Label: Information for the User

Levofloxacino Dermogen 250 mg Film-Coated Tablets

Read this label carefully before you start taking this medicine because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

This medication contains an active ingredient called levofloxacino, which belongs to a group of medications known as antibiotics. Levofloxacino is a type of antibiotic called a quinolone, and it works by eliminating the bacteria that cause infections in your body.

Levofloxacino Dermogen can be used to treat infections in:

- the sinuses

- the lungs, in people with long-term respiratory problems or pneumonia

- the urinary tract, including the kidneys or bladder

- the prostate, when the infection is persistent

- the skin and under the skin, including the muscles. This is sometimes referred to as "soft tissues"

In some special situations, Levofloxacino Dermogen may be used to reduce the risk of acquiring a lung infection called anthrax or a worsening of the disease after exposure to the anthrax-causing bacteria.

Do not take Levofloxacino Dermogen

• If you are allergic to levofloxacino or any of the other components of this medication (listed in section 6).
• If signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have or have had epilepsy.
• If you have ever had problems with tendons, such as tendinitis, related to taking medications like quinolones. The tendon is the tissue that connects your muscle to the skeleton.
• If you are a child or adolescent in the growth period.
• If you are pregnant or may become pregnant or think you may be pregnant.
• If you are breastfeeding.

Do not take this medication if any of the above cases apply to you. If in doubt, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to take Levofloxacino Dermogen:

• • If you are 60 years old or older
• If you are taking corticosteroids, sometimes called steroids (see section “Other medications and Levofloxacino”)
• If you have ever had a seizure (convulsion)
• If you have had any brain damage due to a stroke or other brain injury
• If you have kidney problems
• If you have what is known as “glucose-6-phosphate dehydrogenase deficiency”, as you may be prone to severe blood problems when taking this medication
• If you have ever had mental health problems
• If you have ever had heart problems: you should be cautious when using this type of medication, if you were born with, or have a family history of, prolonged QT interval (seen on the electrocardiogram (ECG), a graphical representation of the heart's electrical activity), have an imbalance of electrolytes in the blood (especially low levels of potassium or magnesium in the blood), have a slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an older person, or are taking other medications that may cause abnormal changes in the ECG (see section “Other medications and Levofloxacino Dermogen”).
• If you are diabetic
• If you have ever had liver problems
• If you have myasthenia gravis.
• If you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves).
• If you have been diagnosed with an aneurysm of a large blood vessel (aneurysm of the aorta or aneurysm of a large peripheral vessel).
• If you have had a previous episode of aortic dissection (tear in the wall of the aorta).
• If 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 or Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or atherosclerosis known, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).
• If you have ever developed a severe skin rash or peeling of the skin, blisters, and/or mouth sores after taking levofloxacino.

While taking Levofloxacino Dermogen

• If you experience a sudden, severe pain in the abdomen or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency service. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of palpitations (sensation of rapid or irregular heartbeat), you should inform your doctor immediately.

• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions - consult a doctor immediately, as these may be signs of myoclonia. Your doctor may need to interrupt the treatment with levofloxacino and start an appropriate treatment

• If you experience fatigue, pale skin, hematoma, uncontrolled bleeding, fever, sore throat, and a severe deterioration of your general condition, or a feeling that your resistance to infections may be decreased - consult a doctor immediately, as these may be signs of blood disorders. Your doctor should monitor your blood with blood counts. In case of abnormal blood counts, your doctor may need to interrupt the treatment.

Inform your doctor or pharmacist before taking this medication, if you are unsure whether any of the above cases apply to you.

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, ring-shaped spots or circular patches often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin eruptions often precede fever and/or flu-like symptoms. The eruptions may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a rash on the face, followed by a more widespread rash with elevated body temperature, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

If you develop a severe skin rash or any of these skin symptoms, stop taking levofloxacino and contact your doctor or seek immediate medical attention.

Other medications and Levofloxacino Dermogen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Particularly, inform your doctor if you are taking any of the following medications, as it increases the likelihood of adverse effects when taken with Levofloxacino Dermogen:

• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to experience inflammation and/or tendon rupture
• Warfarin - used to make the blood thinner. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood clots properly
• Theophylline - used for respiratory problems. You may be more likely to experience a seizure (convulsion) if you take it with Tavanic
• Nonsteroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, phenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsion) when taking them with this medication
• Ciclosporin - used after organ transplants. You may be more likely to experience the adverse effects of ciclosporin
• Medications known to affect your heart rhythm. This includes medications used for 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 for gout) and cimetidine (used for ulcers and heartburn). You should be especially careful when taking these medications with this medication. If you have kidney problems, your doctor may want to give you a lower dose.

