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Generated Narrative: Bundle TEST PURPOSES ONLY - quinsair

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Generated Narrative: MedicinalProductDefinition mp8077ecb6bda7580081b9f65b63060e8a

identifier: http://ema.europa.eu/identifier/EU/1/14/973/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Quinsair 240 mg nebuliser solution

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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-	Country	Jurisdiction	Language
*	EU	EU	en

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Generated Narrative: Composition composition-en-8077ecb6bda7580081b9f65b63060e8a

identifier: http://ema.europa.eu/identifier/EU/1/14/973/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - quinsair

Attesters

What is in this leaflet

1. What Quinsair is and what it is used for
2. What you need to know before you use Quinsair
3. How to use Quinsair
4. Possible side effects
5. How to store Quinsair
6. 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.

Do not use Quinsair:

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. Tell your doctor before using Quinsair 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, Sj gren 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. Children and adolescents 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. Other medicines and Quinsair 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. 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 an increase in bleeding. Your doctor may need to give you regular blood tests to check how well your blood can clot.

Theophylline (used to treat breathing problems) or non-steroidal anti-inflammatory medicines (NSAIDs) such as fenbufen, acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting) or ibuprofen. Taking Quinsair at the same time as these medicines could increase your risk of a fit (seizure).

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.

Ciclosporin (used after organ transplants) or medicines that affect your heart beat (such as antiarrhythmics, tricyclic antidepressants, macrolide antibiotics or antipsychotics). Quinsair can interfere with the effects of these medicines. Your doctor will explain more. Pregnancy and breast-feeding 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. Driving and using machines 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. How much do I use? 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. When do I use it? 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. How long do I use it for? 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. If you experience breathing difficulties when you use Quinsair what additional medicine may your doctor prescribe for you? 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. What if I am using several different inhalers and other therapies for cystic fibrosis? 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 How to use it 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. Important information to know before you start

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 mix Quinsair with any other medicines in the Zirela Nebuliser Handset.

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. ON Quinsair Use it twice a day for 28 days OFF Quinsair Do not use it for the next 28 days Repeat cycle How do I prepare my Nebuliser System to inhale the medicine? Keep the Zirela Instructions for Use in a safe place as they give full details on assembling the device. 1) Make sure that the Zirela Nebuliser Handset is on a flat and stable surface. 2) Squeeze all of the contents of one ampoule into the medicine reservoir of the Zirela Nebuliser Handset (Figure 1). Ensure that you completely empty the ampoule, gently tapping it against the side of the reservoir if necessary. Figure 1 3) Close the medicine reservoir by aligning the tabs of the medicine cap with the slots of the reservoir (a). Press down and turn the cap clockwise as far as it will go (b, Figure 2). Figure 2 How do I use the Zirela Nebuliser System? 1) When you start your treatment, sit in a relaxed, upright position. 2) Hold the handset level, press and hold the on/off button on the controller for a few seconds. You will hear one beep and the status light will turn green. 3) After a few seconds, an aerosol mist will begin to flow into the aerosol chamber of the Zirela Nebuliser Handset. If aerosol mist does not begin to flow, please refer to the Zirela Manufacturer s Instructions for Use for help. 4) Keeping the handset level, place the mouthpiece in your mouth and close your lips around it (Figure 3). Figure 3 5) Breathe normally (inhale and exhale) through the mouthpiece. Try not to breathe through your nose. Continue to inhale and exhale comfortably until the treatment is finished. It takes about 5 minutes to inhale the medicine using the nebuliser. 6) When all of the medicine has been delivered, you will hear two beeps , which means the treatment is complete. 7) Once complete, open the medicine cap to ensure all of 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 ok. However if there are more than a few drops left, replace the medicine cap and restart treatment, from step 1. 8) Once treatment is complete, disconnect the controller and take apart the Zirela Nebuliser Handset for cleaning and disinfecting. The Manufacturer s Instructions for Use will give full details on cleaning and disinfecting. What if I need to stop my treatment before I ve finished? 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. How and when do I replace the Zirela Nebuliser Handset? 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 use more Quinsair than you should 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 to use Quinsair 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. If you stop using Quinsair 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. Some side effects can be serious 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 Stop using Quinsair and tell your doctor immediately:

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: Very common: may affect more than 1 in 10 people

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) Common: may affect up to 1 in 10 people

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 Uncommon: may affect up to 1 in 100 people

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: Uncommon: may affect up to 1 in 100 people

Feeling confused or nervous

Shaking

Sensation of dizziness, spinning or falling over (vertigo)

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

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 Not known: frequency cannot be estimated from the available data

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. Reporting of side effects 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.

What Quinsair contains

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. What Quinsair looks like and contents of the pack 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: On the front of the ampoule tail Quinsair 240 mg Nebuliser Solution Levofloxacin Inhalation use 2.4 mL In the crimped area on either side of the ampoule tail 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, 20060 Pessano con Bornago (MI) Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Chiesi sa/nv T l/Tel: + 32 (0)2 788 42 Lietuva Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073 Chiesi Bulgaria EOOD Te .: + 359 29201Luxembourg/Luxemburg Chiesi sa/nv T l/Tel: + 32 (0)2 788 42 esk republika Chiesi CZ s.r.o. Tel: + 420 261221Magyarorsz g Chiesi Hungary Kft. Tel.: + 36-1-429 1Danmark Chiesi Pharma AB Tlf: + 46 8 753 35 Malta Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Deutschland Chiesi GmbH Tel: + 49 40 89724-0 Nederland Chiesi Pharmaceuticals B.V. Tel: + 31 88 501 64 Eesti Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Norge Chiesi Pharma AB Tlf: + 46 8 753 35
Chiesi Hellas AEBE : + 30 210 6179 sterreich Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Espa a Chiesi Espa a, S.A.U. Tel: + 34 93 494 8Polska Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1France Chiesi S.A.S. T l: + 33 1 47688Portugal Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Hrvatska Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Rom nia Chiesi Romania S.R.L. Tel: + 40 212023Ireland Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2Slovenija Chiesi Slovenija d.o.o. Tel: + 386-1-43 00 sland Chiesi Pharma AB S mi: +46 8 753 35 Slovensk republika Chiesi Slovakia s.r.o. Tel: + 421 259300Italia Chiesi Italia S.p.A. Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB Puh/Tel: +46 8 753 35
Chiesi Farmaceutici S.p.A. : + 39 0521 2Sverige Chiesi Pharma AB Tel: +46 8 753 35 Latvija Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2This leaflet was last revised in MM/YYYY. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: