Azelin

Package leaflet: Information for the patient

AZELIN
(137 micrograms + 50 micrograms)/dose, nasal aerosol, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What AZELIN is and what it is 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 AZELIN is and what it is 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, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

AZELIN is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicinal products containing either an antihistamine or a corticosteroid alone is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: plant pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
AZELIN relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use AZELIN, discuss this with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has an infection inside the nose. Nasal passage infections should be treated with antibacterial or antifungal medicines. Patients who have been treated for nasal infection may continue to treat allergies using AZELIN.
• If the patient has tuberculosis or untreated infection.
• If the patient experiences changes in vision or has previously been diagnosed with increased intraocular pressure, glaucoma and/or cataracts. Patients affected by these conditions will be closely monitored during treatment with AZELIN.
• If the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with AZELIN.
• If the patient has severe liver disease. In such cases, the risk of systemic adverse effects increases.

In these cases, the decision on whether AZELIN can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated below in section 3 or as directed by the treating physician. Using intranasal corticosteroids at doses higher than recommended may lead to adrenal suppression, a condition in which reduced body weight, fatigue, muscle weakness, low blood sugar levels, increased salt craving, joint pain, depression, and darker skin pigmentation may occur. In such cases, the doctor may recommend taking another medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the medicine at the lowest effective dose that still controls symptoms of nasal mucosal inflammation.
In children and adolescents, long-term use of intranasal corticosteroids (such as AZELIN) may impair growth rate. The doctor will regularly monitor the child's growth and ensure that the child is receiving the lowest effective dose.
If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting treatment with AZELIN.

Children
This medicine is not recommended for use in children under 12 years of age.

AZELIN and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines.
Some medicines may increase the effect of AZELIN nasal aerosol, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents: ketoconazole).
If the patient is taking sedatives or medicines acting on the central nervous system, contact the doctor.

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

Driving and operating machinery
AZELIN has minimal influence on the ability to drive and operate machinery.
Very rarely, fatigue and dizziness may occur, which may be caused either by the underlying illness or by the use of AZELIN. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

AZELIN contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray, equivalent to 0.014 mg/0.14 g. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.
If the patient experiences discomfort during use of the aerosol, inform the doctor or pharmacist.

3. How to use the medicine AZELIN

The medicine AZELIN should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
To achieve the best therapeutic effect, AZELIN must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (aged 12 years and older)

• It is recommended to administer one dose into each nostril in the morning and evening.

Use in children under 12 years of age

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

Use in patients with renal or hepatic impairment

• There is no data available regarding use in patients with renal or hepatic impairment.

Method of administration
Nasal administration.
Please read the following instructions carefully and use the medicine exactly as directed.

INSTRUCTIONS FOR USE
Preparing the aerosol

1. Gently shake the bottle vertically up and down for 5 seconds, then remove the dust cap (see Figure 1).
   Figure 1
   

2. If the nasal aerosol is being used for the first time, prime the pump by releasing a dose into the air.

3. Prime the pump by placing two fingers on either side of the pump and the thumb underneath the base 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 aerosol has not been used for more than 7 days, re-prime the pump by pressing and releasing it once.

Using the aerosol

1. Gently shake the bottle vertically up and down for 5 seconds, then remove the dust cap (see Figure 1).

2. Blow your nose to clear the nasal passages.

3. Tilt your head forward toward your toes. Do not tilt your head backward.

4. Hold the bottle upright and gently insert the spray tip into one nostril.

5. Block the other nostril with a finger, press the pump quickly once, and at the same time inhale gently (see Figure 3).

6. Breathe out through the mouth.
   Figure 3
   

7. Repeat the same procedure for the other nostril.

8. After administering the medicine, continue to breathe gently through the nose and do not tilt your head backward. This helps prevent the medicine from draining into the throat and causing an unpleasant taste (see Figure 4).
   Figure 4
   

9. After each use, wipe the spray tip with a clean tissue or cloth and replace the dust cap.

10. If the aerosol does not spray, do not pierce the spray tip. Clean the spray tip with water.

It is important to use the dose prescribed by your doctor. Only use the dosage regimen recommended by your physician.

Duration of treatment
AZELIN may be used long-term. The duration of treatment should correspond to the period during which allergy symptoms are present.

Use of more than the recommended dose of AZELIN
If an excessive dose of the nasal spray is used, the likelihood of adverse effects is low. However, consult your doctor if you experience any concerns or if a higher-than-recommended dose has been used for a prolonged period. If anyone, especially a child, accidentally swallows AZELIN, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of AZELIN
Use the nasal spray as soon as you remember, then continue with the next dose at the usual time. Do not use a double dose to make up for a missed dose.

Stopping AZELIN treatment
Do not stop using AZELIN without consulting your doctor, due to the risk of reduced treatment effectiveness.

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

4. Possible adverse effects

Like all medicines, AZELIN may cause adverse effects, although they do not occur in everyone.

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

• Nosebleeds

Common adverse effects (may affect less than 1 in 10 people):

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

Uncommon adverse effects (may affect less than 1 in 100 people):

• Mild irritation inside the nose. This may cause a slight stinging sensation, itching or sneezing
• Dryness in the nose, cough, dry throat or throat irritation

Rare adverse effects (may affect less than 1 in 1,000 people):

• Dryness in the mouth

Very rare adverse effects (may affect less than 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma or increased intraocular pressure, which may lead to loss of vision and (or) redness and pain in the eyes. These adverse effects have been reported after long-term use of nasal aerosol containing fluticasone propionate.
• Damage to the skin and nasal mucosa
• Malaise, feeling of fatigue, exhaustion or weakness
• Rash, itching or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the lower airways)

Seek immediate medical help if any of the following symptoms occur:

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

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

• Blurred vision
• Ulceration of the nasal mucosa

When the medicine is used in high doses over a long period of time, systemic adverse effects (affecting the whole body) may occur. The likelihood of such effects is significantly lower with corticosteroids administered as a nasal aerosol than with oral corticosteroid therapy. These effects may vary among individual patients and depending on the corticosteroid used (see section 2). Nasally administered corticosteroids may affect normal hormone production processes in the body, especially when used long-term at high doses. In children and adolescents, these adverse effects may lead to growth suppression.
In rare cases, decreased bone density (osteoporosis) has been observed with long-term use of corticosteroids administered via the nasal route.

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, 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
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 AZELIN medicine

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and the carton
after: EXP. The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Shelf-life after first opening the bottle: Unused medicine should be discarded 6 months after
first opening the nasal aerosol.
Medicines should not be disposed of via wastewater or household waste. 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 the medicinal product AZELIN contains
The active substances in this medicine are: azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365
micrograms of fluticasone propionate.
Each actuation of the pump (0.14 g) delivers 137 micrograms of azelastine hydrochloride (=125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
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 amber glass type I bottle with a PP, PE, POM, elastomer and stainless steel spray pump, nasal applicator made of polypropylene, and dust cap, packed in a cardboard box.
The 25 mL bottle contains 23 g of nasal aerosol in the form of a suspension (providing at least 120 doses).

Marketing Authorisation Holder and Manufacturer:
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
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
Greece
Tel.: +30 2106039326
e-mail: [email protected]