Dazlaris

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Dazlaris

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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Dazlaris and what is it used for

Dazlaris 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.

Dazlaris is used to relieve 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.

Dazlaris relieves allergy symptoms, such as: nasal discharge, postnasal drip, sneezing, itching, and stuffy nose.

2. Important information before using Dazlaris

When not to use Dazlaris

• 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 Dazlaris, discuss it with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medications. Patients who have been treated with medications for a nasal infection may continue to treat their allergy with Dazlaris.
• 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 Dazlaris.
• If the patient has adrenal gland problems. Caution should be exercised when switching from systemic steroid therapy to Dazlaris therapy.
• If the patient has severe liver disease. This increases the risk of systemic side effects.

In these cases, the doctor will decide whether Dazlaris can be used.

It is essential for the patient to take the medicine in the dose prescribed below in section 3 or as recommended by the doctor.

Taking nasal corticosteroids in higher doses than recommended may cause adrenal gland problems, which can lead to weight loss, fatigue, muscle weakness, low blood sugar, increased salt requirements, joint pain, depression, and darkening of the skin.

In such cases, the doctor may recommend taking another medicine during periods of stress or scheduled surgery.

To avoid adrenal gland problems, the doctor may recommend taking the medicine in the smallest dose that will continue to effectively control the symptoms of allergic rhinitis.

If the patient experiences blurred vision or other vision problems, they should contact their doctor.

In case of doubt as to whether the patient is affected by any of the above situations, they should consult their doctor or pharmacist before starting to use Dazlaris.

Children and adolescents

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

In children and adolescents, long-term use of nasal corticosteroids (such as Dazlaris) may slow down growth.

The doctor will regularly check the child's growth and ensure that they are taking the medicine in the lowest effective dose.

Dazlaris and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those available without a prescription.

Some medicines may increase the effects of Dazlaris, and the doctor may recommend close monitoring if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole).

If you are taking sedatives or medicines that affect the central nervous system, do not use Dazlaris.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Dazlaris has a minor influence on the ability to drive and use machines.

Very rarely, drowsiness and dizziness may occur, which may be caused by the disease itself or the use of Dazlaris.

In such cases, do not drive or operate machinery.

Be aware that drinking alcohol may increase such effects.

Dazlaris contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride in each spray.

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Dazlaris

This medicine should always be used as directed by your doctor.

In case of doubt, consult your doctor or pharmacist.

For the treatment to be most effective, Dazlaris must be used regularly.

Avoid contact with the eyes.

Use in adults and adolescents (12 years and older)

One dose should be used in each nostril, in the morning and evening.

Use in children under 12 years

Dazlaris 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 Dazlaris in patients with renal and hepatic impairment.

Method of administration

Nasal administration.

Read the instructions below carefully 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.
• 2. If the nasal spray is 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 your thumb on the bottom of the bottle.
• 4. Press and release the pump 6 times, until a fine mist appears (see figure a).

a

• 5. The pump is now primed and ready for use.

• 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.
• 2. Blow your nose to clear your nostrils.
• 3. Tilt your head forward towards your toes. Do not tilt your head back.
• 4. Hold the bottle upright and gently place the tip of the doser in one nostril.
• 5. Close the other nostril with your finger, press the pump quickly once, and breathe in gently at the same time (see figure b).

b

• 6. Breathe out through your mouth.
• 7. Repeat the same steps for the other nostril.
• 8. After administration, breathe in gently and do not tilt your head back. This will prevent the medicine from entering your throat and causing an unpleasant taste.
• 9. After each use, wipe the tip of the doser with a clean tissue or cloth and replace the protective cap.
• 10. If the tip of the doser becomes blocked, do not try to unblock it or use a sharp object to clear it. Rinse the tip of the doser with water.

It is essential to use the dose prescribed by your doctor.

Duration of treatment

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

Use of a higher than recommended dose of Dazlaris

In case of accidental use of a higher dose of the nasal spray, there is a low risk of complications.

Consult your doctor if you have any concerns or if you have been taking a higher dose than recommended for a long time.

If someone, especially a child, accidentally swallows Dazlaris, seek medical attention immediately.

Missing a dose of Dazlaris

Use the nasal spray as soon as you remember, and then use the next dose at the usual time.

Do not use a double dose to make up for a missed dose.

Stopping treatment with Dazlaris

Do not stop using Dazlaris without consulting your doctor, due to the risk of ineffective treatment.

In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Nasal bleeding

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

• Headache
• Bitter taste in the mouth, especially if you tilt your head back during administration of the nasal spray. This taste should disappear if you drink 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 mild stinging sensation, 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
• Malaise, fatigue, weakness, or exhaustion
• Rash, itching, or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the airways)

Seek medical attention immediately if you experience any of the following symptoms:

Facial swelling, lip, tongue, or throat swelling, which may cause difficulty swallowing

and/or breathing, as well as sudden appearance of skin rash.These may be symptoms of a severe allergic reaction.

Note: these symptoms are very rare.

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

• Blurred vision
• Ulceration of the nasal mucosa

In case of use of high doses for a long time, systemic side effects may occur (side effects affecting the whole body).

The likelihood of their occurrence is much lower when using nasal corticosteroids than during treatment with oral corticosteroids.

These side effects may vary from patient to patient and after use of 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides, 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, you can help provide more information on the safety of this medicine.

5. How to store Dazlaris

Keep this medicine 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 that month.

Do not store in the refrigerator or freeze.

Shelf life after first opening: Do not use Dazlaris after 6 months from the first opening of the nasal spray.

Medicines should 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 Dazlaris contains

• The active substances are azelastine hydrochloride and fluticasone propionate.

Each gram of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

• Other ingredients are disodium edetate, glycerol, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Dazlaris looks like and contents of the pack

Dazlaris is a white or almost white homogeneous suspension.

Dazlaris is available in a brown glass bottle with a pump spray, applicator, and protective cap, in a cardboard box.

The 25 mL bottle contains 23 g of nasal spray suspension (at least 120 doses).

Dazlaris is available in:

a pack containing 1 bottle of 23 g nasal spray suspension.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer

FARMEA
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France

FARMACLAIR
440 Avenue Du Général De Gaulle
14200 Hérouville-Saint-Clair
France

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Dazlaris
Sweden: Dazlaris
Czech Republic: Dazlaris

Date of last revision of the leaflet: 17/04/2025