What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/14/973/001.

Quinsair 240 mg nebuliser solution

Package leaflet: Information for the patient

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.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • 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 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

1. What Quinsair is and what it is used for

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. If the infection is not properly treated it will continue to damage the lungs, causing further problems with breathing.

2. What you need to know before you use Quinsair

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 broken tendon) during treatment with another quinolone antibiotic
  • if you suffer from epilepsy
  • if you are pregnant or breast-feeding

Warnings and precautions

Tell your doctor before using Quinsair if you have or have ever had any of the following:

  • 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
    Quinsair can cause peripheral neuropathy (nerve damage). If you experience pain, burning, tingling, numbness or weakness in your limbs, stop using Quinsair and tell your doctor immediately.
  • A disease causing muscle weakness and fatigue called myasthenia gravis.
  • Inflammation of a tendon causing pain, stiffness and/or swelling in the joints (tendonitis).
  • Difficulty in breathing 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.

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 (NSAlDs) 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. Tell your doctor if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby.

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.

3. How to use Quinsair

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?

lnhaling 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 aIfa

3rd Airway clearance techniques

4th Quinsair

5th Inhaled steroids

How to use it

Quinsair should be taken by inhalation using 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.

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.

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).

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).

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.

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. 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.

4. Possible side effects

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 and weight loss
  • 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

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

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

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:

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie

Malta

ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Quinsair

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date 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.

6. Contents of the pack and other information

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 and each box contains 14 sachets.

Each 28-day pack of Quinsair contains one box of 56 (14 sachets of 4) ampoules and one box holding a Zirela Nebuliser Handset with the Manufacturer's Instructions for Use.

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, 13
20060 Pessano con Bornago (MI)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Chiesi Ltd
Tel: + 44 (0)161 488 5555

This leaflet was last revised in 06/2018

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

0108004760/01

CP0063/1