EPIFLOXIN 250 mg Film-Coated Tablets

Зміст інструкції

1. EPIFLOXIN 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is EPIFLOXIN tablets and what is it used for
   2. What you need to know before taking EPIFLOXIN tablets
   3. How to take EPIFLOXIN tablets
   4. Possible side effects
   5. How to store EPIFLOXIN tablets
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Levofloxacin
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What EPIFLOXIN tablets are and what they are used for
• 2. What you need to know before you take EPIFLOXIN tablets
• 3. How to take EPIFLOXIN tablets
• 4. Possible side effects
• 5. How to store EPIFLOXIN tablets
• 6. Contents of the pack and other information

1. What is EPIFLOXIN tablets and what is it used for

EPIFLOXIN tablets contains the active substance called levofloxacin. This medicine belongs to the
group of medicines called antibiotics. Levofloxacin is a “quinolone” antibiotic. This medicine
works by killing the bacteria that cause infections in the body.

EPIFLOXIN tablets can be used for the treatment of infections:

• of the sinuses
• of the lungs, in patients with chronic respiratory problems 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 called “soft tissues”. In some special situations, EPIFLOXIN tablets can be used to decrease the likelihood of contracting a lung disease called anthrax or the worsening of the disease after exposure to the bacterium that causes anthrax.

2. What you need to know before taking EPIFLOXIN tablets

Do not take this medicine and tell 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). The 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 had problems affecting your tendons, such as tendinitis, related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures that connect muscles to the skeleton
• you are a child or adolescent during the growth period
• you are pregnant, may become pregnant or think you may be pregnant
• you are breastfeeding.

Do not take this medicine if the above applies to you. If you have any doubts, ask 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 of age or older
• you are taking corticosteroids, sometimes called steroids (see “Other medicines and EPIFLOXIN”)
• you have had a transplant
• you have had seizures
• you have suffered brain damage following a stroke or other brain damage
• you have kidney problems
• you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Giving you this medicine makes it more likely to develop serious blood problems
• you have suffered from mental health problems
• 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 prolonged QT interval (seen on an electrocardiogram, the electrical tracing of the heart), have an imbalance of salts 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 a woman or elderly/a or are taking other medicines that can alter the electrocardiogram (see section “Other medicines and EPIFLOXIN”).
• you have diabetes
• you have had liver problems
• you have myasthenia gravis
• you have problems with your nerves (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 and mitral regurgitation)
• you have a family history of aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue diseases 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, Behcet's syndrome, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart])
• you have developed a severe skin reaction or skin peeling, blisters and/or mouth sores after taking any medicine containing levofloxacin.

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

• SJS and TEN can initially appear on the body as reddish spots or circular patches often with central blisters. Mouth, throat, nose, genitals and eye sores (red and swollen eyes) can also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes can progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents as flu-like symptoms and a skin rash on the face, then a widespread rash with fever, increased levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes. If you develop a severe skin rash or another of these skin symptoms, stop taking levofloxacin and contact your doctor or seek medical attention immediately.

You should not take antibacterial medicines based on quinolones/fluoroquinolones, including Epifloxin, if you have previously had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

When you are taking this medicine

• If you experience severe, sudden abdominal, chest or back pain, which may be a symptom of aneurysm and aortic dissection, go to the emergency room immediately. The risk may be higher if you are taking systemic corticosteroids.
• Immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of a rapid or irregular heartbeat).
• If you start to experience sudden involuntary jerks, fasciculations or muscle contractions - see a doctor immediately as these may be signs of myoclonus. The doctor may need to stop treatment with levofloxacin and start appropriate treatment.
• In case of nausea, general malaise, severe discomfort or persistent or worsening abdominal pain or vomiting - see a doctor immediately as this may be an inflammation of the pancreas (acute pancreatitis).
• In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and severe worsening of your general condition, or if you feel that your resistance to infections has decreased - see a doctor immediately as these may be signs of a blood disease. The doctor should monitor the blood with a blood count. If the blood count is abnormal, the doctor may need to stop treatment.

Pain and swelling in the joints and inflammation or rupture of tendons can rarely occur. The risk is greater if you are elderly (over 60 years of age), if you have received an organ transplant, if you have kidney problems or if you are being treated with corticosteroids. Inflammation and rupture of tendons can occur within the first 48 hours of treatment and up to several months after discontinuation of Epifloxin therapy. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Epifloxin, see your doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
Pain and swelling in the joints and inflammation or rupture of tendons can rarely occur. 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, can occur. In this case, stop treatment with Epifloxin and immediately inform your doctor to prevent nerve damage from becoming permanent.

