Icsori 250 micrograms/inhalation suspension for inhalation in pressurized container

Patient Information Leaflet

Introduction

Patient Information Leaflet

Icsori 250 micrograms/inhalation suspension for inhalation under pressure

fluticasone, propionate

Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are possible adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Icsori is and what it is used for

This medicine contains the active substance fluticasone propionate, which belongs to a group of medicines called corticosteroids.

Icsori works by reducing inflammation in the lungs. This helps prevent asthma attacks in patients who require regular treatment. This medicine takes 4 to 7 days to take effect, so it is very important that you use it regularly.

Icsori is not indicated for the treatment of acute asthma attacks, which involve sudden episodes of breathlessness. In such cases, another medicine will be needed to treat the acute attacks.

2. What you need to know before using Icsori

Do not use Icsori:

• if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Stop using Icsori immediately

• if you experience difficulty breathing with an immediate increase in wheezing right after taking a dose of this medicine.

Consult your doctor, pharmacist, or nurse before starting to use Icsori:

• if you have ever received treatment for tuberculosis (TB),
• if you have a history of diabetes mellitus (since fluticasone may increase blood glucose levels),
• if you have used high doses of this medicine for a prolonged period of time and experience the following symptoms:
• weight gain and facial rounding (moon face) (Cushing's syndrome),
• nonspecific symptoms such as abdominal pain, nausea, diarrhea, headache, or drowsiness (adrenal suppression, acute adrenal crisis). These symptoms are more likely during an infection, such as viral infections or stomach upset,
• loss of bone mass,
• eye problems (cataracts and glaucoma),
• growth retardation (this occurs mainly in children and adolescents).

If you are unsure whether any of the above apply to you, consult your doctor, nurse, or pharmacist before using Icsori.

Contact your doctor if you experience blurred vision or other visual disturbances.

Using Icsori with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Specifically, tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines used to treat various types of infections, such as ketoconazole, clarithromycin, telithromycin, atazanavir, indinavir, nelfinavir, or saquinavir.

• corticosteroid tablets, together with the Icsori inhaler or if you have recently stopped treatment with corticosteroid tablets. You should carry a steroid warning card, as there is a possibility of adrenal function disturbance, especially during stressful situations such as a serious accident or surgery, and your doctor may decide to administer additional corticosteroids for a period of time.

• Some medicines may increase the effects of Icsori, and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Icsori.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

It is unlikely that Icsori will affect your ability to drive or operate tools or machinery.

3. How to use Icsori

Icsori is available in two different dosage forms for inhalation use. Your doctor will decide the dose of medicine you need. Always follow your doctor's instructions on how to take this medicine. If in doubt, consult your doctor, nurse, or pharmacist again.

Use of this medicine

• Icsori can be used with a Volumatic spacer device in patients who have difficulty releasing a dose (actuation) of the medicine immediately after starting to inhale.

• The initial dose will be determined according to the severity of the disease. Your doctor will monitor your treatment and adjust the dose down to the lowest dose that effectively controls your asthma.

Adults and adolescents over 16 years of age:

The recommended dose is 50 to 500 micrograms twice daily.

Use in children

The use of Icsori is not recommended in children under 16 years of age.

If you are using high doses of inhaled corticosteroids over a prolonged period, you may occasionally require additional corticosteroids, for example, during stressful situations such as a traffic accident or before surgery. Your doctor may decide to prescribe additional corticosteroids during these periods.

Instructions for use

Your doctor, nurse, or pharmacist should show you how to use your inhaler. They should periodically check your inhaler technique. Incorrect use of Icsori or failure to use it as prescribed may result in inadequate improvement of asthma symptoms.

The medicine is packaged in a pressurized cartridge inside a plastic casing with a mouthpiece. To prevent blockage of the inhaler, it is important to clean it at least once a week.

Checking the inhaler

1. Before using the inhaler for the first time, check that it is working properly. Remove the mouthpiece cap by gently pressing the sides with your thumb and index finger, and then remove it.
2. To check that the inhaler is working correctly, shake it well, point the mouthpiece away from you, and press the cartridge to release four puffs into the air. If the inhaler has not been used for one week or longer, release two puffs into the air.

Using the inhaler

Just before using the inhaler, begin breathing out as slowly as possible.

1. You may do this either standing or sitting.

2. Remove the mouthpiece cap. Inspect the inside and outside of the mouthpiece to ensure it is clean and free from particles (figure A).

3. Shake the inhaler 4 or 5 times to ensure any foreign particles are removed and to properly mix the contents of the inhaler (figure B).

4. Hold the inhaler upright with your thumb placed at the base, below the mouthpiece. Breathe out as completely as possible (figure C). Do not inhale yet.

5. Place the inhaler mouthpiece between your teeth and close your lips around it. Do not bite it (see figure D).

6. Breathe in through your mouth, and just after starting to inhale, press the top of the cartridge to release one dose of the medicine. Continue inhaling deeply and steadily (figure D).

7. Hold your breath, remove the inhaler from your mouth, and remove your finger from the top of the inhaler. Continue holding your breath for a few seconds, or as long as possible (figure E).

8. If your doctor has instructed you to take two inhalations, wait approximately half a minute before taking the next dose, and repeat steps 3 to 7.

