Quinsair 240 mg solution for inhalation by nebulizer

Patient Information Leaflet

Introduction

Patient Information Leaflet

Quinsair 240 mg solution for inhalation by nebulizer

levofloxacin

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

Contents of this leaflet

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

1. What Quinsair is and what it is used for

Quinsair contains an antibiotic medicine called levofloxacin. It belongs to a group of antibiotics known as fluoroquinolones.

Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis. It is an antibiotic that is inhaled directly into the lungs, where it kills the bacteria causing the infection. This helps improve breathing in people with cystic fibrosis.

2. What you need to know before using Quinsair

Do not use Quinsair:

• if you are allergic to levofloxacin, or to any other quinolone antibiotic, such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had tendon problems (inflammation or tendon rupture) during treatment with a quinolone or fluoroquinolone antibiotic
• if you have epilepsy
• if you are pregnant or breastfeeding

Warnings and precautions

Before starting this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Quinsair, if you have previously experienced a serious adverse reaction when taking a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

During treatment with this medicine

Rarely, joint pain and swelling, or tendon inflammation or rupture, may occur. The risk is higher if you are elderly (over 60 years of age), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Quinsair. At the first sign of tendon pain or inflammation (for example, in the ankle, wrist, elbow, shoulder or knee), stop taking Quinsair, contact your doctor immediately, and rest the affected area. Avoid unnecessary physical activity, as this could increase the risk of tendon rupture.

Tell your doctor before starting Quinsair

if you have or have had any of the following conditions:

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

Antibacterial medicines containing fluoroquinolones or quinolones, including Quinsair, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling or potentially irreversible. These include tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, burning or stinging (paresthesia), sensory disturbances such as reduced vision, taste, smell or hearing, depression, memory and concentration problems, severe fatigue and serious sleep disturbances.

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 treatment, possibly considering the use of an antibiotic from another class.

• Severe kidney problems.

• A serious allergic reaction. Symptoms are listed in section 4.

• Serious skin reactions

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

• Liver problems. Symptoms are listed in section 4.

• Heart rhythm disturbances

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

• Seizures and convulsions

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

• Depression or mental health problems.

• Nerve damage

Rarely, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, stinging, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms. If this occurs, stop taking Quinsair immediately and contact your doctor without delay to prevent the development of a potentially irreversible disorder.

• A disease causing muscle weakness and fatigue called myasthenia gravis.

• Tendon inflammation causing pain, stiffness and/or swelling in the joints (tendinitis)

• If you have experienced breathing difficulties after receiving Quinsair, which may be mild or severe (bronchospasm)

• Coughing up blood or bloody mucus from the airways

• Glucose-6-phosphate dehydrogenase deficiency

In patients with glucose-6-phosphate dehydrogenase deficiency (a rare inherited condition), quinolone antibiotics such as Quinsair may predispose to blood (haematological) complications, leading to a sudden rise in body temperature, yellowing of the skin and mucous membranes (jaundice), dark urine, paleness, fatigue, rapid and laboured breathing, and a fast, weak pulse. Consult your doctor if in doubt.

• Diabetes

Quinolone antibiotics, including Quinsair, may cause blood glucose levels to become too high or too low. If you have diabetes, you must carefully monitor your blood glucose levels.

• Diarrhoea

You may develop diarrhoea during or after treatment with Quinsair. If diarrhoea becomes severe or persistent, or if you notice blood in your stools, stop using Quinsair immediately and consult your doctor. Do not take any anti-diarrhoeal medicine without first consulting your doctor.

• Antibiotic resistance

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

• Superinfections

• Prolonged antibiotic treatment may sometimes lead to another infection caused by bacteria not affected by the antibiotic (superinfection). Consult your doctor if you have any questions or concerns about superinfection and the use of Quinsair.

• Vision problems

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

• Photosensitivity

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

• False test results

Certain tests (e.g. to confirm tuberculosis or detect strong painkillers) may give false results while you are being treated with Quinsair.

• If you have been diagnosed with an enlarged blood vessel or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).

• If you have previously experienced aortic dissection (a tear in the wall of the aorta).

• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

• If you experience sudden, severe pain in the abdomen, chest or back, which may be symptoms of aortic dissection or aneurysm, seek emergency medical help immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or develop palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

Children and adolescents

Quinsair must not be given to children or adolescents under 18 years of age, as there is insufficient information on its use in this age group.

Other medicines and Quinsair

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

Tell your doctor if you are taking any of the following medicines:

• Vitamin K antagonists such as warfarin (used to prevent blood clots). Taking these medicines with Quinsair may lead to increased bleeding. Your doctor may need to perform regular blood tests to check your blood clotting.

• Theophylline (used to treat breathing problems) or non-steroidal anti-inflammatory drugs (NSAIDs) such as fenbufen, acetylsalicylic acid (an active ingredient in many medicines used to relieve pain, reduce fever, and prevent blood clots) or ibuprofen. Taking Quinsair at the same time as these medicines may increase the risk of seizures.

• Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers). Taking Quinsair at the same time as these medicines may affect how your kidneys process the medicine, which is particularly important if you have kidney problems.

• Cyclosporine (used after organ transplants) or medicines that affect heart rhythm (such as antiarrhythmics, tricyclic antidepressants, macrolide antibiotics and antipsychotics). Quinsair may interfere with the effects of these medicines. Your doctor will provide further information.

Pregnancy and breastfeeding

Quinsair must not be used during pregnancy or breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Quinsair may make you feel dizzy, tired or weak, or cause vision problems. If this happens, do not drive or operate tools or machinery.

3. How to use Quinsair

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor again.

How much should I use?

Inhale the contents of one vial (240 mg) twice daily using the Zirela nebulizer system. It takes approximately 5 minutes to inhale the medication with the nebulizer.

When should I use it?

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

• 1 vial in the morning using the Zirela nebulizer
• 1 vial in the evening using the Zirela nebulizer

Ideally, leave an interval of about 12 hours between doses.

How long should I use it?

You should use Quinsair every day for 28 days, followed by a 28-day break during which you do not inhale Quinsair. After this, you will start a new treatment cycle.

It is important that you continue using the medicine twice daily during the 28-day treatment period and maintain the 28-day on/28-day off cycle for as long as your doctor instructs.

If you experience breathing difficulties when using Quinsair, what additional medicine might your doctor prescribe?

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

What if I am using several different inhalers and other treatments for cystic fibrosis?

If you are receiving several different inhaled treatments and other therapies for cystic fibrosis, it is recommended that you use the medicines in the following order:

1. Bronchodilators
2. Dornase alfa
3. Airway clearance techniques
4. Quinsair
5. Inhaled corticosteroids

How to use it

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

Information that is important to know before starting

• Each vial is for single use only. Once opened, the vial's contents must be used immediately.
• Do not use Quinsair if you notice that the pouch or vials have been tampered with.
• Do not use Quinsair if it appears cloudy or if you see particles in the solution.
• Do not mix Quinsair with any other medicine in the Zirela handheld nebulizer.
• Do not put any other medicine besides 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 properly before starting treatment.
• Do not swallow the liquid from the vial.

Carefully read the manufacturer's instructions for use that come with your Zirela handheld nebulizer.

How should I prepare my nebulizer system to inhale the medicine?

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

1. Make sure to place the Zirela handheld nebulizer on a flat, stable surface.

2. Pour the entire contents of one vial into the medication reservoir of the Zirela handheld nebulizer (Figure 1). Make sure to empty the vial completely, tapping it gently against the side of the reservoir if necessary.

1. Close the medication reservoir by aligning the tabs on the medication cap with the slots on the reservoir (a). Press down and turn the cap clockwise as far as it will go (b, Figure 2).

