Brinsupri 25 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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 Brinsupri is and what it is used for
2. What you need to know before you take Brinsupri
3. How to take Brinsupri
4. Possible side effects
5. How to store Brinsupri
6. Contents of the pack and other information

Brinsupri contains the active substance brensocatib, which belongs to the class of medicines called dipeptidyl peptidase 1 (DPP1) inhibitors.

Brinsupri is used to treat patients 12 years and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more flare-ups or worsening of symptoms (also known as exacerbations) in the past 12 months. NCFB is a long-term (chronic) condition where the airways of the lungs are damaged, causing a cough with mucus production.

Brinsupri targets a protein called DPP1, which is involved in the process that causes inflammation in the lungs. By blocking the activity of this protein, the medicine prevents flare-ups in the lungs and may improve some symptoms of NCFB.

Talk to your doctor or pharmacist before taking Brinsupri if you have recently had or plan to have a vaccination.

Do not give this medicine to children under 12 years of age because its safety and benefits are not known in children in this age group.

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.

Benefits and potential risks of use of Brinsupri during pregnancy have not been established. Brinsupri may be used during pregnancy where the expected benefit to the mother outweighs the unknown risk to the unborn child. Your doctor will discuss this with you.

There is not enough information to say whether the medicine passes into human breast milk. A decision must be made whether to stop breast-feeding or to stop using Brinsupri, based on the benefit of breast-feeding for the child and the benefit of treatment for the mother. Your doctor will discuss this with you.

Brinsupri is unlikely to affect your ability to drive and use machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

If you take more Brinsupri than you should, seek urgent medical attention, taking the medicine packaging with you.

Take your next dose at the usual time the next day. Do not take a double dose to make up for a forgotten tablet.

You should not stop taking Brinsupri without discussing this with your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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 active substance is brensocatib. Each film-coated tablet contains 25 mg of brensocatib (as monohydrate).
• The other ingredients are:
  Tablet core: cellulose, microcrystalline; calcium hydrogen phosphate dihydrate; sodium starch glycolate; silica, colloidal hydrated; and glycerol dibehenate. See section 2 ‘Brinsupri contains sodium’ for further information.
  Film-coating: poly(vinyl alcohol); titanium dioxide; macrogol; talc; and black iron oxide (E172).

Brinsupri 25 mg film-coated tablets (tablets) are round, grey tablets approximately 9 mm in diameter, with “25” on one side and “BRE” on the other side.

The film-coated tablets are provided in aluminium foil blister cards containing 14 film-coated tablets. Each pack contains 28 film-coated tablets.