• 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.

1. What Cayston is and what it is used for
2. What you need to know before you take Cayston
3. How to take Cayston
4. Possible side effects
5. How to store Cayston
6. Contents of the pack and other information

• if you are allergic to aztreonam or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before taking Cayston:

• if you are allergic to any other antibiotics (such as penicillins, cephalosporins, and/or carbapenems)
• if you do not tolerate or have chest tightness from taking other inhaled medicines
• if you have kidney problems
• if you have ever coughed up any blood
• if you have ever had low lung function tests.

If any of these apply to you tell your doctor before using Cayston.

As an inhaled medicine, Cayston could cause you to cough and this could lead to coughing up blood. If you have ever coughed up blood you should only use Cayston if your doctor thinks the benefit of taking this medicine outweighs the risk of coughing up blood.

You may get a temporary lowering of lung function test result during treatment with Cayston, but this is typically not a lasting effect.

Cayston is not for use in children under the age of 6 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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.

There are no clinical data on the use of Cayston in pregnant women, therefore you should not take Cayston during pregnancy unless specifically discussed with your doctor.

If you plan to breast-feed ask your doctor for advice before taking Cayston. You can breast-feed during treatment with Cayston because the amount of Cayston likely to be passed to your child during breast-feeding will be extremely small.

Cayston is not expected to affect your ability to drive or use machines.

You will need the following:

• One amber-coloured vial of Cayston with a blue cap.
• One plastic ampoule of solvent (0.17% w/v sodium chloride). The information that appears on the solvent ampoule is provided in English only (see section 6).
• An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an eFlow Control Unit of the type 178 (eFlow rapid) or type 678 (eBase Controller).

You must use the Cayston specific Altera Nebuliser Handset containing an Altera Aerosol Head.

Do not try to take Cayston using any other type of nebuliser handset (including the eFlow rapid handset).

Check that your nebuliser works properly before starting your treatment with Cayston. Read the manufacturer’s instructions for use provided with your Altera Nebuliser System carefully.

• Do not prepare Cayston until you are ready to administer a dose.
• Do not use Cayston if you notice that the package has been tampered with.
• Do not use Cayston if it has been stored outside a refrigerator for more than 28 days.
• Do not use the solvent or prepared Cayston if it is cloudy or if there are particles in the solution.

1. Take one amber vial of Cayston and one ampoule of solvent from the box. Solvent ampoules must be separated by gently pulling them apart.
2. Gently tap the amber vial containing the Cayston so that the powder settles at the bottom. This helps to ensure that you get the proper dose of medicine.
3. Follow Step A to D in Figure 1 below to open the amber vial:

Step A: With the blue cap tab facing toward you, place the vial on a flat surface. Using one hand to hold the vial steady, use the other hand to slowly flip up the blue cap.

Step B: Pull the blue cap down to a flat (horizontal) position (where the bottom of the blue cap faces up), to prepare the metal seal for removal. Do not completely tear through the metal seal.

Step C: While continuing to hold the vial steady with one hand, use the other hand to slowly pull the blue cap in a counterclockwise direction. Do not twist the blue cap.

Step D: When the metal seal opens, continue to slowly pull on the blue cap in a counterclockwise direction until the metal seal is completely removed.

Figure 1

4. Safely dispose of the metal seal. Carefully remove (but do not yet discard) the rubber stopper.
5. Open the ampoule of solvent by twisting off the tip. Squeeze out the contents completely into the vial (Figure 2). Next, gently swirl the vial until the powder has completely dissolved and the liquid is clear.

It’s best to use Cayston immediately after you have made up the solution. But, if you cannot use the prepared dose straight away, replace the stopper in the vial and store in a refrigerator. Use the prepared solution within 8 hours.

1. Make sure the Altera Nebuliser Handset is on a flat, stable surface.
2. Remove the medicine cap by twisting anticlockwise.
3. Pour all of the prepared Cayston from the vial into the Altera Nebuliser Handset medicine reservoir (Figure 3a). Be sure to completely empty the vial. Gently tap the vial against the side of the medicine reservoir if necessary.
4. Close the medicine reservoir by aligning the tabs of the medicine cap with the slots on the reservoir. Press down and turn the cap clockwise as far as it will go (Figure 3b).

1. Begin your treatment. Sit in a relaxed, upright position. Hold the handset level and place the mouthpiece in your mouth and close your lips around it (Figure 4).

Keep the handset level.

2. Press the On/Off button on the Control Unit. You will hear one “beep”.
3. After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset. If aerosol mist does not begin to flow, please refer to the Altera manual for information.
4. Breathe normally (inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue to inhale and exhale comfortably until the treatment is finished.
5. When all of the medicine has been delivered, you will hear a tone that means “treatment complete” (2 beeps).
6. When treatment is complete, open the medicine cap to ensure that all medicine has been used. A few drops of medicine may remain in the reservoir at the end of treatment. If there is more than a few drops of liquid left, replace the medicine cap and restart treatment.
7. Once treatment is complete, disconnect the Control Unit and take apart the Altera Nebuliser Handset for cleaning and disinfecting. For complete details on cleaning and disinfecting refer to the manufacturer’s instructions for use provided with your Altera Nebuliser Handset.
What if I need to stop my treatment before I’ve finished?
8. If for any reason you must stop the treatment before you have finished, press and hold the On/Off button for one full second. To re-start the treatment, press and hold the On/Off button for one full second and then restart the treatment.

Refer to the Altera Nebuliser Handset instructions for use for guidance on when to replace the handset. If you notice that the performance has changed before this time (for instance, if it takes longer to produce a mist, more than 5 minutes), please refer to the Altera Nebuliser instructions for use.

If you have taken more Cayston than you should, talk to a doctor or pharmacist immediately.

If you miss a dose, you can still take all 3 daily doses as long as they are at least 4 hours apart. If you can’t leave a gap of 4 hours just skip the missed dose.

Do not stop taking Cayston without first talking to your doctor.

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

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

• The powder vial contains 75 mg aztreonam (as lysine).
• The solvent ampoule contains water for injections and sodium chloride. The ampoule is imprinted in English only. The information that appears on the ampoule is presented below:

Solvent for Cayston

Sodium Chloride 0.17%

Inhalation use only

1 ml

GILEAD SCIENCES

Cayston is a white to off-white powder and solvent for nebuliser solution.

Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and aluminium tear-off overseal with a blue cap.

The 1 ml solvent is contained in a plastic ampoule.

Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 solvent ampoules. The four additional solvent ampoules are provided in case of spillage.

The following pack sizes are available:

• 28-day pack of Cayston
• Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset

Not all pack sizes may be marketed.

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