KETOFTIL*EYE DROPS 10ML 0.5MG/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 ophthalmic antihistamines-antiallergics.

Ketoftil is used to treat acute and chronic allergic inflammations (seasonal, atopic and others) of the eyes such as:
- conjunctivitis
- keratoconjunctivitis

Contact 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
Talk to your doctor or pharmacist before using Ketoftil.
This medicine may cause a mild 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 corneal epithelial erosion).

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

Frequency not known (frequency cannot be estimated from the available data)
- hypersensitivity reactions including local allergic reactions (mainly contact dermatitis, swelling around the eye, eyelid itching and swelling);
- systemic allergic reactions including facial swelling (facial oedema) and, in some cases, associated with contact dermatitis;
- exacerbation 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.