RELESTAT*EYE DROPS SOL 5ML 0.5MG/ML

Relestat, 0.5 mg/ml, eye drops, solution
Epinastine hydrochloride

What it is and what it is used for
Relestat is an antiallergic medicine.
It is an eye drop solution used for the treatment of symptoms of seasonal allergic conjunctivitis, a seasonal allergic condition affecting the eye. The main symptoms treated by Relestat include watery eyes and itching, redness, and swelling of the eyes or eyelids.

What you need to know before taking the medicine
Do not use Relestat:
• If you are allergic to epinastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Relestat.
• If you wear soft contact lenses: you must remove them before using Relestat eye drops.
After using Relestat, wait at least 15 minutes before reinserting your lenses. Also see "Relestat contains benzalkonium chloride" in section 2.
• If you have used any other eye drops during treatment with Relestat: wait at least 10 minutes between administering Relestat and other eye drops.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Probably none of these side effects will be serious; most of them will likely be mild and only affect the eye.

If you experience any of the following side effects, stop using Relestat and contact your doctor immediately or go to the nearest hospital:
• asthma (an allergic condition involving the lungs that causes breathing difficulties)
• symptoms of angioedema (swelling of the face, tongue, or throat; difficulty swallowing; itching and difficulty breathing)

The following side effects may occur:

Common (may affect up to 1 in 10 people)
• burning or stinging sensation in the eye (usually mild)

Uncommon (may affect up to 1 in 100 people)

General side effects:
• headache
• swelling and irritation inside the nose, which may cause runny or blocked nose, sneezing
• unusual taste in the mouth

Side effects involving the eye:
• eye redness
• dry eyes
• eye itching
• difficulty seeing clearly
• eye discharge

Not known (frequency cannot be estimated from the available data)
• increased lacrimation
• eye pain
• allergic reaction in the eyes
• eye swelling
• eyelid swelling
• skin rashes and redness

Other side effects reported with the use of eye drops containing phosphates
This medicine contains 23.75 mg of phosphates per 5ml, equivalent to 4.75 mg/ml.

If you have severe damage to the outermost clear layer of the eye (the cornea), phosphates can very rarely cause cloudy patches on the cornea due to calcium build-up during treatment (see section 4).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.