaction.

What benefit has Emadine shown during the studies?

Emadine was as effective as levocabastine in reducing the symptoms of seasonal conjunctivitis. In both groups of patients the score related to pruritus decreased from about 5.1 points measured at the start of the study to about 3.8 after five minutes from the administration up to about 2.7 after two hours. Similar reductions were observed in the redness score, with decreases from 4.5 to 3.7 after five minutes and 2.7 after two hours. In the long term the score decreased on average by around 3.9 points on the first day, falling to 0.8 in patients treated with Emadine and 2.0 in the group treated with levocabastine after six weeks of treatment. For redness, the score went from around 2.7 to 0.5 in the Emadine group and to 1.1 in the levocabastine group. Similar results have been observed in adults and children.

The results of allergen provocation tests confirm these observations.

What is the risk associated with Emadine?

The most frequent side effects with Emadine (seen in 1-10 patients in 100) are headache, eye pain, eye irritation, blurred vision, itching (pruritic eye), dry eye, corneal staining (the transparent layer in front of the pupil) and conjunctival hyperemia (inflow of blood in the eye that leads 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 ingredients. Emadine in a bottle contains benzalkonium chloride, which can make soft contact lenses opaque. Therefore, people who wear soft contact lenses should pay particular attention.

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 and therefore recommended that it be given marketing authorization.