AZELASTINA 137 MICROGRAMS/50 MICROGRAMS Spray do nosa, zawiesina

Treść ulotki

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

Azelastina e Fluticasone Zentiva

137 micrograms/50 micrograms per nasal spray delivery, suspension
Generic medicine

Read this leaflet carefully before 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Azelastina and Fluticasone Zentiva and what is it used for

Azelastina and Fluticasone Zentiva contains two active ingredients: azelastine hydrochloride and fluticasone
propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing 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 a group of medicines called corticosteroids, which reduce inflammation.

Azelastina and Fluticasone Zentiva 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
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 Zentiva relieves allergy symptoms, such as runny nose, postnasal drip, sneezing, itchy nose or stuffy nose.

2. What you need to know before using Azelastina and Fluticasone Zentiva

Do not use Azelastina and Fluticasone Zentiva

• 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 and Fluticasone Zentiva.

• if you have recently had nasal surgery.
• if you have a nasal infection. Nasal airway infections should 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 and Fluticasone Zentiva to treat your allergies.
• if you have tuberculosis or an untreated infection.
• if you have changes in vision or a history of increased eye pressure, glaucoma and/or cataracts. If you have these conditions, you will be carefully monitored during use of Azelastina and Fluticasone Zentiva.
• if you suffer from adrenal insufficiency. Extreme caution is required when switching from systemic corticosteroid treatment to Azelastina and Fluticasone Zentiva.
• if you suffer from a severe liver disease. Your risk of experiencing undesirable systemic effects is greater.

In these cases, your doctor will decide whether or not you can use Azelastina and Fluticasone Zentiva.
It is important that you take your dose, as indicated in the following section 3 or as
advised by your doctor. Treatment with doses of nasal corticosteroids higher than
those recommended can cause adrenal suppression, a condition that can cause
weight loss, fatigue, muscle weakness, reduced blood sugar, 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
effectively controls your rhinitis symptoms.
Contact your doctor if you have blurred vision or other visual disturbances.
If you are unsure whether the conditions mentioned above apply to you, talk to your doctor
or pharmacist before using Azelastina and Fluticasone Zentiva.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
If taken for long periods, nasal corticosteroids (such as Azelastina and Fluticasone Zentiva)
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.

Other medicines and Azelastina and Fluticasone Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Some medicines can increase the effects of Azelastina and Fluticasone Zentiva 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). Do not use Azelastina and Fluticasone Zentiva if you are taking
sedatives or medicines that act on the central nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Azelastina and Fluticasone Zentiva has a negligible effect on the ability to drive and use
machines.
Very rarely, fatigue or dizziness may occur due to either the disease itself or
the use of Azelastina and Fluticasone Zentiva. In these cases, avoid driving or using
machines. You should be aware that consuming alcohol can increase these effects.

Azelastina and Fluticasone Zentiva contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per delivery. Benzalkonium
chloride can cause irritation and swelling inside the nose, especially if used for long
periods.

3. How to use Azelastina and Fluticasone Zentiva

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 Zentiva 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 renal and hepatic impairment
There is no data available on patients with renal and hepatic impairment.

Method of administration
For nasal use.
Read the following instructions carefully and use the spray only as directed.

INSTRUCTIONS FOR USE
Preparing the spray

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

a

• 5. Now the pump is primed and ready for use.
• 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 about 5 seconds, tilting it up and down and then remove the protective cap.
• 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, gently inhale (see figure b).

b

• 6. Exhale through your mouth.
• 7. Repeat the same procedure for the other nostril.
• 8. Gently inhale without tilting your head back after spraying. This will prevent the medicine from going down your throat, causing you to experience an unpleasant taste.
• 9. After each use, wipe the tip of the spray with a tissue or clean cloth and then reinsert the protective cap.
• 10. If you think the applicator is blocked, do not use a pin or other sharp object to clean it. 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 Zentiva is suitable for long-term use. The duration of treatment should
correspond to the period in which allergy symptoms occur.

If you use more Azelastina and Fluticasone Zentiva than you should
If you spray an excessive dose of this medicine into your nose, it is unlikely that you will have problems. If you
are concerned 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 Zentiva, especially by
a child, contact your doctor, hospital or poison control center as soon as possible.

If you forget to use Azelastina and Fluticasone Zentiva
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 a missed dose.

If you stop using Azelastina and Fluticasone Zentiva
Do not stop using Azelastina and Fluticasone Zentiva without asking your doctor, as
this puts the success of the treatment at risk.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Azelastina e Fluticasone Zentiva can cause side effects,
although not everybody gets them.
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 back when using the nasal spray. It 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 or irritated 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
• glaucoma, cataracts or increased pressure in the eye, resulting in loss of vision and/or red and 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 of nausea, fatigue, tiredness or weakness
• skin rash, itching or redness of the skin, hives
• bronchospasm (narrowing of the airways in the lungs)

Seek immediate medical attention if you experience 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 may be signs of a severe allergic reaction. Note: This is very rare.

Side effects with frequency not known (the frequency cannot be estimated from the 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. It is
less likely that these effects occur if you use a nasal spray containing
corticosteroids, compared to taking corticosteroids by mouth. These effects can vary
among individual patients and between different corticosteroid preparations (see section 2).
Nasal corticosteroids can affect the normal production of hormones in the body, in
particular 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. 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 Zentiva

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
outer packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Shelf life after first opening: dispose of 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. Contents of the pack and other information

What contains Azelastina e Fluticasone Zentiva

• 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, phenylethyl alcohol and purified water.

Description of the appearance of Azelastina e Fluticasone Zentiva and contents of the pack
Azelastina e Fluticasone Zentiva is a white to almost white, homogeneous suspension.
Azelastina e Fluticasone Zentiva is available in an amber glass bottle, equipped with a
spray pump, an applicator and a protective closing cap.
The 25 mL bottle contains 23 g of nasal spray, suspension (at least 120 actuations).
Azelastina e Fluticasone Zentiva is presented in:
pack containing 1 bottle with 23 g of nasal spray, suspension

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via Paleocapa, 7
20121 Milano
Italy

Manufacturer
Farmea
Zac D Orgemont
10 Rue Bouche Thomas
Angers, 49000,
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: Azelastin/Fluticason Zentiva 137 Mikrogramm/50 Mikrogramm pro Sprühstoß
Nasenspray, Suspension
Denmark, Czech Republic, Norway, Slovakia, Sweden: Lutonaze
France: AZELASTINE CHLORHYDRATE / FLUTICASONE PROPIONATE ZENTIVA
137 micrograms/50 micrograms, suspension for nasal spray
Italy: Azelastina e Fluticasone Zentiva
Hungary: Lutonaze 137 mikrogramm/50 mikrogramm szuszpenziós orrspray
Lithuania: AZAVIN 137 mikrogramai/50 mikrogramų/dozėje nosies purškalas (suspensija)
Poland: Flazena
Romania: Lutonaze 137 micrograme/50 micrograme/doza spray nazal, suspensie