InfoCons Consumer Protection informs you – Quofenix – Package Leaflet

Before anything else

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This med icine 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 n ot listed in this leaflet. See section 4.

ℹ️ 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 fluoroquin olones.

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

• infections of the skin and tissue under the skin
• infection of the lungs called ‘pneumonia’.

It works by blocking bacteria enzymes needed to copy and to repair their DNA. By blocking these enzymes Quofenix kills bac teria that cause the infection.

⚠️ 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 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.

Warnings and precautions

Before taking this medicine You should not take 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 taking this medicine 49 • Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if yo u 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) suc h 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 taking 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 fluoro quinolone 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 yor 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 antibi otics or up to 2 months after wards. 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 Quofen ix.
• 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 diabet es, 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.

Prolonged, disabling and potentially irreversible serious side effects Fluoroquinolone/quinolone antibacterial medicines have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower li mbs, 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, depression, memory impairment, severe fatigue and severe sleep disorders.

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

Children and adolescents

This medicine must not be used in children and adolescents as it has not been studied enough 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 that has magnesium, aluminium, iron, or zinc
• sucralfate
• didanosine buffered tablets for oral suspensio n or the paediatric 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 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 taking this medicine.

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

Driving and using machines

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.

Quofenix contains sodium

This medic ine contains 39 mg of sodium (main component of cooking salt) in each tablet . This i s equivalent to 2 % of the recommended maximum daily dietary intake of sodium for an adult.

💊 3. H ow to take Quofenix

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The recommended dose is 450 mg oral every 12 hours for a total duration of 5 to 14 days for skin infections and 5 to 10 days for pneumonia, at the discretion of your doctor. The tablets are swallowed 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, tell a doctor or get other medical advice. Take the medicine pack with you.

If you forget to take Quofenix

If you miss a dose, you should take it as soon as possible anytime up to 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, wait u ntil the next scheduled dose.

Do not take a double dose to make up for a forgotten dose.

51 If you stop taking Quofenix If you stop taking Quofenix without the advice of your doctor, your symptoms may get worse. Talk to your doctor or pharmacist before you stop taking your medicine.

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

❗ 4. Possible side effects

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

Serious side effects

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 thro at tightening and severe rash . These may be signs and symptoms of a hypersensitivity (allergic) reaction and may be life- threatening. These severe reaction s are uncommon side effect s 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 diarrh oea; fever and nausea. These may be signs of an infection of the bowel, which should not be treated with diarrhoea medicines that stop your bowels from moving. Infection of the bowel ( Clostridi oides 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
• 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 h aemoglobin 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 d
• Abnormal sweat
• Allergic skin reaction
• Itchiness, red rash
• Joint pain 52 • 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)
• Reduc ed kidneys 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)

• 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 s weat
• 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 53 Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), as well as impairment of hearing, vision, and taste and s mell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre- existing risk factors.

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.

Reporting of si de 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. How to store 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 that month.

This medicinal product does not require any s pecial temperature storage conditions.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Quofenix contains

• The active substance is delafloxacin. Each tablet contains 450 mg of delafloxacin (as meglumine) .
• The other ingredients are cellulose microcrystalline, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, c itric acid, m agnesium s tearate.

What Quofenix looks like and contents of the pack

Quofenix is a beige to mottled beige, oblong biconvex tablets .

It is available in blister pack of 5 tablets , into pack size of 10, 20, 30, 50, 60 or 100 tablets per carton.

Not all pack sizes may be marketed .

Marketing Authorisation Holder

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

Via Sette Santi 3 50131 Florence Italy

Manufacturer

54 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545 Lietuva UAB “BERLIN -CHEMIE MENARINI BALTIC” Tel: +370 52 691 947 България Берлин -Хеми/А. Менарини България ЕООД тел.: +359 2 454 0950 Luxembourg/Luxemburg Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545 Česká republika Berlin -Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333 Magyarország Berlin -Chemie/A. Menarini Kft.

Tel.: +36 17997320 Danmark A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. Tel: +39 -055 56801 Malta A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. Tel: +39 -055 56801 Deutschland Berlin -Chemie AG Tel: +49 (0) 30 67070 Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545 Eesti OÜ Berlin -Chemie Menarini Eesti Tel: +372 667 5001 Norge A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. Tel: +39 -055 56801 Ελλάδα MENARINI HELLAS AE Τηλ: +30 210 8316111-13 Österreich A. Menarini Pharma GmbH. Tel: +43 1 879 95 85-0 España Laboratorios Menarini S.A.

Tel: +34 -93 462 88 00 Polska Berlin -Chemie/Menarini Polska Sp. z o.o.

Tel.: +48 22 566 21 00 55 France MENARINI France Tél: +33 (0)1 45 60 77 20 Portugal A. Menarini Portugal – Farmacêutica, S.A.

Tel: +351 210 935 500 Hrvatska Berlin -Chemie Menarini Hrvatska d.o.o.

Tel: + 385 1 4821 361 România Berlin -Chemie A. Menarini S.R.L.

Tel: +40 21 232 34 32 Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744 Slovenija Berlin -Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160 Ísland A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. Tel: +39 -055 56801 Slovenská republika Berlin -Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730 Italia A. Menarini – Industrie Farmaceutiche Riunite – s.r.l.

Tel: +39 -055 56801 Suomi/Finland Berlin -Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760 Κύπρος MENARINI HELLAS AE Τηλ: +30 210 8316111-13 Sverige A. Menarini – Industrie Farmaceutiche Riunite – s.r.l. Tel: +39 -055 56801 Latvija SIA Berlin -Chemie/Menarini Baltic Tel: +371 67103210 United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L.

Tel: +44 (0)1628 856400

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Quofenix (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1393).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.