AZELASTINA 137 MICROGRAMS/50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. Azelastina e Fluticasone Viatris 137 micrograms/50 micrograms per actuation nasal spray
2. azelastine hydrochloride/fluticasone propionate
   1. What is Azelastina and Fluticasone Viatris nasal spray and what is it used for
   2. What you need to know before using Azelastina e Fluticasone Viatris nasal spray
   3. How to use Azelastina and Fluticasone Viatris nasal spray
   4. Possible side effects
   5. How to store Azelastina and Fluticasone Viatris nasal spray
   6. Package contents and other information

Azelastina e Fluticasone Viatris 137 micrograms/50 micrograms per actuation nasal spray

nasal, suspension

azelastine hydrochloride/fluticasone propionate

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Azelastina and Fluticasone Viatris nasal spray contains two active ingredients: azelastine hydrochloride and
fluticasone propionate.

• Azelastine hydrochloride belongs to the pharmacotherapeutic category of antihistamines. Antihistamines work by blocking the effects of substances such as histamine, which the body produces following an allergic reaction, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to the pharmacotherapeutic category of corticosteroids, which reduce inflammation. Azelastina and Fluticasone Viatris nasal spray is used to relieve the symptoms of seasonal and perennial allergic rhinitis, from moderate to severe, when the use of antihistamine alone or corticosteroid alone via the intranasal route is not considered sufficient.

Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), dust mites, molds, dust or pets.
Azelastina and Fluticasone Viatris nasal spray relieves allergy symptoms, such as excessive
nasal mucus production, runny nose, sneezing, itchy nose or stuffy nose.

2. What you need to know before using Azelastina e Fluticasone Viatris nasal spray

Do not use Azelastina e 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 Azelastina e Fluticasone Viatris nasal spray:

• if you have recently had nasal surgery
• if you have had a nasal infection. Nasal and airway infections must be treated with an antibacterial or antifungal medicine. If you have been given a medicine for a nasal infection, you can continue to use Azelastina e Fluticasone Viatris nasal spray to treat your allergies
• if you have tuberculosis or an untreated infection
• if you have had vision disorders or if you have a history of increased eye pressure, glaucoma and/or cataracts. If you have these conditions, you will be carefully monitored during the use of Azelastina e Fluticasone Viatris nasal spray
• if you suffer from adrenal insufficiency. Extreme caution should be exercised when switching from systemic corticosteroid treatment to Azelastina e Fluticasone Viatris nasal spray
• if you suffer from a severe liver disease. Your risk of developing undesirable systemic effects is greater.

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 the following section 3 or
as recommended by your doctor. Treatment with doses of inhaled corticosteroids higher than those
recommended can cause adrenal suppression, a condition that can cause weight loss, fatigue, muscle weakness, reduced 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 in case of elective surgery.
To avoid adrenal suppression, your doctor will advise you to take the lowest dose that can
effectively control your rhinitis symptoms.
If taken for long periods, inhaled corticosteroids (such as Azelastina e Fluticasone Viatris nasal spray) can cause a slowing of growth in children and adolescents. Your doctor will regularly check
your child's height and ensure they take the lowest effective dose possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure whether the conditions mentioned above apply to you, talk to 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 Azelastina e Fluticasone Viatris nasal spray
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can increase the effects of Azelastina e Fluticasone Viatris nasal spray and your
doctor may want to keep you under close observation if you are taking these medicines
(including some medicines for the treatment of HIV: ritonavir, cobicistat and medicines for the
treatment of fungal infections: ketoconazole).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using Azelastina e Fluticasone Viatris
nasal spray.

Driving and using machines
Azelastina e Fluticasone Viatris nasal spray negligibly alters the ability to drive vehicles
and use machines.
Very rarely, fatigue or dizziness may occur due to the disease itself or
the use of Azelastina e Fluticasone Viatris nasal spray. In these cases, avoid driving or
using machines. You should be aware that consuming alcohol can increase these
effects.

Azelastina e Fluticasone Viatris nasal spray contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per actuation, equivalent to
0.014 mg/0.14 g. Benzalkonium chloride can cause irritation and swelling inside the nose,
especially if used for long periods.

3. How to use Azelastina and Fluticasone Viatris nasal spray

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
It is essential to use Azelastina and Fluticasone Viatris nasal spray regularly to obtain the
full therapeutic benefit.
Avoid contact with the eyes.

Adults and adolescents (from 12 years of age)

• The recommended dose is one spray in each nostril in the morning and evening.

Use in children under 12 years of age

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

Use in patients with impaired renal and hepatic function

• No data are available on patients with renal and hepatic insufficiency.

Method of administration
For nasal use.
Read what is reported in this leaflet and follow the instructions.

INSTRUCTIONS FOR USE
Preparing the spray

• 1. Gently shake the bottle for 5 seconds, tilting it up and down, then remove the protective cap (see figure 1).

Figure 1

• 2. The first time you use the nasal spray, you must prime the pump by spraying the product into the air.

