Quinsair
levofloxacin
levofloxacin
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Quinsair is and what it is used for
What you need to know before you use Quinsair
How to use Quinsair
Possible side effects
How to store Quinsair
Contents of the pack and other information
Quinsair contains an antibiotic medicine called levofloxacin. It belongs to the group of antibiotics called fluoroquinolones.
Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis. It is an antibiotic medicine that is breathed (inhaled) directly into the lungs where it kills the bacteria causing the infection. This helps to improve breathing in people with cystic fibrosis.
if you are allergic to levofloxacin, to any other quinolone antibiotics, 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 a problem with your tendons (inflammation of a tendon or a ruptured tendon) during treatment with a quinolone or fluoroquinolone antibiotic
if you suffer from epilepsy
if you are pregnant or breast-feeding Warnings and precautions
Before taking this medicine
You should not take fluoroquinolone/quinolone antibacterial medicines, including Quinsair, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.
When taking this medicine
Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Quinsair therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quinsair, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
if you have or have ever had any of the following:
Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines, including Quinsair, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
If you experience any of these side effects after taking Quinsair, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Severe kidney problems.
A severe allergic reaction. Symptoms are listed in section 4.
Severe skin reactions
If you are treated with Quinsair, you may have a severe skin reaction such as blistering or lesions. Tell your doctor if you notice any skin reactions after using Quinsair.
Liver problems. Symptoms are listed in section 4.
Heart rhythm abnormalities
Quinsair can cause changes to your heart rhythm, especially if you are taking any medicines to treat heart problems or low levels of potassium or magnesium in the blood. Women who take these types of medicines may be more likely to be affected. If you experience palpitations or an irregular heart beat whilst using Quinsair you should tell your doctor immediately.
Seizures and convulsions
Quinolone antibiotics, including Quinsair, may cause seizures or convulsions (fits). If this happens, stop using Quinsair and contact your doctor immediately.
Depression or mental health problems.
Nerve damage
You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Quinsair and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
A disease causing muscle weakness and fatigue called myasthenia gravis.
Inflammation of a tendon causing pain, stiffness and/or swelling in the joints (tendonitis).
If you have experienced difficulty in breathing after receiving Quinsair, which can range from mild to severe (bronchospasm).
Coughing up blood or blood-stained mucus from the airways.
Glucose-6-phosphate dehydrogensae deficiency
Quinolone antibiotics, such as Quinsair, can cause patients with glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease) to be prone to blood complications leading to a sudden rise in body temperature, yellowing of the skin and mucous membranes, dark coloured urine, paleness, tiredness, heavy, fast breathing and a weak, rapid pulse. Talk to your doctor if you have any questions about this.
Diabetes
Quinolone antibiotics, including Quinsair, may cause levels of glucose in the blood to be either too high or too low. If you are diabetic, you should monitor your blood glucose levels carefully.
Diarrhoea
You may develop diarrhoea during or after your treatment with Quinsair. If this becomes severe or persistent, or you notice blood in your stools, you should stop using Quinsair immediately and talk to your doctor. Do not take any medicines to treat your diarrhoea without first checking with your doctor.
Resistance to antibiotics
Bacteria can 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 by Pseudomonas aeruginosa. Talk to your doctor if you have any concerns or questions about this.
Superinfections
Sometimes lengthy treatment with antibiotics can mean that you get another infection caused by other bacteria which are not affected by the antibiotic (superinfection). Talk to your doctor if you have any concerns or questions about this and using Quinsair.
Vision problems
If you notice any changes in your eyesight or any other problems with your eyes whilst using Quinsair, contact an eye specialist immediately.
Photosensitivity
Quinsair may make your skin become more sensitive to sunlight. You should avoid prolonged exposure to sunlight or strong sunlight and should not use sunbeds or any other UV lamps whilst using Quinsair and for 48 hours after stopping treatment.
False test results
Certain tests (e.g. to confirm tuberculosis or screening for strong painkillers) may give false results whilst you are being treated with Quinsair.
if you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
if you have been diagnosed with leaking heart valves (heart valve regurgitation).
if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell
arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints,] or endocarditis [an infection of the heart]).
If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.
If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.
Quinsair should not be given to children and adolescents less than 18 years old as there is not enough information about its use in this age group.
Tell your doctor or a pharmacist if you are taking, have recently taken or might take any other medicines. These medicines may interfere with the effects of Quinsair.
Vitamin K antagonists such as warfarin (used to prevent blood clots). Taking these medicines with Quinsair may lead to an increase in bleeding. Your doctor may need to give you regular blood tests to check how well your blood can clot.
Medicines such as probenecid (used to prevent gout) or cimetidine (used to treat ulcers).
