Epifloxin: detailed information

Package leaflet: Information for the user

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

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

EPIFLOXIN 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 bacteria responsible for infections in the body.
EPIFLOXIN tablets can be used to treat the following infections:

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

In certain special situations, EPIFLOXIN tablets may also be used to reduce the risk of developing a lung disease called anthrax or to prevent worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you should know before taking EPIFLOXIN 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: skin 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 tendinitis, related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to bones
- you are a child or adolescent during the growth period
- you are pregnant, may become pregnant, or think you might be pregnant
- you are breastfeeding.

Do not take this medicine if any of the above applies to you. If you have any doubts, consult your
doctor, nurse, or pharmacist before taking EPIFLOXIN.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:

you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see “Other medicines and EPIFLOXIN”)
you have had an organ transplant
you have had seizures
you have suffered brain damage due to stroke or other brain injury
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 had 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 trace), 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 may alter the electrocardiogram (see section “Other medicines and EPIFLOXIN”).
you have diabetes
you have had liver problems
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral 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, 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, Behçet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart])
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 complications or even death.
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 rash or any of these other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical help.

You must not take quinolone/fluoroquinolone antibacterial medicines, including Epifloxin, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
While taking this medicine

If you experience sudden, severe pain in your abdomen, chest, or back, which may be a sign of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroids.
Inform your doctor immediately if you notice sudden 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 may be signs of myoclonus. Your doctor may need to discontinue levofloxacin treatment and start appropriate therapy.
If you experience nausea, general malaise, severe discomfort, or persistent or worsening stomach pain or vomiting – consult a doctor immediately, as this may indicate inflammation of the pancreas (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 may be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If blood tests are abnormal, your doctor may need to discontinue treatment.

Rarely, joint pain and swelling, tendon inflammation, or tendon 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 Epifloxin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Epifloxin, consult your doctor, and rest the affected area. Avoid unnecessary movement, 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 taking Epifloxin and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Epifloxin, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as itching, tingling, prickling, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these side effects after taking Epifloxin, 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 EPIFLOXIN.
Other medicines and EPIFLOXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because EPIFLOXIN may affect the action of other medicines. Likewise, some medicines may affect the action of EPIFLOXIN.
In particular, inform your doctor if you are taking any of the following medicines. This is because
taking EPIFLOXIN together with other medicines may increase the likelihood
that you experience 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 breathing problems. The risk of seizures is higher if you take theophylline together with EPIFLOXIN.
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 EPIFLOXIN.
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, sotalol, dofetilide, ibutilide, and amiodarone), 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. Consult your doctor if any of the above applies to you.

Do not take EPIFLOXIN tablets together with the following medicines. This is because the
mechanism of action of EPIFLOXIN 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 salt tablets, zinc supplements, antacids, didanosine, or sucralfate”.

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

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

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 impair concentration and reaction speed. If this occurs, do not drive or operate machinery requiring high attention.
EPIFLOXIN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take EPIFLOXIN tablets

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How to take this medicine

take this medicine by mouth
swallow the tablets whole with water
the tablets may be taken with or without food

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after
treatment has ended. This is because your skin will become much more sensitive to sunlight and may burn, itch, or
develop serious skin lesions if you do not follow the precautions listed below:

make sure to use a sunscreen with a high sun protection factor
always wear a hat and clothing that covers your arms and legs
avoid sunbeds (tanning beds)

If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate

Do not take these medicines at the same time as EPIFLOXIN. Take the prescribed dose of these medicines at least 2 hours before or after taking EPIFLOXIN tablets.

