KETOFTIL*EYEDROPS25VIALS0.5ML0.5MG/ML

Ketoftil 0.5 mg/ml eye drops, solution
Ketotifen

What it is and what it is used for
Ketoftil contains the active ingredient ketotifen and belongs to a group of medicines called antihistamine-antiallergic ophthalmic drugs.
Ketoftil is used to treat acute and chronic allergic inflammations (seasonal, atopic, and other) of the eyes such as:
- conjunctivitis;
- keratoconjunctivitis.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use Ketoftil
- if you are allergic to ketotifen or any of the other ingredients of this medicine (listed in section 6);
- if you are pregnant (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Consult your doctor or pharmacist before using Ketoftil.
This medicine may cause a slight and temporary burning sensation upon application.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

Common (may affect up to 1 in 10 people)
- eye pain and/or irritation;
- inflammation of the cornea (punctate keratitis);
- damage to the corneal epithelium (punctate erosion of the corneal epithelium).

Uncommon (may affect up to 1 in 100 people)
- allergy (hypersensitivity);
- headache;
- blurred vision (especially during application of the eye drops), dry eye, eyelid disorders, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival hemorrhage;
- dry mouth;
- skin rash, eczema, urticaria;
- drowsiness.

Not known (frequency cannot be estimated from the available data)
- hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling of the area around the eye, itchy eyelid and swelling);
- systemic allergic reactions including facial swelling (facial edema) and, in some cases, associated with contact dermatitis;
- exacerbations of pre-existing allergic conditions such as asthma and eczema.

Reporting of side effects
If you get 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.