Azelastine misom

Package leaflet: Information for the user

Azelastine Misom, 0.5 mg/mL eye drops, solution
azelastine hydrochloride
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 2 days, you should contact your doctor.

Contents of the leaflet

1. What Azelastine Misom is and what it is used for
2. What you need to know before using Azelastine Misom
3. How to use Azelastine Misom
4. Possible side effects
5. How to store Azelastine Misom
6. Contents of the pack and other information

1. What Azelastine Misom is and what it is used for

This medicine belongs to a group of medicines called antihistamines. The active substance is azelastine hydrochloride.
Azelastine Misom is used for symptomatic treatment and prevention of allergic conjunctivitis, as well as allergic conjunctivitis associated with allergic rhinitis.
Allergic diseases may occur seasonally (e.g. pollen allergy, sometimes called hay fever) or throughout the year (e.g. allergy to house dust mites or pet dander from dogs or cats). Symptoms include redness, itching or watering of the eyes, sometimes accompanied by sneezing, watery nasal discharge, nasal itching or nasal congestion. Azelastine Misom is intended for the treatment and prevention of these symptoms.
This medicine is intended for use in adults, adolescents, and children aged 4 years and older.

2. Important information before using Azelastine Misom

When not to use Azelastine Misom:

• If the patient is allergic to azelastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• This medicine must not be used in children under 4 years of age.

Warnings and precautions

Before starting to use Azelastine Misom, discuss this with your doctor or pharmacist.

• if the patient is unsure whether the eye symptoms are caused by allergy, particularly if symptoms affect only one eye, there is impaired vision or eye pain, and the patient does not have nasal symptoms.
• if symptoms worsen or persist for more than 48 hours without noticeable improvement despite using Azelastine Misom. This medicine is not intended for the treatment of eye infections.

If any of the above situations apply, the patient should consult a doctor, who may decide to change the treatment.

Azelastine Misom and other medicines

Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient may take in the future, including those available without a prescription.

No interactions are known between Azelastine Misom and other medicines.

Pregnancy and breastfeeding

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

Pregnancy: Before using any medicine, consult a doctor or pharmacist. Consult a doctor regarding the use of Azelastine Misom during pregnancy.

Breastfeeding: Since a small amount of the active substance passes into breast milk, breastfeeding should be avoided during treatment with Azelastine Misom. Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery

Transient eye irritation may occur after using Azelastine Misom, but this should not affect vision. If transient visual disturbances occur during treatment, do not drive or operate machinery until vision returns to normal.

Azelastine Misom contains benzalkonium chloride

The medicine contains 0.125 mg of benzalkonium chloride per mL. Benzalkonium chloride may be absorbed by soft contact lenses and may change their colour. Contact lenses should be removed before instillation, and at least 15 minutes should be waited before reinserting them.

Benzalkonium chloride may also cause eye irritation, particularly in individuals with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after using the medicine, consult a doctor.

3. How to use Azelastine Misom

This medicine should always be used exactly as described in this leaflet or as prescribed by your doctor.
If in doubt, the patient should consult a doctor or pharmacist.
This medicinal product is intended for adults, adolescents, and children aged 4 years and older.
The recommended dose is 1 drop in each eye, in the morning and evening. In case of severe allergic symptoms, the doctor may increase the dose to 1 drop in each eye, four times daily.

How to use the medicine
For proper instillation of Azelastine Misom, it is recommended to begin by applying the drops in front of a mirror.
Wash your hands before administering eye drops.

1. Gently wipe the area around the eyes with a tissue (Fig. 1).
2. Unscrew the cap and check whether the dropper is clean.
3. Before first use, pierce the seal with the spike located in the cap.
4. Gently pull down the lower eyelid (Fig. 2).
5. Carefully instill one drop into the conjunctival sac (Fig. 3). Be careful not to touch the eye with the tip of the dropper.
6. Release the eyelid and gently press the inner corner of the eye near the nose. While pressing the inner corner of the eye near the nose with a finger, blink slowly several times to evenly distribute the medicine over the eye surface. Gently wipe away any excess solution with a tissue (Fig. 4).
7. Repeat all steps for the other eye.

Duration of treatment
If there is no improvement or if symptoms worsen after 2 days, consult a doctor.
Treatment with Azelastine Misom should be limited to a maximum of 6 weeks, as there is no experience with longer-term use. Do not use the product for longer than 6 weeks without consulting a doctor.

Use of a higher than recommended dose of Azelastine Misom
If too many drops of Azelastine Misom are used, no problems are expected. If concerned, consult a doctor. The risk of overdose after swallowing Azelastine Misom is negligible due to the small amount of active substance contained in the medicine.
However, if someone, especially a child, accidentally swallows Azelastine Misom, seek medical help immediately.

Missed dose of Azelastine Misom
Do not use a double dose to make up for a missed dose.
If the patient forgets to use the medicine at the scheduled time, it is not a concern. The medicine can be used as soon as the patient remembers, without hesitation. The next dose should be administered at the scheduled time.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects are usually mild, and the most common adverse effect is eye irritation.
Common adverse effects (may occur in up to 1 in 10 people):
Mild eye irritation (burning, itching, tearing).
Uncommon adverse effects (may occur in up to 1 in 100 people):
Bitter taste in the mouth, which should quickly disappear, especially if the patient drinks a non-alcoholic beverage.
Very rare adverse effects (may occur in up to 1 in 10,000 people):
Allergic reactions (such as rash and itching).

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181 C
PL-02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Azelastine Misom

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "EXP".
The expiry date refers to the last day of the stated month.
Unopened: This medicine does not require any special storage conditions.
After first opening: Do not use this medicine if the bottle has been open for longer than 28 days. Do not store at temperatures above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. These measures help protect the environment.

6. Contents of the package and other information

What Azelastine Misom contains
The active substance is azelastine hydrochloride 0.5 mg/mL. One drop contains 0.015 mg of azelastine hydrochloride.
The other ingredients are: benzalkonium chloride, solution, disodium edetate, hypromellose 4000, sorbitol liquid, crystallizing, sodium hydroxide, water for injections.

What Azelastine Misom looks like and contents of the pack
Azelastine eye drops are a clear, colourless solution; practically free from visible particles.
Azelastine eye drops in a 10 mL bottle made of LDPE with a BFS (Blow Fill Seal) closure with a white polypropylene cap with a tamper-evident ring.
A 10 mL bottle contains approximately 334 drops, an 8 mL bottle contains approximately 253 drops, and a 6 mL bottle contains approximately 190 drops. Outer packaging: cardboard box.
One bottle contains 6 mL, 8 mL or 10 mL of eye drops, solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: +48 22 732 77 00

Importer
Eurofins BioPharma Product Testing Budapest Kft.
Anonymus Utca 6
Kerulet, 1045 Budapeszt IV
Hungary

This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Azelastine Misom
Poland: Azelastine Misom
Romania: Azelastină Misom 0.5 mg/mL, eye drops solution