Package leaflet: Information for the user

SUMMAFLOX 250 mg film-coated tablets, 500 mg film-coated tablets

Levofloxacin
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What SUMMAFLOX tablets are and what they are used for
What you need to know before taking SUMMAFLOX tablets
How to take SUMMAFLOX tablets
Possible side effects
How to store SUMMAFLOX tablets
Contents of the pack and other information

1. What SUMMAFLOX tablets are and what they are used for

SUMMAFLOX tablets contain the active substance called levofloxacin. This medicine
belongs to a group of medicines known as antibiotics. Levofloxacin is a
"quinolone" antibiotic. This medicine works by killing the bacteria responsible for infections
in the body.
SUMMAFLOX tablets can be used to treat infections of:

the sinuses
the lungs, in patients with chronic respiratory conditions or pneumonia
the urinary tract, including kidneys and bladder
the prostate, where a persistent infection may develop
the skin and subcutaneous tissues, including muscles. These are sometimes referred to as "soft tissues"

2. What you need to know before taking SUMMAFLOX tablets

Do not take this medicine and inform your doctor if:

you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6).
Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
you have had epilepsy
you have previously experienced tendon problems, such as tendonitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures connecting skeletal muscles
you are a child or adolescent during the growth period
you are pregnant, may become pregnant, or think you might be
you are breastfeeding

Do not take this medicine if any of the above apply to you. If you have any
doubts, consult your doctor or pharmacist before taking SUMMAFLOX tablets.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine if:

you are aged 60 years or older
you are taking corticosteroids, sometimes called steroids (see "Other medicines and SUMMAFLOX tablets")
you have undergone an organ transplant
you have had seizures
you have suffered brain damage due to stroke or other brain injuries
you have kidney problems
you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems.
you have previously suffered from mental health issues
you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the heart's electrical tracing), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that can alter the electrocardiogram (see section “Other medicines and SUMMAFLOX tablets”)
you have diabetes
if you have diabetes and have had liver problems
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
if you have been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation)
if you have a family history of aortic aneurysm, aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [heart inflammation])
you have developed a severe skin reaction, skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin

Severe skin reactions
Severe skin reactions have been reported with the use of levofloxacin, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS).

SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red and swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzymes in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin reaction or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.
You must not take quinolone/fluoroquinolone antibacterial medicines, including SUMMAFLOX, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.
While taking this medicine:
If you experience sudden abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.

Inform your doctor immediately if you notice sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
if you begin to experience sudden involuntary jerks, muscle fasciculations or contractions – consult a doctor immediately as these could be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
If you experience nausea, general malaise, severe discomfort or persistent or worsening stomach pain, or vomiting, contact your doctor immediately, as these could be signs of pancreas inflammation (acute pancreatitis).
if you experience fatigue, pale skin, bruising, uncontrolled bleeding, fever, sore throat, severe worsening of your general condition, or feel that your resistance to infections has decreased – consult a doctor immediately as these could be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If blood counts are abnormal, your doctor may need to stop treatment.

Rarely, joint pain and swelling, and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping SUMMAFLOX. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with SUMMAFLOX, consult your doctor, and keep the affected area rested. Avoid unnecessary movements, as the risk of tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with SUMMAFLOX and contact your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including SUMMAFLOX, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, and may not improve. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking SUMMAFLOX, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
If you have any doubts about whether any of the above may apply to you, consult your doctor or pharmacist before taking SUMMAFLOX tablets.
Other medicines and SUMMAFLOX tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines and herbal supplements. This is because SUMMAFLOX tablets may affect how other medicines work. Likewise, some medicines may affect how SUMMAFLOX tablets work.
In particular, inform your doctor if you are taking any of the following medicines. This is because
administration of SUMMAFLOX tablets in combination with other medicines may increase the risk of
experiencing side effects:

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is higher.
warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for respiratory problems. The risk of seizures is higher if you take theophylline together with SUMMAFLOX tablets.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures is higher when taken together with SUMMAFLOX tablets.
cyclosporine – used for organ transplants. The risk of experiencing typical cyclosporine side effects is higher.
medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin).
probenecid – used to treat gout. Your doctor may prescribe a lower dose if you have kidney problems.
cimetidine – used for ulcers and heartburn. Your doctor may prescribe a lower dose if you have kidney problems.

Do not take SUMMAFLOX tablets at the same time as the following medicines. This is because the
mechanism of action of SUMMAFLOX tablets may be affected:

iron salts in tablets (for anemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine or sucralfate (for gastric ulcers). See section 3 “If you are taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate”.

Urine test for opiates
In patients taking SUMMAFLOX tablets, urine tests may give "false-positive" results for strong painkillers called "opiates". If your doctor considers it necessary to perform urine tests, inform them that you are taking SUMMAFLOX tablets.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests that detect bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not take this medicine if:

you are pregnant, may become pregnant, or think you might be
you are breastfeeding or think you might breastfeed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.
Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances. Some of these side effects may affect your ability to concentrate and your reaction speed. If this happens, do not drive or operate machinery requiring high attention.