• 3. Prime the pump by placing two fingers on both sides of the spray pump and placing your thumb on the base of the bottle.
• 4. Press down and release the pump 6 times, until a fine mist comes out (see figure 2).
• 5. Now the pump is primed and ready for use. Figure 2

• 6. If the nasal spray has not been used for more than 7 days, you will need to re-prime the pump once, by pressing and releasing the pump itself.

Using the spray

• 1. Gently shake the bottle for 5 seconds, tilting it up and down, then remove the protective cap (see figure 1).
• 2. Blow your nose to clear your nostrils.
• 3. Keep your head tilted downwards towards your feet. Do not tilt your head back.
• 4. Hold the bottle upright and gently insert the tip of the spray 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. Exhale through your mouth.

Figure 3

• 7. Repeat the same procedure for the other nostril.
• 8. Inhale gently without tilting your head back after spraying. This will prevent the medicine from going down your throat, causing you to experience an unpleasant taste (see figure 4).

Figure 4

• 9. After each use, wipe the tip of the spray with a tissue or a clean cloth and then reinsert the protective cap.
• 10. Do not poke the nozzle if you do not get the spray. Clean the tip of the spray with water.

It is important that you take your dose as recommended by your doctor. Use only the amount recommended
by your doctor.

Duration of treatment
Azelastina and Fluticasone Viatris nasal spray is indicated for long-term use. The duration of
treatment should correspond to the period in which the symptoms of allergy manifest.

If you use moreAzelastina and Fluticasone Viatris nasal spraythan you should
If you spray an excessive dose of this medicine into your nose, it is unlikely that any
problems will occur. If you are worried or if you have used higher doses than recommended for a long
period, contact your doctor. In case of accidental ingestion of Azelastina and Fluticasone Viatris nasal
spray, especially by a child, contact your doctor or the nearest
hospital emergency room as soon as possible.

If you forget to use Azelastina and Fluticasone Viatris nasal spray
Use the nasal spray as soon as you remember, then take the next dose as usual. Do not
take a double dose to make up for the missed dose.

If you stop using Azelastina and Fluticasone Viatris nasal spray
Do not stop using this medicine without asking your doctor, as this puts
the success of the treatment at risk.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Seek immediate medical assistance if you notice any of the following symptoms:

• Swelling of the face, lips, tongue or throat, which can cause difficulty swallowing/breathing and sudden onset of 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) :

• nosebleed

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

• headache
• bitter taste in the mouth, especially if you tilt your head back when using the nasal spray. This should disappear quickly if you sip a non-alcoholic beverage for a few minutes after using this medicine.
• unpleasant smell

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

• mild irritation of the inside of the nose. This can cause a slight burning, itching or sneezing
• nasal dryness, cough, dry throat or throat irritation

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

• dry mouth

Uncommon side effects(may affect up to 1 in 10,000 people) :

• dizziness or drowsiness
• cataract, glaucoma or increased eye pressure, resulting in loss of vision and/or red and painful eyes. These side effects have been reported after prolonged treatment with fluticasone propionate-based nasal sprays.
• damage to the skin and mucous membrane of the nose
• feeling unwell, exhaustion, fatigue or weakness
• rash, itching or redness of the skin, raised itchy welts
• bronchospasm (narrowing of the airways in the lungs)

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

• blurred vision
• Nasal ulcers

It is possible that systemic side effects (side effects involving the whole body) may occur when this medicine is used at high doses for a long period. These effects are much less likely to occur if you use a corticosteroid nasal spray, compared to taking corticosteroids by mouth. These effects can vary in individual patients and between different corticosteroid preparations (see paragraph 2)
Nasal corticosteroids can affect the normal production of hormones in the body, particularly if you use high doses for a long period. In children and adolescents, this side effect can cause a slowing of growth.
In rare cases, a reduction in bone density (osteoporosis) has been observed when inhaled corticosteroids have been administered for a long period.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Azelastina 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 which is stated on the label of the bottle and on the
pack after “Exp.”. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Shelf life after first opening: discard any unused medicine 6 months after the first
opening of the nasal spray.
Do not dispose of any medicine in 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 ingredients are: azelastine hydrochloride and fluticasone propionate.
Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and
365 micrograms of fluticasone propionate.
Each actuation (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 carboxymethylcellulose,
polysorbate 80, benzalkonium chloride solution, phenyl ethyl alcohol and purified water.

Description of the appearance ofAzelastina e Fluticasone Viatris nasal sprayand contents of the
pack
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 actuations). The 25 mL bottle contains 23 g of nasal spray, suspension (at least 120 actuations).
Azelastina e Fluticasone Viatris nasal spray is available in:
Packs containing 1 bottle with 6.4 g of nasal spray, suspension
Packs containing 1 bottle with 23 g of nasal spray, suspension
Multipacks comprising 10 bottles, each containing 6.4 g of nasal spray, suspension
Multipacks comprising 3 bottles, each containing 23 g of nasal spray, suspension
Not all pack sizes may be marketed.

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

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 authorised in the Member States of the European Economic Area with the following
names: