Azelastine hydrochloride + fluticasone propionate teva

Package leaflet: Information for the user

Azelastine hydrochloride + Fluticasone propionate Teva
(137 micrograms + 50 micrograms)/dose, nasal aerosol, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• 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 individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Azelastine hydrochloride + Fluticasone propionate Teva is and what it is 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 pack and other information

1. What Azelastine hydrochloride + Fluticasone propionate Teva is and what it is 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, thereby reducing 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 when treatment with other intranasal medicines 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: pollen (hay fever), house dust mites, mould spores, dust, or pet dander.
Azelastine hydrochloride + Fluticasone propionate Teva relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, and nasal itching or congestion.

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

Do not use Azelastine hydrochloride + Fluticasone propionate Teva:

• If you are 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 using Azelastine hydrochloride + Fluticasone propionate Teva, talk to your doctor or pharmacist if:

• You have recently had surgery or an injury to your nose or mouth.
• You have an infection in your nose. Nasal infections should be treated with antibacterial or antifungal medicines. People who have been treated for nasal infections may continue to treat their allergies using Azelastine hydrochloride + Fluticasone propionate Teva.
• You have tuberculosis or an untreated infection.
• You notice changes in your vision or have previously been diagnosed with increased intraocular pressure, glaucoma, and (or) cataracts. Such patients will be closely monitored during treatment with Azelastine hydrochloride + Fluticasone propionate Teva.
• You have adrenal gland problems. Caution is required when switching from systemic steroid therapy to treatment with Azelastine hydrochloride + Fluticasone propionate Teva.
• You have severe liver disease. This increases the risk of systemic side effects.

In these cases, your doctor will decide whether Azelastine hydrochloride + Fluticasone propionate Teva can be used.
It is important that you use the medicine at the dose specified in section 3 below or as directed by your doctor. 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, increased salt craving, joint pain, depression, and darker skin pigmentation may occur. In such cases, your doctor may recommend taking another medicine during periods of stress or before planned surgery.
To avoid adrenal suppression, your doctor may recommend using the lowest effective dose that still controls your nasal inflammation symptoms adequately.
In children and adolescents, long-term use of intranasal corticosteroids (such as Azelastine hydrochloride + Fluticasone propionate Teva) may slow growth rate. Your doctor will regularly monitor your child's growth and ensure they are using the lowest effective dose.
If you experience blurred vision or other visual disturbances, contact your doctor.
If you are unsure whether any of the above situations apply to you, consult your 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
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effect of the Azelastine hydrochloride + Fluticasone propionate Teva nasal aerosol, and your doctor may recommend careful monitoring if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Azelastine hydrochloride + Fluticasone propionate Teva if you are taking sedatives or medicines affecting the central nervous system.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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, fatigue, weakness, or dizziness may occur, which may be due to the disease itself or to the use of Azelastine hydrochloride + Fluticasone propionate Teva. In such cases, you should not drive or operate machinery. Be aware that drinking alcohol may worsen these effects.

Azelastine hydrochloride + Fluticasone propionate Teva contains benzalkonium chloride.
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause nasal irritation or swelling, especially if used for a prolonged period.
If you experience discomfort while using the aerosol, tell your doctor or pharmacist.

3. How to use Azelastine hydrochloride + Fluticasone propionate Teva

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
For the treatment to be most effective, Azelastine hydrochloride + Fluticasone propionate Teva
must be used regularly.
Avoid contact with the eyes.

Adults and adolescents (aged 12 years and older)

• It is recommended to use one spray 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 up and down for 5 seconds, then remove the protective 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 at 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 aerosol has not been used for more than 7 days, re-prime the pump. Gently shake the bottle up and down for 5 seconds, then remove the protective cap (see Figure 1), and press and release the pump once.

Using the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nasal passages.
3. Tilt your head forward, looking toward your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the nozzle into one nostril.
5. Close 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 your mouth.

Figure 3

7. Repeat the same procedure for the other nostril.
8. After administering the medicine, take gentle breaths and do not tilt your head backward. This will help prevent the medicine from running down into your throat and causing an unpleasant taste (see Figure 4).

Figure 4

9. After each use, wipe the nozzle with a clean tissue or cloth and replace the protective cap.

10. If the aerosol does not spray, do not pierce the nozzle. Wash the nozzle with water.

It is important to use the dose prescribed by your doctor. Always follow the dosage instructions given by your doctor.

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

Use of more than the recommended dose of Azelastine hydrochloride + Fluticasone propionate Teva
If too much nasal medicine is used, the risk of adverse effects is low. However, if you are concerned or if a higher-than-recommended dose has been used for a prolonged period, consult your doctor. If anyone, especially a child, accidentally swallows Azelastine hydrochloride + Fluticasone propionate Teva, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of Azelastine hydrochloride + Fluticasone propionate Teva
Use the nasal aerosol as soon as you remember, then continue with the next dose at your usual time. Do not use a double dose to make up for a missed dose.

Stopping Azelastine hydrochloride + Fluticasone propionate Teva
Do not stop using Azelastine hydrochloride + Fluticasone propionate Teva without consulting your doctor, as this may result in reduced treatment effectiveness.

If you have any further questions about 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 everybody will get them.

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

• Nosebleeds

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

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

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

• Slight irritation inside the nose. This may cause mild stinging, itching or sneezing
• Dryness in the nose, cough, dryness or irritation of the throat

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

• Dry mouth

Very rare adverse reactions (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 reactions have been reported after long-term use of nasal spray 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 onset of skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms occur very rarely.

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

• Blurred vision
• Ulceration of the nasal mucosa

When the medicine is used in high doses for a long time, systemic adverse reactions (reactions affecting the whole body) may occur. The likelihood of such reactions is much lower with corticosteroids administered as a nasal spray than with oral corticosteroid treatment. These reactions may vary between individual patients and depending on the corticosteroid medicine used (see section 2).
Corticosteroids administered intranasally may affect the normal processes of hormone production in the body, especially when used long-term at high doses. In children and adolescents, these adverse reactions may lead to a slowing of growth rate.
In rare cases, decreased bone density (osteoporosis) has been observed with long-term intranasal use of corticosteroids.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Azelastine hydrochloride + Fluticasone propionate Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton label after: EXP. The expiry date refers to the last day of the stated month.
Do not store in a refrigerator or freeze.
Storage period after first opening of the bottle: Unused medicine should be discarded 6 months after first opening of the nasal aerosol.
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 Azelastine hydrochloride + Fluticasone propionate Teva contains
The active substances are: azelastine hydrochloride and fluticasone propionate.
Each mL of suspension contains 1,000 micrograms of azelastine hydrochloride and 365
micrograms of fluticasone propionate.
Each actuation of the pump (0.14 g) delivers 137 micrograms of azelastine hydrochloride
(which corresponds to 125 micrograms of azelastine) and 50 micrograms of fluticasone
propionate.
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 aerosol suspension, available in an amber glass bottle with a spray pump, nasal applicator, and protective cap.
Each 25 mL bottle contains 23 g of nasal aerosol suspension (providing at least 120 doses).
Each pack contains one bottle with 23 g of nasal aerosol suspension or a multipack containing three bottles, each containing 23 g of nasal aerosol suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

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

For further information, contact the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
tel. +48 22 345 93 00

This medicinal product is authorised in the European Economic Area member states under the following names:
Belgium: Riniforce, 137 microgram/50 microgram/dosis neusspray, suspensie
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