ZADITEN OFTABAK "0.25 MG/ML EYE DROPS SOLUTION" 5 ML MULTIDOSE BOTTLE"

Name
ZADITEN OFTABAK 0.25 mg/ml eye drops, solution
Ketotifen


What is it and what is it used for?
ZADITEN OFTABAK is a preservative-free eye drop solution containing ketotifen, which is an antiallergic substance.
ZADITEN OFTABAK is used to treat the 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 sensitivity to light. Symptoms are recurrent and are triggered by the start of pollen season. Seasonal allergic conjunctivitis may also be associated with other hay fever symptoms, such as rhinitis.
Contact your doctor if you notice no improvement (after 7 days) or if you notice worsening of symptoms (see section 2).


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


Warnings and precautions
Talk to your doctor, pharmacist or nurse before using ZADITEN OFTABAK.
Contact your doctor if you do not notice any improvement after 7 days or if you notice worsening of your symptoms.
The following signs and symptoms are uncommon in seasonal allergic conjunctivitis:
- purulent discharge,
- impaired vision,
- morning crusting, difficulty opening the eyelids in the morning,
- swollen lymph nodes near the ears,
- persistent symptoms,
- unilateral symptoms.

If you experience any of these signs or symptoms, you may have an 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 any other serious side effects, stop taking ZADITEN OFTABAK and contact your doctor or nearest hospital emergency department immediately.
The following side effects have been reported:
- Common (affects less than 1 in 10 patients)
eye irritation or pain, inflammation of the eye.
- Uncommon (affects less than 1 in 100 patients)
blurred vision,
dry eye,
eyelid disorder,
conjunctivitis (inflammation of the surface of the eye),
increased sensitivity of the eyes to light,
visible bleeding in the white of the eye,
heachache,
drowsiness,
skin rash (which may also be itchy),
eczema (itching, redness, burning of the skin rash),
dry mouth.
- Not known: frequency cannot be established based on 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 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.