Azelastine and fluticasone Viatri

Package leaflet: Information for the patient

Azelastine and Fluticasone Viatris 137 micrograms/50 micrograms per spray

Nasal spray, suspension
azelastine hydrochloride/fluticasone propionate
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Azelastine and Fluticasone Viatris nasal spray is and what it is used for
2. What you need to know before using Azelastine and Fluticasone Viatris nasal spray
3. How to use Azelastine and Fluticasone Viatris nasal spray
4. Possible side effects
5. How to store Azelastine and Fluticasone Viatris nasal spray
6. Contents of the pack and other information

1. What Azelastine and Fluticasone Viatris nasal spray is and what it is used for

Azelastine and Fluticasone Viatris nasal spray contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to the pharmacotherapeutic group of antihistamines. Antihistamines work by blocking the effects of substances such as histamine, which the body produces during an allergic reaction, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to the pharmacotherapeutic group of corticosteroids, which reduce inflammation. Azelastine and Fluticasone Viatris nasal spray is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with either an antihistamine or a corticosteroid alone via intranasal route is considered insufficient.

Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, moulds, dust, or pets.
Azelastine and Fluticasone Viatris nasal spray relieves allergy symptoms such as excessive nasal mucus production, runny nose, sneezing, nasal itching, or nasal congestion.

2. What you need to know before using Azelastine and Fluticasone Viatris nasal spray

Do not use Azelastine and Fluticasone Viatris nasal spray:

• 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
Talk to your doctor or pharmacist before using Azelastine and Fluticasone Viatris nasal spray:

• if you have recently had nasal surgery
• if you have had a nasal infection. Nasal airway infections should be treated with an antibacterial or antifungal medicine. If you have been prescribed a medicine for a nasal infection, you may continue using Azelastine and Fluticasone Viatris nasal spray for the treatment of your allergies
• if you have tuberculosis or an untreated infection
• if you have experienced vision problems or have a history of increased intraocular pressure, glaucoma and/or cataracts. If any of these conditions apply to you, you will be closely monitored during treatment with Azelastine and Fluticasone Viatris nasal spray
• if you have impaired adrenal function. Extreme caution is required when switching from systemic corticosteroid therapy to Azelastine and Fluticasone Viatris nasal spray
• if you have severe liver disease. Your risk of experiencing unwanted systemic effects is higher.

In these cases, your doctor will decide whether or not you can use this medicine.
It is important that you take your dose as indicated in section 3 below or as advised by your doctor.
Treatment with inhaled corticosteroid doses higher than recommended may cause adrenal suppression, a condition that can lead to weight loss, fatigue, muscle weakness, low blood sugar levels, craving for salty foods, joint pain, depression, and darkening of the skin. If these conditions occur, your doctor may recommend another medicine during periods of stress or before elective surgery.
To avoid adrenal suppression, your doctor will advise you to take the lowest dose that effectively controls your rhinitis symptoms.
If used for prolonged periods, inhaled corticosteroids (such as Azelastine and Fluticasone Viatris nasal spray) may cause slowed growth in children and adolescents. Your doctor will regularly monitor your child's height and ensure they are taking the lowest effective dose.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are unsure whether the conditions mentioned above apply to you, discuss them with your doctor or pharmacist before using this medicine.

Children
The use of this medicine is not recommended in children under 12 years of age.

Other medicines and Azelastine and Fluticasone Viatris nasal spray
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may increase the effects of Azelastine and Fluticasone Viatris nasal spray, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat, and antifungal medicines: ketoconazole).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using Azelastine and Fluticasone Viatris nasal spray.

Driving and using machines
Azelastine and Fluticasone Viatris nasal spray has a negligible effect on the ability to drive and use machines.
Very rarely, fatigue or dizziness may occur due to the condition itself or to the use of Azelastine and Fluticasone Viatris nasal spray. In such cases, avoid driving or operating machinery. You should be aware that alcohol consumption may worsen these effects.

Azelastine and Fluticasone Viatris nasal spray 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 and swelling inside the nose, especially if used for prolonged periods.

3. How to use Azelastine and Fluticasone Viatris nasal spray

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is essential to use Azelastine and Fluticasone Viatris nasal spray regularly to achieve full therapeutic benefit.
Avoid contact with the eyes.
Adults and adolescents (aged 12 years and older)

• The recommended dose is one spray into each nostril in the morning and one spray into each nostril in the 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 are no data available in patients with renal or hepatic impairment.

Method of administration
For nasal use only.
Read the information provided in this leaflet and follow the instructions carefully.
INSTRUCTIONS FOR USE
Preparing the spray

1. Gently shake the bottle for 5 seconds, tilting it downwards and upwards, then remove the protective cap (see Figure 1).

Figure 1

2. When using the nasal spray for the first time, you must prime the pump by spraying the product into the air.
3. Prime the pump by placing two fingers on either side of the spray pump and your thumb on the base of the bottle.
4. Press down and release the pump 6 times until a fine mist appears (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, you must re-prime the pump by pressing and releasing it once.

