Azelin

Package Leaflet: Information for the Patient

AZELIN

(137 micrograms + 50 micrograms)/dose, nasal spray, suspension
Azelastine hydrochloride + Fluticasone propionate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is AZELIN and what is it used for

AZELIN contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the action of substances such as histamine, which the body produces as part of an allergic reaction, and thus reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

AZELIN is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis, if the use of other nasal products containing only an antihistamine or corticosteroid is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as plant pollen (hay fever), house dust mites, mold spores, dust, or pet dander.
AZELIN relieves allergy symptoms, such as: nasal discharge, postnasal drip, sneezing, itching, and a feeling of nasal congestion.

2. Important information before using AZELIN

When not to use AZELIN:

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

Warnings and precautions

Before starting to use AZELIN, the patient should discuss it with their doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has a nasal infection. The nasal infection should be treated with antibacterial or antifungal medicines. Patients who have been treated with medicines for a nasal infection may continue to treat their allergy with AZELIN.
• If the patient has tuberculosis or an untreated infection.
• If the patient notices a change in vision or has been diagnosed with increased intraocular pressure, glaucoma, and/or cataract. Patients with these conditions will be closely monitored during treatment with AZELIN.
• If the patient has adrenal gland problems. Caution is advised when switching from systemic steroid therapy to AZELIN therapy.
• If the patient has severe liver disease. This increases the risk of systemic side effects.

In these cases, the doctor will decide whether AZELIN can be used.
It is important for the patient to take the medicine as directed in section 3 or as advised by the doctor.
Using nasal corticosteroids in higher doses than recommended may cause adrenal gland problems, a condition in which the body's production of cortisol may decrease, leading to weight loss, fatigue, muscle weakness, low blood sugar, increased salt cravings, joint pain, depression, and darker skin pigmentation. In such cases, the doctor may prescribe another medicine during periods of stress or planned surgery.
To avoid adrenal gland problems, the doctor may prescribe the medicine in the smallest effective dose to maintain control of allergic rhinitis symptoms.
In children and adolescents, long-term use of nasal corticosteroids (such as AZELIN) may slow growth rates. The doctor will regularly check the child's growth and ensure they are taking the medicine in the lowest effective dose.
If the patient experiences blurred vision or other vision problems, they should contact their doctor.
In case of doubt whether any of the above situations apply to the patient, they should consult their doctor or pharmacist before using AZELIN.

Children

AZELIN is not recommended for use in children under 12 years of age.

AZELIN and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
Some medicines may increase the effects of AZELIN nasal spray, and the doctor may recommend close monitoring if the patient is taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole).
If the patient is taking sedatives or central nervous system depressants, they should consult their doctor.

Pregnancy and breastfeeding

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

Driving and using machines

AZELIN has a minor influence on the ability to drive and use machines.
Rarely, fatigue and dizziness may occur, which may be caused by the disease itself or the use of AZELIN. In such cases, the patient should not drive or operate machinery. They should be aware that drinking alcohol may increase these effects.

AZELIN contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride per actuation, which is equivalent to 0.014 mg/0.14 g. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
If the patient experiences discomfort during use, they should tell their doctor or pharmacist.

3. How to use AZELIN

AZELIN should always be used as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.
To get the most benefit from the treatment, AZELIN must be used regularly.
The patient should avoid contact with the eyes.

Adults and adolescents (12 years and older)

• One dose should be administered into each nostril in the morning and evening.

Use in children under 12 years

• AZELIN is not recommended for use in children under 12 years of age.

Use in patients with renal and hepatic impairment

• There are no data on the use of AZELIN in patients with renal and hepatic impairment.

Method of administration

Nasal administration.
The patient should carefully read the instructions below and use the medicine only as directed.

INSTRUCTIONS FOR USE

Preparing the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1). Figure 1

• 2. If the nasal spray is used for the first time, prime the pump by releasing a dose into the air.
• 3. To prime the pump, place two fingers on either side of the pump and the thumb on the bottom of the bottle.
• 4. Press and release the pump 6 times, until a fine mist is produced (see Figure 2).
• 5. The pump is now primed and ready for use. Figure 2

• 6. If the nasal spray has not been used for more than 7 days, re-prime the pump by pressing and releasing it once.

Using the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1).
• 2. Blow the nose to clear the nostrils.
• 3. Tilt the head forward towards the toes. Do not tilt the head back.
• 4. Hold the bottle upright and gently place the tip of the nozzle in the nostril.
• 5. Block the other nostril with a finger, press the pump quickly once, and at the same time, take a gentle breath in (see Figure 3).
• 6. Breathe out through the mouth.

Figure 3

• 7. Repeat the same steps for the other nostril.
• 8. After administration, take gentle breaths in and do not tilt the head back. This will prevent the medicine from going down the throat and causing an unpleasant taste (see Figure 4).

Figure 4

• 9. After each use, wipe the nozzle tip with a clean tissue or cloth and replace the protective cap.
• 10. If the spray does not spray, do not puncture the nozzle tip. Wash the nozzle tip with water.

It is essential to use the dose prescribed by the doctor. The patient should only use the dose recommended by the doctor.

Duration of treatment

AZELIN can be used for a long time. The duration of treatment should correspond to the period during which allergy symptoms occur.

Using a higher dose of AZELIN than recommended

In case of using too much nasal spray, there is a small risk of complications. The patient should consult their doctor if they are concerned or if they have been taking a higher dose than recommended for a long time. If someone, especially a child, accidentally swallows AZELIN, they should immediately contact a doctor or the nearest hospital emergency department.

Missing a dose of AZELIN

The patient should use the nasal spray as soon as they remember, and then use the next dose at the usual time. They should not use a double dose to make up for a missed dose.

Stopping treatment with AZELIN

The patient should not stop using AZELIN without consulting their doctor, due to the risk of reduced treatment effectiveness.
If the patient has any further questions about using this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 people):

• Nosebleeds

Common side effects (may affect up to 1 in 10 people):

• Headache
• Bitter taste in the mouth, especially if the patient tilts their head back during nasal spray administration. This taste should disappear if the patient drinks a non-alcoholic beverage a few minutes after using the medicine
• Unpleasant odor

Uncommon side effects (may affect up to 1 in 100 people):

• Mild irritation inside the nose. This may cause a feeling of tingling, itching, or sneezing
• Dryness in the nose, cough, dry throat, or throat irritation

Rare side effects (may affect up to 1 in 1,000 people):

• Dry mouth

Very rare side effects (may affect up to 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma, or increased eye pressure, which may cause vision loss and/or eye redness and pain. These side effects have been reported after long-term use of nasal sprays containing fluticasone propionate.
• Skin and nasal mucosa damage
• General feeling of being unwell, tiredness, fatigue, or weakness
• Rash, itching, or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the airways)

The patient should seek immediate medical attention if they experience any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, and sudden appearance of a skin rash.These may be symptoms of a severe allergic reaction. These symptoms are very rare.

Side effects with unknown frequency (cannot be estimated from the available data):

• Blurred vision
• Ulceration of the nasal mucosa

In case of using the medicine in high doses for a long time, systemic side effects (affecting the whole body) may occur. The likelihood of these side effects is much lower when using nasal corticosteroids than when treated with oral corticosteroids. These side effects may vary between patients and after using different corticosteroid medicines (see section 2).
Nasal corticosteroids may affect the normal production of hormones in the body, especially when used for a long time in high doses. In children and adolescents, these side effects may cause growth retardation.
In rare cases, a decrease in bone density (osteoporosis) has been observed when corticosteroids were used nasally for a long time.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store AZELIN

The medicine should be stored out of 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 month.
Do not store in the refrigerator or freeze.
Shelf life after first opening the bottle: The unused medicine should be discarded 6 months after first opening the nasal spray.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AZELIN contains

The active substances of AZELIN are azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.
After each actuation (0.14 g), 137 micrograms of azelastine hydrochloride (=125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are delivered.
The other ingredients are disodium edetate, glycerol, microcrystalline cellulose, sodium carmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What AZELIN looks like and contents of the pack

AZELIN is a white or almost white, homogeneous suspension.
AZELIN is available in a 25 mL glass bottle (type I) with a pump spray (PP, PE, POM, elastomer, and stainless steel), a nasal applicator (polypropylene), and a protective cap, in a cardboard box.
The 25 mL bottle contains 23 g of nasal spray suspension (at least 120 doses).

Marketing authorization holder and manufacturer:

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Polska (Poland)
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Manufacturer:

ELPEN Pharmaceutical Co. Inc. S.A.
Marathonos Avenue 95, Pikermi
19009
Greece (Greece)
Tel.: +30 2106039326
e-mail: [email protected]

Date of last revision of the leaflet: