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Opatanol 1 mg/mL eye drops, solution
olopatadine
What it is and what it is used for
Opatanol is indicated for the treatment of the signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain materials (allergens) such as pollen, house dust or animal dander can cause allergic reactions, causing itching, redness and even swelling of the eye surface.
Opatanol is a medicine for the treatment of allergic eye conditions. It works by reducing the intensity of the allergic reaction.
What you need to know before taking the medicine
Do not use Opatanol
• If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine (listed in section 6).
• You must not use Opatanol if you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before using Opatanol.
If you wear contact lenses, remove them before using Opatanol.
Children
Do not use Opatanol in children under 3 years of age. Do not give this medicine to children under 3 years of age as there are no data to confirm that it is safe and effective in children under 3 years of age.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed with Opatanol:
Common (may affect up to 1 in 10 people)
Effects on the eye
Eye pain, eye irritation, dry eye, abnormal sensation in the eyes, eye discomfort.
General side effects
Headache, fatigue, dry nose, bad taste.
Uncommon (may affect up to 1 in 100 people)
Effects on the eye
Blurred, reduced, or abnormal vision, corneal disorder, inflammation, with or without damage, of the eye surface, inflammation or infection of the conjunctiva, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.
General side effects
Abnormal or reduced sensitivity, dizziness, runny nose, dry skin, skin inflammation.
Not known (frequency cannot be estimated from the available data)
Effects on the eye
Eye swelling, corneal swelling, change in pupil size.
General side effects
Shortness of breath, increased allergy symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinusitis, skin redness and itching.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have developed opaque spots on the cornea due to calcium accumulation during treatment.
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.