Using the spray

1. Gently shake the bottle for 5 seconds, tilting it downwards and upwards, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nostrils.
3. Keep your head tilted slightly forward (towards your feet). Do not tilt your head backwards.
4. Hold the bottle upright and gently insert the spray tip into one nostril.
5. Close the other nostril with a finger, press down 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. Breathe in gently without tilting your head backwards after administration. This will help prevent the medicine from running down your throat, which may cause an unpleasant taste (see Figure 4).

Figure 4

9. After each use, wipe the spray tip with a tissue or clean cloth and replace the protective cap.
10. Do not poke the nozzle if the spray does not work. Clean the spray tip with water.

It is important that you take your dose as prescribed by your doctor. Use only the amount recommended by your doctor.
Duration of treatment
Azelastine and Fluticasone Viatris nasal spray is intended for long-term use. The duration of treatment should correspond to the period during which allergy symptoms occur.
If you use more Azelastine and Fluticasone Viatris nasal spray than you should
If you spray an excessive dose of this medicine into your nose, it is unlikely that any serious problems will occur. If you are concerned or if you have used higher than recommended doses for a prolonged period, contact your doctor. In case of accidental ingestion of Azelastine and Fluticasone Viatris nasal spray, especially by a child, contact your doctor or the nearest hospital emergency department as soon as possible.
If you forget to use Azelastine and Fluticasone Viatris nasal spray
Use the nasal spray as soon as you remember, then take your next dose as usual. Do not use a double dose to make up for the missed dose.
If you stop using Azelastine and Fluticasone Viatris nasal spray
Do not stop using this medicine without first consulting your doctor, as this may reduce the effectiveness of treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Seek immediate medical help if you notice any of the following symptoms:

• Swelling of the face, lips, tongue or throat, which may cause difficulty swallowing/breathing and sudden onset of skin rash. These could be signs of a severe allergic reaction.

Other side effects include:
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 you tilt your head backwards when using the nasal spray. This should go away quickly if you sip a non-alcoholic drink for a few minutes after using this medicine.
• unpleasant odour

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

• mild irritation inside the nose. This may cause mild burning, itching or sneezing
• dry nose, cough, dry throat or sore throat

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, leading to loss of vision and/or red, painful eyes. These side effects have been reported after prolonged treatment with fluticasone propionate nasal sprays.
• damage to the skin and mucous membrane of the nose
• feeling unwell, weakness, fatigue or tiredness
• skin rash, itching or redness of the skin, raised itchy hives
• bronchospasm (narrowing of the airways in the lungs)

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

• blurred vision
• nasal ulcers

Systemic side effects (side effects affecting the whole body) may occur when this medicine is used at high doses for a prolonged period. It is much less likely that such effects will occur with a corticosteroid nasal spray than with oral corticosteroids. These effects may vary between individual patients and between different corticosteroid preparations (see section 2).
Nasal corticosteroids may affect the normal production of hormones in the body, particularly if high doses are used for a long time. In children and adolescents, this side effect may cause slowed growth.
In rare cases, reduced bone density (osteoporosis) has been observed when inhaled corticosteroids are administered for prolonged periods.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azelastine and Fluticasone Viatris nasal spray

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the box after "Exp.". The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Period of validity after first opening: dispose of unused medicine 6 months after first opening of the nasal spray.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azelastina e Fluticasone Viatris nasal spray contains
The active substances are: azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and
365 micrograms of fluticasone propionate.
Each spray (0.14 g) delivers 137 micrograms of azelastine hydrochloride
(= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other components are: disodium edetate, glycerol, microcrystalline cellulose, sodium carmellose,
polysorbate 80, benzalkonium chloride solution, phenylethyl alcohol and purified water.

Description of the appearance of Azelastina e Fluticasone Viatris nasal spray and contents of the
package
Azelastina e Fluticasone Viatris nasal spray is a white, homogeneous suspension.
Azelastina e Fluticasone Viatris nasal spray is supplied in an amber glass bottle equipped
with a spray pump, an applicator, and a protective cap.
The 10 mL bottle contains 6.4 g of nasal spray suspension (at least 28 sprays). The 25 mL bottle contains 23 g of nasal spray suspension (at least 120 sprays).
Azelastina e Fluticasone Viatris nasal spray is available in:
Packages containing 1 bottle with 6.4 g of nasal spray suspension
Packages containing 1 bottle with 23 g of nasal spray suspension
Multiple packs containing 10 bottles, each with 6.4 g of nasal spray suspension
Multiple packs containing 3 bottles, each with 23 g of nasal spray suspension
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstraße 1
D-61352 Bad Homburg
Germany
Haupt Pharma Amareg GmbH
Donaustaufer Straße 378
D-93055 Regensburg
Germany

This medicinal product is authorized in the European Economic Area countries under the following
names: