Package leaflet: Information for the patient

Quinsair 240 mg solution for nebuliser

levofloxacin
Please read all of this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Quinsair is and what it is used for
What you need to know before using Quinsair
How to use Quinsair
Possible side effects
How to store Quinsair
Contents of the pack and other information

1. What Quinsair is and what it is used for

Quinsair contains an antibiotic called levofloxacin. This medicine 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 inhaled antibiotic that is breathed 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, 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 previously had tendon problems ( tendon inflammation or tendon rupture ) while being treated with a quinolone or fluoroquinolone antibiotic
if you have epilepsy
during pregnancy or breastfeeding

Warnings and precautions
Before taking this medicine
Do not take quinolone/fluoroquinolone antibacterial medicines, including Quinsair, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such case, inform your doctor as soon as possible.
When taking this medicine
Joint pain and swelling, and tendon inflammation or rupture, may rarely occur. The risk is higher if you are elderly (over 60 years of age), if you have had an organ transplant, if you have kidney problems, or if you are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Quinsair. At the first signs of tendon pain or inflammation (for example, in the ankle, wrist, elbow, shoulder or knee), stop treatment with Quinsair, consult your doctor and rest the affected area. Avoid any unnecessary movement, as this may increase the risk of tendon rupture.
Inform your doctor before using Quinsair
if you have or have previously had any of the following conditions:

Severe, prolonged, disabling and potentially irreversible side effects Fluoroquinolone/quinolone antibacterial medicines, including Quinsair, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell or hearing, depression, memory and concentration impairment, severe fatigue and severe sleep disturbances. If you experience any of these side effects after taking Quinsair, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
Serious kidney problems.
Severe allergic reaction. Symptoms are listed in section 4.
Serious skin reactions Serious skin reactions such as blistering or lesions may occur while being treated with Quinsair. Inform your doctor if you notice any skin reaction after using Quinsair.
Liver problems. Symptoms are listed in section 4.
Heart rhythm abnormalities Quinsair may alter heart rhythm, especially if you are taking any medicine for heart problems or have low levels of potassium or magnesium in the blood. Women taking such medicines may be at higher risk. If you experience palpitations or an irregular heartbeat while using Quinsair, inform your doctor immediately.
Seizures and convulsions Quinolone antibiotics, such as Quinsair, may cause seizures or convulsions (“fits”). In such cases, stop using Quinsair and contact your doctor immediately.
Depression or mental health problems.
Nerve damage Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Quinsair and contact your doctor immediately to avoid permanent nerve damage.
A disease causing muscle weakness and fatigue, called myasthenia gravis.
Tendon inflammation causing pain, stiffness and/or swelling in joints (tendinitis).
If, after receiving Quinsair, you experienced difficulty breathing, which may range from mild to severe (bronchospasm).
Coughing up blood or mucus mixed with blood.
Glucose-6-phosphate dehydrogenase deficiency Quinolone antibiotics, such as Quinsair, may predispose patients with glucose-6-phosphate dehydrogenase deficiency (a rare inherited disorder) to blood-related complications, resulting in sudden fever, yellowing of the skin and mucous membranes (jaundice), dark urine, paleness, fatigue, shortness of breath, rapid breathing and weak, rapid pulse. Contact your doctor if you have any questions about this.
Diabetes Quinolone antibiotics, such as Quinsair, may excessively increase or decrease blood glucose levels. If you have diabetes, you must monitor your blood sugar levels very closely.
Diarrhoea Diarrhoea may occur during or after treatment with Quinsair. If diarrhoea is severe or persistent, or if you notice blood in your stools, stop using Quinsair immediately and contact your doctor. Do not take any medicine for diarrhoea without first consulting your doctor.
Antibiotic resistance Over time, bacteria may become resistant to antibiotic treatment. This means Quinsair must not be used to prevent lung infections. It should only be used to treat lung infections caused by Pseudomonas aeruginosa. Contact your doctor if you have any doubts or questions about this.
Superinfections Sometimes, during prolonged antibiotic treatment, you may develop another infection caused by different bacteria that are not affected by the antibiotic being used (superinfection). Contact your doctor if you have any doubts or questions about this and about the use of Quinsair.
Vision problems If you notice any changes in vision or other eye problems while using Quinsair, contact an ophthalmologist immediately.
Photosensitisation Quinsair may make your skin more sensitive to sunlight. Avoid prolonged exposure to sunlight or intense sunlight, and do not use sunbeds or other UV lamps while using Quinsair and for 48 hours after stopping treatment.
False results in certain laboratory tests Certain laboratory tests (e.g. tests to confirm tuberculosis or to detect strong painkillers) may give false positive results during treatment with Quinsair:
if you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
if you have previously experienced episodes of aortic dissection (a tear in the aortic wall).
if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
if you have a family history of aortic aneurysm or congenital heart valve disease, or of aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).

If you experience sudden pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroids.
Contact your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
Children and adolescents
Quinsair must not be given to children and 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 take any other medicines. These medicines may interfere with the effects of Quinsair.
Inform 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 increase the risk of bleeding. Your doctor may need to perform periodic blood tests to monitor your blood’s ability to clot.
Theophylline (used to treat breathing problems) or non-steroidal anti-inflammatory drugs (NSAIDs) such as fenbufen, acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting) or ibuprofen. Taking Quinsair together with these medicines may increase the risk of seizures.
Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers). Taking Quinsair together with these medicines may alter how the kidneys react to 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 or 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, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
Quinsair may cause dizziness, fatigue or weakness, or cause vision problems. If this occurs, do not drive and do not operate tools or machinery.

3. How to use Quinsair

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor.
What dose should I use?
Inhale the contents of one vial (240 mg) twice daily using the Zirela nebulizer.
The inhalation of the medicine with the nebulizer takes approximately 5 minutes.
When should I inhale?
Inhaling Quinsair at the same time each day will help you remember when to take the medicine. The
medicine should be inhaled as follows:

1 vial in the morning using the Zirela nebulizer
1 vial in the evening using the Zirela nebulizer
It is best to leave approximately 12 hours between doses.

How long should I use the medicine?
Use Quinsair every day for 28 days, followed by a 28-day break during which you must not inhale
Quinsair. After the break, start a new treatment cycle.
It is important to use the medicine twice daily during the 28 days of treatment and to continue alternating
28 days of treatment with 28 days without treatment for the entire duration prescribed by your doctor.
Repeat the cycle.
If you have difficulty breathing when using Quinsair, what other medicine might your doctor
prescribe?
If you have difficulty breathing after using Quinsair, your doctor may prescribe an inhaled bronchodilator (e.g., salbutamol). You must inhale this medicine at least 15 minutes and up to 4 hours before the next dose of Quinsair.
What if I am using other inhaled therapies and treatments for cystic fibrosis?
If you are using multiple inhaled therapies and other treatments for cystic fibrosis, it is recommended that you use the medicines in the following order:

Bronchodilators
Dornase alfa
Airway clearance techniques
Quinsair
Inhaled corticosteroids
How to use the medicine
Quinsair must be inhaled using the portable nebulizer Zirela (including a Zirela aerosol head). The nebulizer must be connected to a control unit, either the eBase Controller or eFlow rapid.
Important information before starting

Each vial is for single use only. After opening the vial, the contents must be used immediately.
Do not use Quinsair if you notice that the sealed foil pouch or the vials have been tampered with.
Do not use Quinsair if you notice that the solution is cloudy or contains particles.
Do not mix Quinsair with other medicines in the portable Zirela nebulizer.
Do not put any medicine other than Quinsair into the portable Zirela nebulizer.
Do not attempt to inhale Quinsair using another type of portable nebulizer.
Check that the Zirela nebulizer is working properly before starting treatment.
Do not swallow the liquid in the vial. Read carefully the instructions for use provided with the portable Zirela nebulizer.

How should I prepare the nebulizer for inhalation of the medicine?
Keep the instructions for use of Zirela in a safe place, as they contain detailed information on how to assemble the device.

Check that the portable Zirela nebulizer is placed on a flat, stable surface.
Transfer the entire contents of one vial into the medication reservoir of the portable Zirela nebulizer (Figure 1). Check that you have completely emptied the vial, tapping gently on the side of the reservoir if necessary.

Technical drawing of a hand dispensing liquid drops into a medical device with an arrow indicating the drug reservoir

Figure 1
3) Close the medication reservoir by aligning the tabs on the medication closure cap with the slots on the reservoir (a). Press and turn the closure cap clockwise until it stops (b, Figure 2).

Tab
Slot
Figure 2
How should I use the Zirela nebulizer?

