Azelastine and fluticasone Substipharm

Patient Information Leaflet

Azelastine and Fluticasone Substipharm

137 micrograms/50 micrograms per dose, nasal spray, suspension
azelastine hydrochloride/fluticasone propionate
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 their symptoms are the same as yours, as it could 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 Substipharm is and what it is used for
2. What you need to know before using Azelastine and Fluticasone Substipharm
3. How to use Azelastine and Fluticasone Substipharm
4. Possible side effects
5. How to store Azelastine and Fluticasone Substipharm
6. Contents of the pack and other information

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

Azelastina e Fluticasone Substipharm 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 e Fluticasone Substipharm is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with either an antihistamine or a corticosteroid used alone via nasal route 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 e Fluticasone Substipharm 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 Substipharm

Do not use Azelastine 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 Azelastine 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 prescribed a medicine for a nasal infection, you may continue using Azelastine and Fluticasone Substipharm 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 Substipharm.
• If you have impaired adrenal function. Extreme caution is required when switching from systemic corticosteroid therapy to Azelastine and Fluticasone Substipharm.
• 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 Azelastine and Fluticasone Substipharm.
It is important that you take your dose as indicated in section 3 below or as advised by your doctor. Treatment with higher than recommended doses of intranasal corticosteroids may cause adrenal suppression, a condition that may 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 symptoms occur, your doctor may recommend an alternative 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 adequately controls your rhinitis symptoms.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are unsure whether any of the conditions listed above apply to you, speak to your doctor or pharmacist before using Azelastine and Fluticasone Substipharm.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
Long-term use of intranasal corticosteroids (such as Azelastine and Fluticasone Substipharm) may cause slowed growth in children and adolescents. Your doctor will regularly monitor your child's height and ensure they receive the lowest effective dose.

Other medicines and Azelastine and Fluticasone Substipharm
Inform 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 Substipharm, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Azelastine and Fluticasone Substipharm 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 breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Azelastine and Fluticasone Substipharm may have a slight effect on the ability to drive and use machines.
Very rarely, fatigue or dizziness may occur, either due to the underlying illness or to the use of Azelastine and Fluticasone Substipharm. In such cases, avoid driving or operating machinery. You should be aware that alcohol consumption may worsen these effects.

Azelastine and Fluticasone Substipharm 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 Substipharm

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

Use in 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
No data are 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. 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 both sides 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 the nostrils.
3. Keep your head tilted slightly forward (towards your feet). 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 through the nose (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 to take your dose as prescribed by your doctor. Use only the amount recommended by your doctor.

Duration of treatment
Azelastine and Fluticasone Substipharm 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 Substipharm than you should
If you spray an excessive dose of this medicine into your nose, it is unlikely to cause problems. However, if you are concerned or have used higher than recommended doses for a prolonged period, contact your doctor. In case of accidental ingestion of Azelastine and Fluticasone Substipharm, especially by a child, contact your doctor, hospital, or poison control center immediately.

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

If you stop using Azelastine and Fluticasone Substipharm
Do not stop using Azelastine and Fluticasone Substipharm without first consulting your doctor, as this may compromise 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, 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 backwards when using the nasal spray. This should disappear quickly if you drink a non-alcoholic beverage 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.
• dryness in the 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 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
• nausea, malaise, fatigue, or weakness
• skin rash, itching or redness of the skin, hives
• 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 or breathing, and sudden onset of skin rash. These could be signs of a severe allergic reaction. Note: this 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 corticosteroid nasal spray than with oral corticosteroids. These effects may vary between individual patients and different corticosteroid preparations (see section 2).

Nasal corticosteroids may affect the body's normal hormone production, particularly if high doses are used over a long period. In children and adolescents, this side effect may cause slowed growth.

In rare cases, reduced bone density (osteoporosis) has been observed when inhaled corticosteroids have been administered over a long period.

Reporting of side effects

If you experience any side effects, 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Azelastine and Fluticasone Substipharm

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 outer packaging after "Exp". The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Period of validity after first opening: discard 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Azelastina e Fluticasone Substipharm 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 dose (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 Substipharm and contents of the pack
Azelastina e Fluticasone Substipharm is a white to almost white, homogeneous suspension.
Azelastina e Fluticasone Substipharm is supplied in an amber glass bottle equipped with a
spray pump, an 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 Substipharm is available in:
packs containing 1 bottle of 23 g of nasal spray, suspension.

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
SE Azelastine /Fluticasone Substipharm
FR AZÉLASTINE CHLORHYDRATE/FLUTICASONE PROPIONATE SUBSTIPHARM
137 microgrammes/50 microgrammes, suspension pour pulvérisation nasale
IT Azelastina e Fluticasone Substipharm
DK Azelastinhydrochlorid/Fluticasonpropionat Substipharm
NO Azelastine hydrochloride/Fluticasone Substipharm