Patient Information Leaflet

Quinsair 240mg solution for inhalation by nebulizer

levofloxacino

Please read this leaflet carefully before you start using this medicine, as 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this leaflet. See section4.

1.What Quinsair is and what it is used for

2.What you need to know before you start using Quinsair

3.How to use Quinsair

4.Possible side effects

5.Storage of Quinsair

6.Contents of the pack and additional information

Quinsair contains an antibiotic medication called levofloxacino. It belongs to a group of antibiotics called fluoroquinolonas.

Quinsair is used to treatlung infectionscaused byPseudomonas aeruginosain adults withcystic fibrosis. If the infection is not properly controlled, it will continue to damage your lungs, and cause further respiratory problems.

No use Quinsair:

• if you areallergictolevofloxacin,or to any otherquinolone antibiotic, such as moxifloxacino, ciprofloxacino, or ofloxacino, or to any of the other components of this medication (listed in section6)
• if you have ever had problems with your tendons(inflammationorrupture of a tendon) during treatment with aquinolone or fluoroquinolone antibiotic
• if you haveepilepsy
• if you arepregnantorbreastfeeding

Warnings and precautions

Before starting to take this medication

You should not take fluoroquinolone or quinolone antibiotics, including Quinsair, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

During treatment with this medication

In rare cases, you may experience pain and swelling in the joints and inflammation or rupture of tendons. The risk is higher if you are over 60 years old, have received an organ transplant, have kidney problems, or are taking corticosteroids. Inflammation and tendon rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Quinsair. If you experience any signs of pain or inflammation of a tendon (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking Quinsair, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as it may increase the risk of tendon rupture.

Inform your doctor before starting to use Quinsairif you have or have had any of the following conditions:

• Severe, long-lasting, disabling, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, including Quinsair, have been associated with rare but severe adverse effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, burning, or itching (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Quinsair, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of an antibiotic of another class.

• Kidney problems

• Asevere allergic reaction. The symptoms are listed in section4.

• Severe skin reactions

If you receive treatment with Quinsair, you may experience a severe skin reaction such as blistering or lesions. Inform your doctor if you notice any skin reaction after using Quinsair.

• Liver problems. The symptoms are listed in section4,

• Cardiac rhythm disorders

Quinsair may cause changes in your heart rhythm, especially if you are taking medications to treat heart problems or have low levels of potassium or magnesium in your blood. Women taking these medications are more likely to be affected. If you experience palpitations or irregular heartbeat while taking Quinsair, inform your doctor immediately.

• Seizures and convulsions

Fluoroquinolone antibiotics, including Quinsair, may cause seizures or convulsions. If this occurs, stop using Quinsair and contact your doctor immediately.

• Depressionormental health problems

• Nerve damage

In rare cases, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, itching, numbness, tingling, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Quinsair and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• In a disease that causes muscle weakness and fatigue calledmyasthenia gravis.

• Inflammation of a tendon that causespain, stiffness, and/or swelling in the joints(tendinitis)

• Difficulty breathingthat may be mild or severe (bronchospasm)

• Coughing or mucous with bloodfrom the respiratory tract

• Glucose-6-phosphate dehydrogenase deficiency

In patients with glucose-6-phosphate dehydrogenase deficiency (a rare inherited disease), fluoroquinolone antibiotics, such as Quinsair, may cause an increased risk of blood complications (hematological) that can lead to a sudden increase in body temperature, yellowing of the skin and mucous membranes, dark urine, pallor, fatigue, rapid and labored breathing, and a weak and rapid pulse. Consult your doctor if you are unsure.

• Diabetes

Fluoroquinolone antibiotics, including Quinsair, may cause high or low blood sugar levels. If you are diabetic, you should carefully control your blood sugar levels.

• Dysentery

You may experience diarrhea during or after treatment with Quinsair. If diarrhea becomes severe or persistent, or if you notice blood in your stool, stop using Quinsair immediately and consult your doctor. Do not take any medication for diarrhea without consulting your doctor first.

• Antibiotic resistance

Bacteria may become resistant to treatment with an antibiotic over time. This means that Quinsair should not be used to prevent lung infections. It should only be used to treat lung infections caused byPseudomonas aeruginosa.Consult your doctor if you have any doubts or concerns about this.

• Superinfections

Occasionally, prolonged treatment with antibiotics can lead to the development of another infection caused by bacteria that are not affected by the antibiotic (superinfection). Consult your doctor if you have any doubts or concerns about superinfection and the use of Quinsair.

