Azelastin comod

1.3.1 SPC, labelling and package leaflet
Azelastin COMOD,
0.5 mg/ml, eye drops, solution
Azelastini hydrochloridum
Read the entire package leaflet carefully before use, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as advised by the doctor or pharmacist. Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 2 days of treatment, or if symptoms worsen, consult your doctor.

Contents of the package leaflet:

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

1. What Azelastin COMOD is and what it is used for

Azelastin COMOD contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antiallergic agents (antihistamines). Antihistamines work by blocking the action of substances such as histamine, which the body releases during an allergic reaction. Azelastine has been shown to reduce eye inflammation.

Azelastin COMOD may be used for the treatment and prevention of eye symptoms caused by seasonal allergic conjunctivitis (allergic rhinoconjunctivitis) in adults and children aged 4 years and older.

Azelastin COMOD may also be used for the treatment of eye symptoms caused by allergies to substances such as house dust mites or animal dander (perennial allergic conjunctivitis) in adults and children aged 12 years and older.
Azelastin COMOD is not suitable for the treatment of eye infections.
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1.3.1 SPC, labelling and package leaflet

2. Important information before using Azelastin COMOD

When not to use Azelastin COMOD:

• if the patient has a known hypersensitivity to azelastine hydrochloride or any of the other ingredients of Azelastin COMOD (see section 6 "What does Azelastin COMOD contain").

Warnings and precautions
Before starting treatment with Azelastin COMOD, discuss the following with your doctor or pharmacist:

• if the patient is unsure whether the eye symptoms are caused by allergy. In particular, if symptoms affect only one eye, if there is visual impairment or eye pain, and the patient does not have nasal symptoms, this is more likely to be an eye infection rather than allergy.
• if symptoms worsen or persist for more than 48 hours without noticeable improvement, despite using Azelastin COMOD.
• if the patient wears contact lenses.

Children and adolescents
For the treatment of eye disorders caused by hay fever (seasonal allergic conjunctivitis):
The medicine should not be used in children under 4 years of age, as safety and efficacy have not been established.
For the treatment of eye disorders caused by non-seasonal (perennial) allergic conjunctivitis:
The medicine should not be used in children under 12 years of age, as safety and efficacy have not been established.

Azelastin COMOD and other medicines
No cases of interactions with other medicines have been reported. Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Transient blurred vision may occur after using Azelastin COMOD. In such a case, wait until symptoms resolve before driving or operating machinery.

3. How to use Azelastin COMOD

This medicine should always be used as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Remember:
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1.3.1 SPC, labelling and package leaflet

• Azelastin COMOD is for ophthalmic use only.

The usual dose, unless otherwise advised by your doctor:
Eye disorders due to allergic rhinitis (seasonal allergic conjunctivitis)

• In adults and children aged 4 years and older
• usually 1 drop into each eye twice daily (morning and evening).

Prior to anticipated allergen exposure, the dose of Azelastin COMOD should be used prophylactically before leaving the house.
Allergic eye disorders (perennial/non-seasonal conjunctivitis)

• In adults and children aged 12 years and older
• usually 1 drop into each eye twice daily (morning and evening).

In cases of severe symptoms, your doctor may increase the dose to 1 drop into each eye, up to four times daily.
Allergic eye symptoms should improve within 15–30 minutes.
Instructions for administration

Wash your hands.
Gently dry the edge of the lower eyelid with a clean, single-use tissue.
Fig. 1:
Before each use, remove the cap from the dispenser.
Before first use of Azelastin COMOD, point the dropper bottle vertically downwards and press the base of the bottle several times until the first drop appears. After completing this step, the bottle is ready for instillation.
Fig. 2:

Holding the bottle with the dropper pointing downwards, place your thumb on the top of the bottle and the remaining fingers on its base.
Fig. 3:

Rest the hand holding the Azelastin COMOD bottle on the other hand, as shown in the illustration.
Fig. 4:

Tilt your head slightly backwards and, with the free hand, gently pull down the lower eyelid. Then press quickly and firmly on the center of the bottle base. This activates the single-drop delivery mechanism. Thanks to the special valve technology of the COMOD® system, the drop size and delivery speed will be consistent each time, regardless of the pressure applied to the base. After instillation, close the eyelids slowly to allow even distribution of the solution across the eye.
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1.3.1 SPC, labelling and package leaflet

	ocular surface.
	Fig. 5: Then release the eyelid, and gently press the inner corner of the eye near the nose (Fig. 5). Perform several gentle blinks to evenly distribute the medication over the surface of the eye.
	Fig. 6: After each use, immediately close the bottle carefully with the cap. Ensure that the dropper tip remains dry.

Duration of treatment
Azelastin COMOD should be used regularly, if possible, until symptoms have resolved.
Do not use Azelastin COMOD for longer than 6 weeks.

Use of more than the recommended dose of Azelastin COMOD
If too much Azelastin COMOD has been instilled into the eyes, no problems should occur.
If you are concerned, contact your doctor.
In case of accidental ingestion of Azelastin COMOD, seek immediate medical advice from your doctor or the nearest hospital emergency department.

Missed dose of Azelastin COMOD
Instill the eye drops as soon as possible, then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.

Stopping Azelastin COMOD
If you stop using Azelastin COMOD, your symptoms are likely to return.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Azelastin COMOD can cause adverse reactions, although they do not occur in everyone.
These adverse reactions include:
Common (may occur in less than 1 in 10 patients):
mild eye irritation (burning, itching, tearing) after administration of Azelastin COMOD. These symptoms should quickly resolve.
Uncommon (may occur in less than 1 in 100 patients):
bitter taste in the mouth. This should quickly resolve, especially after drinking a non-alcoholic beverage.
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1.3.1 SPC, labelling and package leaflet
Very rare (may occur in less than 1 in 10,000 patients):
allergic reactions (such as rash and itching).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Azelastin COMOD

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer packaging (mm/rrrr). The expiry date refers to the last day of the specified month.
Shelf-life after opening the bottle: Properly used Azelastin COMOD eye drops may be used for 12 weeks after first opening.
Azelastin COMOD eye drops should only be used if the packaging seal is intact before first use.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Azelastin COMOD contains

• The active substance is azelastine hydrochloride at a concentration of 0.05% (0.50 mg/mL). One drop of the medicinal product with a volume of approximately 30 µL contains 0.015 mg of azelastine hydrochloride.
• Other ingredients of the medicinal product are: disodium edetate, hypromellose, sorbitol, sodium hydroxide (for pH adjustment), and water for injections.

What Azelastin COMOD looks like and contents of the pack
Azelastin COMOD is a clear, colourless solution contained in a 10 mL bottle with a dropper made of LDPE, with a closure made of HDPE and a tamper-evident seal, packed in a cardboard box.
Each pack contains 1 multi-dose hermetically sealed container.
Edition 07/2024
1.3.1 SPC, labelling and package leaflet
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
URSAPHARM Poland sp. z o.o.,
Wybrzeże Gdyńskie 27,
01-531 Warsaw, Poland
Telephone: 22 732 07 90
Fax: 22 732 07 99
e-mail: [email protected]
Manufacturer:
URSAPHARM Arzneimittel GmbH,
Industriestraße 35,
66129 Saarbrücken,
Germany
Edition 07/2024