Allergodil

Leaflet accompanying the packaging: patient information

ALLERGODIL, eye drops, solution, 0.5 mg/ml
Azelastine hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 2 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Allergodil, eye drops and what is it used for
• 2. Important information before using Allergodil, eye drops
• 3. How to use Allergodil, eye drops
• 4. Possible side effects
• 5. How to store Allergodil, eye drops
• 6. Contents of the pack and other information

1. What is Allergodil, eye drops and what is it used for

Allergodil, eye drops belongs to a group of medicines called antihistamines. Antihistamines work by preventing the action of histamine, which is produced by the body as a result of an allergic reaction.

Indications for use of Allergodil, eye drops are:

• ●treatment and prevention of symptoms of allergic seasonal conjunctivitis in adults and children over 4 years of age;
• ●treatment of symptoms of perennial allergic conjunctivitis in adults and children over 12 years of age.

Allergodil, eye drops is used to relieve redness, itching, and tearing of the eyes, occurring with hay fever or as a result of allergic reactions to factors such as dust mites and animal dander.

2. Important information before using Allergodil, eye drops

When not to use Allergodil, eye drops

If the patient is allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Allergodil, eye drops, the patient should discuss it with their doctor or pharmacist.

• if there is uncertainty whether the symptoms are caused by an allergy, especially when the symptoms affect only one eye, or are accompanied by vision disturbances or eye pain without nasal symptoms
• if the symptoms worsen or do not improve within 48 hours despite using Allergodil, eye drops.

Allergodil, eye drops is not indicated for the treatment of eye infections.

Children

Seasonal allergic conjunctivitis:
Allergodil, eye drops should not be used in children under 4 years of age.
Perennial (year-round) allergic conjunctivitis:
Allergodil, eye drops should not be used in children under 12 years of age.

Allergodil, eye drops and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Mild, transient eye irritation may occur after using the eye drops. Allergodil, eye drops is not expected to affect vision. However, patients experiencing any transient vision disturbances should not drive, operate machinery, or work without proper protection until the symptoms have resolved.

3. How to use Allergodil, eye drops

This medicine should always be used exactly as directed by the doctor or pharmacist.

Method of administration

• Gently wipe the skin around the eyes with a cloth, removing excess moisture (see diagram 1). Remove the cap from the dropper bottle.
• Lean the head back slightly, gently pull down the lower eyelid (see diagram 2), and carefully instill 1 drop into the conjunctival sac (see diagram 3).
• Be careful not to touch the tip of the dropper to the eye.
• Release the lower eyelid and gently press the inner corner of the eye towards the nose (see diagram 4). Slowly blink several times to distribute the drop over the surface of the eyeball.
• Remove any excess medicine.
• To administer the medicine to the other eye, follow the same steps as above.

The patient should continue using Allergodil, eye drops after the symptoms have resolved, as long as they are exposed to allergens (e.g., pollen, dust).

Duration of treatment

In the case of perennial (year-round) allergic conjunctivitis, the duration of treatment with Allergodil, eye drops should be limited to a maximum of 6 weeks, as the safety and tolerability of the medicine were only studied for this period.

Use of a higher than recommended dose of Allergodil, eye drops

After using the eye drops, no specific overdose reactions are known and are not expected with this route of administration.

Missed dose of Allergodil, eye drops

If a dose of Allergodil, eye drops is missed, there is no need for special actions. The patient should continue treatment as planned.

Discontinuation of Allergodil, eye drops

Whenever possible, the patient should use Allergodil, eye drops regularly until the symptoms have resolved.

4. Possible side effects

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

Adverse reactions

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.

5. How to store Allergodil, eye drops

Keep out of sight and reach of children.

Shelf life after opening the bottle

Do not use Allergodil, eye drops for more than 4 weeks after first opening the bottle.

6. Contents of the pack and other information

What Allergodil, eye drops contains

The active substance is azelastine hydrochloride. 1 ml of solution contains 0.5 mg of azelastine hydrochloride.

What Allergodil, eye drops looks like and contents of the pack

Allergodil, eye drops is a clear, colorless solution.

Marketing authorisation holder:

Cooper Consumer Health B.V.

Manufacturer:

Tubilux Pharma S.p.A.