• Visual problems

If you notice any changes in your vision or any other eye problems while taking Quinsair, contact an ophthalmologist immediately.

• Sensitivity to light

Quinsair may make your skin more sensitive to sunlight. You should avoid prolonged exposure to sunlight and intense sunlight, and do not use sunbeds or any other UV lamps while taking Quinsair and for 48 hours after stopping treatment.

• Falsely positive test results

Determined tests (e.g., to confirm tuberculosis or detect strong analgesics) may produce false results while you are being treated with Quinsair.

If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel).

If you have had a previous episode of aortic dissection (tear in the wall of the aorta).

If you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or known atherosclerosis).

If you experience a severe and sudden pain in the abdomen, chest, or back, go to an emergency department immediately.

Children and adolescents

Quinsair should not be administered to children or adolescents under 18 years old, as there is not enough information available about its use in this age group.

Use of Quinsair with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. These medications may interact with the effects of Quinsair.

Inform your doctorif you are taking any of the following medications:

• Anticoagulants such aswarfarin(used to prevent blood clots). Taking these medications with Quinsair may increase the risk of bleeding. Your doctor may need to perform regular blood tests to check if your blood clots properly.

• Theophylline(used to treat respiratory problems) or nonsteroidal anti-inflammatory drugs (NSAIDs) such asfenbufen,aspirin(a component of many medications used to relieve pain and reduce fever, as well as to prevent blood clots) oribuprofen. Taking Quinsair at the same time as these medications may increase the risk of seizures.

• Medications such asprobenecid(used to prevent gout) orcimetidine(used to treat ulcers). Taking Quinsair at the same time as these medications may affect how your kidneys process the medication, which is particularly important if you have kidney problems.

• Ciclosporin(used after organ transplants) ormedications that affect heart rhythm(such as antiarrhythmics, tricyclic antidepressants, macrolide antibiotics, and antipsychotics). Quinsair may interact with the effects of these medications. Your doctor will explain this in more detail.

Pregnancy and breastfeeding

Quinsair should not be used while pregnant or breastfeeding.Inform your doctorif you arepregnantor inbreastfeeding, think you may be pregnant, or plan to become pregnant.

Driving and operating machinery

Quinsair may cause dizziness, fatigue, or weakness, or cause visual problems. If you experience any of these symptoms, do not drive or operate tools or machinery.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

How much product should I use?

Inhale the contents ofone ampoule (240mg) twice a day using the Zirela nebulizer system.It takes around 5minutes to inhale the medication with the nebulizer.

When should I use it?

Inhaling Quinsair at the same time every day will help you remember when to take the medication. Inhale the medication as follows:

• 1ampoule in the morning using the Zirela nebulizer
• 1ampoule at night using the Zirela nebulizer

It is ideal to leave a gap of around 12hours between the two doses.

For how long should I use it?

You should use Quinsair every day for 28days and then take a break of 28days during which you will not inhale Quinsair. After that, you will start a new treatment cycle.

It is essential to continue using the medication twice a day during the 28days of treatment and maintain the cycle of 28days with treatment and 28days without treatment for the time your doctor indicates.

If I experience breathing difficulties while using Quinsair, what additional medication can my doctor prescribe?

If you experience breathing difficulties after using Quinsair, your doctor may prescribe an inhaler containing a bronchodilator medication (e.g. salbutamol). Inhale this medication at least 15minutes and up to 4hours before your next dose of Quinsair.

What happens if I am using multiple inhalers and other treatments for cystic fibrosis?

If you are receiving multiple inhaled medications and other treatments for cystic fibrosis, it is recommended that you use the medications in the following order:

1stBronchodilators

2ndDornase alfa

3rdAirway permeabilization techniques

4thQuinsair

5thInhaled steroids

How to use it

Quinsair should be administered by inhalation using ahandheld nebulizer Zirela(which includes a Zirela aerosol head). This should be connected either to an eBase controller or to an eFlow rapid control unit.

Important information to know before starting

• Carefully read the instructions for use of the manufacturer that accompanies your Zirela nebulizer.
• Each ampoule isonly for single use. Once opened, the contents should be used immediately.
• Do not use Quinsair if you notice that the packaging or ampoules have been tampered with.
• Do not use Quinsair if you notice that it is cloudy or there are particles in the solution.

