AZELASTINA 137 MICROGRAMS/50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

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

Azelastina e Fluticasone Substipharm

137 micrograms/50 micrograms per actuation, nasal spray, suspension

azelastine hydrochloride/fluticasone propionate

Generic medicine

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 they have the same symptoms as you, as it may 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 Substipharm is and what it is used for
• 2. What you need to know before you use Azelastina e Fluticasone Substipharm
• 3. How to use Azelastina e Fluticasone Substipharm
• 4. Possible side effects
• 5. How to store Azelastina e Fluticasone Substipharm
• 6. Contents of the pack and other information

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

Azelastina and Fluticasone Substipharm 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 Substipharm 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 Substipharm 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 Substipharm

Do not use Azelastina and Fluticasone Substipharm

• 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 Substipharm .

• 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 Substipharm 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 the use of Azelastina and Fluticasone Substipharm
• If you suffer from adrenal insufficiency. Extreme caution should be exercised when switching from systemic corticosteroid treatment to Azelastina and Fluticasone Substipharm
• 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 Azelastina and Fluticasone Substipharm .
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 corticosteroids administered via the nasal route 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 capable of
effectively controlling 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 Substipharm .
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
Substipharm )can cause a slowing of growth in children and adolescents. Your doctor
will regularly check your child's height and ensure that they take the lowest effective dose
possible.

Other medicines and Azelastina and Fluticasone Substipharm
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 Substipharm 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 Substipharm if you are taking
sedatives or medicines that act on the central nervous system.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Azelastina and Fluticasone Substipharm slightly impairs the ability to drive and operate
machinery.
Very rarely, fatigue or dizziness may occur due to either the disease itself or
the use of Azelastina and Fluticasone Substipharm .In these cases, avoid driving or operating
machinery. You should be aware that consuming alcohol can increase these effects.

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

3. How to use Azelastina and Fluticasone Substipharm

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 Substipharm regularly to obtain the full
therapeutic benefit.
Avoid contact with the eyes.

Use in 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 closing 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, then remove the protective closing 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 taste an unpleasant flavor.
• 9. After each use, wipe the tip of the spray with a tissue or clean cloth and then reinsert the protective closing 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 Substipharm 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 Substipharm 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 Substipharm, especially by a
child, contact your doctor, hospital or poison control center as soon as possible.

If you forget to use Azelastina and Fluticasone Substipharm
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 Substipharm
Do not stop using Azelastina and Fluticasone Substipharm 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 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 sensation, 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

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

• dizziness or drowsiness
• glaucoma, cataracts or increased pressure inside the eye, leading to 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, weakness, fatigue, or asthenia
• 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 could be signs of a severe allergic reaction. Note: this is very rare

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

• blurred vision
• nasal ulcers

Systemic side effects (side effects involving the whole body) are possible 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 between individual patients and between different corticosteroid preparations (see section 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. 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 e Fluticasone Substipharm

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 "Scad". 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 Substipharm 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, phenylethyl alcohol and purified water.

Description of the appearance of Azelastina e Fluticasone Substipharm and package contents
Azelastina e Fluticasone Substipharm is a suspension from white to almost white, homogeneous.
Azelastina e Fluticasone Substipharm 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 Substipharm is presented in:
packs containing 1 bottle of 23 g of nasal spray, suspension

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUBSTIPHARM, 24 Rue Erlanger, 75016 Paris - France
Manufacturer
FARMEA
ZAC D’Orgemont
10, rue Bouché Thomas
49000 Angers
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
SE Azelastine /Fluticasone Substipharm
FR AZÉLASTINE CHLORHYDRATE/FLUTICASONE PROPIONATE SUBSTIPHARM
137 micrograms/50 micrograms, nasal spray suspension
IT Azelastina e Fluticasone Substipharm
DK Azelastinhydrochlorid/Fluticasonpropionat Substipharm
NO Azelastine hydrochloride/Fluticasone Substipharm