What you need to know before using Quinsair<\/h2>\n\n\n\nDo not use Quinsair<\/h2>\n\n\n\n- if you are\u00a0allergic<\/strong>\u00a0to\u00a0\u00a0levofloxacin<\/strong>, to other\u00a0quinolone antibiotics, e.g.\u00a0moxifloxacin,\u00a0ciprofloxacin\u00a0or ofloxacin, or any of the other ingredients of this medicine (listed in section 6)<\/li>
- if you have or have had problems with your tendons (\u00a0inflammation\u00a0of a\u00a0tendon\u00a0or a\u00a0tendon rupture\u00a0) during treatment with other\u00a0quinolone\u00a0or fluoroquinolone antibiotics<\/li>
- if you have\u00a0epilepsy<\/li>
- if you are\u00a0pregnant\u00a0or\u00a0breastfeeding.<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Before taking this medicine<\/strong><\/p>\n\n\n\nYou should not take\u00a0antibacterial\u00a0fluoroquinolone\/quinolone medicines, including Quinsair if you have previously had any serious\u00a0side effects\u00a0from taking any\u00a0quinolone\u00a0or fluoroquinolone medicines.\u00a0If this is the case, contact your doctor as soon as possible.<\/p>\n\n\n\n
When you take this medicine<\/strong><\/p>\n\n\n\nIn rare cases, joint pain and swelling and\u00a0inflammation\u00a0or tendon rupture may occur.\u00a0The risk increases if you are older (over 60 years), have undergone an organ transplant, have kidney problems, or if are being treated with\u00a0cortisone\u00a0(\u00a0corticosteroids\u00a0).\u00a0Inflammation\u00a0and tendon rupture can occur within the first 48 hours of treatment but also up to several months after the end of treatment with Quinsair.\u00a0At the first sign of pain or\u00a0inflammation\u00a0in a tendon (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking Quinsair, consult a doctor and let the painful area rest.\u00a0Avoid unnecessary effort as it may increase the risk of stretch marks.<\/p>\n\n\n\n
Tell your doctor before taking Quinsair<\/strong><\/p>\n\n\n\nif you have or have had any of the following:<\/p>\n\n\n\n
- Long-term, disabling,<\/em> and possibly lasting serious\u00a0side\u00a0effectsAntibacterial\u00a0fluoroquinolone\/quinolone drugs, including Quinsair, have been linked to very rare but serious\u00a0side effects.\u00a0Some of these have been long-lasting (up to months or years), disabled, or possibly permanent.\u00a0This includes pain in tendons, muscles, and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation (\u00a0paresthesia\u00a0), and sensory disorders in the form of impaired vision, taste, and smell and hearing, depression, memory loss, extreme fatigue, and severe sleep disorders. If you get any of these\u00a0side effects\u00a0after taking Quinsair, talk to your doctor immediately before continuing treatment.\u00a0You and your doctor will decide if you should continue treatment or consider using another type of\u00a0antibiotic.<\/li>
- Serious kidney problems<\/li>
- A\u00a0severe\u00a0allergic reaction.\u00a0The symptoms are listed in section 4.<\/li>
- Serious skin reactions
If you are treated with Quinsair, you may experience serious skin reactions such as blisters or injuries.\u00a0Tell your doctor if you notice any skin reactions after using Quinsair.<\/li> - Liver problem.\u00a0The symptoms are listed in section 4.<\/li>
- Abnormal heart rhythm
Quinsair can lead to changes in the heart rhythm, especially if you are taking medicines to treat heart problems or if you have low levels of\u00a0potassium\u00a0or\u00a0magnesium\u00a0in your blood.\u00a0Women who take these types of drugs are more likely to be affected.\u00a0If you experience palpitations or irregular heartbeat while using Quinsair, contact your doctor immediately.<\/li> - Seizures and seizures
Quinolone antibiotics, including Quinsair, can cause seizures or seizures.\u00a0If this happens, stop using Quinsair and contact a doctor immediately.<\/li> - Depression\u00a0or\u00a0mental health problems<\/li>
- Nerve
damage In rare cases, you may experience symptoms of nerve damage (\u00a0neuropathy\u00a0) such as pain, a burning, and stinging sensation, numbness, and\/or weakness, especially in the feet and legs or in the hands and arms.\u00a0If this happens, stop taking Quinsair and contact a doctor immediately to prevent the development of a possible permanent condition.<\/li> - A disease that leads to muscle weakness and fatigue is called\u00a0myasthenia gravis.<\/li>
- Inflammation\u00a0of a tendon that leads to\u00a0pain, stiffness, and\/or swelling in the joints\u00a0(tendinitis).<\/li>
- If you have had\u00a0difficulty breathing\u00a0after taking Quinsair, the symptoms may be mild to severe (\u00a0bronchospasm\u00a0)<\/li>
- Cough or blood-mixed mucus\u00a0from the respiratory tract<\/li>
- Glucose\u00a0\u20116 \u2011 phosphate
dehydrogenase deficiency Quinolone antibiotics, such as Quinsair, can make patients with\u00a0glucose\u00a0\u20116 \u2011 dehydrogenase deficiency (a rare hereditary disease) susceptible to blood complications leading to a sudden increase in body temperature, yellowing of the skin, dark skin and mucous membranes, fatigue, heavy and fast breathing and weak, fast\u00a0pulse.\u00a0Talk to your doctor if you have any questions about this.<\/li> - Diabetes
Quinolone antibiotics, including Quinsair, can cause your blood sugar levels to become either too high or too low.\u00a0If you have\u00a0diabetes, you should monitor your blood sugar levels closely.<\/li> - Diarrhea
You may get diarrhea during or after treatment with Quinsair.\u00a0If it becomes difficult or persistent, or if you notice blood in the stool, stop taking Quinsair immediately and contact a doctor.\u00a0Do not take any medicine to treat diarrhea without first talking to a doctor.<\/li> - Antibiotic\u00a0resistance Bacteria can\u00a0eventually
become resistant to treatment with\u00a0antibiotics.\u00a0This means that Quinsair should not be used to prevent lung infections.\u00a0It should only be used to treat lung infections caused by\u00a0Pseudomonas\u00a0aeruginosa.\u00a0Talk to your doctor if you are worried or have any questions about this.<\/li> - Superinfections
Sometimes long-term treatment with\u00a0antibiotics\u00a0can mean that you get another\u00a0infection\u00a0caused by other bacteria that are not affected by the\u00a0antibiotic\u00a0(superinfection).\u00a0Talk to your doctor if you are worried or have any questions about this and using Quinsair.<\/li> - Vision problems
If you notice changes in vision or other eye problems while using Quinsair, contact your doctor immediately.<\/li> - Hypersensitivity of the skin to light
Quinsair may cause your skin to become more sensitive to sunlight.\u00a0You should not be\u00a0exposed\u00a0to sunlight for long periods or too intense sunlight.\u00a0Do not use tanning beds or other UV lamps while taking Quinsair and for 48 hours after stopping treatment.<\/li> - False test results<\/em>
Some tests (eg to confirm\u00a0tuberculosis\u00a0or the use of strong painkillers) may give false results during treatment with Quinsair.<\/li><\/ul>\n\n\n\n- if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral\u00a0aneurysm\u00a0in a large blood vessel).<\/li>
- if you have had an aortic dissection (a rupture of the aortic wall).<\/li>
- if you have been diagnosed with leaky heart valves.<\/li>
- if someone in your family has or has had an aortic aneurysm, aortic dissection or congenital heart valve disease, or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan syndrome,\u00a0Ehlers-Danlos syndrome,\u00a0Turner syndrome,\u00a0Sj\u00f6gren’s syndrome\u00a0(an\u00a0inflammatory\u00a0autoimmune\u00a0disease) or vascular diseases such as Takayasu’s arteritis, giant cell arteritis, Beh\u00e7et’s disease, high\u00a0blood pressure\u00a0or known atherosclerosis,\u00a0rheumatoid arthritis\u00a0(a joint disease) or\u00a0endocarditis\u00a0(an\u00a0infection\u00a0of the heart)).<\/li>
- If you experience sudden, severe pain in the abdomen, chest, or back, visit an emergency room immediately as this may be a symptom of aortic aneurysm and aortic dissection.\u00a0The risk of developing this may be increased if you are being treated with systemic\u00a0corticosteroids\u00a0(“cortisone”).<\/li>
- if you experience sudden shortness of breath, especially when you lie down in bed, notice swelling in your ankles, feet, or stomach, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately.<\/li><\/ul>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Quinsair should not be given to children and adolescents under 18 years of age as there is insufficient information on use in this age group.<\/p>\n\n\n\n
Other drugs and Quinsair<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0These medicines may affect the way Quinsair works.<\/p>\n\n\n\n
Tell your doctor<\/strong> if you are taking any of the following medicines:<\/p>\n\n\n\n- Vitamin\u00a0K inhibitors such as\u00a0warfarin<\/strong>\u00a0(used to prevent blood clots).\u00a0Taking these medicines with Quinsair may lead to an increased bleeding time.\u00a0Your doctor may need to take blood samples regularly to check how well your blood is clotting.<\/li>
- Theophylline<\/strong>\u00a0(used to treat respiratory problems) or non-steroidal anti-inflammatory drugs (\u00a0NSAIDs\u00a0) such as\u00a0fenbufen<\/strong>,\u00a0acetylsalicylic acid<\/a>\u00a0(a substance found in many medicines used to relieve pain and lower fever and prevent blood clots), or\u00a0ibuprofen.\u00a0Taking Quinsair while you are taking these medicines may increase the risk of having a seizure.<\/li>
- Medicines such as\u00a0probenecid<\/strong>\u00a0(used to prevent\u00a0gout\u00a0) or\u00a0cimetidine<\/strong>\u00a0(used to treat\u00a0stomach ulcers\u00a0).\u00a0Taking Quinsair while you are taking these medicines may affect your kidneys’ way of handling medicines, which is especially important if you have kidney problems.<\/li>
- Ciclosporin<\/strong>\u00a0(used after organ transplantation) or\u00a0medicines that affect the heartbeat<\/strong>\u00a0(such as\u00a0antiarrhythmics\u00a0,\u00a0tricyclic antidepressants\u00a0, macrolide antibiotics or antipsychotics).\u00a0Quinsair may affect the effect of these medicines.\u00a0The doctor can tell you more.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Quinsair must not be used during pregnancy or breast-feeding.\u00a0If you are pregnant\u00a0or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Quinsair may make you feel dizzy, tired, weak, or cause vision problems.\u00a0If this happens to you, do not drive or use any tools or machines.<\/p>\n\n\n\n
How to use Quinsair<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
How much should I use?<\/strong><\/p>\n\n\n\nInhale the contents of\u00a0one\u00a0ampoule\u00a0(240 mg) twice daily with the Zirela nebulizer system<\/strong>.\u00a0It takes about 5 minutes to inhale the medicine with the nebulizer.<\/p>\n\n\n\nWhen should I use it?<\/strong><\/p>\n\n\n\nIf you inhale Quinsair at the same time each day, it will be easier to remember when to take the medicine. Inhale the medicine as follows:<\/p>\n\n\n\n
- 1 ampoule in the morning with Zirela nebulizer<\/li>
- 1 ampoule in the evening with Zirela nebulizer<\/li><\/ul>\n\n\n\n
It should be as close to 12 hours between doses as possible.<\/p>\n\n\n\n
How long should I use it?<\/strong><\/p>\n\n\n\nYou should use Quinsair every day for 28 days and then take a break of 28 days as you should not inhale Quinsair. Then you start with a new treatment regimen.<\/p>\n\n\n\n
It is important that you continue to use the medicine twice every day for the 28 days of treatment and that you continue the treatment cycle with 28 days of treatment followed by a 28-day treatment break as long as your doctor tells you to.<\/p>\n\n\n\n![\"Illustration](\"https:\/\/www.fass.se\/imaging\/resources\/9e2ca452-666f-4e41-b86f-a9a7040ae043\" "\\"Illustration")
<\/a><\/figure>\n\n\n\nIf you experience breathing problems while using Quinsair, what additional medicines can your doctor prescribe?<\/strong><\/p>\n\n\n\nIf you experience difficulty breathing after using Quinsair, your doctor may prescribe an inhaler that contains a bronchodilator (dilates the trachea) (eg salbutamol ). Inhale this medicine for at least 15 minutes or up to 4 hours before the next dose of Quinsair.<\/p>\n\n\n\n
What should I do if I use the <\/strong>different\u00a0inhalers\u00a0and other treatments for\u00a0cystic fibrosis?<\/strong><\/p>\n\n\n\nIf you are using several different inhalation treatments and other treatments for\u00a0cystic fibrosis, you should use the medicines in the following order:<\/p>\n\n\n\n
- Tracheal dilators<\/li>
- Dornan alfa<\/li>
- Techniques that keep the airways open<\/li>
- Quinsair<\/li>
- Inhalation cortisone<\/li><\/ol>\n\n\n\n
How to use it<\/strong><\/p>\n\n\n\nQuinsair should be taken by\u00a0inhalation\u00a0with\u00a0a Zirela hand nebulizer<\/strong>\u00a0(including a Zirela aerosol head).\u00a0This should be connected to either an ease controller or an eFlow rapid controller.<\/p>\n\n\n\nImportant information before starting treatment<\/strong><\/p>\n\n\n\n- One\u00a0ampoule\u00a0is\u00a0for single use only<\/strong>\u00a0.\u00a0Once an\u00a0ampoule\u00a0has been opened, the contents should be used immediately.<\/strong><\/li>
- Do not use Quinsair if you notice that the sealed foil sachet or\u00a0ampoules\u00a0have been tampered with.<\/li>
- Do not use Quinsair if it is cloudy or if the solution contains particles.<\/li>
- Do not mix Quinsair with other medicines in<\/strong>\u00a0the Zirela hand nebulizer.<\/li>
- No medicines other than Quinsair may be used in the Zirela hand nebulizer.<\/li>
- Do not try to inhale Quinsair with any other type of\u00a0nebulizer\u00a0.<\/li>
- Before starting treatment, check that the Zirela nebulizer system is working properly.<\/li>
- You must not swallow the liquid in\u00a0ampoule\u00a0one.<\/li><\/ul>\n\n\n\n
Carefully read the instructions for use that come with the Zirela hand nebulizer.<\/p>\n\n\n\n
How do I prepare the nebuliser system for inhalation of the drug?<\/strong><\/p>\n\n\n\nKeep the Zirela Instructions for Use in a safe place as they contain complete information on fitting the nebulizer.<\/p>\n\n\n\n
1) Place the Zirela hand nebulizer<\/strong> on a flat and stable surface.<\/p>\n\n\n\n2) Squeeze all the contents of an ampoule<\/strong> into the medicine container on the Zirela hand nebulizer (Figure 1). Make sure you have emptied the entire ampoule one. If necessary, tap it gently against the medicine container.<\/p>\n\n\n\n![\"Zirela](\"https:\/\/www.fass.se\/imaging\/resources\/007f2576-0be6-4ba1-b5d4-3835b8da3afa\" "\\"Zirela")
<\/a><\/figure>\n\n\n\n3) Close the medicine container<\/strong> by aligning the tabs on the medicine lid with the grooves on the medicine container (a). Press down and turn the cover clockwise as far as it will go (Figure 2).<\/p>\n\n\n\n
- if you are\u00a0allergic<\/strong>\u00a0to\u00a0\u00a0levofloxacin<\/strong>, to other\u00a0quinolone antibiotics, e.g.\u00a0moxifloxacin,\u00a0ciprofloxacin\u00a0or ofloxacin, or any of the other ingredients of this medicine (listed in section 6)<\/li>
- if you have or have had problems with your tendons (\u00a0inflammation\u00a0of a\u00a0tendon\u00a0or a\u00a0tendon rupture\u00a0) during treatment with other\u00a0quinolone\u00a0or fluoroquinolone antibiotics<\/li>
- if you have\u00a0epilepsy<\/li>
- if you are\u00a0pregnant\u00a0or\u00a0breastfeeding.<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Before taking this medicine<\/strong><\/p>\n\n\n\n
You should not take\u00a0antibacterial\u00a0fluoroquinolone\/quinolone medicines, including Quinsair if you have previously had any serious\u00a0side effects\u00a0from taking any\u00a0quinolone\u00a0or fluoroquinolone medicines.\u00a0If this is the case, contact your doctor as soon as possible.<\/p>\n\n\n\n
When you take this medicine<\/strong><\/p>\n\n\n\n
In rare cases, joint pain and swelling and\u00a0inflammation\u00a0or tendon rupture may occur.\u00a0The risk increases if you are older (over 60 years), have undergone an organ transplant, have kidney problems, or if are being treated with\u00a0cortisone\u00a0(\u00a0corticosteroids\u00a0).\u00a0Inflammation\u00a0and tendon rupture can occur within the first 48 hours of treatment but also up to several months after the end of treatment with Quinsair.\u00a0At the first sign of pain or\u00a0inflammation\u00a0in a tendon (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking Quinsair, consult a doctor and let the painful area rest.\u00a0Avoid unnecessary effort as it may increase the risk of stretch marks.<\/p>\n\n\n\n
Tell your doctor before taking Quinsair<\/strong><\/p>\n\n\n\n
if you have or have had any of the following:<\/p>\n\n\n\n
- Long-term, disabling,<\/em> and possibly lasting serious\u00a0side\u00a0effectsAntibacterial\u00a0fluoroquinolone\/quinolone drugs, including Quinsair, have been linked to very rare but serious\u00a0side effects.\u00a0Some of these have been long-lasting (up to months or years), disabled, or possibly permanent.\u00a0This includes pain in tendons, muscles, and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation (\u00a0paresthesia\u00a0), and sensory disorders in the form of impaired vision, taste, and smell and hearing, depression, memory loss, extreme fatigue, and severe sleep disorders. If you get any of these\u00a0side effects\u00a0after taking Quinsair, talk to your doctor immediately before continuing treatment.\u00a0You and your doctor will decide if you should continue treatment or consider using another type of\u00a0antibiotic.<\/li>
- Serious kidney problems<\/li>
- A\u00a0severe\u00a0allergic reaction.\u00a0The symptoms are listed in section 4.<\/li>
- Serious skin reactions
If you are treated with Quinsair, you may experience serious skin reactions such as blisters or injuries.\u00a0Tell your doctor if you notice any skin reactions after using Quinsair.<\/li>- Liver problem.\u00a0The symptoms are listed in section 4.<\/li>
- Abnormal heart rhythm
Quinsair can lead to changes in the heart rhythm, especially if you are taking medicines to treat heart problems or if you have low levels of\u00a0potassium\u00a0or\u00a0magnesium\u00a0in your blood.\u00a0Women who take these types of drugs are more likely to be affected.\u00a0If you experience palpitations or irregular heartbeat while using Quinsair, contact your doctor immediately.<\/li>- Seizures and seizures
Quinolone antibiotics, including Quinsair, can cause seizures or seizures.\u00a0If this happens, stop using Quinsair and contact a doctor immediately.<\/li>- Depression\u00a0or\u00a0mental health problems<\/li>
- Nerve
damage In rare cases, you may experience symptoms of nerve damage (\u00a0neuropathy\u00a0) such as pain, a burning, and stinging sensation, numbness, and\/or weakness, especially in the feet and legs or in the hands and arms.\u00a0If this happens, stop taking Quinsair and contact a doctor immediately to prevent the development of a possible permanent condition.<\/li>- A disease that leads to muscle weakness and fatigue is called\u00a0myasthenia gravis.<\/li>
- Inflammation\u00a0of a tendon that leads to\u00a0pain, stiffness, and\/or swelling in the joints\u00a0(tendinitis).<\/li>
- If you have had\u00a0difficulty breathing\u00a0after taking Quinsair, the symptoms may be mild to severe (\u00a0bronchospasm\u00a0)<\/li>
- Cough or blood-mixed mucus\u00a0from the respiratory tract<\/li>
- Glucose\u00a0\u20116 \u2011 phosphate
dehydrogenase deficiency Quinolone antibiotics, such as Quinsair, can make patients with\u00a0glucose\u00a0\u20116 \u2011 dehydrogenase deficiency (a rare hereditary disease) susceptible to blood complications leading to a sudden increase in body temperature, yellowing of the skin, dark skin and mucous membranes, fatigue, heavy and fast breathing and weak, fast\u00a0pulse.\u00a0Talk to your doctor if you have any questions about this.<\/li>- Diabetes
Quinolone antibiotics, including Quinsair, can cause your blood sugar levels to become either too high or too low.\u00a0If you have\u00a0diabetes, you should monitor your blood sugar levels closely.<\/li>- Diarrhea
You may get diarrhea during or after treatment with Quinsair.\u00a0If it becomes difficult or persistent, or if you notice blood in the stool, stop taking Quinsair immediately and contact a doctor.\u00a0Do not take any medicine to treat diarrhea without first talking to a doctor.<\/li>- Antibiotic\u00a0resistance Bacteria can\u00a0eventually
become resistant to treatment with\u00a0antibiotics.\u00a0This means that Quinsair should not be used to prevent lung infections.\u00a0It should only be used to treat lung infections caused by\u00a0Pseudomonas\u00a0aeruginosa.\u00a0Talk to your doctor if you are worried or have any questions about this.<\/li>- Superinfections
Sometimes long-term treatment with\u00a0antibiotics\u00a0can mean that you get another\u00a0infection\u00a0caused by other bacteria that are not affected by the\u00a0antibiotic\u00a0(superinfection).\u00a0Talk to your doctor if you are worried or have any questions about this and using Quinsair.<\/li>- Vision problems
If you notice changes in vision or other eye problems while using Quinsair, contact your doctor immediately.<\/li>- Hypersensitivity of the skin to light
Quinsair may cause your skin to become more sensitive to sunlight.\u00a0You should not be\u00a0exposed\u00a0to sunlight for long periods or too intense sunlight.\u00a0Do not use tanning beds or other UV lamps while taking Quinsair and for 48 hours after stopping treatment.<\/li>- False test results<\/em>
Some tests (eg to confirm\u00a0tuberculosis\u00a0or the use of strong painkillers) may give false results during treatment with Quinsair.<\/li><\/ul>\n\n\n\n- if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral\u00a0aneurysm\u00a0in a large blood vessel).<\/li>
- if you have had an aortic dissection (a rupture of the aortic wall).<\/li>
- if you have been diagnosed with leaky heart valves.<\/li>
- if someone in your family has or has had an aortic aneurysm, aortic dissection or congenital heart valve disease, or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan syndrome,\u00a0Ehlers-Danlos syndrome,\u00a0Turner syndrome,\u00a0Sj\u00f6gren’s syndrome\u00a0(an\u00a0inflammatory\u00a0autoimmune\u00a0disease) or vascular diseases such as Takayasu’s arteritis, giant cell arteritis, Beh\u00e7et’s disease, high\u00a0blood pressure\u00a0or known atherosclerosis,\u00a0rheumatoid arthritis\u00a0(a joint disease) or\u00a0endocarditis\u00a0(an\u00a0infection\u00a0of the heart)).<\/li>
