Azelastine hidrohloride + Fluticasone propionate Teva

Leaflet accompanying the packaging: patient information

Azelastine hydrochloride + Fluticasone propionate Teva

(137 micrograms + 50 micrograms)/dose nasal spray, suspension
Azelastini hydrochloridum + Fluticasoni propionas

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azelastine hydrochloride + Fluticasone propionate Teva and what is it used for
• 2. Important information before using Azelastine hydrochloride + Fluticasone propionate Teva
• 3. How to use Azelastine hydrochloride + Fluticasone propionate Teva
• 4. Possible side effects
• 5. How to store Azelastine hydrochloride + Fluticasone propionate Teva
• 6. Contents of the packaging and other information

1. What is Azelastine hydrochloride + Fluticasone propionate Teva and what is it used for

used for
Azelastine hydrochloride + Fluticasone propionate Teva 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.

Azelastine hydrochloride + Fluticasone propionate Teva is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis, if the use of other nasal sprays containing only an antihistamine or a 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.
Azelastine hydrochloride + Fluticasone propionate Teva relieves allergy symptoms, such as: nasal discharge, postnasal drip, sneezing and itching or a feeling of nasal congestion.

2. Important information before using Azelastine hydrochloride + Fluticasone propionate Teva

propionate Teva

When not to use Azelastine hydrochloride + Fluticasone propionate Teva:

• 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 treatment with Azelastine hydrochloride + Fluticasone propionate Teva, the patient should discuss with their doctor or pharmacist if:

• The patient has recently undergone nasal or oral surgery.
• The patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medications. Patients who have been treated for a nasal infection may continue to treat their allergy with Azelastine hydrochloride + Fluticasone propionate Teva.
• The patient has tuberculosis or an untreated infection.
• The patient has noticed a change in vision or has been diagnosed with increased intraocular pressure, glaucoma, and/or cataracts. Patients with these conditions will be closely monitored while using Azelastine hydrochloride + Fluticasone propionate Teva.
• The patient has adrenal gland problems. Caution is advised when switching from systemic steroid therapy to Azelastine hydrochloride + Fluticasone propionate Teva treatment.
• The patient has severe liver disease. This increases the risk of systemic side effects.

In these cases, the doctor will decide whether Azelastine hydrochloride + Fluticasone propionate Teva can be used.
It is essential to use the medicine in the dose prescribed below in section 3 or as recommended by the doctor.
Using 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 darker skin pigmentation. In such cases, the doctor may prescribe another medicine during periods of stress or scheduled surgery.
To avoid adrenal gland problems, the doctor may recommend using the medicine in the smallest effective dose to control the symptoms of allergic rhinitis.
In children and adolescents, long-term use of nasal corticosteroids (such as Azelastine hydrochloride + Fluticasone propionate Teva) may slow down growth rates. The doctor will regularly check the child's growth and ensure they are using the medicine in the lowest effective dose.
If the patient experiences blurred vision or other vision problems, they should consult their doctor.
If the patient is unsure whether any of the above situations apply to them, they should consult their doctor or pharmacist before using Azelastine hydrochloride + Fluticasone propionate Teva.

Children

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

Azelastine hydrochloride + Fluticasone propionate Teva and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.
Some medicines may enhance the effect of Azelastine hydrochloride + Fluticasone propionate Teva 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). Do not use Azelastine hydrochloride + Fluticasone propionate Teva if the patient is taking sedatives or central nervous system depressants.

Pregnancy and breastfeeding

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

Driving and using machines

Azelastine hydrochloride + Fluticasone propionate Teva has a minor influence on the ability to drive and use machines.
Very rarely, drowsiness, weakness, or dizziness may occur, which may be caused by the disease itself or the use of Azelastine hydrochloride + Fluticasone propionate Teva. In such cases, the patient should not drive or operate machinery. They should be aware that drinking alcohol may enhance this effect.

Azelastine hydrochloride + Fluticasone propionate Teva contains benzalkonium chloride.

This medicine contains 14 micrograms of benzalkonium chloride per spray. 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 inform their doctor or pharmacist.

3. How to use Azelastine hydrochloride + Fluticasone propionate Teva

This medicine should always be used as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
For the treatment to be effective, Azelastine hydrochloride + Fluticasone propionate Teva must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (12 years and older)

• One dose is recommended for each nostril in the morning and evening.

Use in children under 12 years of age

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

Use in patients with renal or hepatic impairment

• There are no data on the use of Azelastine hydrochloride + Fluticasone propionate Teva in patients with renal or hepatic impairment.

