EXBLIFEP 2 g/0.5 g powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to cefepime, enmetazobactam or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to cephalosporins, which are antibiotics used to manage a wide range of infections.
• if you have had a severe allergic reaction (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue or throat; or difficulty swallowing or breathing) to so-called beta-lactam antibiotics (antibiotics such as penicillins, carbapenems or monobactams).

Talk to your doctor or pharmacist before using EXBLIFEP if:

• you are allergic to cephalosporins, penicillins or other antibiotics (see ‘Do not use Exblifep’)
• you have or have had asthma or are sensitive to have allergic reactions. Your doctor will check for any signs of allergies the first time you are given this medicine (see section 4).
• you have kidney problems. Your doctor may need to change the dose of this medicine.
• you have any upcoming blood or urine tests scheduled. This medicine can alter the results of some tests (see section 4).

Talk to your doctor or pharmacist while using EXBLIFEP if:

• you develop severe and persistent diarrhoea during or right after treatment. This may be a sign of an inflammation of the large bowel and needs urgent medical intervention.
• you suspect to have developed a new infection during prolonged use of EXBLIFEP. This may be caused by micro-organisms which are insensitive to cefepime and may require interruption of EXBLIFEP treatment.

This medicine should not be given to children under 18 years old because there is not enough information on its use in this age group.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor if you use the following:

• other antibiotics, in particular aminoglycosides (such as gentamicin) or 'water tablets' (diuretics, such as furosemide). If you are using these medicines, your kidney function should be monitored.
• medicines that are used to prevent your blood from clotting (coumarin anticoagulants, such as warfarin). Their effect may be greater when you take Exblifep.
• certain types of antibiotics (bacteriostatic antibiotics). These can affect how well EXBLIFEP works.

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 using this medicine. Your doctor will advise if you should receive EXBLIFEP during pregnancy.

Exblifep may pass into breast milk. If you are breast-feeding, your doctor will advise you on whether you should stop breast-feeding or abstain fromEXBLIFEP therapy, taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.

This medicine may cause dizziness, which can affect your ability to drive and use machines. Do not drive or use machines until you no longer feel dizzy.

As this product is given by a doctor or other healthcare professional, it is unlikely that you will be given too much EXBLIFEP. However, let your doctor or nurse know immediately if you have any concerns.

If you think you have not been given a dose of EXBLIFEP, tell your doctor or other healthcare professional immediately.

Rare: may affect up to 1 in 1 000 people

• anaphylactic (allergic) reaction and angioedema. This may be life-threatening. Signs and symptoms may be a sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.

Not known: frequency cannot be estimated from the available data

• Stevens-Johnson syndrome and toxic epidermal necrolysis. Extremely intense and serious skin reactions. The adverse reaction of the skin may appear as rashes with or without blisters. Skin irritation, sores or swelling in the mouth, throat, eyes, nose and around the genitals and fever and flulike symptoms may occur. The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.

Other side effects which may occur after Exblifeb treatment include those listed below

Very common : may affect more than 1 in 10 people

Side effect seen in blood tests:

• positive Coombs test (a blood test checking for antibodies that attack your body’s red blood cells)

Common: may affect up to 1 in 10 people

• infusion site phlebitis (inflammation at the site of infusion, causing pain, swelling and redness along a vein)
• reaction, pain and inflammation at the infusion site
• diarrhoea
• skin rash
• headache

Side effects seen in blood tests:

• increased liver enzyme levels in the blood
• increased levels of bilirubin (a substance produced by the liver) in the blood
• increased levels of amylase (an enzyme that helps the body digest carbohydrates) in the blood
• increased levels of lipase (an enzyme that helps the body digest fat) in the blood
• increased levels of lactate dehydrogenase (a marker indicating cell and tissue damage in the body) in the blood
• changes in your white blood cell count (eosinophilia)
• low levels of red blood cells (anaemia)
• blood coagulation delayed (increased time for blood to clot)

Uncommon: may affect up to 1 in 100 people

• clostridioides difficile-associated diarrhoea (CDAD), painful, severe diarrhoea caused by a bacteria called clostridioides difficile
• fungal infection in the mouth
• vaginal infection
• inflammation of the large intestine, causing diarrhoea, usually with blood and mucus
• dizziness, nausea, vomiting
• reddening of the skin, hives, iching
• fever
• infusion site inflammation

Side effects seen in blood tests:

• low levels of certain blood cells (leucopenia, neutropenia, thrombocytopenia)
• increased levels of urea and creatinine (measures indicating reduced kidney function) in the blood

Rare: may affect up to 1 in 1 000 people

• shortness of breath
• stomach pain, constipation
• fungal infection
• convulsion (fits)
• distortion of the sense of taste
• sensation of pricking or numbness of your skin, pins and needles
• itching in and around the vaginal area
• allergic dermatitis
• chills
• widening of blood vessels in the body

Not known: frequency cannot be estimated from the available data

• coma
• reduced consciousness
• encephalopathy (a brain disorder caused by harmful substance or infection)
• altered state of consciousness
• muscle jerks
• confusion, hallucinations
• false positive urinary glucose tests
• kidney problems (failure or any other structural changes or dysfunction)
• bleeding
• erythema multiforme (a skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).

Side effects seen in blood tests:

• very low levels of granulocytes, a type of white blood cells (agranulocytosis)
• red blood cells destroyed too quickly (haemolytic anaemia)
• low levels of red blood cells caused by the inability of your bone marrow to make enough new cells (aplastic anaemia)

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

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 substances are cefepime and enmetazobactam.
  Each vial contains cefepime dihydrochloride monohydrate equivalent to 2 g cefepime and 0.5 g enmetazobactam.
• The other ingredient is L-arginine.

EXBLIFEP is a white to yellowish powder for concentrate for solution for infusion (powder for concentrate) supplied in a 20 mL glass vial with a bromobutyl rubber stopper and flip-off seal.

Pack size of 10 vials.