How should I use the Zirela nebulizer system?

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

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

3. After a few seconds, a mist of aerosol will begin flowing into the aerosol chamber of the Zirela handheld nebulizer. If the aerosol mist does not start, refer to the manufacturer's instructions for use of Zirela to troubleshoot.

4. While keeping the nebulizer level, place the mouthpiece in your mouth and close your lips around it (Figure 3).

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 approximately 5 minutes to inhale the medication with the nebulizer.

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

2. After completion, open the medication cap to ensure all the medication has been used. A few drops of medication may remain in the bottom of the reservoir at the end of treatment. This is normal. However, if more than a few drops remain, replace the cap and resume treatment.

3. After treatment is complete, disconnect the controller and disassemble the Zirela handheld nebulizer for cleaning and disinfection. The manufacturer's instructions for use contain all details regarding cleaning and disinfection.

What if I need to stop treatment before it is finished?

If you need to stop treatment for any reason before it is complete, press and hold the on/off button on the controller for one second. Once fully switched off, and when you are ready to resume, press and hold the on/off button for one second again. The treatment will resume. You should then inhale and exhale through the mouthpiece as before.

How and when should I replace the Zirela handheld nebulizer?

A Zirela handheld nebulizer should be used for one 28-day treatment cycle. Refer to the manufacturer's instructions for use for information on cleaning and storage.

If you use more Quinsair than you should

If you have used more Quinsair than you should, inform your doctor as soon as possible. You may experience symptoms such as irregular heartbeat, which your doctor should check. If you accidentally swallow the contents of a vial, do not worry, but inform your doctor as soon as possible.

If you forget to use Quinsair

If you miss a dose, take it as soon as you remember, provided there is at least an 8-hour interval until your next scheduled dose. If it is almost time for your next dose, skip the missed dose.

Do not inhale the contents of more than one vial to make up for a missed dose.

If you stop treatment with Quinsair

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious

If you experience a severe allergic reaction after inhaling Quinsair, seek immediate emergency medical attention. Symptoms include:

• Widespread itching and a feeling of warmth particularly affecting the scalp, mouth, throat, palms of the hands, and soles of the feet
• Severe whistling sounds when breathing (wheezing), or noisy or difficult breathing
• Pronounced hives or rashes
• Swelling of the lips, face, throat, or tongue
• Pale or greyish skin color
• Rapid heartbeat
• Fainting or loss of consciousness

Stop using Quinsair and contact your doctor immediately if:

• You experience joint pain, stiffness, and/or swelling

• You develop liver problems. Symptoms include:

• Loss of appetite

• Yellowing of the skin and eyes (jaundice)

• Dark-colored urine

• Itching

• Pain around the stomach (abdomen)

Other possible adverse reactions:

Very common: may affect more than 1 in 10 people

• Cough
• Abnormal sense of taste
• Tiredness, weakness, and reduced exercise tolerance
• Loss of appetite and weight loss
• Shortness of breath
• Changes in the amount and thickness of mucus or phlegm
• Coughing up blood
• Decrease in the amount of air you can exhale in one second (reduced FEV1 test result)

Common: may affect up to 1 in 10 people

• Fungal infection around the vagina
• Insomnia or difficulty sleeping
• Headache
• Dizziness
• Ringing or noises in the ear (tinnitus)
• Changes in voice
• Nausea and vomiting
• Abdominal pain
• Diarrhea
• Constipation
• Rash
• Joint (arthralgia) or muscle pain
• Fever
• Abnormal blood test results (increased blood concentration of certain liver enzymes or bilirubin, and reduced kidney function test values)
• Reduced lung function test values
• Increased or decreased blood sugar (glucose) levels
• Abnormal breathing sounds

