RELESTAT 0.5 MG/ML EYE DROPS 5 ML LDP BOTTLE

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


What is it and what is it used for?
Relestat is an anti-allergy medicine.
It is an eye drop solution used to treat the symptoms of seasonal allergic conjunctivitis , a seasonal allergic disorder that affects the eyes. 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 putting your lenses back in. See also section 2 "Relestat contains benzalkonium chloride";
• if you have used any other eye drops during treatment with Relestat: wait at least 10 minutes between administering Relestat and any other eye drops.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. None of these side effects are likely to be serious; most are likely to 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 disorder 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 sensation or irritation of the eye (usually mild).

Uncommon (may affect up to 1 in 100 people):

General side effects :
• heachache;
• swelling and irritation inside the nose, which may cause nasal dripping or blockage, sneezing;
• unusual taste in the mouth.

Side effects involving the eye :
• redness of the eyes;
• dry eyes;
• itchy eyes;
• difficulty seeing clearly;
• discharge from the eyes.

Not known (frequency cannot be estimated from the available data):
• increased tearing;
• eye pain;
• allergic reaction to 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 clear, outer layer of your eye (the cornea), phosphates may in very rare cases cause cloudy spots on the cornea due to calcium build-up during treatment (see section 2).

Reporting of side effects
If you experience any side effects, including any 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.