Serious, prolonged, disabling and potentially irreversible adverse reactions
Antibacterial medicines based on fluoroquinolones/quinolones, including Epifloxin, have been associated with very rare but serious adverse reactions, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include pain in the tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning (paresthesia), sensory organ disorders such as altered vision, taste, smell and hearing, depression, impaired memory, severe fatigue and severe sleep disturbances.
If you experience any of these adverse reactions after taking Epifloxin, see your doctor immediately before continuing treatment. The doctor will decide with you whether to continue treatment and will also consider using an antibiotic from another class.
If you have any doubts that the above may apply to you, see your doctor or pharmacist before taking EPIFLOXIN.

Other medicines and EPIFLOXIN
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is because EPIFLOXIN can affect the mechanism of action of other medicines. Also, some medicines can affect the mechanism of action of EPIFLOXIN.

In particular, tell your doctor if you are taking any of the following medicines. This is because administering EPIFLOXIN in combination with other medicines can increase the possibility that you experience adverse effects:

• Corticosteroids, sometimes called steroids - used to treat inflammation. The possibility of developing tendon and/or tendon rupture inflammation is greater.
• Warfarin - used to thin the blood. The possibility of bleeding is greater. Your doctor may ask you to have regular blood tests to check your blood clotting.
• Theophylline - used for breathing problems. The possibility of having a seizure (epileptic fit) is greater if you take theophylline in combination with EPIFLOXIN.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility of having a seizure (epileptic fit) if taken in combination with EPIFLOXIN is greater.
• Cyclosporine - used for organ transplants. The possibility of experiencing the typical adverse effects of cyclosporine is greater.
• Medicines known for their effects on the heartbeat. 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. Contact your doctor if the above applies to you in any way.

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

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

Urine test for opioids
In patients taking EPIFLOXIN, urine tests may give “false-positive” results for strong painkillers called ‘opioids’. If your doctor deems it necessary to have urine tests, inform him/her that you are taking EPIFLOXIN.

Tuberculosis test
This medicine can cause “false-negative” results in some laboratory tests that look for the bacteria that cause tuberculosis.

Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, may become pregnant or think you may be pregnant
• you are breastfeeding or think you may be breastfeeding

Driving and using machines
Some adverse reactions may occur after taking this medicine that include dizziness, drowsiness, a subjective sensation of movement (vertigo) or visual disturbances. Some of these adverse reactions may impair your ability to concentrate and your reaction speed. If this happens, do not drive vehicles or perform activities that require a high level of 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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Taking this medicine

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

Protect the skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after the
end of treatment. This is because the skin will become much more sensitive to the sun and may burn, itch or
serious lesions may occur if you do not observe the following precautions:

• make sure to use a sunscreen with a high protection factor
• always wear a hat and clothing that covers your arms and legs
• avoid sunbeds

If you are already taking iron salts in 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

• The doctor will decide how much EPIFLOXIN tablets you must take
• The dose will depend on the type of infection you have contracted and the location of the infection in the body
• 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 dosage on your own but consult your doctor

Adults and the elderly
Infections of the facial sinuses

• two EPIFLOXIN 250 mg tablets once a day
• or, one EPIFLOXIN 500 mg tablet once a day Lung infections, in patients with chronic respiratory problems
• two EPIFLOXIN 250 mg tablets once a day
• or, one EPIFLOXIN 500 mg tablet once a day Pneumonia
• two EPIFLOXIN 250 mg tablets one or two times a day
• or, one EPIFLOXIN 500 mg tablet one or two times a day Urinary tract infections including kidneys or bladder
• one or two EPIFLOXIN 250 mg tablets once a day
• or, half or one EPIFLOXIN 500 mg tablet once a day Prostate infections
• two EPIFLOXIN 250 mg tablets once a day
• or, one EPIFLOXIN 500 mg tablet once a day Skin and subcutaneous tissue infections, including muscles
• two EPIFLOXIN 250 mg tablets one or two times a day
• or, one EPIFLOXIN 500 mg tablet one or two times a day

Adults and elderly with kidney problems
The doctor may deem it necessary to reduce the dosage.

Children and adolescents
This medicine should not be given to children or adolescents.

If you take more EPIFLOXIN tablets than you should
If you accidentally take more tablets than you should, immediately inform your doctor or ask
elsewhere for medical advice. Bring the package of the medicine with you. This will allow the doctor to know what
you have taken. The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling of fainting, tremor and heart problems – which can lead to irregular heartbeats and a feeling of unwellness (nausea) or heartburn.

If you forget to take EPIFLOXIN tablets
If you forget to take a dose, take it as soon as you remember unless it is time to take the
next dose. Do not take a double dose to make up for the missed dose.

If you stop taking EPIFLOXIN tablets
Do not stop taking EPIFLOXIN just because you feel better. It is important that you complete the course of
tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may recur and the conditions may worsen or bacteria may develop resistances to the medicine.
If you have any doubts about the use of this medicine, ask 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 or moderate and often disappear after a short time.

