PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicine
Read this leaflet carefully before taking this medicine.

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. Never give it to other people, even if their symptoms are the same as yours, as it could be dangerous. If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Findatur is and what it is used for
Before you take Findatur
How to take Findatur
Possible side effects
How to store Findatur
Contents of the pack and other information

1. WHAT FINDATUR IS AND WHAT IT IS USED FOR

Findatur contains a medicine called levofloxacin. Levofloxacin is an antibiotic belonging to the "fluoroquinolone" class.
Findatur is used to treat infections caused by bacteria that are susceptible to the medicine. Findatur is indicated for the treatment of infections:

of the sinuses,
of the lungs, in patients with long-term respiratory problems or pneumonia,
of the urinary tract, including the kidneys or bladder,
of the prostate gland, in case of persistent infection,
of the skin and underlying layers, including muscles (also known as "soft tissue").

2. BEFORE TAKING FINDATUR

Do not take Findatur

if you are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic, or to any of the excipients of Findatur (listed in section 6).
if you suffer from epilepsy (a condition causing loss of consciousness and violent, involuntary muscle contractions).
if you have had tendon problems (e.g. tendinitis) related to treatment with a “quinolone antibiotic”. Tendons are fibrous structures connecting muscles to bones.

Findatur must not be administered to children and adolescents during the growth period.
Findatur must not be used during pregnancy and breastfeeding (see “Pregnancy and breastfeeding”).
Do not take this medicine if any of the above applies to you. If you have any doubts, consult your doctor or pharmacist before taking Findatur.

Warnings and precautions

Consult your doctor or pharmacist before taking Findatur if:

you are elderly;
you are taking corticosteroids, medicines used to treat inflammation (see “Findatur and other medicines”);
you have had an organ transplant;
you have experienced seizures (sudden, involuntary, uncontrolled muscle movements);
you have kidney problems;
you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (an inherited genetic disorder that may cause destruction of red blood cells following recent illness or use of certain medicines);
you have or have previously had mental health problems;
you have heart problems (if you were born with or have a family history of long QT syndrome, or irregular heartbeat);
you have an electrolyte imbalance (especially low levels of potassium or magnesium in the blood);
you suffer from bradycardia (slow heart rate);
you suffer from heart failure (inability of the heart to pump adequate blood, causing shortness of breath and ankle swelling);
you have had a heart attack (death of heart cells due to prolonged lack of oxygen);
you have diabetes (a disease characterized by high blood glucose levels due to reduced insulin production by the pancreas);
you have liver problems;
you suffer from myasthenia gravis (a muscle disease causing weakness and fatigue);
you suffer from peripheral neuropathy (a nerve disorder causing pain, numbness, tingling, and weakness);
you have been diagnosed with an aneurysm of the aorta or a peripheral aneurysm of a large blood vessel (an enlargement or bulging of a large blood vessel);
you have previously experienced aortic dissection, a serious condition involving a tear in the wall of the largest artery in the body (the aorta);
you have been diagnosed with insufficiency of one of the heart valves;
you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions, such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (autoimmune inflammatory diseases), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure, atherosclerosis (build-up of fat in and on artery walls), rheumatoid arthritis (an autoimmune disease), or endocarditis (inflammation of the heart);
you have developed a severe skin reaction, skin peeling, blisters, and/or mouth ulcers after taking levofloxacin.

Severe skin reactions
Serious 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 may also occur, and eyes may become red and swollen. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and potentially life-threatening or fatal complications.
DRESS initially presents with flu-like symptoms and a skin rash on the face, followed by widespread skin rash, fever, elevated liver enzymes in blood tests, eosinophilia, and swollen lymph nodes.
If you develop a severe skin rash or any of these skin symptoms, stop taking levofloxacin immediately and contact your doctor or seek immediate medical attention.
You must not take quinolone/fluoroquinolone antibacterial medicines, including Findatur, 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 Findatur:

If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Findatur.
If you experience sudden, severe pain in the abdomen, chest, or back, 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 corticosteroids (medicines used to treat inflammation).
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 suddenly develop involuntary muscle spasms, muscle twitches, or contractions, consult a doctor immediately, as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
If you experience fatigue, paleness, bruising, uncontrolled bleeding, fever, sore throat, severe worsening of your general condition, or a feeling that your resistance to infections may be reduced, consult your doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with laboratory tests. If abnormalities occur, your doctor may need to stop treatment. Rarely, joint pain and swelling, tendon inflammation, or tendon rupture may occur. The risk is higher if you are elderly, have had an organ transplant, have kidney problems, or are taking corticosteroids (medicines used to treat inflammation). Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Findatur. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Findatur, consult your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase. Rarely, symptoms of nerve damage 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 Findatur and inform your doctor immediately to avoid the development of potentially irreversible neuropathy.

Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Findatur, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, paresthesia (abnormal sensations such as tingling, prickling, itching, numbness, or burning), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe weakness, and serious sleep disturbances.
If you experience any of these side effects after taking Findatur, 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 suspect that any of the conditions listed above may apply to you, speak with your doctor or pharmacist before taking Findatur.

Other medicines and Findatur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Findatur may affect the action of other medicines, and some medicines may affect the action of Findatur.
In particular, inform your doctor if you are taking any of the following medicines.
Because taking them together with Findatur may increase the risk of side effects:

Corticosteroids, used for inflammation. The risk of developing tendon inflammation and/or rupture is higher.
Warfarin, used to delay blood clotting. The risk of bleeding is higher. Your doctor may order regular blood tests to monitor blood clotting.
Theophylline, used for respiratory problems. The risk of seizures (involuntary, sudden, uncontrolled muscle movements) is higher if you take theophylline together with Findatur.
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 Findatur.
Cyclosporine, used after 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 rhythms (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), antidepressants (tricyclic antidepressants such as amitriptyline and imipramine), antipsychotics (for mental disorders), and antibiotic macrolides such as erythromycin, azithromycin, and clarithromycin used for bacterial infections.
Probenecid, used for gout (a disease causing joint pain, swelling, and redness). If you have kidney problems, your doctor may prescribe a lower dose.
Cimetidine, used for ulcers and heartburn. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Findatur tablets together with the following medicines. This is because the mechanism of action of Findatur tablets may be affected:

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

Urine testing for opioids
In patients taking Findatur, urine tests may yield “false-positive” results for strong painkillers called “opioids”. If your doctor considers it necessary to perform a urine test, inform them that you are taking Findatur.

Tuberculosis testing
This medicine may cause “false-negative” results in certain laboratory tests used to detect the bacterium causing tuberculosis.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine is contraindicated during pregnancy and breastfeeding (see “What you need to know before taking Findatur”).

Driving and using machines
Findatur may slightly or moderately impair the ability to drive vehicles and operate machinery.
Some side effects may occur after taking this medicine, including drowsiness, dizziness (sensation of movement, spinning, and loss of balance), or visual disturbances.
Some of these side effects may affect concentration and reaction speed. Do not drive or perform activities requiring high attention levels.

Important information about some excipients in Findatur
Findatur contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
Findatur contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. HOW TO TAKE FINDATUR

Always take this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Taking this medicine

Take this medicine by mouth
Swallow the tablets whole with a glass of water
The tablets may be taken during meals or at any time between meals

If you are already taking medicines containing iron, zinc, antacids, didanosine, or sucralfate
Do not take these medicines at the same time as Findatur tablets. Take the dose of these medicines at least 2 hours before or after taking Findatur tablets.
Dosage

Your doctor will decide how many Findatur tablets you should take
The dose depends on the type of infection you have and the location of the infection
The duration of treatment depends on the severity of the infection. If you feel that the effect of the medicine is too weak or too strong, do not change the dose on your own initiative; instead, consult your doctor.

Adults and elderly:
Paranasal sinus infections

Two Findatur 250 mg tablets in two divided doses per day
Or one Findatur 500 mg tablet daily

Lung infections in patients with chronic respiratory problems

Two Findatur 250 mg tablets once daily
Or one Findatur 500 mg tablet once daily

Pneumonia

Two Findatur 250 mg tablets once or twice daily
Or one Findatur 500 mg tablet once daily

Urinary tract infections, including kidneys or bladder

One or two Findatur 250 mg tablets once daily
Or half or one Findatur 500 mg tablet once daily

Prostate infections

Two Findatur 250 mg tablets once daily
Or one Findatur 500 mg tablet once daily

Skin and subcutaneous tissue infections, including muscles

Two Findatur 250 mg tablets once or twice daily
Or one Findatur 500 mg tablet once or twice daily

Adults and elderly with kidney problems:
Your doctor may decide to prescribe a reduced dose.
Children and adolescents:
This medicine must not be administered to children or adolescents during their growth period.
Protect your skin from sunlight
Do not expose yourself directly to sunlight during treatment with this medicine and for two days after the end of treatment. This is because your skin becomes more sensitive to sunlight and may develop sunburn, itching, or severe blisters if you do not take the following precautions:

Make sure to use high-protection-factor sunscreen creams
Always wear a hat and clothing that covers arms and legs
Avoid sunbeds (tanning beds)

If you take more Findatur tablets than you should
If you have accidentally taken more tablets than prescribed, contact your doctor immediately or seek other medical assistance. Bring the medicine package with you. This will allow the doctor to know what you have taken. The following adverse effects may occur: seizures (sudden, involuntary, and uncontrollable muscle movements), confusion, dizziness (sensation of movement, spinning, and loss of balance), feeling faint, tremor, and heart problems – which may lead to irregular heartbeats and feelings of discomfort (nausea) or stomach burning.

If you forget to take Findatur tablets
If you have forgotten to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Then continue as before. Never take a double dose to make up for a missed dose.

If you stop taking Findatur tablets
Do not stop taking Findatur 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 recur, your condition may worsen, or the bacteria may develop resistance to the medicine.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Stop taking Findatur and contact your doctor immediately if you notice any of the following adverse effects – you may require urgent medical treatment:

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

You have an allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
Watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
Pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
Seizures (sudden, involuntary, and uncontrollable muscle movements)
Hallucinations and paranoia (seeing or hearing things that are not real)
Feeling depressed, mental disturbances, agitation (feeling restless), unusual dreams or nightmares
Widespread skin rash, fever, elevated liver enzymes (which may indicate liver damage), eosinophilia (abnormal blood count), 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 section 2)
SIADH (Syndrome of Inappropriate Antidiuretic Hormone Secretion, associated with inadequate water excretion and low sodium levels)
Hypoglycaemia (low blood sugar levels) or hypoglycaemic coma (low blood sugar leading to deep unconsciousness). This is particularly important for people with diabetes.

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

Burning, tingling, pain, or numbness. These symptoms may indicate a condition called "neuropathy".

Not known (frequency cannot be estimated from available data)

Severe skin rashes, including skin lesions or peeling, such as 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 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, including potentially fatal liver failure.
Psychotic reactions (loss of contact with reality), with risk of suicidal thoughts or suicidal behaviour.
Nausea, general malaise, stomach discomfort or pain, or vomiting. These may be signs of acute pancreatitis (inflammation of the pancreas) – see section 2.
If your vision becomes blurred or you experience any eye discomfort while taking Findatur, 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, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy symptoms), depression, fatigue, sleep disturbances, memory impairment, and changes in hearing, vision, taste, or smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aneurysms and dissections (dilation and weakening of the aortic wall or aortic wall tear), potentially leading to rupture and death, as well as cases of heart valve incontinence (blood regurgitation through the valves), have been reported in patients treated with fluoroquinolones – see also section 2.

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

Common (may affect up to 1 in 10 patients)

Insomnia (sleep problems making it difficult to fall or stay asleep)
Headache
Dizziness (sensation of movement, spinning, and loss of balance)
Feeling unwell (nausea, vomiting)
Diarrhoea
Increased liver enzyme levels in the blood, which may indicate liver damage (ALT/AST, alkaline phosphatase, GGT)

Uncommon (may affect up to 1 in 100 patients)

Fungal infection, including Candida, which may require treatment
Resistant pathogens (bacteria able to survive and even multiply in the presence of an antibiotic)
Leucopenia and eosinophilia (changes in white blood cell count as shown in blood test results)
Anxiety (feeling of stress)
Confusion
Nervousness
Drowsiness
Tremor
Vertigo (sensation of movement, spinning, and loss of balance)
Dyspnoea (difficulty breathing)
Dysgeusia (altered taste)
Abdominal pain
Indigestion (difficulty digesting)
Flatulence
Constipation
Itching and skin rash
Urticaria (severe itching or skin rash)
Hyperhidrosis (excessive sweating)
Joint pain or muscle pain
Increased bilirubin and creatinine (due to liver or kidney problems, respectively)
Generalised weakness