Uncommon: may affect up to 1 in 100 people

• Fungal infection in the mouth
• Reduced number of red blood cells in the blood (anemia) or of blood cells that help with clotting (platelets)
• Reduced or increased number of white blood cells in the blood
• Feeling anxious, restless, agitated, and/or depressed
• Reduced sense of smell
• Drowsiness
• Changes in vision
• Hearing loss
• Increased heart rate
• Difficulty breathing
• Retching
• Indigestion
• Flatulence
• Hives, rashes, and itching
• Pain in the chest wall (thoracic pain)
• Kidney failure
• Changes in heart rhythm
• Pain, burning, stinging, tingling, numbness, or weakness in the limbs (neuropathy)

The following adverse effects have also been reported after taking tablets or receiving intravenous infusions containing levofloxacin, and therefore may also occur with the use of Quinsair:

Uncommon: may affect up to 1 in 100 people

• Feeling confused or nervous
• 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 dreams or nightmares
• Seizures (fits)
• Tingling sensation ("pins and needles") and/or numbness
• Palpitations
• Low blood pressure
• Muscle weakness
• Syndrome associated with disturbances in water elimination and low sodium levels (SIADH)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, DRESS)
• Clearly defined erythematous patches with or without blisters

Frequency unknown: cannot be estimated from available data

• Reduced number of all types of blood cells
• Diabetic coma
• Severe mental health problems (in very rare cases, may lead to self-harm)
• Pain, burning, stinging, tingling, numbness, or weakness in the limbs (neuropathy)
• Involuntary muscle movements, tics, or spasms
• Fainting
• Severe, stabbing headaches with loss of vision
• Temporary loss of vision
• Fast or irregular heartbeat
• Inflammation of the lungs
• Severe skin reactions such as painful blisters or lesions possibly affecting the mouth, nose, or vagina
• Increased sensitivity of the skin to sunlight or ultraviolet light (sunbeds or other UV lamps)
• Inflammation of blood vessels
• Inflammation of the mouth or lips
• Rapid breakdown of muscles
• Inflammation of a tendon or tendon rupture
• Pain, including back, chest (thoracic), arm, and leg pain

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, stinging, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal thoughts), and reduced hearing, vision, taste, and smell—some cases occurring regardless of the presence of pre-existing risk factors.

Cases of aortic wall enlargement, weakening, or tearing (aneurysms and dissections), which could lead to rupture and may be fatal, as well as heart valve insufficiency, have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quinsair

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

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

Each ampoule is for single use only. Once the ampoule is opened, the contents should be used immediately. Any unused product must be discarded. Unused, unopened ampoules should be returned to the paper pouch to protect them from light.

Store in the original container to protect from light. This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quinsair

• The active substance is levofloxacin. One vial contains levofloxacin hemihydrate equivalent to 240 mg of levofloxacin.
• The other components are magnesium chloride hexahydrate and water for injections.

Nature of the product and contents of the container

Quinsair is a clear, pale yellow inhalation solution for use with a nebulizer.

The medicine is supplied in small 3 ml plastic vials. Four vials are sealed in each paper pouch.

Quinsair is available in 28-day packs (containing an inner box with 56 (14 pouches of 4) vials) or 2-day packs (containing an inner box with 8 (2 pouches of 4) vials), and a box containing a Zirela handheld nebulizer with the manufacturer's instructions for use.

Only certain pack sizes may be marketed.

The vial is labelled in English only. The information on the vial is as follows:

On the front of the end of the vial

Quinsair 240 mg
Inhalation solution for nebulizer
Levofloxacin
For inhalation use 2.4 ml

On the “wavy area” on both sides of the end of the vial

LOT

EXP

Marketing Authorization Holder

Chiesi Farmaceutici S.p.A.
Via Palermo, 26/A
43122 Parma
Italy

Manufacturer

Adare Pharmaceuticals S.r.l.
Via Martin Luther King, 13
20060 Pessano con Bornago (MI)
Italy

Further information on this medicine is available by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: MM/YYYY

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu. Links to other websites on rare diseases and orphan medicinal products are also provided.