Taking Quinsair at the same time as these medicines could affect how your kidneys deal with the medicine which is particularly important if you suffer from kidney problems.
Quinsair must not be used whilst pregnant or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Quinsair may make you feel dizzy, tired or weak, or cause problems with your eyesight. If this happens to you, do not drive or use any tools or machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Inhale the contents of one ampoule (240 mg) twice a day using the Zirela Nebuliser System. It takes about 5 minutes to inhale the medicine using the nebuliser.
Inhaling Quinsair at the same time each day will help you remember when to take your medicine. Inhale your medicine as follows:
1 ampoule in the morning using the Zirela Nebuliser
1 ampoule in the evening using the Zirela Nebuliser It is best to leave close to 12 hours between your doses.
You use Quinsair every day for 28 days, then take a 28-day break, during which you do not inhale any Quinsair. You then start another treatment course.
It is important that you keep using the medicine twice a day during your 28 days on treatment and that you keep to the 28-days on, 28-days off cycle for as long as your doctor tells you to.
Repeat cycle
If you experience breathing difficulties after using Quinsair, your doctor may prescribe you an inhaler containing a bronchodilator medicine (e.g. salbutamol). Inhale this medicine at least 15 minutes or up to 4 hours before your next dose of Quinsair.
If you are using several different inhaled treatments and other therapies for cystic fibrosis, it is recommended that you use your medicines in the following order:
1st Bronchodilators 2nd Dornase alfa
3rd Airway clearance techniques 4th Quinsair
5th Inhaled steroids
Quinsair should be taken by inhalation using a Zirela Nebuliser Handset (including a Zirela Aerosol Head). This should be connected to either an eBase Controller or an eFlow rapid Control Unit.
Each ampoule is for single use only. Once an ampoule is opened, the contents should be used immediately.
Do not use Quinsair if you notice that the sealed foil sachet 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 put any medicines other than Quinsair in the Zirela Nebuliser Handset.
Do not try to inhale Quinsair using any other type of nebuliser handset.
Check that your Zirela Nebuliser System works properly before starting your treatment.
Do not swallow the liquid in the ampoule.
Carefully read the Manufacturer’s Instructions for Use, provided with your Zirela Nebuliser Handset.
Keep the Zirela Instructions for Use in a safe place as they give full details on assembling the device.
Figure 1
Figure 2 How do I use the Zirela Nebuliser System?
You will hear one ‘beep’ and the status light will turn green.
Figure 3
5 minutes to inhale the medicine using the nebuliser.
If for any reason you must stop the treatment before it's finished, press and hold the controller’s on/off button for one second. After it has completely turned itself off and when you are ready to restart, press and hold the on/off button for one second again. Treatment will restart. You must inhale and exhale through the mouthpiece as before.
One nebuliser handset should be used for one 28-day treatment course. Please refer to the Manufacturer’s Instructions for Use for cleaning and storage advice.
If you have used more Quinsair than you should, tell your doctor as soon as possible. You may experience symptoms like irregular heart beat, which needs to be checked by your doctor. If the contents of the ampoule are swallowed, don’t worry but tell your doctor as soon as possible.
If you forget a dose, use it as soon as you remember as long as there is an 8-hour interval before inhaling the next dose. However if it is nearly the time for your next dose, skip the missed dose.
Do not inhale the contents of more than one ampoule to make up for a missed dose.
Do not stop using Quinsair without first talking to your doctor as your lung infection may worsen.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Get urgent medical treatment immediately if you notice a severe allergic reaction after inhaling Quinsair. Symptoms include:
General itching and feeling of heat – especially affecting the scalp, mouth, throat, palms or soles of your feet
Severe wheezing, or noisy or difficult breathing
Severe hives/nettle rash
Swelling of the lips, face, throat or tongue
Pale or greyish skin colour
A fast heart beat
Faintness or passing out
if you experience pain, stiffness and/or swelling in your joints
if you develop problems with your liver. Symptoms include:
Loss of appetite
Yellowing of the skin and eyes (jaundice)
Dark coloured urine
Itching
Tenderness (pain) around the stomach (abdomen)
Other side effects can include:
Cough
Abnormal sense of taste
Tiredness, weakness and lower tolerance to exercise
Loss of appetite
Shortness of breath
Changes in the amount and thickness of mucus/phlegm
Coughing up blood
Decreased amount of air that can be breathed out in one second (decreased FEV1 test)
Fungal infection around vagina
Insomnia or difficulty sleeping
Headache
Dizziness
Ringing or noise in the ears (tinnitus)
Change to the voice
Feeling and being sick
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, and decreased kidney function test)
Decreased lung function test
Increased or decreased amount of sugar (glucose) in the blood
Abnormal breathing sounds
Fungal infection of the mouth
Low numbers of red cells in the blood (anaemia) or the cells in the blood that help it clot (platelets)
Low or high numbers of white cells in the blood
Feeling anxious, restless or agitated and/or depressed
Reduced sense of smell
Feeling sleepy
Changes in eyesight
Loss of hearing
Increased heart beat
Difficulty in breathing
Retching
Indigestion
Passing wind
Hives/nettle rash and itching
Chest wall pain
Kidney failure
Changes in heart rhythm
Pain, burning, tingling, numbness and/or weakness in the limbs (neuropathy)
The following side effects have also been reported after taking tablets or an intravenous infusion containing levofloxacin, so they might possibly occur after using Quinsair:
Feeling confused or nervous
Shaking
Sensation of dizziness, spinning or falling over (vertigo)
Excessive sweating
Hallucinations and/or feeling paranoid
Feeling agitated
Unusual dreams or nightmares
Convulsions (fits)
Tingling sensation (pins and needles) and/or numbness
Palpitations
Low blood pressure
Muscle weakness
Syndrome associated with impaired water excretion and low levels of sodium (SIADH)
Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms)
Sharply demarcated, erythematous patches with/without blistering
Low numbers of all types of cells in the blood
Diabetic coma
Severe mental problems (which in very rare cases may lead to self-harm)
Pain, burning, tingling, numbness and/or weakness in the limbs (neuropathy)
Involuntary muscle movements, twitching or spasms
Fainting
Severe throbbing headaches with loss of eyesight
Temporary loss of vision
Rapid or abnormal heart beat
Inflammation of the lung
Severe skin reactions such as painful blistering or lesions possibly in the mouth, nose or vagina
Increased sensitivity of the skin to sunlight or UV light (sunbeds or other UV lamps)
Inflammation of the blood vessels
Inflammation of the mouth or lips
Rapid breakdown of muscles
Inflammation of a tendon or a broken tendon
Pain including pain in the back, chest, arms and legs and arms
Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule, the foil sachet and the boxes after EXP. The expiry date refers to the last day of that month.
Each ampoule is for single use only. Once an ampoule is opened, the contents should be used immediately. Any unused product must be thrown away. Replace any unused, unopened ampoules from the strip back into the sachet to protect them from light.
Store in the original package in order to protect from light. This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is levofloxacin. One ampoule contains levofloxacin hemihydrate equivalent to 240 mg of levofloxacin.
The other ingredients are magnesium chloride hexahydrate and water for injections.
Quinsair is a clear, pale yellow nebuliser solution. The medicine comes in small 3 mL plastic ampoules. Four ampoules are sealed in a foil sachet.
Quinsair is supplied as 28-day pack (containing one box of 56 (14 sachets of 4) ampoules) or as 4-day pack (containing 8 (2 sachets of 4) ampoules) and one box holding a Zirela Nebuliser Handset with the Manufacturer’s Instructions for Use.
Not all pack sizes may be marketed.
The ampoule is labelled in English only. The information that appears on the ampoule is:
Quinsair 240 mg Nebuliser Solution Levofloxacin
Inhalation use 2.4 mL
Lot EXP
Chiesi Farmaceutici S.p.A.
Via Palermo, 26/A 43122 Parma
Italy
Adare Pharmaceuticals S.r.l. Via Martin Luther King, 13
20060 Pessano con Bornago (MI) Italy
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00
Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Chiesi Bulgaria EOOD Teл.: + 359 29201205
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00
Chiesi CZ s.r.o.
Tel: + 420 261221745
Chiesi Pharma AB Tlf: + 46 8 753 35 20
Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Chiesi GmbH
Tel: + 49 40 89724-0
Chiesi Pharmaceuticals B.V. Tel: + 31 88 501 64 00
Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Chiesi Pharma AB Tlf: + 46 8 753 35 20
Chiesi Hellas AEBE
Τηλ: + 30 210 6179763
Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Chiesi España, S.A.U. Tel: + 34 93 494 8000
Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1421
Chiesi S.A.S.
Tél: + 33 1 47688899
Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Chiesi Romania S.R.L. Tel: + 40 212023642
Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Chiesi Slovenija d.o.o. Tel: + 386-1-43 00 901
Chiesi Pharma AB Sími: +46 8 753 35 20
Chiesi Italia S.p.A. Tel: + 39 0521 2791
Chiesi Pharma AB Puh/Tel: +46 8 753 35 20
Chiesi Farmaceutici S.p.A.
Τηλ: + 39 0521 2791
Chiesi Pharma AB Tel: +46 8 753 35 20
Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919
Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
. There are also links to other websites about rare diseases and treatments.