Azelastine and fluticasone Zentiva

Patient Information Leaflet

Azelastine and Fluticasone Zentiva

137 micrograms/50 micrograms per dose nasal spray, suspension
Generic medicine
Please 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Azelastina and Fluticasone Zentiva contains two active substances: 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 during 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 symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with either an antihistamine or an intranasal corticosteroid alone is not considered sufficient.
Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, moulds, dust or pets.
Azelastina and Fluticasone Zentiva relieves allergy symptoms such as runny nose, postnasal drip, sneezing, nasal itching or nasal congestion.

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

Do not use Azelastine 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 Azelastine 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 prescribed a medicine for a nasal infection, you may continue using Azelastine and Fluticasone Zentiva for the treatment of your allergies.
• if you have tuberculosis or an untreated infection.
• if you have vision problems or 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 Zentiva.
• if you have impaired adrenal function. Extreme caution is required when switching from systemic corticosteroid therapy to Azelastine and Fluticasone Zentiva.
• if you have severe liver disease. Your risk of experiencing systemic side effects is higher.

In these cases, your doctor will decide whether you can use Azelastine and Fluticasone Zentiva.
It is important that you take your dose as indicated in section 3 below or as advised by your doctor.
Treatment with nasal corticosteroid doses higher than recommended may cause adrenal suppression, a condition that can lead to weight loss, fatigue, muscle weakness, low blood sugar levels, salt cravings, joint pain, depression, and darkening of the skin.
If these symptoms 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 effective dose that controls your rhinitis symptoms.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before using Azelastine and Fluticasone Zentiva.

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

Other medicines and Azelastine 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 may increase the effects of Azelastine and Fluticasone Zentiva, and your doctor may need to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Azelastine and Fluticasone Zentiva if you are taking sedatives or medicines that act on the central nervous system.

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 taking this medicine.

Driving and using machines
Azelastine and Fluticasone Zentiva has negligible influence on the ability to drive or use machines.
Very rarely, fatigue or dizziness may occur, either due to the underlying illness or to the use of Azelastine and Fluticasone Zentiva. In such cases, avoid driving or operating machinery. You should be aware that alcohol consumption may increase these effects.

Azelastine and Fluticasone Zentiva contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to use Azelastine and Fluticasone Zentiva

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is essential to use Azelastine and Fluticasone Zentiva regularly to achieve the full therapeutic benefit.
Avoid contact with the eyes.

Adults and adolescents (from 12 years of age)
The recommended dose is one spray into 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 or hepatic impairment
There are no data available in patients with renal or hepatic impairment.

Method of administration
For nasal use only.
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 downwards and upwards, 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 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 a).

a

5. The pump is now primed and ready for use.
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 about 5 seconds, tilting it downwards and upwards, then remove the protective cap.
2. Blow your nose to clear your nostrils.
3. Keep your head tilted forward slightly. Do not tilt your head backward.
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 breathe in gently (see figure b).

b

6. Breathe out through your mouth.
7. Repeat the same procedure for the other nostril.
8. Breathe in gently without tilting your head backward after administration. This will help prevent the medicine from running down your throat, which may cause an unpleasant taste.
9. After each use, wipe the spray tip with a tissue or clean cloth and replace the protective cap.
10. If you think the nozzle is blocked, do not use a pin or any other sharp object to clean it. Clean the spray tip with water.

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

Duration of treatment
Azelastine and Fluticasone Zentiva is suitable 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 Zentiva than you should
It is unlikely that you will experience problems if you spray an excessive dose of this medicine into your nose. 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 Zentiva, especially by a child, contact your doctor, hospital, or poison control center immediately.

If you forget to use Azelastine and Fluticasone Zentiva
Use the nasal spray as soon as you remember, then continue with your next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Azelastine and Fluticasone Zentiva
Do not stop using Azelastine and Fluticasone Zentiva without first consulting your doctor, as this may jeopardize the success of treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Azelastina e Fluticasone Zentiva can cause side effects,
although not everyone 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 backwards when using the nasal spray. This should disappear quickly if you sip a non-alcoholic drink for a few minutes after using this medicine
• unpleasant smell

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
• glaucoma, cataract or increased intraocular pressure, resulting in loss of vision and/or red, painful eyes. These side effects have been reported after prolonged treatment with fluticasone propionate nasal sprays.
• skin and nasal mucosa damage
• nausea, malaise, fatigue or weakness
• skin rash, itching or redness of the skin, urticaria
• bronchospasm (narrowing of the airways in the lungs)

Seek immediate medical help if you experience any of the following symptoms:

• swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing/breathing and sudden onset of skin rash. These could be signs of a severe allergic reaction. Note: This occurrence is very rare.

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 over a long period. It is much less likely that such effects will occur with a nasal corticosteroid 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 prolonged period. In children and adolescents, this side effect may cause slowed growth.
In rare cases, reduced bone mineral density (osteoporosis) has been observed when inhaled corticosteroids have been administered for a prolonged period.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Azelastine and Fluticasone Zentiva

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 the outer packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Duration of use after first opening: discard any 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 Zentiva 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, 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 or almost white, homogeneous suspension.
Azelastina e Fluticasone Zentiva is available in an amber glass bottle equipped with a spray pump, a nasal applicator and a protective closure cap.
The 25 mL bottle contains 23 g of nasal spray suspension (providing at least 120 sprays).
Azelastina e Fluticasone Zentiva is available as:
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 European Economic Area countries under the following names:
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 microgrammes/50 microgrammes, suspension pour pulvérisation nasale
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