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

Thrombocytopenia (reduced number of platelets in the blood, which may cause bruising and increased bleeding tendency)
Neutropenia (low white blood cell count)
Hypersensitivity (exaggerated immune response)
Paresthesia (tingling sensation in hands and feet)
Tinnitus (perception of sound with no external source, so others cannot hear it)
Blurred vision
Tachycardia (unusually fast heartbeat)
Palpitations (awareness of heartbeat)
Hypotension (low blood pressure)
Muscle weakness. This is particularly important for patients with myasthenia gravis (see section “Warnings and precautions”)
Memory impairment
Impaired kidney function and occasional kidney failure, possibly caused by an allergic reaction affecting the kidneys known as interstitial nephritis
Fever

Not known (frequency cannot be estimated from available data)

Bone marrow failure (which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding)
Aplastic anaemia (may cause paleness or yellowish skin due to damage to red blood cells)
Pancytopenia (reduction in the number of all types of blood cells)
Agranulocytosis (reduction in white blood cells causing fever, sore throat, and persistent general malaise)
Haemolytic anaemia (reduction in red blood cells due to their destruction)
Anaphylactic shock (a severe allergic reaction causing sudden drop in blood pressure, breathing difficulty due to airway constriction)
Hyperglycaemia (increased blood sugar levels – particularly important for people with diabetes)
Parosmia (altered perception of smell)
Anosmia and ageusia (reduced or loss of smell and taste)
Mania (feeling very excited, euphoric, restless, or enthusiastic)
Dyskinesia (involuntary muscle movements)
Extrapyramidal disorders (difficulty moving and walking)
Syncope (sudden, temporary loss of consciousness)
Temporary loss of vision
Uveitis (a form of eye inflammation that may cause pain, redness, and blurred vision)
Worsening or loss of hearing
QT interval prolongation (abnormal and accelerated heart rhythm, which may develop into a life-threatening irregular heartbeat leading to cardiac arrest)
Bronchospasm (difficulty breathing or wheezing due to airway constriction)
Allergic reactions affecting the lungs
Pancreatitis (inflammation of the pancreas)
Hepatitis (inflammation of the liver)
Photosensitivity (increased skin sensitivity to sunlight or ultraviolet rays)
Vasculitis (inflammation of blood vessels throughout the body due to an allergic reaction)
Stomatitis (inflammation of the internal tissues of the mouth)
Rhabdomyolysis (muscle breakdown and destruction)
Arthritis (redness and swelling of joints)
Pain, including back, chest, and limb pain
Myoclonus (muscle contractions, spasms, or sudden involuntary muscle contractions)
Attacks of porphyria (painful episodes lasting days or weeks in people who already have porphyria, a very rare metabolic disorder affecting the nervous system and/or skin)
Benign intracranial hypertension (persistent headache with or without blurred vision)

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

5. HOW TO STORE FINDATUR

Keep this medicine out of the sight and reach of children.
Do not use Findatur after the expiry date stated on the carton, blister pack, and tablet container.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of 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 PACKAGE AND OTHER INFORMATION

What Findatur contains

The active substance is levofloxacin. Each film-coated tablet contains 250 mg of levofloxacin, equivalent to 256.23 mg of levofloxacin hemihydrate. Each film-coated tablet contains 500 mg of levofloxacin, equivalent to 512.46 mg of levofloxacin hemihydrate.
The other components are:
Tablet core: sodium stearyl fumarate, crospovidone, anhydrous colloidal silica, copovidone, silicified microcrystalline cellulose (98% microcrystalline cellulose and 2% colloidal silica).
Tablet coating: pink Opadry II (monohydrate lactose, hypromellose 15 cP, titanium dioxide, triacetin, red iron oxide (E172) and yellow iron oxide (E172)).

Description of the appearance of Findatur and contents of the pack
Findatur 250 mg film-coated tablets.
Pink, biconvex tablets with a dividing line on one side and the inscription "L" imprinted on the other side, approximately 13 mm long and 6 mm wide.
The tablet can be divided into two equal parts.
Findatur 500 mg film-coated tablets.
Pink, biconvex tablets with a dividing line on one side and the inscription "L" imprinted on the other side, approximately 16 mm long and 8 mm wide.
The tablet can be divided into two equal parts.
Blister packs:
Pack sizes: 5 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Genetic S.p.A.
Via G. Della Monica, 26
84083 Castel San Giorgio (SA), Italy

Manufacturers
Findatur 250 mg film-coated tablets
Actavis hf.
Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland
Actavis Ltd
BLB016, Bulebel Industrial Estate, Zejtun,
ZTN 3000, Malta
Findatur 500 mg film-coated tablets
Genetic S.p.A., Contrada Canfora – 84084 Fisciano (SA), Italy

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: FINDATUR