ALLERGODIL*NASAL SPRAY 6ML 0.05%

ALLERGODIL 0.5 mg/ml eye drops, solution
Azelastine hydrochloride

What it is and what it is used for
Allergodil contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergics (antihistamines). Antihistamines work by preventing the effects of substances such as histamine, which the body produces in response to an allergic reaction. Allergodil has been shown to reduce eye inflammation.

Allergodil can be used for the treatment and prevention of eye conditions caused by hay fever (seasonal allergic conjunctivitis), in adults and children aged 4 years and older.

Allergodil can be used for eye conditions caused by an allergy to substances such as dust mites or animal dander (perennial allergic conjunctivitis), in adults and children aged 12 years and older.

Consult your doctor if you do not feel better or if you feel worse after 2 days.

Allergodil is not indicated for the treatment of eye infections.

What you need to know before taking the medicine
Do not use Allergodil:
• if you are allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Allergodil
- if you are not sure that your eye problems are caused by an allergy. In particular, if only one eye is affected; if your vision is impaired; or if your eye burns but you have no nasal symptoms, you may have an infection rather than an allergy;
- if your symptoms worsen or last for more than 48 hours without noticeable improvement despite using Allergodil;
- if you wear contact lenses.

Children and adolescents
For the treatment of eye conditions caused by hay fever (seasonal allergic conjunctivitis): do not administer this medicine to children under 4 years of age, as its safety and efficacy have not been demonstrated.

For the treatment of eye conditions caused by an allergy (non-seasonal (perennial) allergic conjunctivitis): do not administer this medicine to children under 12 years of age, as its safety and efficacy have not been demonstrated.

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

These effects include:
• Common (may affect up to 1 in 10 people): slight irritation (burning, itching, tearing) in the eyes after applying Allergodil. It should not last long.
• Uncommon (may affect up to 1 in 100 people): bitter taste in the mouth. It should disappear quickly, especially if you sip a non-alcoholic drink.
• Very rare (may affect up to 1 in 10,000 people): allergic reaction (such as rash and itching).

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.