KORTANT 137 MICROGRAMS/50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

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

Kortant

137 micrograms/50 micrograms per actuation,
nasal spray, suspension
azelastine hydrochloride/fluticasone propionate

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 Kortant is and what it is used for
• 2. What you need to know before you use 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 is Kortant and what is it used for

Kortant 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.

Kortant 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 the 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.
Kortant relieves allergy symptoms, such as runny nose, postnasal drip, sneezing, itchy
nose or stuffy nose.

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
• if you have an infection in your nose. Nasal airway infections must be treated with an antibacterial or antifungal medicine. If you have been given a medicine for an infection in your nose, you can continue to use Kortant to treat your allergies.
• if you have tuberculosis or an untreated infection
• if you have changes in vision or if you have a history of increased eye pressure, glaucoma and/or cataracts. If you have these conditions, you will be carefully monitored during use of Kortant
• if you suffer from adrenal insufficiency. Extreme caution should be exercised when switching from systemic corticosteroid treatment to Kortant
• 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 Kortant.
It is important that you take your dose, as indicated in section 3 below or as recommended
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 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 that can
effectively control your rhinitis symptoms.
Contact your doctor if you have blurred vision or other visual disturbances.
If you are not sure whether the conditions mentioned above apply to you, talk to 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.
If taken for long periods, nasal corticosteroids (such as Kortant) 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 Kortant
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 Kortant and your doctor may want to monitor you
closely 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 Kortant if you are taking sedatives or medicines that affect the central nervous system.

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

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

Kortant 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 take Kortant

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
It is essential to use Kortant regularly, to obtain the full therapeutic benefit.
Avoid contact with 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
No data are 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 place 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 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 cap.
• 10. If you think the applicator is blocked, do not use a pin or other sharp objects 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
Kortant is suitable for long-term use. The duration of treatment should correspond to the period in
which the symptoms of allergy occur.

If you use more Kortant 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 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 as usual. Do not
take a double dose to make up for a missed dose.

If you stop taking Kortant
Do not stop using Kortant without asking your doctor, as this puts the success of
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. This 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 sensation, 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 inside the eye, leading to vision loss 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, raised itchy welts
• 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 (frequency cannot be estimated from 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. 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 in 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 effect
may cause a slowing of growth.
In rare cases, a decrease in bone density (osteoporosis) has been observed when corticosteroids
nasal sprays have been administered for a long period.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 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.
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. Contents of the pack and other information

What Kortant 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 Kortant and contents of the pack
Kortant is a suspension from white to almost white, homogeneous.
Kortant is available in an amber-colored 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).
Kortant is presented in:
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)
Manufacturer
Farmea
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France
This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Sweden Emmacortal - 137 micrograms/50 micrograms/spray
Italy Kortant - 137 micrograms/50 micrograms per actuation,
nasal spray, suspension