KETOFTIL "0.05% OPHTHALMIC GEL" 10 G TUBE"

Name
Ketoftil 0.5 mg/g ophthalmic gel
Ketotifen


What is it and what is it for?
Ketoftil contains the active substance ketotifen and belongs to a group of medicines called antihistamines and antiallergics for ocular use.

Ketoftil is used to treat acute and chronic inflammation of the eyes of an allergic nature (spring, atopic and others) such as:
- conjunctivitis
- keratoconjunctivitis

Talk to your doctor if you do not feel better or if you feel worse after a short time 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.
After application, Ketoftil may cause slight blurring of vision for a few minutes. If this occurs, do not drive or operate machinery (see "Driving and using machines").
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)
- pain and/or irritation of the eye;
- inflammation of the cornea (punctate keratitis);
- damage to the corneal epithelium (punctuate erosion of the corneal epithelium).

Uncommon (may affect up to 1 in 100 people)
- allergy (hypersensitivity);
- heachache;
- blurred vision (especially during application of the gel), dry eye, eyelid discomfort, conjunctivitis, excessive sensitivity to light (photophobia), conjunctival haemorrhage;
- dry mouth;
- skin rash, eczema, hives;
- drowsiness.

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

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.