ZADITEN OFTABAK*EYE DROPS FL5ML

ZADITEN OFTABAK 0.25 mg/ml eye drops, solution
Ketotifen

What it is and what it is used for
ZADITEN OFTABAK is a preservative-free eye drop solution containing ketotifen, which is an anti-allergic substance.
ZADITEN OFTABAK is used for the treatment of symptoms of seasonal allergic conjunctivitis.
The most common symptoms of seasonal allergic conjunctivitis are intense itching of both eyes associated with redness, swelling, excessive tearing, chemosis, and light sensitivity. Symptoms are recurrent and triggered by the start of the pollen season. Seasonal allergic conjunctivitis can also be associated with other hay fever symptoms such as rhinitis.
Consult your doctor if you do not notice improvements (after 7 days) or if you notice a worsening of symptoms (see paragraph 2).

What you need to know before taking the medicine
Do not use ZADITEN OFTABAK:
If you are allergic (hypersensitive) to ketotifen (the active ingredient), or to any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Consult your doctor, pharmacist, or nurse before using ZADITEN OFTABAK.
Consult your doctor if you do not notice improvements after 7 days or if you notice a worsening of symptoms.
The following signs and symptoms are not common in seasonal allergic conjunctivitis:
- purulent discharge,
- vision impairment,
- morning crusting, difficulty opening eyelids in the morning,
- enlarged lymph nodes near the ears,
- persistent symptoms,
- unilateral symptoms.

If you experience any of these signs or symptoms, you may be suffering from another eye condition other than seasonal allergic conjunctivitis.
You should consult a doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience allergic reactions, including skin rash, swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing, or if you experience other serious side effects, stop taking ZADITEN OFTABAK and contact your doctor or the nearest hospital emergency room immediately.
The following side effects have been reported:
- Common (affecting less than 1 in 10 patients)
eye irritation or pain, eye inflammation.
- Uncommon (affecting less than 1 in 100 patients)
blurred vision,
dry eye,
eyelid disorder,
conjunctivitis (inflammation of the eye surface),
increased eye sensitivity to light,
visible bleeding in the white of the eye,
headache,
drowsiness,
skin rash (which may also be itchy),
eczema (itchy, red, burning skin rash),
dry mouth.
- Not known: frequency cannot be estimated from the available data
allergic reactions (including swelling of the face and eyelids) and increased severity of existing allergic conditions, such as asthma and eczema,
dizziness.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, tell 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.