Patient Information Leaflet

Fluticasona Cipla 250 micrograms/inhalation suspension for inhalation in a pressurized container

Fluticasona, propionate

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

This medication contains the active substance propionate of fluticasona, which belongs to a group of medicationsknown as corticoesteroides.

Fluticasona Cipla acts by reducing inflammation in the lungs. This helps to prevent asthma attacks in patients who require regular treatment. This medication takes effect between 4 to 7days, so it is very important to use it regularly.

Fluticasona Cipla is not indicated for treating acute asthma attacks that cause sudden episodes of choking. In such cases, another medication will be necessary to treat acute attacks.

Do not use Fluticasona Cipla:

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

Warnings and precautions

Stop using Fluticasona Cipla immediately

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

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

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

If you are unsure about any of the above, consult your doctor, nurse, or pharmacist before using Fluticasona Cipla.

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

Use of Fluticasona Cipla with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those obtained without a prescription. In particular, inform your doctor or pharmacist if you are taking any of the following medications:

• medications used to treat various types of infections, such as ketoconazole, clarithromycin, telithromycin, atazanavir, indinavir, nelfinavir, or saquinavir.
• steroid tablets, in addition to the Fluticasona Cipla inhaler or after completing treatment with steroid tablets. You should carry a warning card about steroids, as there is a possibility of adrenal function impairment, especially during stressful situations such as a serious accident or surgery, and your doctor may decide to administer extra steroids for a period of time.

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

If you are unsure about any of the above, consult your doctor or pharmacist before taking Fluticasona Cipla.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

It is unlikely that Fluticasona Cipla will affect your ability to drive or use tools or machinery.

Fluticasona Cipla is marketed in two presentations of different doses for inhalation use. Your doctor will decide the dose of the medication you need. Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor, nurse, or pharmacist again.

Use of this medication

• Fluticasona Cipla can be used with a Volumatic inhalation chamber in patients who have difficulty releasing a dose (pulsation) of the medication just after starting to inhale.

• The initial dose will be indicated according to the severity of the disease. Your doctor will monitor your treatment to reduce the dose until the lowest dose that effectively controls asthma.

Adults and adolescents over 16 years old:

The recommended dose is 50 to 500 micrograms twice a day.

Use in children

The use of Fluticasona Cipla is not recommended in children under 16 years old.

If you are using high doses of inhaled corticosteroids for a prolonged period of time, it is possible that you may need more corticosteroids, for example, during stressful situations such as a car accident or before a surgical procedure. Your doctor may decide to prescribe more corticosteroids during these situations.

Instructions for use

Your doctor, nurse, or pharmacist should teach you how to use your inhaler. Periodically, they should check how you use it. Improper use of Fluticasona Cipla or not using it as prescribed may result in asthma not improving as it should.

The medication is packaged in a pressurized cartridge, inside a plastic casing with a mouthpiece. To avoid the inhaler becoming clogged, it is essential to clean it at least once a week.

Checking the inhaler

1. Before using the inhaler for the first time, check that it works properly. Remove the mouthpiece protector, pressing it gently with your thumb and index finger, and remove it.
2. To check that the inhaler works correctly, shake it well, direct the mouthpiece away from you, and press the cartridge to release four puffs of air. When you have not used the inhaler for a week or a longer period, release two puffs of air.

Using the inhaler

Just before using the inhaler, start breathing as slowly as possible.

1. You can do it both standing and sitting.

1. Remove the mouthpiece protector. Inspect the inside and outside of the mouthpiece to ensure it is clean and free of particles (Figure A).

3Shake the inhaler 4 or 5times to ensure the removal of any foreign particles and that the contents of the inhaler are mixed properly (Figure B).

4Hold the inhaler in a vertical position with your thumb positioned at the base, below the mouthpiece. Expel as much air from your lungs as possible (FigureC). Do not inhale yet.

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

6Inhale through your mouth and, just after starting to take air, press the top of the cartridge to release a dose of the medication. Continue inhaling deeply and constantly (Figure D).

7Hold 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).

8If your doctor has indicated that you should administer two inhalations, wait approximately half a minute before applying another inhalation and repeat steps 3 to 7.

