EUSTAMYL*EYE DROPS 25 VIALS 0.5ML 0.05%

EUSTAMYL 0.5 mg/ml eye drops, solution
ketotifen fumarate

What it is and what it is used for
EUSTAMYL contains the active ingredient ketotifen fumarate which belongs to a class of medicines with antiallergic activity.
EUSTAMYL is used for the local treatment of allergic inflammations (seasonal, atopic and others) of short and long duration of the eyes such as:
• conjunctivitis
• keratoconjunctivitis.

Consult your doctor if you do not feel better or feel worse after using the medicine.

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

Warnings and precautions
Consult your doctor or pharmacist before using EUSTAMYL.

You should only use EUSTAMYL to treat the external part of your eyes.
When applied to the eyes, EUSTAMYL may cause a slight and fleeting burning sensation.

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 side effects (may affect up to 1 in 10 people):
- eye irritation;
- eye pain;
- inflammation with painful lesions of the cornea, the transparent membrane covering the front part of the eye (punctate keratitis);
- loss or damage to the corneal surface (corneal epithelium) with small punctate erosions (punctate epithelial erosion);

Uncommon side effects (may affect up to 1 in 100 people):
- allergic reactions (hypersensitivity);
- headache;
- blurred vision during application of eye drops;
- dry eye;
- eyelid disorders;
- inflammation of the conjunctiva, i.e. the semi-transparent membrane lining the inner surface of the eyelids and the front part of the eye (conjunctivitis);
- discomfort in the eyes caused by light (photophobia);
- severe conjunctival bleeding (conjunctival hemorrhage);
- dry mouth;
- skin redness (rash);
- skin inflammation characterized by itching, redness, scaling and raised skin (eczema);
- skin disease characterized by sudden onset of skin rash and itching (urticaria);
- drowsiness.

Rare side effects (may affect up to 1 in 1000 people):
- slight burning,
- local irritation with redness (hyperemia) and inflammation of the eyelids (blepharitis).

The following side effects have been reported after marketing the medicinal product, with the following frequency:

Frequency unknown (frequency cannot be estimated from the available data):
- allergic reactions (hypersensitivity reactions) including local ones (such as contact dermatitis, characterized by redness, scaling, small blisters, bullae, small superficial wounds and crusts that appear when in contact with certain substances; swelling of the eyes; itchy eyelids and edema, fluid accumulation with swelling) and those affecting the entire body (systemic) such as swelling and fluid accumulation in the face, often associated with contact dermatitis;
- worsening of existing allergic conditions such as asthma (inflammatory disease of the respiratory tract characterized by difficulty breathing, wheezing, coughing and chest tightness) and eczema (skin inflammation characterized by itching, redness, scaling and raised skin).

If you follow the instructions provided, you reduce the risk of side effects.

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.