• Do not mix Quinsair with any other medicationin the Zirela handheld nebulizer.
• Do not introduce any other medication other than Quinsair into the Zirela handheld nebulizer.
• Do not attempt to inhale Quinsair using any other type of handheld nebulizer.
• Check that your Zirela nebulizer system is working correctly before starting your treatment.
• Do not swallow the liquid from the ampoule.

How to prepare my nebulizer system for inhaling the medication?

Save the instructions for use of Zirela in a safe place, as they detail how to assemble the device.

1. Make sure to place the Zirela handheld nebulizeron a horizontal and stable surface.

1. Insert the entire contents of one ampouleinto the medication container of the Zirela handheld nebulizer (Figure1). Make sure to empty the ampoule completely, giving it a few taps against the side of the container if necessary.

Figure1

1. Close the medication containerby aligning the tabs of the medication cap with the slots of the container (a). Press and turn the cap clockwise as far as possible (b, Figure2).

Figure2

How to use the Zirela nebulizer system?

1. To start your treatment,sit in a relaxed and upright position.

1. Hold the nebulizer levelled, press and hold the on/off button of the controller for a few seconds. You will hear a beep and the status light will turn green.

1. After a few seconds, a cloud of aerosol will start to flowinto the aerosol chamber of the Zirela handheld nebulizer. If the aerosol cloud does not start to flow, try to solve the problem by consulting the instructions for use of the Zirela manufacturer.

1. Keeping the nebulizer levelled, insert the mouthpiece into your mouth and close your lips around it (Figure3).

Figure3

1. Breathe normally(inhale and exhale) through the mouthpiece. Try not to breathe through your nose. Continue inhaling and exhaling comfortably until the treatment is complete.
   It takes around 5minutes to inhale the medication with the nebulizer.

1. When the medication has been fully released, you will hear two beeps, indicating that the treatment is complete.

1. Once complete, open the medication capto ensure that all the medication has been used. You may notice some medication left in the container at the end of the treatment. This is normal. However, if there is more medication left than a few drops, replace the cap and restart the treatment.

1. Once the treatment is complete, disconnect the controller and disassemble the Zirela handheld nebulizer for cleaning and disinfection. The instructions for use of the manufacturer detail all the details on cleaning and disinfection.

What happens if I need to stop the treatment before it is complete?

If for any reason you need to stop the treatment before it is complete, press and hold the on/off button of the controller for a second. Once turned off completely and when you are ready to restart it, press and hold the on/off button for a second again. The treatment will restart. Now you should inhale and exhale through the mouthpiece as before.

How and when should I replace the Zirela nebulizer?

The Zirela handheld nebulizer should be used for a treatment cycle of 28days. Consult the information on cleaning and storage in the instructions for use of the manufacturer.

If I use more Quinsair than I should

If you have used more Quinsair than you should,inform your doctor as soon as possible. If you swallow the contents of the ampoule, do not worry, but inform your doctor as soon as possible.

If I forget to use Quinsair

If you forget a dose, administer it as soon as you remember, as long as there is a gap of 8hours until the next dose. If it is almost time for the next dose, skip the missed dose.

Do not inhale the contents of more than one ampoule to compensate for the missed dose.

If I interrupt the treatment with Quinsair

Do not stop using Quinsair without consulting your doctor first, as your lung infection may worsen.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious

If you notice asevere allergic reactionafter inhaling Quinsair, seekimmediate medical attention. Symptoms include:

• Generalized itching and a sensation of heat that affects the scalp, mouth, throat, palms of the hands, and soles of the feet.
• Important high-pitched sounds that occur when breathing (sibilance), or noisy or difficult breathing
• Urticaria or severe hives
• Swelling of the lips, face, throat, or tongue
• Pale or grayish skin color
• Accelerated heart rate
• Loss of consciousness or fainting

Stop using Quinsair and contact your doctor immediately:

• if you experiencejoint pain, stiffness, and/or swelling
• if you presentliver problems. Symptoms are:

• Loss of appetite
• Yellowing of the skin and eyes (jaundice)
• Dark-colored urine
• Itching
• Pain around the stomach (abdomen)

Other possible side effects:

Very common: may affect more than 1 in 10 people

• Cough
• Abnormal taste
• Fatigue, weakness, and reduced tolerance to exercise
• Loss of appetite and weight loss
• Shortness of breath
• Changes in the amount and density of mucus or sputum
• Coughing up blood
• Reduced lung function (FEV1 reduced)