Stop taking EPIFLOXIN and see your doctor or go to hospital immediately 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: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Stop taking EPIFLOXIN and see your doctor immediately 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 with possible blood, sometimes accompanied by stomach cramps and high fever. This may indicate a serious intestinal problem.
• Pain and inflammation of tendons or ligaments which may, in some cases, rupture. The Achilles tendon is most commonly affected.
• Convulsions.
• Seeing or hearing things that are not there (hallucinations, paranoia).
• Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares.
• Widespread rash, fever, increased 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 paragraph 2.
• Syndrome associated with insufficient water excretion and low sodium levels (SIADH).
• Decrease in blood sugar levels (hypoglycaemia) or decrease in blood sugar levels leading to coma (hypoglycaemic coma). This is important for people who have diabetes.

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

• Burning, tingling, pain or numbness. These signs may indicate a disease called “neuropathy”.

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

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the body as reddish spots or as circular patches often with blisters in the centre, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. See also paragraph 2.
• Loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems which can include fatal liver failure (liver failure that can cause death).
• Changes in opinion and thoughts (psychotic reactions) with the risk of having suicidal thoughts or suicidal actions.
• Nausea, general feeling of unwellness, discomfort or pain in the stomach area, or vomiting. These may be signs of inflammation of the pancreas (acute pancreatitis). See paragraph 2.

If your vision becomes blurred or if 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
inflammation of the tendons, tendon rupture, joint pain, pain in arms or legs, difficulty
walking, abnormal sensations such as prickling, tingling, itching, burning, numbness or pain
(neuropathy), fatigue, impaired memory and concentration, effects on mental health (which may include sleep
disorders, anxiety, panic attacks, depression and suicidal ideation), as well as hearing, vision, taste and
smell disorders have been associated with the use of antibiotics of the quinolone and fluoroquinolone type,
in some cases independently of pre-existing risk factors.
Cases of dilatation and weakening of the aortic wall or of aortic dissection (aneurysms and
dissections), with possible ruptures that can be fatal, as well as cases of backflow of blood through the
heart valves, have been reported in patients treated with fluoroquinolones. See also paragraph 2.

Tell your doctor if any of the following side effects worsen or lasts more than a few
days:
Common(may affect up to 1 in 10 people)

• difficulty sleeping
• 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 the number of white blood cells shown in blood tests (leucopenia, eosinophilia)
• feeling stressed (anxiety), feeling confused, feeling nervous, drowsiness, tremor, dizziness
• shortness of breath (dyspnoea)
• change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence), constipation
• itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• blood tests may show abnormal results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• general weakness

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

• bruising and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• low number of white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• feeling of tingling in the hands and feet (paresthesia)
• hearing (tinnitus) or vision (blurred vision) problems
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system)
• impaired kidney function and occasional kidney failure which may be caused by an allergic reaction to the kidneys called interstitial nephritis
• fever
• clearly defined reddish patches, with or without blister formation that develop within a few hours of administering levofloxacin and heal leaving the reddened part; usually reappear in the same area of skin or mucous membrane after subsequent exposure to levofloxacin
• impaired memory

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

• decrease in red blood cells (anaemia). This can 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)
• the bone marrow stops producing new blood cells, which can 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 decrease in the number of white blood cells in the blood (agranulocytosis)
• lack of blood flow (anaphylactic shock)
• increased blood sugar levels (hyperglycaemia). This is important for those who suffer from diabetes
• change in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia)
• feeling very excited, euphoric, agitated or enthusiastic (mania)
• difficulty moving and 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 the heartbeat (called “prolongation of the QT interval” seen on the electrocardiogram, electrical activity of the heart)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions to the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
• inflammation of the blood vessels throughout the body due to an allergic reaction (vasculitis)
• inflammation of the inner tissues of the mouth (stomatitis)
• rupture and destruction of muscles (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back pain, chest pain and limb pain
• sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
• attacks of porphyria in patients already suffering from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 particular storage conditions but it is best to store
EPIFLOXIN tablets in the blister and in the original box and in a dry place.
Do not use this medicine after the expiry date which is reported on the box and on the aluminum foil
after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how to eliminate
the medicines that you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What EPIFLOXIN tablets contain
The active ingredient 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 ingredients 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 contents of the pack
EPIFLOXIN 250 mg film-coated tablets, pink in colour, oblong with a break line. Pack
of 5 tablets.
EPIFLOXIN 500 mg film-coated tablets, pink in colour, oblong with a break line. Pack
of 5 tablets.
Not all pack sizes may be marketed.

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

Manufacturers
Doppel Farmaceutici S.r.l. - Via Volturno, 48 – 20089 Quinto dè Stampi – Rozzano (MI)
Doppel Farmaceutici S.r.l. - Vai Martiri delle Foibe,1 – 29016 Cortemaggiore (PC)
For further information or if you have any doubts, please ask your doctor or pharmacist.