Method of administration

Nasal spray.
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 (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. Prime the pump by placing 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. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1), and press and release the pump 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 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 sprayer in one nostril.
• 5. Block the other nostril with your finger, press the pump quickly once, and breathe in gently at the same time (see Figure 3).
• 6. Breathe out through your mouth.

Figure 3

• 7. Repeat the same steps for the other nostril.
• 8. After using the medicine, breathe in gently and do not tilt your head back. This will prevent the medicine from entering your throat and causing an unpleasant taste (see Figure 4).

Figure 4

• 9. After each use, wipe the tip of the sprayer with a clean tissue or cloth and replace the protective cap.

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

Azelastine hydrochloride + Fluticasone propionate Teva can be used long-term. The duration of treatment should correspond to the period during which allergy symptoms occur.

Using a higher dose of Azelastine hydrochloride + Fluticasone propionate Teva than recommended

Teva

In the event of an overdose of the nasal spray, there is a low risk of complications. The patient should consult their doctor if they are concerned or have been using a higher dose than recommended for an extended period. If someone, especially a child, accidentally ingests Azelastine hydrochloride + Fluticasone propionate Teva, they should immediately contact a doctor or the nearest hospital emergency department.

Missing a dose of Azelastine hydrochloride + Fluticasone propionate Teva

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 Azelastine hydrochloride + Fluticasone propionate Teva

The patient should not stop using Azelastine hydrochloride + Fluticasone propionate Teva without consulting their doctor, as this may lead to a lack of treatment effectiveness.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Azelastine hydrochloride + Fluticasone propionate Teva 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 the patient tilts their head back while using the nasal spray. 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 mild stinging, itching, or sneezing sensation
• Nasal dryness, cough, throat dryness, or throat irritation

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

• Dry mouth

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

• Dizziness or drowsiness
• Cataracts, glaucoma, or increased eye pressure, which can 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 mucous membrane damage
• General malaise, fatigue, exhaustion, 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 and (or) breathing, as well as a sudden skin rash.These may be symptoms of a severe allergic reaction. These symptoms are very rare.

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

• Blurred vision
• Ulcers on the nasal mucosa

In the event of using the medicine in high doses for a long time, systemic side effects may occur (side effects affecting the entire body). The likelihood of their occurrence is much lower when using nasal corticosteroids than during treatment 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 inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Azelastine hydrochloride + Fluticasone propionate Teva

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 stated.
Do not store in the refrigerator or freeze.
Shelf life after first opening the bottle: The unused medicine should be discarded 6 months after 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 packaging and other information

What Azelastine hydrochloride + Fluticasone propionate Teva contains

The active substances of the medicine are azelastine hydrochloride and fluticasone propionate.
Each mL of suspension contains 1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.
After each actuation of the pump (0.14 g), 137 micrograms of azelastine hydrochloride (corresponding to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are released.
The other ingredients are disodium edetate, glycerol (E 422), microcrystalline cellulose, sodium carmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and water for injections.

What Azelastine hydrochloride + Fluticasone propionate Teva looks like and contents of the pack

Azelastine hydrochloride + Fluticasone propionate Teva is a white nasal spray suspension, available in a brown glass bottle with a pump sprayer, nasal applicator, and protective cap.
Each bottle with a capacity of 25 mL contains 23 g of nasal spray suspension (at least 120 doses).
Each pack contains one bottle with 23 g of nasal spray suspension or a multipack containing three bottles, each containing 23 g of nasal spray suspension.
Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands

Manufacturer

Teva Czech Industries s.r.o.
Ostravská 305/29
747 70 Opava - Komárov
Czech Republic

For more information, please contact the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00

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

Belgium:
Riniforce, 137 microgram/50 microgram/dose nasal spray, suspension
Riniforce 137 microgrammes/50 microgrammes/dose suspension pour pulvérisation nasale
Riniforce 137 Mikrogramm/50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Estonia:
AzoFix 137 mikrogrammi/50 mikrogrammi
Lithuania:
Dunoase 137 mikrogramai/50 mikrogramų/ spūsnyje nosies purškalas (suspensija)
Latvia:
AzoFix 137 mikrogrami/50 mikrogrami izsmidzinājumā deguna aerosols, suspensija
Germany:
AzeFlut-ratiopharm 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
Poland:
Azelastine hydrochloride + Fluticasone propionate Teva

Date of last revision of the leaflet: June 2025