How much medicine to take

Your doctor will decide how many EPIFLOXIN tablets you should take
The dose will depend on the type of infection you have and where in the body the infection is located
The duration of treatment will depend on the severity of the infection
If you think that the effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor

Adults and elderly patients
Sinus infections

two EPIFLOXIN 250 mg tablets once daily
or, one EPIFLOXIN 500 mg tablet once daily

Lung infections in patients with chronic respiratory problems

two EPIFLOXIN 250 mg tablets once daily
or, one EPIFLOXIN 500 mg tablet once daily

Pneumonia

two EPIFLOXIN 250 mg tablets once or twice daily
or, one EPIFLOXIN 500 mg tablet once or twice daily

Urinary tract infections, including kidneys or bladder

one or two EPIFLOXIN 250 mg tablets once daily
or, half or one EPIFLOXIN 500 mg tablet once daily

Prostate infections

two EPIFLOXIN 250 mg tablets once daily
or, one EPIFLOXIN 500 mg tablet once daily

Skin and subcutaneous tissue infections, including muscles

two EPIFLOXIN 250 mg tablets once or twice daily
or, one EPIFLOXIN 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems
Your doctor may decide that a lower dose is necessary.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more EPIFLOXIN tablets than you should
If you accidentally take more tablets than prescribed, contact your doctor immediately or seek medical
advice. Take the medicine pack with you. This will help the doctor understand what you have taken.
The following side effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremors, and heart problems – which may lead to irregular heartbeats and feelings of discomfort (nausea) or stomach burning.
If you forget to take EPIFLOXIN 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 forgotten dose.
If you stop taking EPIFLOXIN tablets
Do not stop taking EPIFLOXIN 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 become resistant to the medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. Usually, these effects are mild to moderate in severity and often disappear after a short time.
Stop taking EPIFLOXIN 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 EPIFLOXIN 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 are not real (hallucinations, paranoia).
Feeling depressed, mental disturbances, feeling restless (agitation), abnormal 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 levels 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 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 behaviour (psychotic reactions) with risk of suicidal thoughts or actions.
Nausea, feeling unwell, 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 you experience any eye discomfort while taking EPIFLOXIN, 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, pain in arms or legs, 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 disturbances, anxiety, panic attacks, depression and suicidal ideation), as well as disturbances 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 possible rupture that may lead to death, 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 liver enzyme levels in 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)
Change in 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 bleeding tendency due to reduced platelet count in blood (thrombocytopenia)
Low white blood cell count (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
Well-demarcated erythematous patches, with or without blister formation, developing within hours of levofloxacin administration and healing with redness; usually reappear at the same skin or mucosal site after subsequent exposure to levofloxacin
Memory impairment

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 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 illness 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 how things smell, loss of smell or taste (parosmia, anosmia, ageusia)
Feeling extremely 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 (called "prolongation of the QT interval" seen on electrocardiogram, electrical activity of the heart)
Breathing difficulty or wheezing (bronchospasm)
Allergic reactions affecting the lungs
Pancreatitis
Inflammation of the liver (hepatitis)
Increased skin sensitivity 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 internal mouth tissues (stomatitis)
Muscle breakdown and destruction (rhabdomyolysis)
Joint redness and swelling (arthritis)
Pain, including back, chest and extremity pain
Sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
Acute attacks of porphyria 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EPIFLOXIN tablets

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions; however, it is better to store EPIFLOXIN tablets in the original blister and packaging, in a dry place.
Do not use this medicine after the expiry date stated on the carton and on the aluminium sheet after "Exp.". The expiry date refers to the last day of that month.
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. PACKAGING CONTENTS AND OTHER INFORMATION

What EPIFLOXIN tablets contain
The active substance is levofloxacin. Each EPIFLOXIN 250 mg tablet contains 250 mg of levofloxacin and each EPIFLOXIN 500 mg tablet contains 500 mg of levofloxacin.
The other components are:

For the tablet core: crospovidone, hypromellose, microcrystalline cellulose and sodium stearyl fumarate
For the coating: hypromellose, titanium dioxide (E171), talc, macrogol, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of EPIFLOXIN tablets and packaging contents
EPIFLOXIN 250 mg film-coated tablets, pink in colour, oblong-shaped with a breakline. Pack size: 5 tablets.
EPIFLOXIN 500 mg film-coated tablets, pink in colour, oblong-shaped with a breakline. Pack size: 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturers
Doppel Farmaceutici S.r.l. - Via Volturno, 48 – 20089 Quinto de' Stampi – Rozzano (MI)
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

This patient information leaflet does not contain all the information available on this medicine. If you need further information or have any questions, please consult your doctor or pharmacist.