QUOFENIX 450 mg TABLETS

2. What you need to know before you take Quofenix

Do not take Quofenix

• 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 antibacterial medicine of the fluoroquinolone or quinolone type.
• If you have ever had a tendon problem, 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, plan to become pregnant, or think you may be pregnant.
• If you are breast-feeding
• If you are a child or adolescent under 18 years of age.

Warnings and precautions

Before taking this medicine

Do not take fluoroquinolone or quinolone-type antibacterial medicines, including Quofenix, if you have experienced any serious side effect in the past when taking a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

When taking this medicine

• Rarely, pain and swelling in the joints, and inflammation or rupture of the tendons may occur. Your risk increases if you are an elderly patient (over 60 years of age), 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 up to several months after stopping treatment with Quofenix. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Quofenix, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture.

• Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms, may occur. If this happens, stop taking Quofenix and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Tell your doctor or pharmacist or nurse before taking Quofenix if:

• You have been diagnosed with an enlargement or bulge of a large blood vessel (aortic or peripheral large vessel aneurysm).
• You have had a tear in the wall of the aorta (the main blood vessel of the heart) known as an aortic dissection.
• You have been diagnosed with a heart valve problem (heart valve regurgitation).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as 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, arterial hypertension, or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• If you have had tendon problems during previous treatment with a fluoroquinolone or quinolone-type antibiotic.
• If you have or may have problems with your central nervous system (e.g., severe cerebral arteriosclerosis, epilepsy) or have other risk factors that may increase the risk of having seizures (fits). In these cases, your doctor will consider whether this treatment is the best option for you.
• If you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen.
• If you suffer from diarrhea or have previously suffered from 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 medicine to treat diarrhea without first consulting your doctor.
• If you have kidney problems.
• If you have sometimes had prolonged treatment with antibiotics; this may mean that 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.
• If you may have a severe skin reaction, such as blisters or lesions.
• If you or a family member has a deficiency of glucose-6-phosphate dehydrogenase.
• If you suffer from diabetes. Fluoroquinolone-type antibiotics, including Quofenix, may cause blood glucose levels to increase or decrease too much. If you have diabetes, you must carefully monitor your blood glucose levels.

If you feel a sudden, severe pain in your abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.

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

Severe, prolonged, disabling, and potentially irreversible side effects

Fluoroquinolone/quinolone-type antibacterial medicines have been associated with very rare but serious side effects, some of which are long-lasting (for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as tingling, prickling, numbness, or burning (paresthesia), sensory disorders such as impaired vision, taste, and smell, and hearing, depression, memory impairment, 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, also considering an antibiotic of another class.

Children and adolescents

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

Other medicines and Quofenix

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

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
• buffered didanosine tablets for oral suspension or pediatric powder for oral solution

Pregnancy and breast-feeding

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

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.

If you could become pregnant, you must use effective contraception during treatment with Quofenix.

Driving and using machines

Quofenix may make you feel dizzy and lightheaded. Do not drive, use machines, or perform other activities that require mental alertness or coordination until you know how Quofenix affects you.

Quofenix contains sodium

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

3. How to take Quofenix

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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, talk to a doctor or go to a hospital immediately. Take the medicine pack with you.

If you forget to take Quofenix

If you forget to take a dose, take it as soon as you remember, but not later than 8 hours before the next scheduled dose. If there are less than 8 hours left before the next dose, wait until the next scheduled dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Quofenix

If you stop taking Quofenix without your doctor's advice, your symptoms may worsen. Talk to your doctor or pharmacist before stopping treatment with your medicine.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Quofenix can cause side effects, although not everybody gets them.

Serious side effects

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

• Difficulty swallowing or difficulty breathing and coughing; swelling of the lips, face, throat, or tongue; dry throat or narrowing of the throat and severe rash. These may be signs and symptoms of a hypersensitivity (allergic) reaction and can be life-threatening. These severe reactions are uncommon side effects that may affect up to 1 in 100 people.
• Low blood pressure; blurred vision; dizziness. This severe reaction is an uncommon side effect that may affect up to 1 in 100 people.
• Abdominal pain (stomach) with possible severe diarrhea, fever, and nausea. These may be signs of an intestinal infection, which should not be treated with medicines that stop the movement of the intestine. Intestinal infection (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
• Increased levels of liver enzymes (transaminases) in the blood, which are shown in blood tests
• Itching

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

• Low white blood cell count (leucopenia)
• Low hemoglobin levels (anemia)
• Allergic reaction
• High blood glucose levels
• Decreased appetite
• Insomnia
• Muscle weakness in the limbs
• Sensations such as numbness, tingling, and prickling
• Decreased sense of touch
• Altered taste
• Feeling of heartbeats (palpitations)
• High blood pressure
• Redness (e.g., in the face or neck)
• Inflammation of the stomach lining, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort or indigestion, dry mouth, flatulence
• Abnormal sweating
• Allergic skin reaction
• Red itchy rash
• Joint pain
• Pain and swelling of the tendons
• Musculoskeletal pain (e.g., pain in the limbs, back pain, neck pain), muscle weakness
• Increased levels of creatine phosphokinase in the blood (an indicator of muscle damage)
• Decreased kidney function
• Feeling of tiredness
• Abnormal blood test results related to liver function (increased alkaline phosphatase in the blood)
• Increased body temperature (pyrexia)
• Swelling of the lower limbs

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

• Urinary tract infection
• Inflammation of the nasal mucosa
• Low white blood cell count (reduction in the number of blood cells)
• Decrease in a special type of blood cell necessary for blood clotting
• Changes in tests that measure how blood clotting works
• Seasonal allergy
• Low blood glucose levels
• High levels of uric acid
• High levels of potassium in the blood
• Low levels of potassium in the blood
• Hearing things that do not exist (auditory hallucinations)
• Anxiety
• Sleep disorders
• Confusion
• Drowsiness
• Feeling of dizziness or fainting, usually due to a drop in blood pressure
• Dry eyes
• Dizziness or loss of balance (vertigo)
• Ringing in the ears (tinnitus)
• Balance disorder
• Irregular or rapid heartbeat, decreased heart rate
• Swollen, red, and irritated veins (phlebitis)
• Blood clot, known as deep vein thrombosis
• Acid reflux, acid regurgitation
• Loss of sensation in the mouth
• Decreased sensation in the mouth
• Burning sensation in the mouth
• Change in the color of the stool
• Abnormal blood test results related to liver function (decreased albumin in the blood and increased gamma-glutamyltransferase)
• Cold sweat
• Nocturnal sweating
• Abnormal hair loss
• Muscle spasms
• Muscle inflammation/pain
• Joint inflammation, pain in hands or feet, back pain
• Blood in the urine
• Cloudy urine due to the presence of solid components
• Chills
• Worsening of wounds
• Peripheral edema

Very rare side effects (may affect less than 1 in 1000 people) have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases independently of pre-existing risk factors, such as permanent or long-lasting (for months or years) reactions, including 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 impairment, as well as alterations in hearing, vision, taste, and smell.

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

Reporting of side effects

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 national reporting system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Quofenix

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

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Quofenix Composition

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

Product Appearance and Package Contents

Quofenix is a biconvex, oblong tablet, beige to mottled 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Via Sette Santi 3

50131 Florence

Italy

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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:09/2024

Other Sources of Information

Detailed information on this medication is available on the European Medicines Agency website http://www.ema.europa.eu.