When starting treatment, sit comfortably with your back straight.
Keep the portable nebulizer upright and press and hold the on/off button on the control unit for several seconds. You will hear a single beep and the indicator light will turn green.
After a few seconds, a mist of aerosol will begin to flow into the aerosol chamber of the portable Zirela nebulizer. If the aerosol mist does not start flowing, refer to the Zirela instructions for use.
Continue to keep the portable nebulizer upright and place the mouthpiece in your mouth, holding it firmly between your lips (Figure 3).

Figure 3
5) Breathe normally (inhaling and exhaling) through the mouthpiece. Try not to breathe through your nose. Continue to inhale and exhale calmly until the end of the treatment. The inhalation of the medicine with the nebulizer takes approximately 5 minutes.
6) When all the medicine has been delivered, you will hear a double-tone beep indicating the end of treatment.
7) At this point, open the medication closure cap to check that all the medicine has been used. A few drops of medicine may remain at the bottom of the reservoir at the end of treatment. This is not a problem. However, if more than a few drops remain, close the medication closure cap again and restart the treatment from step 1.
8) At the end of treatment, disconnect the control unit from the portable Zirela nebulizer so that it can be cleaned and disinfected. Detailed instructions for cleaning and disinfection are provided in the instructions for use.
What should I do if I need to interrupt the treatment before it is complete?
If, for any reason, you need to interrupt the treatment before it is complete, press and hold the on/off button on the control unit for one second. After it has completely switched off, and when you are ready to resume, press and hold the on/off button again for one second. The treatment will resume.
You must continue to inhale and exhale through the mouthpiece as before.
How and when should I replace the portable Zirela nebulizer?
A portable nebulizer should be used for one 28-day treatment cycle. For cleaning and storage recommendations, refer to the manufacturer's instructions for use.
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 should be evaluated by your doctor. If you have swallowed the contents of the vial, do not worry, but inform your doctor as soon as possible.
If you forget to use Quinsair
If you forget a dose, take it as soon as you remember, provided that there are at least 8 hours before the next scheduled dose. If it is almost time for your next dose, skip the missed dose.
Do not inhale more than one vial to make up for a missed dose.
If you stop treatment with Quinsair
Do not stop treatment with Quinsair without first consulting your doctor, as otherwise your lung infection may worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Seek immediate emergency treatment if you experience a severe allergic reaction after inhaling Quinsair. Symptoms include:

Widespread itching and feeling of warmth, particularly on the scalp, mouth, throat, palms of the hands or soles of the feet
Severe wheezing or noisy breathing or difficulty breathing
Severe hives
Swelling of the lips, face, throat or tongue
Pallor or greyish skin colour
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 or eyes (jaundice)
Dark-coloured urine
Itching
Increased sensitivity (pain) around the stomach (abdomen)

Other possible side effects include:
Very common: may affect more than 1 in 10 people

Cough
Changes in taste sensation
Tiredness, weakness and reduced exercise tolerance
Loss of appetite
Shortness of breath
Changes in the amount and thickness of mucus/sputum
Coughing up blood
Reduced volume of air you can exhale in one second (reduced FEV test)

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

Fungal infection of the mouth
Decreased number of red blood cells in the blood (anaemia) or of blood cells involved in clotting (platelets)
Decreased or increased number of white blood cells in the blood
Feelings of anxiety, restlessness or agitation and/or depression
Reduced sense of smell
Drowsiness
Vision disturbances
Hearing loss
Increased heart rate
Difficulty breathing
Nausea (urge to vomit)
Indigestion
Flatulence
Hives and itching
Chest pain
Kidney failure
Changes in heart rhythm
Pain, burning, tingling, numbness, and/or weakness in the limbs (neuropathy)

The following side effects have been reported with oral tablets or intravenous infusion of levofloxacin and may therefore 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 loss of balance (vertigo)
Excessive sweating

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

Hallucinations and/or paranoid thoughts
Feeling agitated
Abnormal dreams or nightmares
Seizures ("fits")
Sensation of tingling and/or numbness
Palpitations
Low blood pressure
Muscle weakness
Syndrome associated with inadequate water excretion and low sodium levels (SIADH)
Widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms – DRESS)
Clearly defined red patches, with or without blister formation