Common: may affect up to 1 in 10 people

• Vaginal fungal infection around the vagina
• Insomnia or difficulty sleeping
• Headache
• Dizziness
• Tinnitus (ringing in the ears)
• Changes in voice
• Nausea and vomiting
• Abdominal pain
• Diarrhea
• Constipation
• Exanthema
• Joint or muscle pain
• Fever
• Abnormal blood test results (elevated liver enzymes or bilirubin, and reduced renal function)
• Reduced lung function
• Changes in blood sugar levels
• Abnormal respiratory sounds

Uncommon: may affect up to 1 in 100 people

• Mouth fungal infection
• Reduced red blood cell count (anemia) or platelet count
• Reduced or increased white blood cell count
• Feeling anxious, restless, or agitated and/or depressed
• Reduced sense of smell
• Somnolence
• Changes in vision
• Loss of hearing
• Accelerated heart rate
• Difficulty breathing
• Cramps
• Indigestion
• Flatulence
• Urticaria or hives and itching
• Chest pain (thoracic)
• Renal insufficiency
• Changes in heart rhythm

The following side effects have also been reported after taking tablets or receiving an intravenous infusion containing levofloxacin, so they may appear after using Quinsair:

Uncommon: may affect up to 1 in 100 people

• Feeling of confusion or nervousness
• Tremor
• Sensation of dizziness, spinning, or falling (vertigo)
• Excessive sweating

Rare: may affect up to 1 in 1,000 people

• Hallucinations and/or paranoid perceptions
• Feeling agitated
• Unusual or disturbing dreams
• Seizures (convulsions)
• Sensation of pins and needles and/or numbness
• Palpitations
• Low blood pressure
• Weakness in muscles

Unknown frequency: cannot be estimated from available data

• Reduced count of all types of blood cells
• Diabetic coma
• Severe mental problems (in very rare cases, may lead to self-harm)
• Pain, burning, itching, numbness, tingling, or weakness in the extremities (neuropathy)
• Involuntary muscle movements, tics, or spasms
• Loss of consciousness
• Severe headache with loss of vision
• Temporary loss of vision
• Abnormal heart rhythm
• Pneumonia
• Severe skin reactions such as painful blisters or lesions in the mouth, nose, or vagina
• Sensitivity of the skin to sunlight or ultraviolet light (sunlamps or other UV lamps)
• Inflammation of blood vessels
• Inflammation of the mouth or lips
• Rapid muscle degeneration
• Inflammation of a tendon or tendon rupture
• Pain, including back pain, chest pain (thoracic), arm pain, and leg pain

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term or permanent adverse reactions (even months or years after treatment), such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations, such as pinching, tingling, itching, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, and hearing, vision, taste, and smell impairment, in some cases regardless of pre-existing risk factors.

Reporting of adverse reactions

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

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

Do not use this medication after the expiration date that appears on the vial, paper envelope, and box after CAD. The expiration date is the last day of the month indicated.

Each vial is only for single use. Once the vial is opened, the contents must be used immediately. Any unused product must be discarded. Return unused vials to the paper envelope to protect them from light.

Store in the original packaging to protect it from light. This medication does not require any special storage temperature.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Quinsair

• The active ingredient is levofloxacin. A vial contains levofloxacin hemihydrate equivalent to 240 mg of levofloxacin.
• The other components are magnesium chloride hexahydrate and water for injection preparations.

Appearance of the product and contents of the package

Quinsair is a transparent, pale yellow solution for inhalation by nebulizer.

The medication is prepared in small plastic vials of 3 ml. There are four sealed vials in each paper envelope, and each box contains 14 envelopes.

Each Quinsair package for 28 days contains a box of 56 (14 envelopes of 4) vials and a box containing a Zirela handheld nebulizer with the manufacturer's usage instructions.

The vial is only labeled in Spanish. The information that appears on the vial is:

On the front of the vial

Quinsair 240 mg

Inhalation solution for nebulizer

Levofloxacin

Inhalation route2.4 ml

On the "wavy zone" on both sides of the vial

LOT

CAD

Marketing authorization holder

Chiesi Farmaceutici S.p.A.

Via Palermo, 26/A

43122 Parma

Italy

Responsible for manufacturing

Adare Pharmaceuticals S.r.l.

Via Martin Luther King, 13

20060 Pessano con Bornago (MI)

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet: July 2024.

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website:https://www.ema.europa.eu. There are also links to other websites about rare diseases and orphan drugs.