Package Insert: Information for the Patient

Quofenix 450 mg Tablets

delafloxacino

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Quofenix is an antibiotic that contains the active ingredient delafloxacino. It belongs to a group of medications called fluoroquinolones.

It is used for the treatment in adults of severe and short-term infections caused by certain bacteria, when usual antibiotics cannot be used or have not been effective:

• skin and subcutaneous tissue infections
• lung infection called “pneumonia”

It blocks the enzymes that bacteria need to copy and repair their DNA. By blocking these enzymes, Quofenix kills the bacteria that cause the infection.

Do not take Quofenix

• If you are allergic to delafloxacino or any of the other components of this medication (listed in section 6).
• If you are allergic to any other fluoroquinolone or quinolone antibiotic.
• If you have ever had a problem with tendons, such as tendinitis, related to treatment with "quinolone-type antibiotics". A tendon is the cord that connects the muscle to the skeleton.
• If you are pregnant, intend to become pregnant, or think you may be pregnant.
• If you are breastfeeding.
• If you are a child or adolescent under the age of 18 years.

Warnings and precautions

Before taking this medication

Do not take fluoroquinolone or quinolone antibiotics, including Quofenix, if you have had a severe reaction in the past to taking a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

While taking this medication

• In rare cases, you may experience pain and swelling in the joints, inflammation, or rupture of tendons. Your risk increases if you are an elderly patient (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and ruptures can occur within the first 48 hours of treatment and even several months after stopping Quofenix treatment. At the first sign of tendon pain or inflammation (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking Quofenix, contact your doctor, and rest the affected area. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.

• In rare cases, you may 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 to prevent the development of a potentially irreversible alteration.

Consult your doctor, pharmacist, or nurse before taking Quofenix if:

• You have been diagnosed with a large artery aneurysm or peripheral artery aneurysm.
• You have had a tear in the wall of the aorta (the main artery of the heart) known as aortic dissection.
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis or giant cell arteritis, Behçet's disease, hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have had tendon problems during previous treatment with a quinolone-type antibiotic.
• You have or may have central nervous system problems (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that may increase the risk of seizures (attacks). In these cases, your doctor will consider whether this treatment is the best option for you.
• You have myasthenia gravis (a type of muscle weakness), as symptoms may worsen.
• You have diarrhea, or have had diarrhea when taking antibiotics or up to 2 months after. Contact your doctor immediately if you have diarrhea during or after treatment. Do not take any medication to treat diarrhea without consulting your doctor first.
• You have kidney problems.
• You have had prolonged antibiotic treatment; this may mean you contract another infection caused by other bacteria (superinfection) that cannot be treated with the antibiotic. Consult your doctor if you have any doubts or questions about this and about the use of Quofenix.
• You may have a severe skin reaction, such as blisters or lesions.
• You or a family member has glucose-6-phosphate dehydrogenase deficiency.
• You have diabetes. Fluoroquinolone antibiotics, including Quofenix, may cause blood glucose levels to rise or fall too low. If you have diabetes, you must carefully control your blood glucose levels.

If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. You may be at increased risk if you are receiving systemic corticosteroid treatment.

If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Severe, prolonged, incapacitating, and potentially irreversible side effects

Fluoroquinolone/quinolone antibiotics have been associated with very rare but severe side effects, some of which are of long duration (lasting months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as tingling, numbness, or burning (paresthesia), sensory disorders such as vision, taste, and smell deterioration, and hearing, depression, memory deterioration, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Quofenix, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also an antibiotic of another class.

Children and adolescents

This medication should not be used in children and adolescents, as it has not been sufficiently studied in these groups.

Other medications and Quofenix

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Quofenix tablets should be taken at least 2 hours before or 6 hours after:

• An antacid, multivitamin, or other product containing magnesium, aluminum, iron, or zinc.
• Sucralfate.
• Didanosine tablets for oral suspension or pediatric powder for oral solution.

Pregnancyandlactation

Quofenix should not be used if you are pregnant or breastfeeding. Quofenix should not be used in fertile women who do not use effective contraceptive methods.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

If you may become pregnant, use effective contraceptive methods during Quofenix treatment.

Driving and operating machinery

Quofenix may make you feel dizzy and disoriented. Until you know how Quofenix affects you, do not drive, operate machinery, or perform other activities that require mental acuity or coordination.

Quofenix contains sodium

This medication contains 39 mg of sodium (main component of table salt for cooking) in each tablet. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 450 mg orally every 12 hours for a total duration of 5 to 14 days for skin infections and 5 to 10 days for pneumonia, as determined by your doctor. The tablets should be taken whole with a sufficient amount of water, and can be taken with or without food.

If you take more Quofenix than you should

If you accidentally take more tablets than you should, consult your doctor or seek medical advice. Bring the medication with you.

