Quofenix 450 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Quofenix 450 mg tablets

delafloxacin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What Quofenix is and what it is used for

Quofenix is an antibiotic that contains the active substance delafloxacin. It belongs to a group of medicines called fluoroquinolones.

It is used in adults to treat serious, short-term infections caused by certain bacteria, when standard antibiotics cannot be used or have not worked:

• infections of the skin and underlying tissue
• 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 causing the infection.

2. What you need to know before taking Quofenix

Do not take Quofenix

• If you are allergic to delafloxacin or to 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 tendon problems, such as tendinitis, related to treatment with "quinolone-type antibiotics". A tendon is the cord that connects muscle to bone.
• If you are pregnant, planning to become pregnant, or think you might be pregnant.
• If you are breastfeeding.
• If you are a child or adolescent under 18 years of age who is still growing.

Warnings and precautions

Before taking this medicine

You must not take antibacterial medicines of the fluoroquinolone or quinolone type, including Quofenix, if you have previously experienced a serious adverse reaction to quinolones or fluoroquinolones. In such a case, inform your doctor as soon as possible.

While taking this medicine

• Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. Your risk increases if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and ruptures may occur within the first 48 hours of treatment, and even several months after stopping treatment with Quofenix. 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 physical activity, as this could increase the risk of tendon rupture.

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

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

• You have been diagnosed with an enlargement or bulge in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have experienced a tear in the wall of the aorta (the main blood vessel of the heart), known as aortic dissection.
• You have been diagnosed with heart valve insufficiency (heart valve regurgitation).
• 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 vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis or giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
• You have previously experienced tendon problems during treatment with a fluoroquinolone or quinolone-type antibiotic.
• You have or may have central nervous system disorders (e.g., severe cerebral arteriosclerosis, epilepsy), or have other risk factors that may increase the risk of seizures (fits). In such cases, your doctor will consider whether this treatment is the best option for you.
• You suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen.
• You have diarrhea, or have previously had diarrhea while taking antibiotics or up to 2 months after. Contact your doctor immediately if you develop diarrhea during or after treatment. Do not take any medication for diarrhea without first consulting your doctor.
• You have kidney problems.
• You have previously undergone prolonged antibiotic treatment, which may mean you are at risk of developing another infection caused by different bacteria (superinfection) not treatable with the antibiotic. Consult your doctor if you have any doubts or questions about this and about the use of Quofenix.
• You may experience a severe skin reaction, such as blisters or lesions.
• You or a family member has glucose-6-phosphate dehydrogenase deficiency.
• You have diabetes. Fluoroquinolone-type antibiotics, including Quofenix, may cause blood glucose levels to rise or fall excessively. If you have diabetes, you should carefully monitor your blood glucose levels.

If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek emergency medical attention immediately. Your risk may increase if you are receiving systemic corticosteroid treatment.

If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

Serious, 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 may last for months or years, be disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as tingling, prickling, numbness, or burning (paresthesia), sensory disturbances such as impaired vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.

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, possibly considering an antibiotic from another class.

Children and adolescents

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

Other medicines and Quofenix

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

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 breastfeeding

Quofenix must not be used if you are pregnant or breastfeeding. Quofenix must not be used in women of childbearing potential who are not using contraceptive methods.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

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

Driving and use of machines

Quofenix may cause dizziness and lightheadedness. Until you know how Quofenix affects you, do not drive, operate machinery, or perform other activities requiring mental alertness or coordination.

Quofenix contains sodium

This medicine contains 39 mg of sodium (the main component of table salt used in cooking) per tablet. This corresponds to 2% of the maximum daily sodium intake recommended for an adult.

3. How to take Quofenix

Follow exactly the instructions for using this medicine as given 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, according to medical judgment. The tablets should be taken whole with a sufficient amount of water, and may 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. Take the medicine with you.

If you forget to take Quofenix

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

If you stop taking Quofenix

If you stop treatment with Quofenix without the advice of your doctor, your symptoms may worsen. Speak to your doctor or pharmacist before stopping treatment with your medicine.

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

4. Possible adverse effects

Like all medicines, Quofenix may cause adverse effects, although not everyone experiences them.

Serious adverse effects

Please inform your doctor or nurse immediately if you experience any of the following symptoms, as treatment with this medicine should be stopped and you may require urgent medical attention:

• Difficulty swallowing or breathing and coughing; swelling of the lips, face, throat or tongue; dry throat or tightness in the throat, and severe rash. These may be signs and symptoms of a hypersensitivity (allergic) reaction, which can be potentially life-threatening. These serious reactions are uncommon adverse effects that may affect up to 1 in 100 people.
• Drop in blood pressure; blurred vision; dizziness. This serious reaction is an uncommon adverse effect that may affect up to 1 in 100 people.
• Abdominal (stomach) pain possibly with severe diarrhoea, fever and nausea. These may be signs of a bowel infection, which should not be treated with anti-diarrhoeal medicines that stop intestinal movement. Bowel infection (Clostridioides difficile infection) is an uncommon adverse effect that may affect up to 1 in 100 people.

Other adverse effects may include:

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

• Fungal infection
• Headache
• Vomiting
• Increase in liver enzymes known as transaminases, seen in blood tests
• Itching

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

• Decrease in the number of white blood cells in the blood (leucopenia)
• Low levels of haemoglobin (anaemia)
• Allergic reaction
• High blood glucose levels
• Decreased appetite
• Insomnia
• Muscle weakness in the limbs
• Sensations such as numbness, tingling and prickling
• Reduced sense of touch
• Taste disturbance
• Awareness of heartbeats (palpitations)
• High blood pressure
• Flushing (e.g. in the face or neck)
• Inflammation of the stomach lining, inflammation of the internal tissues of the mouth, abdominal pain, stomach discomfort/pain or indigestion, dry mouth, flatulence
• Abnormal sweating
• Skin allergic reaction
• Itchy red rash
• Joint pain
• Pain and swelling of tendons
• Musculoskeletal pain (e.g. limb pain, back pain, neck pain), muscle weakness
• Increased blood levels of creatine phosphokinase (a marker of muscle damage)
• Reduced kidney function
• Feeling tired
• Abnormal blood test related to liver function (increased alkaline phosphatase in blood)
• Increased body temperature (pyrexia)
• Swelling of the lower limbs

Rare adverse effects (may affect up to 1 in 1,000 people):

• Urinary tract infection
• Inflammation of the nasal cavity mucosa
• Low white blood cell count (reduction in blood cells)
• Decrease in a special type of blood cells needed for blood clotting
• Changes in tests measuring blood clotting function
• Seasonal allergy
• Low blood glucose levels
• High levels of uric acid
• High levels of potassium in blood
• Low levels of potassium in blood
• Hearing things that are not real (auditory hallucinations)
• Anxiety
• Sleep disturbances
• Confusion
• Drowsiness
• Feeling dizzy or faint, usually due to a drop in blood pressure
• Dry eyes
• Dizziness or loss of balance (vertigo)
• Ringing in the ears (tinnitus)
• Balance disturbance
• Irregular or rapid heartbeat, decreased heart rate
• Swollen, red and irritated veins (phlebitis)
• Blood clot, known as deep vein thrombosis
• Heartburn, acid regurgitation
• Loss of touch sensation in the mouth
• Reduced tactile sensation in the mouth
• Burning sensation in the mouth
• Change in stool colour
• Abnormal blood tests related to liver function (decreased albumin in blood and increased gamma-glutamyltransferase)
• Cold sweat
• Night sweats
• Abnormal hair loss
• Muscle spasms
• Muscle pain and inflammation
• Joint inflammation, pain in hands or feet, back pain
• Blood in urine
• Cloudy urine due to presence of solid components
• Chills
• Worsening of wound
• Peripheral oedema

Very rare cases of adverse drug reactions of a permanent or long-term nature (lasting for months or years), associated with quinolone and fluoroquinolone antibiotics, have been reported, in some cases even without pre-existing risk factors. These include tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as tingling, prickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory disturbances, as well as disturbances in hearing, vision, taste and smell.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may be fatal, and heart valve insufficiency have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V*. By reporting adverse 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 stated on the carton or container after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Quofenix

• The active substance 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.

Appearance of the product and contents of the pack

Quofenix is a biconvex, oblong tablet, beige in colour to mottled beige.

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

Only certain 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 09/2024

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.euopa.eu.