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

10Just after using the inhaler, always put the mouthpiece protector back in place to prevent dust from accumulating. Put the protector back in place, pushing it firmly until you hear a click when it is in its correct position.

It is recommended that you practice in front of a mirror the first few times. If you notice a kind of "mist" coming out of the top of the inhaler or from the corners of your mouth, you should start again.

It may be helpful, for older children or people with little strength in their hands, to hold the inhaler with both hands. Place your two index fingers on the top of the inhaler and your two thumbs on the bottom, below the mouthpiece. Your doctor, nurse, or pharmacist will indicate how to do it.

Cleaning the inhaler

To avoid the inhaler becoming clogged, it is essential to clean it at least once a week.

To do this:

• Remove the mouthpiece protector.
• Do not remove the metal cartridge from the plastic casing.
• Clean the inside and outside of the mouthpiece and plastic casing with adry cloth or a paper towel
• Put the mouthpiece protector back in place.

Do not submerge the metal cartridge in water.

If you use more Fluticasona Cipla than you should

If you have used a higher dose than recommended,consult your doctor as soon as possible.

It is essential that you take the dose indicated on the prescription or as your doctor has indicated. Do not increase or decrease the dose without consulting your doctor first.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to use Fluticasona Cipla

• Take your next dose as scheduled.
• Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Fluticasona Cipla

Do not stop your treatment, even if you feel better, unless your doctor tells you to. Patients who have been on high doses of inhaled corticosteroids for a prolonged period of time should not stop taking the medication without consulting their doctor first, as their asthma may worsen. Sudden discontinuation of treatment may also cause discomfort and may cause symptoms such as vomiting, numbness, nausea, headache, fatigue, loss of appetite, decreased blood glucose levels, and seizures.

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

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

• Allergic reaction (can affect up to 1 in 100 patients) or severe allergic reactions (can affect up to 1 in 10,000 patients), symptoms include skin rashes, redness, itching or "hives or thistle-like" and swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing, itchy rash, feeling of fainting and dizziness, and collapse, respectively.
• If breathing or wheezing worsens immediately after using the inhaler.

Other side effects are:

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

• oral and throat candidiasis.

Common(affect less than 1 in 10people)

• throat irritation and hoarseness
• bruising
• bronchitis (lung infection) in patients with COPD

Inform your doctor if you have any of the following symptoms while inhaling Fluticasona Cipla, they may be symptoms of a lung infection:

• fever or chills
• increased mucus production, change in mucus color
• increased cough or difficulty breathing

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

• problems falling asleep or feelings of concern, overexcitement, and irritability (these effects appear mainly in children),
• may increase blood sugar (glucose) concentration,
• the use of high doses of Fluticasona Cipla for prolonged periods of time may cause: adrenal suppression, adrenal crisis, Cushing's syndrome, bone density decrease, eye problems (such as cataracts and glaucoma, which is high eye pressure) and growth delay in children and adolescents (see Section2 "Warnings and precautions").

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

Unknown frequency(cannot be estimated from available data)

• depression,
• feeling of restlessness or nervousness (these effects occur mainly in children),
• blurred vision.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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 medication after the expiration date that appears on the label and the box after CAD. The expiration date is the last day of the month indicated.

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

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

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Fluticasona Cipla

• The active ingredient is fluticasone propionate. Each measured dose contains 250 micrograms of fluticasone propionate, equivalent to a delivered dose of 227 micrograms of fluticasone propionate.
• This medication contains fluorinated greenhouse gases.
• Each inhaler contains 12.5 g of HFC-134a(norflurane)corresponding to 0.018 tons of CO2equivalent (global warming potential GWP = 1430).

Appearance of the product and contents of the package

• Fluticasona Cipla is a white suspension contained in an aluminum alloy cartridge treated with fluorocarbon polymer, sealed with a dosing valve, an applicator, and a protective cap.
• Package sizes: Single pack - each pack contains a bottle with 120 puffs. Multipack - packed with 2 or 3 packs. Hospital pack - packed with 10 packs. Some package sizes may only be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Cipla Europe NV

De Keyserlei 60C, Bus-1301,

2018, Antwerp,

Belgium

Responsible manufacturer

S&D Pharma CZ, spol. s.r.o
Theodor 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 subsidiary in Spain,

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

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet:January 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/