Kortant

Patient Information Leaflet

Kortant

137 micrograms/50 micrograms per spray,
nasal spray, suspension
azelastine hydrochloride/fluticasone propionate
Please read all of this leaflet carefully before you start using this medicine because 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 others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Kortant is and what it is used for

Kortant 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.

Kortant is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis
when treatment with either an antihistamine or a corticosteroid alone, administered intranasally, is not considered
sufficient.
Seasonal and perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, moulds, dust, or pets.
Kortant relieves allergy symptoms such as runny nose, postnasal drip, sneezing, nasal itching, or nasal congestion.

2. What you need to know before using Kortant

Do not use Kortant

• 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 Kortant if:

• you have recently had nasal surgery
• 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 Kortant for the treatment of your allergies.
• you have tuberculosis or an untreated infection
• you have vision problems or a history of increased intraocular pressure, glaucoma, and/or cataracts. If any of these apply to you, you will be closely monitored during treatment with Kortant
• you have impaired adrenal function. Extreme caution is required when switching from systemic corticosteroid therapy to Kortant
• you have severe liver disease. Your risk of experiencing systemic undesirable effects is higher.

In these cases, your doctor will decide whether you can use Kortant.
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, 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 dose that effectively 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, discuss this with your doctor or pharmacist before using Kortant.

Children and adolescents
The use of this medicine is not recommended in children under 12 years of age.
When used for prolonged periods, nasal corticosteroids (such as Kortant) 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 Kortant
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Kortant, and your doctor may want to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Kortant 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
Kortant has a negligible effect on the ability to drive and use machines.
Very rarely, fatigue or dizziness may occur, either due to the illness itself or to the use of Kortant. In such cases, avoid driving or operating machinery. You should be aware that alcohol consumption may worsen these effects.

Kortant 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 take Kortant

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
It is essential to use Kortant 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
This medicine is not recommended for use in children under 12 years of age.

Use in patients with renal or hepatic impairment
Data are not available for 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 up and down, 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. To prime the pump, place two fingers on both sides of the spray pump and place 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 up and down, then remove the protective cap.
2. Blow your nose to clear the nostrils.
3. Keep your head tilted slightly forward. 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 inhale 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 and causing 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 other sharp objects to clean it. Clean the spray tip 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
Kortant is suitable for long-term use. The duration of treatment should correspond to the period during which allergy symptoms occur.

If you use more Kortant 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 Kortant, especially by a child, contact your doctor, hospital, or poison control center as soon as possible.

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

If you stop using Kortant
Do not stop using Kortant 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, 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 go away quickly if you sip a non-alcoholic drink for 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
• 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 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, raised itchy rashes (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 swallowing/breathing and sudden onset of skin rash. These may 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 for a prolonged 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 normal production of hormones in the body, particularly if high doses are used for a long time. In children and adolescents, this side effect may cause slowed growth.

In rare cases, reduced bone density (osteoporosis) has been observed when nasal 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kortant

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.
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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Kortant 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 actuation (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 Kortant and contents of the package
Kortant is a white to almost white, homogeneous suspension.
Kortant is available 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 actuations).
Kortant is available as:
packs containing 1 bottle of 23 g of nasal spray, suspension.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farma Group S.r.l.
Via Farfisa, 18
60021 Camerano (AN), Italy

Manufacturer
Farmea
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France

This medicinal product is authorised in the European Economic Area Member States under the following names:
Sweden Emmacortal - 137 microgram/50 microgram/spray
Italy Kortant - 137 micrograms/50 micrograms per actuation, nasal spray, suspension