Not known: frequency cannot be estimated from the available data

Decreased number of all types of blood cells
Diabetic coma
Severe mental health problems (which in very rare cases may lead to self-harm)
Pain, burning, tingling, numbness, and/or weakness in the limbs (neuropathy)
Involuntary movements, twitches or muscle spasms
Fainting
Severe pulsating headache with loss of vision
Temporary loss of vision
Rapid or irregular heartbeat
Lung inflammation
Severe skin reactions, such as blisters or painful sores, possibly also in the mouth, nose or vagina
Increased skin sensitivity to sunlight or UV light (sunbeds or other UV lamps)
Inflammation of blood vessels
Inflammation of the mouth or lips
Rapid breakdown of muscle tissue
Inflammation of a tendon or tendon rupture
Pain including back, chest, arm and leg pain

Very rare cases of prolonged (lasting for months or years) or permanent adverse drug reactions such as tendon inflammation, tendon rupture, joint pain, extremity pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration problems, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), and changes in hearing, vision, taste and smell have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Quinsair

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial, the aluminium foil pouch, and the outer carton after EXP/Scad. The expiry date refers to the last day of that month.
Each vial is for single use only. After opening the vial, the contents must be used immediately. Any remaining product must be discarded. Unused, unopened vials within the strip should be returned to the foil pouch to protect them from light.
Store in the original packaging to protect the medicine from light. This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Quinsair contains

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.

Description of the appearance of Quinsair and package contents
Quinsair is a clear, pale yellow solution for nebuliser.
The medicine is supplied in small 3 mL plastic vials. Four vials are sealed in an aluminium foil pouch.
Quinsair is available in a pack sufficient for a 28-day treatment cycle (consisting of one inner cardboard box containing 56 vials (14 pouches of 4)) or a 4-day treatment cycle (containing 8 vials (2 pouches of 4)), and a pack containing a portable Zirela nebuliser with the corresponding instructions for use.
Not all pack sizes may be marketed.
The text on the vial is in English only. The following information appears on the vial:

On the front of the vial end
Quinsair 240 mg
Solution for nebuliser
Levofloxacin
For inhalation use 2.4 mL

On the "wavy" area on both sides of the vial end
Lot
EXP

Marketing Authorisation 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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Chiesi sa/nv Chiesi Pharmaceuticals GmbH
Tél/Tel: + 32 (0)2 788 42 00 Tel: + 43 1 4073919

България Luxembourg/Luxemburg
Chiesi Bulgaria EOOD Chiesi sa/nv
Teл.: + 359 29201205 Tél/Tel: + 32 (0)2 788 42 00

Česká republika Magyarország
Chiesi CZ s.r.o. Chiesi Hungary Kft.
Tel: + 420 261221745 Tel.: + 36-1-429 1060

Danmark Malta
Chiesi Pharma AB Chiesi Farmaceutici S.p.A.
Tlf: + 46 8 753 35 20 Tel: + 39 0521 2791

Deutschland Nederland
Chiesi GmbH Chiesi Pharmaceuticals B.V.
Tel: + 49 40 89724-0 Tel: + 31 88 501 64 00

Eesti Norge
Chiesi Pharmaceuticals GmbH Chiesi Pharma AB
Tel: + 43 1 4073919 Tlf: + 46 8 753 35 20

Ελλάδα Österreich
Chiesi Hellas AEBE Chiesi Pharmaceuticals GmbH
Τηλ: + 30 210 6179763 Tel: + 43 1 4073919

España Polska
Chiesi España, S.A.U. Chiesi Poland Sp. z.o.o.
Tel: + 34 93 494 8000 Tel.: + 48 22 620 1421

France Portugal
Chiesi S.A.S. Chiesi Farmaceutici S.p.A.
Tél: + 33 1 47688899 Tel: + 351 211 246 807

Hrvatska România
Chiesi Pharmaceuticals GmbH Chiesi Romania S.R.L.
Tel: + 43 1 4073919 Tel: + 40 212023642

Ireland Slovenija
Chiesi Farmaceutici S.p.A. Chiesi Slovenija d.o.o.
Tel: + 39 0521 2791 Tel: + 386-1-43 00 901

Ísland Slovenská republika
Chiesi Pharma AB Chiesi Slovakia s.r.o.
Sími: +46 8 753 35 20 Tel: + 421 259300060

Italia Suomi/Finland
Chiesi Italia S.p.A. Chiesi Pharma AB
Tel: + 39 0521 2791 Puh/Tel: +46 8 753 35 20

Κύπρος Sverige
Chiesi Farmaceutici S.p.A. Chiesi Pharma AB
Τηλ: + 39 0521 2791 Tel: +46 8 753 35 20

Latvija
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919

Further sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.