Azelamed

Package leaflet: Information for the user

Azelamed, 0.5 mg/ml, eye drops, solution
Azelastini hydrochloridum
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 possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 2 days or if you feel worse, contact your doctor. Relief of symptoms of allergic conjunctivitis should occur within 15–30 minutes.

Contents of the leaflet

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

1. What Azelamed is and what it is used for

Azelamed contains azelastine, which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the action of histamine, a substance produced by the body during an allergic reaction. Azelastine has been shown to reduce eye inflammation.

Azelamed may be used to treat or prevent symptoms of seasonal allergic eye disorders associated with hay fever (seasonal allergic conjunctivitis) in adults, adolescents, and children aged 4 years and above.

Azelamed may also be used for allergic eye disorders caused by allergens such as house dust mites or animal fur (perennial allergic conjunctivitis) in adults and adolescents aged 12 years and above.

Azelamed is not intended for the treatment of eye infections.
If there is no improvement within 2 days or if you feel worse, contact your doctor.

2. Important information before using Azelamed

When not to use Azelamed

• 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 Azelamed, discuss this with a doctor, pharmacist or optician.
Special caution is needed when using Azelamed:

• if the patient is unsure whether the eye condition is due to allergy. This particularly applies when the problem affects only one eye; when there is worsening of vision or eye pain, but no symptoms affecting the nose. This may indicate an infection rather than allergy;
• if symptoms worsen or persist for longer than 2 days without significant improvement despite using Azelamed. In such a case, consult a doctor or pharmacist.

Contact a doctor, pharmacist or optician before using Azelamed if:

• the patient wears contact lenses.

Children and adolescents
Treatment of eye disorders associated with hay fever (seasonal allergic conjunctivitis):
This medicine should not be used in children under 4 years of age, as safety and efficacy have not been established.
Treatment of eye disorders caused by allergy (perennial [year-round] allergic conjunctivitis):
This medicine should not be used in children under 12 years of age, as safety and efficacy have not been established.

Other medicines and Azelamed
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
The effect of other medicines on Azelamed is not known.

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

Driving and using machines
Blurred vision may occur for a short time after using Azelamed. If this happens, wait until vision returns to normal before driving or operating machinery.

Azelamed contains benzalkonium chloride
The medicine contains 3.75 micrograms of benzalkonium chloride per drop, equivalent to 0.125 mg/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 any abnormal sensation, stinging or pain in the eye occurs after using the medicine, contact a doctor.

3. How to use Azelamed

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use this medicine if the tamper-evident seal on the neck of the bottle is broken before first use. To open the bottle, unscrew the cap by turning it until the seal breaks.

Eye disorders caused by hay fever (seasonal allergic conjunctivitis)

• In adults, adolescents, and children aged 4 years and above.
• The recommended dose is 1 drop in each eye, in the morning and evening.

If exposure to an allergen is expected, the recommended dose should be used prophylactically before going outdoors.

Eye disorders caused by allergy (non-seasonal (perennial) conjunctivitis)

• In adults, adolescents, and children aged 12 years and above.
• The recommended dose is 1 drop in each eye, in the morning and evening.

In case of severe symptoms, your doctor may increase the dose to 1 drop in each eye, four times daily.
Relief of symptoms of allergic conjunctivitis should occur within 15–30 minutes.
If possible, Azelamed should be used regularly until symptoms resolve.
If use of Azelamed is discontinued, there is a possibility of symptom recurrence.

Please remember:

• not to use Azelamed for longer than 6 weeks,
• to use Azelamed in the eyes only.

Administration instructions for Azelamed

To correctly administer eye drops, it may help to sit in front of a mirror during the first few applications.

1. Wash your hands.
2. Gently dry the area around the eye with a clean, single-use tissue (Fig. 1).
3. Unscrew the cap and check that the dropper tip is clean.
4. Gently pull the lower eyelid downwards (Fig. 2).
5. Carefully place one drop inside the lower eyelid (Fig. 3). Be careful not to touch the eye with the dropper tip.
6. Release the eyelid, then gently press the inner corner of the eye near the nose (Fig. 4). Press your finger against the nose and blink gently several times to spread the medicine evenly over the eye surface.
7. Wipe away any excess medicine with a clean tissue.
8. Repeat the above steps to administer the medicine to the other eye.

Fig. 1 Fig. 2 Fig. 3 Fig. 4

Use of a higher than recommended dose of Azelamed

If too much Azelamed has been used in the eye, it is unlikely that any adverse effects will occur. If in doubt, contact your doctor.
If Azelamed is accidentally swallowed, contact your doctor or the nearest emergency department immediately.
There is no experience with the use of toxic (very high, poisonous) doses of azelastine hydrochloride in humans. Based on animal studies, significant overdose or poisoning may lead to central nervous system disturbances (e.g. anxiety, excitation, or profound, prolonged fatigue or drowsiness). In such cases, symptomatic treatment should be administered.

Missed dose of Azelamed

Do not use a double dose to make up for a missed dose. Take the next dose as soon as possible, then continue using the medicine at the usual times.

Discontinuation of Azelamed

If use of Azelamed is stopped, there is a possibility of symptom recurrence.
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common (may occur in up to 1 in 10 patients):
Mild, transient eye irritation (burning, itching, tearing) after administration of the medicine
Azelamed.
Uncommon (may occur in up to 1 in 100 patients):
Bitter taste in the mouth. This should quickly subside, especially after drinking a non-alcoholic
beverage.
Very rare (may occur in up to 1 in 10,000 patients):
Allergic reaction (such as rash and itching).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Azelamed

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the stated month.
Do not store in a refrigerator or freeze.
Shelf life after first opening
Shelf life after first opening of the bottle: 6 weeks.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Azelamed contains:

• The active substance is azelastine hydrochloride. 1 ml of solution contains 0,5 mg of azelastine hydrochloride. Each drop contains 0,015 mg of azelastine hydrochloride.
• The other ingredients are: benzalkonium chloride, disodium edetate, hypromellose 4000, sorbitol liquid crystallizing, sodium hydroxide for pH adjustment, and water for injections.

What Azelamed looks like and contents of the pack
Azelamed is a clear, colourless to slightly yellow solution.
Azelamed is available in a bottle with a dropper and a cap with a tamper-evident seal.
One 10 ml bottle contains 6 ml of eye drops solution.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Azelastin axicur 0,5 mg/ml Augentropfen, Lösung
Poland: Azelamed
Austria: Azedil 0,5 mg/ml Augentropfen
Croatia: Azelamed 0,5 mg/ml kapi za oko, otopina