9. After use, rinse your mouth with water and spit it out. This may help prevent certain side effects in the mouth and throat. You may also brush your teeth.

10. After using the inhaler, always replace the mouthpiece cap to prevent dust accumulation. Replace the cap by firmly pushing it until you hear a click as it locks into place.

It is advisable to practice in front of a mirror the first few times. If you see a kind of "mist" escaping from the top of the inhaler or from the corners of your mouth, you should start again.

It may be helpful for older children or individuals with weak hand strength to hold the inhaler with both hands. Place both index fingers on top of the inhaler and both thumbs underneath the base, below the mouthpiece. Your doctor, nurse, or pharmacist will show you how to do this.

Cleaning the inhaler

To prevent blockage of the inhaler, it should be cleaned at least once a week.

To do this:

• Remove the mouthpiece cap.
• Do not remove the metal cartridge from the plastic casing.
• Clean the inside and outside of the mouthpiece and plastic casing with a dry cloth or a paper tissue.
• Replace the mouthpiece cap.

Do not immerse the metal cartridge in water.

If you use more Icsori than you should

If you have used more than the recommended dose, consult your doctor as soon as possible.

It is important to take the dose prescribed on your prescription or as directed by your doctor. Do not increase or decrease the dose without first consulting your doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.

If you forget to use Icsori

• Take your next dose at the usual scheduled time.
• Do not take a double dose to make up for the missed dose.

If you stop using Icsori

Do not stop your treatment, even if you feel better, unless your doctor tells you to. Patients who have been on high-dose corticosteroid treatment for a prolonged period should not stop taking the medicine without first consulting their doctor, as your asthma may worsen. Abruptly stopping treatment may also make you feel unwell and may cause symptoms such as vomiting, drowsiness, nausea, headache, fatigue, loss of appetite, low blood glucose levels, and seizures.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you experience any of the following serious adverse effects, stop using this medicine and consult your doctor immediately. You may require urgent medical treatment.

• Allergic reaction (may affect up to 1 in 100 patients) or severe allergic reactions (may affect up to 1 in 10,000 patients); signs include skin rash, redness, itching, or "hives or welts," and swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing, pruritic rash, feeling faint, dizziness, and collapse, respectively.
• Worsening of breathing or wheezing immediately after using the inhaler.

Other adverse effects are:

Very common (may affect more than 1 in 10 people)

• Oral and throat candidiasis.

Common (affect less than 1 in 10 people)

• Throat irritation and hoarseness
• Bruising
• Pneumonia (lung infection) in patients with COPD

Inform your doctor if you experience any of the following symptoms while inhaling Icsori, as they could be signs of a lung infection:

• Fever or chills
• Increased mucus production, change in mucus color
• Increased cough or increased breathing difficulties

Very rare (affect less than 1 in 10,000 people)

• Difficulty sleeping or feelings of anxiety, overexcitement, and irritability (these effects occur mainly in children),
• May increase blood sugar (glucose) levels,
• Long-term use of high doses of Icsori may cause: adrenal suppression, adrenal crisis, Cushing's syndrome, decreased bone density, eye problems (such as cataracts and glaucoma, which is high pressure in the eye), and growth retardation in children and adolescents (see Section 2 "Warnings and precautions").

To help prevent these symptoms, your doctor will ensure you are using the lowest corticosteroid dose that controls your asthma.

Frequency not known (cannot be estimated from available data)

• Depression,
• Feeling of restlessness or nervousness (these effects occur mainly in children),
• Blurred vision.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Icsori

Keep this medicine out of the sight and reach of children.

Clean your inhaler weekly, and if it becomes blocked, follow the instructions described in the section "Cleaning the inhaler".

Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month indicated.

The cartridge contains pressurised liquid. Do not expose to temperatures above 50°C. Do not refrigerate or freeze. Do not pierce the cartridge. Protect from very low temperatures and direct sunlight.

If the inhaler is very cold, remove the metal cartridge from the plastic housing and warm it in your hands for a few minutes before use. Never use other methods to heat it.

The metal cartridge is pressurised. Do not pierce, break, or burn it, even if it appears to be empty.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Icsori

• The active substance is fluticasone propionate. Each metered dose contains 250 micrograms of fluticasone propionate, which corresponds to an emitted dose of 227 micrograms of fluticasone propionate.
• This medicinal product contains fluorinated greenhouse gases.
• Each inhaler contains 12.5 g of HFC-134a (norflurane), equivalent to 0.018 tonnes of CO2 equivalent (global warming potential GWP = 1430).

Nature of the product and pack contents

• Icsori is a white suspension contained in a polymer-coated aluminium cartridge sealed with a metering valve, an actuator, and a protective cap.
• Pack sizes: Single pack—each pack contains one bottle with 120 actuations. Multipack—packaged with 2 or 3 packs. Hospital pack—packaged with 10 packs. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp, Belgium

Manufacturer

S&D Pharma CZ, spol. s.r.oTheodor 28,

273 08 Pchery, (Pharmos a.s. facility),

Czech Republic

or

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018 Antwerp, Belgium

Local representative

Cipla Europe NV, Spanish branch

C/ Guzmán el Bueno, 133, Edif Britannia - 28003 - Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/