- If you experience sudden, severe pain in the abdomen, chest, or back, visit an emergency room immediately as this may be a symptom of aortic aneurysm and aortic dissection.\u00a0The risk of developing this may be increased if you are being treated with systemic\u00a0corticosteroids\u00a0(“cortisone”).<\/li>
- if you experience sudden shortness of breath, especially when you lie down in bed, notice swelling in your ankles, feet, or stomach, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately.<\/li><\/ul>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Quinsair should not be given to children and adolescents under 18 years of age as there is insufficient information on use in this age group.<\/p>\n\n\n\n
Other drugs and Quinsair<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.\u00a0These medicines may affect the way Quinsair works.<\/p>\n\n\n\n
Tell your doctor<\/strong> if you are taking any of the following medicines:<\/p>\n\n\n\n
- Vitamin\u00a0K inhibitors such as\u00a0warfarin<\/strong>\u00a0(used to prevent blood clots).\u00a0Taking these medicines with Quinsair may lead to an increased bleeding time.\u00a0Your doctor may need to take blood samples regularly to check how well your blood is clotting.<\/li>
- Theophylline<\/strong>\u00a0(used to treat respiratory problems) or non-steroidal anti-inflammatory drugs (\u00a0NSAIDs\u00a0) such as\u00a0fenbufen<\/strong>,\u00a0acetylsalicylic acid<\/a>\u00a0(a substance found in many medicines used to relieve pain and lower fever and prevent blood clots), or\u00a0ibuprofen.\u00a0Taking Quinsair while you are taking these medicines may increase the risk of having a seizure.<\/li>
- Medicines such as\u00a0probenecid<\/strong>\u00a0(used to prevent\u00a0gout\u00a0) or\u00a0cimetidine<\/strong>\u00a0(used to treat\u00a0stomach ulcers\u00a0).\u00a0Taking Quinsair while you are taking these medicines may affect your kidneys’ way of handling medicines, which is especially important if you have kidney problems.<\/li>
- Ciclosporin<\/strong>\u00a0(used after organ transplantation) or\u00a0medicines that affect the heartbeat<\/strong>\u00a0(such as\u00a0antiarrhythmics\u00a0,\u00a0tricyclic antidepressants\u00a0, macrolide antibiotics or antipsychotics).\u00a0Quinsair may affect the effect of these medicines.\u00a0The doctor can tell you more.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Quinsair must not be used during pregnancy or breast-feeding.\u00a0If you are pregnant\u00a0or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Quinsair may make you feel dizzy, tired, weak, or cause vision problems.\u00a0If this happens to you, do not drive or use any tools or machines.<\/p>\n\n\n\n
How to use Quinsair<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
How much should I use?<\/strong><\/p>\n\n\n\n
Inhale the contents of\u00a0one\u00a0ampoule\u00a0(240 mg) twice daily with the Zirela nebulizer system<\/strong>.\u00a0It takes about 5 minutes to inhale the medicine with the nebulizer.<\/p>\n\n\n\n
When should I use it?<\/strong><\/p>\n\n\n\n
If you inhale Quinsair at the same time each day, it will be easier to remember when to take the medicine. Inhale the medicine as follows:<\/p>\n\n\n\n
- 1 ampoule in the morning with Zirela nebulizer<\/li>
- 1 ampoule in the evening with Zirela nebulizer<\/li><\/ul>\n\n\n\n
It should be as close to 12 hours between doses as possible.<\/p>\n\n\n\n
How long should I use it?<\/strong><\/p>\n\n\n\n
You should use Quinsair every day for 28 days and then take a break of 28 days as you should not inhale Quinsair. Then you start with a new treatment regimen.<\/p>\n\n\n\n
It is important that you continue to use the medicine twice every day for the 28 days of treatment and that you continue the treatment cycle with 28 days of treatment followed by a 28-day treatment break as long as your doctor tells you to.<\/p>\n\n\n\n