If you forget to take Quofenix

If you forget to take a dose, take it as soon as possible up to 8 hours before the next scheduled dose. If there are less than 8 hours before the next dose, wait until the next scheduled dose. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Quofenix

If you interrupt treatment with Quofenix without consulting your doctor, your symptoms may worsen. Talk to your doctor or pharmacist before interrupting treatment with your medication.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like other medications, Quofenix may cause side effects, although not everyone will experience them.

Severe side effects

Please inform your doctor or nurse immediately if you experience any of the following symptoms, as treatment with the medication should be discontinued and you may need urgent medical attention:

- Difficulty swallowing or difficulty breathing and coughing; swelling of the lips, face, throat, or tongue; dry or constricted throat and severe itching. These may be signs and symptoms of an allergic reaction (hypersensitivity) and can be potentially fatal. These severe reactions are rare side effects that can affect up to 1 in 100 people.

- Low blood pressure; blurred vision; dizziness. This severe reaction is a rare side effect that can affect up to 1 in 100 people.

- Abdominal pain (stomach) with possible severe diarrhea, fever, and nausea. These may be signs of intestinal infection, which should not be treated with medications that stop intestinal movement. Intestinal infection (Clostridioides difficile infection) is a rare side effect that can affect up to 1 in 100 people.

Other side effects may include:

Frequent side effects (can affect up to 1 in 10 people):

• Fungal infection
• Headache
• Vomiting
• Increased levels of liver enzymes, called transaminases, shown in blood tests
• Itching

Rare side effects (can affect up to 1 in 100 people):

• Reduction in the number of white blood cells in the blood (leucopenia)
• Low hemoglobin levels (anemia)
• Allergic reaction
• High blood glucose levels
• Loss of appetite
• Insomnia
• Weakness in the limbs
• Sensations of numbness, tingling, and prickling
• Decreased sensation of touch
• Alteration of taste
• Feeling heartbeats (palpitations)
• High blood pressure
• Redness (e.g., on the face or neck)
• Inflammation of the stomach wall, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort, dry mouth, flatulence
• Abnormal sweating
• Skin allergic reaction
• Red, itchy, and prickly rash
• Joint pain
• Tendon pain and swelling
• Musculoskeletal pain (e.g., limb pain, back pain, neck pain), muscle weakness
• Increased levels of creatine phosphokinase in the blood (a marker of muscle damage)
• Decreased kidney function
• Feeling tired
• Alteration of blood tests related to liver function (increased alkaline phosphatase in the blood)
• Increased body temperature (pyrexia)
• Swelling of the lower limbs

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

• Urinary tract infection
• Inflammation of the nasal mucosa
• Low white blood cell count (reduction of the number of blood cells)
• Decreased levels of a specific type of blood cell necessary for blood coagulation
• Changes in blood tests that measure blood coagulation function
• Seasonal allergy
• Low blood glucose levels
• High uric acid levels
• High potassium levels in the blood
• Low potassium levels in the blood
• Heard things that do not exist (auditory hallucinations)
• Anxiety
• Changes in sleep
• Confusion
• Drowsiness
• Sensation of dizziness or fainting, usually due to low blood pressure
• Dry eyes
• Dizziness or loss of balance (vertigo)
• Tinnitus (ringing in the ears)
• Alteration of balance
• Irregular or rapid heartbeats, decreased heartbeats
• Swollen, red, and irritated veins (phlebitis)
• Clot of blood, known as deep vein thrombosis
• Acid reflux, regurgitation of acid
• Loss of sensation of touch in the mouth
• Reduction of tactile sensation in the mouth
• Sensation of burning in the mouth
• Change in stool color
• Alteration of blood tests related to liver function (decreased albumin in the blood and increased gamma-glutamyltransferase)
• Cold sweat
• Nocturnal sweating
• Abnormal hair loss
• Muscle spasms
• Muscle and joint inflammation
• Inflammation of the joints, pain in hands or feet, back pain
• Blood in the urine
• Cloudy urine due to the presence of solid components
• Chills
• Worsening of the wound
• Peripheral edema

There have been associations with the administration of quinolone and fluoroquinolone antibiotics, in some cases independently of pre-existing risk factors, very rare cases of permanent or long-lasting (up to months or years) adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as tingling and prickling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory alterations, as well as alterations of hearing, vision, taste, and smell.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V.*. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box or packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Quofenix

• The active ingredient is delafloxacino. Each tablet contains 450 mg of delafloxacino (as meglumina)
• The other components (excipients) are microcrystalline cellulose, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate.

Appearance of the product and contents of the package

Quofenix is a biconvex, oblong tablet, beige to speckled beige in color.

It is available in blister packs of 5 tablets in packs of 10, 20, 30, 50, 60, or 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

A. Menarini – Industrie Farmaceutiche Riunite – s.r.l.

Via Sette Santi 3

50131 Florence

Italy

Responsible manufacturer

AlfaSigma

1 Via Enrico Fermi

65020 Alanno (PE)

Italy

or

Special Product’s Line S.p.A.

1 Via Fratta Rotonda Vado Largo

03012 Anagni (FR)

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:09/2024

Other sources of information

More detailed information about this medication is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.