Find similiar products:
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 08829/0192.
Quinsair 240 mg nebuliser solution
Quinsair 240 mg nebuliser solution
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.
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.
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:
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.
Tell your doctor if you are taking any of the following medicines:
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.
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:
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.
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.
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.
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).
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).
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.
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 heartbeat, 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:
Stop using Quinsair and tell your doctor immediately:
Other side effects can include:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
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
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
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
or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
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 a 28-day pack (containing one box of 56 (14 sachets of 4) ampoules) or as a 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
This leaflet was last revised in 12/2023
Is this leaflet hard to see or read? Phone 0161 488 5555 for help.