If you experience breathing problems while using Quinsair, what additional medicines can your doctor prescribe?<\/strong><\/p>\n\n\n\n
If you experience difficulty breathing after using Quinsair, your doctor may prescribe an inhaler that contains a bronchodilator (dilates the trachea) (eg salbutamol ). Inhale this medicine for at least 15 minutes or up to 4 hours before the next dose of Quinsair.<\/p>\n\n\n\n
What should I do if I use the <\/strong>different\u00a0inhalers\u00a0and other treatments for\u00a0cystic fibrosis?<\/strong><\/p>\n\n\n\n
If you are using several different inhalation treatments and other treatments for\u00a0cystic fibrosis, you should use the medicines in the following order:<\/p>\n\n\n\n
- Tracheal dilators<\/li>
- Dornan alfa<\/li>
- Techniques that keep the airways open<\/li>
- Quinsair<\/li>
- Inhalation cortisone<\/li><\/ol>\n\n\n\n
How to use it<\/strong><\/p>\n\n\n\n
Quinsair should be taken by\u00a0inhalation\u00a0with\u00a0a Zirela hand nebulizer<\/strong>\u00a0(including a Zirela aerosol head).\u00a0This should be connected to either an ease controller or an eFlow rapid controller.<\/p>\n\n\n\n
Important information before starting treatment<\/strong><\/p>\n\n\n\n
- One\u00a0ampoule\u00a0is\u00a0for single use only<\/strong>\u00a0.\u00a0Once an\u00a0ampoule\u00a0has been opened, the contents should be used immediately.<\/strong><\/li>
- Do not use Quinsair if you notice that the sealed foil sachet or\u00a0ampoules\u00a0have been tampered with.<\/li>
- Do not use Quinsair if it is cloudy or if the solution contains particles.<\/li>
- Do not mix Quinsair with other medicines in<\/strong>\u00a0the Zirela hand nebulizer.<\/li>
- No medicines other than Quinsair may be used in the Zirela hand nebulizer.<\/li>
- Do not try to inhale Quinsair with any other type of\u00a0nebulizer\u00a0.<\/li>
- Before starting treatment, check that the Zirela nebulizer system is working properly.<\/li>
- You must not swallow the liquid in\u00a0ampoule\u00a0one.<\/li><\/ul>\n\n\n\n
Carefully read the instructions for use that come with the Zirela hand nebulizer.<\/p>\n\n\n\n
How do I prepare the nebuliser system for inhalation of the drug?<\/strong><\/p>\n\n\n\n
Keep the Zirela Instructions for Use in a safe place as they contain complete information on fitting the nebulizer.<\/p>\n\n\n\n
1) Place the Zirela hand nebulizer<\/strong> on a flat and stable surface.<\/p>\n\n\n\n
2) Squeeze all the contents of an ampoule<\/strong> into the medicine container on the Zirela hand nebulizer (Figure 1). Make sure you have emptied the entire ampoule one. If necessary, tap it gently against the medicine container.<\/p>\n\n\n\n
3) Close the medicine container<\/strong> by aligning the tabs on the medicine lid with the grooves on the medicine container (a). Press down and turn the cover clockwise as far as it will go (Figure 2).<\/p>\n\n\n\n
- One\u00a0ampoule\u00a0is\u00a0for single use only<\/strong>\u00a0.\u00a0Once an\u00a0ampoule\u00a0has been opened, the contents should be used immediately.<\/strong><\/li>
- Theophylline<\/strong>\u00a0(used to treat respiratory problems) or non-steroidal anti-inflammatory drugs (\u00a0NSAIDs\u00a0) such as\u00a0fenbufen<\/strong>,\u00a0acetylsalicylic acid<\/a>\u00a0(a substance found in many medicines used to relieve pain and lower fever and prevent blood clots), or\u00a0ibuprofen.\u00a0Taking Quinsair while you are taking these medicines may increase the risk of having a seizure.<\/li>
- Vitamin\u00a0K inhibitors such as\u00a0warfarin<\/strong>\u00a0(used to prevent blood clots).\u00a0Taking these medicines with Quinsair may lead to an increased bleeding time.\u00a0Your doctor may need to take blood samples regularly to check how well your blood is clotting.<\/li>