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

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

• If you are allergic to delafloxacin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to any other fluoroquinolone or quinolone antibacterial medicine.
• If you have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton.
• If you are pregnant, might become pregnant, or think you might be pregnant.
• If you are breast-feeding.
• If you are a child or growing adolescent below 18 years of age.

Before you are given this medicine

You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, 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 you are given this medicine

• Prolonged, disabling and potentially irreversible serious side effects
  Fluoroquinolone/quinolone antibacterial medicines, including Quofenix, have been associated with rare but serious side effects, some of them being long lasting (continuing for months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, memory impairment, severe fatigue, and severe sleep disorders. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones.
  If you experience any of these side effects after taking Quofenix, then do not take any further doses and contact your doctor immediately. You and your doctor will decide on whether to continue treatment, considering alternative options.
• You may experience psychiatric reactions when taking Quofenix, including when taking it for the first time. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Quofenix. In rare cases, depression or psychosis can progress to thoughts of suicide or suicide attempts. If this happens, stop taking Quofenix and contact your doctor immediately. You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking Quofenix, and that there may be rare psychiatric side effects. Others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about.
• 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 Quofenix therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact your doctor and rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition.

Talk to your doctor or pharmacist or nurse before you are given Quofenix if:

• You have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
• You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
• You have been diagnosed with leaking heart valves (heart valve regurgitation).
• You have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart] ).
• You have had tendon problems during previous treatment with a fluoroquinolone or quinolone antibiotic.
• You have or may have problems with the central nervous system (e.g. severe cerebral arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having seizures (fits). In those cases your doctor will consider if this treatment is the best option for you.
• You have a myasthenia gravis (a type of muscle weakness), because symptoms can become worse.
• You are suffering from diarrhoea, or have previously suffered from diarrhoea while taking antibiotics or up to 2 months afterwards. Contact your doctor straight away if you have diarrhoea during or after your treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor.
• You have kidney problems.
• You had sometimes long treatment with antibiotics; it can mean that you get another infection caused by other bacteria (superinfection) which cannot be treated by the antibiotic. Talk to your doctor if you have any concerns or questions about this and using Quofenix.
• You may have a severe skin reaction such as blistering or lesion.
• You or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase.
• You have diabetes. Fluoroquinolone antibiotics, including Quofenix, may cause levels of glucose in the blood to rise too high or fall too low. If you have diabetes, you should monitor your blood glucose levels carefully.

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.

This medicine must not be used in children and adolescents, as it has not been studied enough in these groups.

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

There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other supplements or didanosine. However, Quofenix should not be given together with any solution containing substances such as calcium and magnesium, through the same intravenous line.

Quofenix must not be used if you are pregnant or breast-feeding. Quofenix must not be used in women of childbearing potential not using contraception.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.

If you might become pregnant you have to use effective contraception during treatment with Quofenix.

Quofenix can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Quofenix affects you.

This medicine contains 2480 mg of sulfobutylbetadex sodiumin each vial.

This medicine contains 175 mg of sodium (main component of cooking salt) in each vial. This is equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult.

Tell your doctor or nurse immediately if you are concerned that you may have been given too much Quofenix.

Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.

Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine should be stopped and you may need urgent medical attention:

• Difficulty in swallowing or difficulty in breathing and cough; swelling of your lips, face, throat or tongue; dry throat or throat tightening and severe rash. These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be life-threatening. These severe reactions are uncommon side effects that may affect up to 1 in 100 people.
• Drop in blood pressure; blurred vision; dizziness. This severe reaction is an uncommon side effect that may affect up to 1 in 100 people.
• Abdominal (belly) pain with possible severe diarrhoea; fever and nausea. These may be signs of an infection of the bowel, which shouldn’t be treated with diarrhoea medicines that stop your bowels from moving. Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.

Other side effects may include:

Common side effects (may affect up to 1 in 10 people):

• Fungal infection
• Headache
• Vomiting
• Swelling, redness or pain around the needle where the medicine is given into a vein (infusion site reaction)
• Increase in the amount of enzymes produced by your liver called transaminases - shown in blood tests
• Itching

Uncommon side effects (may affect up to 1 in 100 people):

• Reduction in the number of white cells in the blood (leukopenia)
• Low haemoglobin level (anaemia)
• Allergic reaction
• High blood glucose levels
• Decreased appetite
• Insomnia
• Muscle weakness in the extremities
• Sensations like numbness, tingling, pins and needles
• Reduced tactile sensation
• Change in taste
• Feeling your heart beat (palpitation)
• High blood pressure
• Flushing (e.g. redness of the face or neck)
• Inflammation of the lining of the stomach, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence
• Abnormal sweat
• Allergic skin reaction
• Itchiness, red rash
• Joint pain
• Pain and swelling of the tendons
• Muscle and musculoskeletal pain (e.g. pain in extremity, back pain, neck pain), muscle weakness
• Increased level of creatine phosphokinase in blood (an indicator of muscle damage)
• Reduced kidney function
• Feeling tired
• Blood test alteration related to liver function (blood alkaline phosphatase increased)
• Raised body temperature (pyrexia)
• Lower limb swelling

Rare side effects (may affect up to 1 in 1000 people):

• Cases of long lasting (up to months or years) or permanent adverse drug reactions have been associated with quinolone and fluoroquinolone antibiotics. These may include tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, pricking, burning, numbness or pain (neuropathy), fatigue, sleep disorders, memory impairment, mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, confusion, or depression, as well as impairment of hearing, vision, and taste and smell. There are no medicines that have been established as being effective treatments for the symptoms of long lasting or disabling side effects associated with fluoroquinolones.
• Urinary tract infection
• Inflammation of the nasal mucosa tract
• Low white blood cell count (reduction of an amount of blood cells)
• Decrease of special blood cells necessary for blood clotting
• Changes in tests which measure how well your blood clots
• Seasonal allergy
• Low blood glucose levels
• High level of uric acid
• High level of blood potassium
• Low level blood potassium
• Hearing things that do not exist (auditory hallucination)
• Anxiety
• Abnormal dreams
• Confusion
• Somnolence
• Feeling lightheaded or faint, usually because of a drop in blood pressure
• Dry eye
• Dizziness or loss of balance (vertigo)
• Ringing or buzzing in the ears (tinnitus)
• Alteration of the sense of balance
• Irregular or rapid heart beats, decrease of heart beat
• Swollen, red, irritated veins (phlebitis)
• Blood clot, known as a thrombus in the deep vein
• Heartburn/acid regurgitation
• Loss of tactile sensation at the mouth
• Reduced tactile sensation at the mouth
• Burning sensation in the mouth
• Discoloured faeces
• Blood test alteration related to liver function (blood albumin decreased and gamma-glutamyltransferase increased)
• Cold sweat
• Night sweat
• Abnormal hair loss
• Muscle spasm
• Muscle inflammation/pain
• Inflammation of joints, pain in hands or feet, back pain
• Blood in urine
• Cloudy urine because of the presence of solid component
• Chills
• Worsening of a wound
• Oedema peripheral
• Medical device occlusion

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 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 active substance is delafloxacin. Each vial of powder contains 300 mg of delafloxacin (as meglumine).
• The other excipients are meglumine, sulfobutylbetadex sodium,disodium edetate, sodium hydroxide (for pH-adjustment), hydrochloric acid, concentrated (for pH-adjustment).

Quofenix powder for concentrate for solution for infusion is provided in 20 ml clear glass vial. The vial contains light yellow to tan cake powder.

It is available in packs containing 10 vials.

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