3. How to take SUMMAFLOX tablets

Always take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
How to take this medicine
If you are already taking iron supplements, zinc supplements, antacids, didanosine, or
sucralfate
How much medicine to take
Adults and elderly
Sinus infections
two SUMMAFLOX 250 mg tablets once daily
or, one SUMMAFLOX 500 mg tablet once daily
Lung infections, in patients with chronic respiratory problems
two SUMMAFLOX 250 mg tablets once daily
or, one SUMMAFLOX 500 mg tablet once daily
Pneumonia
two SUMMAFLOX 250 mg tablets once or twice daily
or, one SUMMAFLOX 500 mg tablet once or twice daily
Urinary tract infections including kidneys or bladder
Prostate infections
two SUMMAFLOX 250 mg tablets once daily
or, one SUMMAFLOX 500 mg tablet once daily
Skin and subcutaneous tissue infections, including muscles
two SUMMAFLOX 250 mg tablets once or twice daily
or, one SUMMAFLOX 500 mg tablet once or twice daily
Adults and elderly with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be administered to children or adolescents.
Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine. This is because
your skin will become much more sensitive to sunlight and may burn, itch, or develop severe
lesions if you do not follow these precautions:
make sure to use a sunscreen cream with a high protection factor;

always wear a hat and clothing covering arms and legs;
avoid sunbeds

If you take more SUMMAFLOX tablets than you should
If you accidentally take more tablets than you should, inform your doctor immediately or
seek medical advice elsewhere. Take the medicine pack with you. This will allow the doctor
to know what you have taken. The following adverse effects may occur: seizures
(epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems – which may
lead to irregular heartbeat and feelings of discomfort (nausea) or heartburn.
If you forget to take SUMMAFLOX tablets
If you forget to take a dose, take it as soon as you remember, unless it is almost time for
your next dose. Do not take a double dose to make up for the missed dose.
If you stop taking SUMMAFLOX tablets
Do not stop taking SUMMAFLOX tablets just because you feel better. It is important that you
complete the full course of tablets prescribed by your doctor. If you stop taking the tablets
too early, the infection may return, your condition may worsen, or the bacteria may develop
resistance to the medicine.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Usually, these effects are mild or moderate in severity and often disappear after a short time.

Stop taking SUMMAFLOX tablets and go immediately to your doctor or hospital if you notice the following side effect:

Very rare (may affect up to 1 in 10,000 people)

you have an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking SUMMAFLOX and go immediately to your doctor if you notice any of the following side effects – you may need urgent medical treatment:

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

watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious bowel problem
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
seizures
seeing or hearing things that do not exist (hallucinations, paranoia)
feeling depressed, mental problems, feeling restless (agitation), unusual dreams or nightmares
widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2
syndrome associated with inadequate water excretion and low sodium levels (SIADH)
decreased blood sugar levels (hypoglycaemia) or decreased blood sugar leading to coma (hypoglycaemic coma). This is important for people with diabetes.

Very rare (may affect up to 1 in 10,000 people)

burning, tingling, pain or numbness. These signs may indicate a condition called “neuropathy”

Not known (frequency cannot be estimated from the available data)

severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or circular patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2
loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death)
changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or suicidal behaviour
nausea, general feeling of unwellness, stomach discomfort or pain, or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2

If your vision becomes blurred or if you experience any eye discomfort while taking SUMMAFLOX, consult an ophthalmologist immediately.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, arm or leg pain, difficulty walking, abnormal sensations such as pricking, 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), and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with potentially fatal rupture, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Tell your doctor if any of the following side effects worsen or last longer than a few days:

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

sleep problems
headache, dizziness
feeling unwell (nausea, vomiting) and diarrhoea
increased levels of liver enzymes in the blood

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

changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
shortness of breath (dyspnoea)
altered taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach area pain, bloating (flatulence), constipation
itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
joint pain or muscle pain
blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
generalised weakness

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

bruising and increased tendency to bleed due to reduced number of blood platelets (thrombocytopenia)
low number of white blood cells (neutropenia)
exaggerated immune response (hypersensitivity)
tingling sensation in hands and feet (paraesthesia)
hearing problems (tinnitus) or vision problems (blurred vision)
unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
muscle weakness. This is important for patients with myasthenia gravis (a rare nervous system disorder)
changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
fever
clearly defined erythematous skin lesions, with or without blistering, developing within hours of levofloxacin administration and healing with residual redness; usually recurring at the same skin or mucosal site upon subsequent exposure to levofloxacin
poor memory

Not known (frequency cannot be estimated from the available data)

decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in the number of all types of blood cells (pancytopenia)
bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
fever, sore throat and a general feeling of unwellness that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increased blood sugar levels (hyperglycaemia). This is important for people with diabetes
change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
feeling very excited, euphoric, agitated or enthusiastic (mania)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision, eye inflammation
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as “prolongation of the QT interval” seen on electrocardiogram, electrical activity of the heart)
difficulty breathing or wheezing (bronchospasm)
allergic reactions affecting the lungs
pancreatitis
liver inflammation (hepatitis)
increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
inflammation of blood vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle rupture and muscle breakdown (rhabdomyolysis)
redness and swelling of joints (arthritis)
pain, including back, chest and extremity pain
sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
porphyria attacks in patients who already have porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store SUMMAFLOX tablets

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions, but it is best to store SUMMAFLOX in its original blister and carton in a dry place.

Do not use this medicine after the expiry date stated on the carton and aluminium foil after "Exp." Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SUMMAFLOX tablets contain

The active substance is levofloxacin. Each SUMMAFLOX 250 mg tablet contains 250 mg of levofloxacin and each SUMMAFLOX 500 mg tablet contains 500 mg of levofloxacin.

The other components are:

for the tablet core: microcrystalline cellulose, crospovidone, hypromellose, talc, magnesium stearate.
for the coating: hypromellose, titanium dioxide, macrogol 400, talc, yellow iron oxide, red iron oxide.

Description of the appearance of SUMMAFLOX tablets and contents of the pack

Carton containing a blister of 5 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

AGIPS FARMACEUTICI srl – via Amendola, 4 – 16035 Rapallo

Manufacturer

Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 – 03012, Anagni (FR)

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