Do not take Levofloxacino Dermogen at the same time as the following medications, as it may affect the way this medication works:

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

Determination of opiates in urine

Urine tests may show “false positive” results for the presence of strong painkillers called “opioids” in patients taking this medication. Inform your doctor that you are taking this medication if they have prescribed a urine test.

Tuberculosis test

This medication may cause a “false negative” result in some laboratory tests used to search for the bacteria that causes tuberculosis.

Taking Levofloxacino Dermogen with food, drinks, and alcohol

Levofloxacino can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Do not take this medication if:

• You are pregnant, may become pregnant, or think you may be pregnant.
• You are breastfeeding or plan to be.

Driving and operating machines

You may experience some side effects such as dizziness, drowsiness, balance disturbances (vertigo), or visual disturbances. Some of these side effects may affect your ability to concentrate or decrease your reaction time. If this happens, do not drive or perform any work that requires a high level of attention.

Follow exactly the administration instructions for levofloxacino as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration Form

Take this medication by mouth

Swallow the whole tablets with a little water

The tablets can be taken during or between meals

Protect your skin from sunlight

Do not expose your skin directly to the sun (even on cloudy days) while taking this medication and for two days after stopping it, as your skin will become much more sensitive to the sun and may burn, itch, or even blister if you do not take the following precautions:

• Make sure to use high-protection sunscreens
• Always wear a hat and clothing that covers your arms and legs
• Avoid ultraviolet A (UVA) lamps

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

• Do not take these medications at the same time as levofloxacino. You should take these medications at least two hours before or two hours after taking this medication.

What dose should you take

• Your doctor will decide how much Levofloxacino Dermogen you should take.
• The dose will depend on the type of infection you have and where the infection is located in your body.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medication is too weak or too strong, do not change the dose yourself, ask your doctor.

Adults and elderly patients

Paranasal sinus infection

• Two Levofloxacino Dermogen 250 mg tablets, once a day

Pulmonary infection, in people with long-term respiratory problems

• Two Levofloxacino Dermogen 250 mg tablets, once a day

Pneumonia

• Two Levofloxacino Dermogen 250 mg tablets, once or twice a day

Urinary tract infection, including kidneys or bladder

• One or two Levofloxacino Dermogen 250 mg tablets a day

Prostate infection

• Two Levofloxacino Dermogen 250 mg tablets, once or twice a day

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medication should not be given to children or adolescents.

If you take more Levofloxacino Dermogen than you should

If you accidentally take more tablets than you should, inform your doctor or get immediate medical help. Take the medication with you so that the doctor knows what you have taken. The effects that may appear are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart rhythm disturbances that may cause irregular heartbeats as well as discomfort (nausea) or heartburn.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Levofloxacino Dermogen

If you forgot 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 doses.

If you interrupt the treatment with Levofloxacino Dermogen

Do not stop your treatment with this medication even if you feel better. It is essential that you complete the treatment prescribed by your doctor. If you stop taking them too soon, the infection may recur, your condition may worsen, or the bacteria may become resistant to the medication.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, levofloxacino may cause side effects, although not everyone will experience them. Normally, they are mild to moderate and usually disappear quickly.

Stop taking Levofloxacino Dermogen and contact a doctor or go to a hospital immediately if you notice any of the following side effects:

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

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

Stop taking Levofloxacino Dermogen and contact a doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

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

• Watery diarrhea that may contain blood, possibly with stomach cramps and fever. These may be signs of a serious intestinal problem
• Pain and inflammation in tendons or ligaments, which may lead to rupture. The Achilles tendon is most frequently affected
• Seizures (convulsions)
• Generalized rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and other organs involved (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with impaired water excretion and low sodium levels (SIADH)

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

• Burning, tingling, pain, or numbness. These may be signs of what is called "neuropathy"

Frequency not known (cannot be estimated from available data):

• Severe skin eruptions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red macules in the shape of a target or circular patches often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by symptoms similar to the flu. See also section 2.

• Loss of appetite, yellow skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems that may include fulminant liver failure

Consult an eye specialist immediately if your vision worsens or you experience any other eye problems while taking this medication.

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

Frequent(may affect up to 1 in 10 people)

• Sleep problems
• Headache, dizziness
• Uncomfortable feeling (nausea, vomiting) and diarrhea
• Increased levels of certain liver enzymes in the blood

Occasional(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection by Candida, which may require treatment
• Changes in the number of white blood cells in blood test results (leucopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, sensation of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling bloated (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Muscle or joint pain
• Abnormal values in blood test results due to liver or kidney problems (elevated bilirubin or creatinine)
• General weakness

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

• Bleeding or bruising easily due to a decrease in platelet count in the blood (thrombocytopenia)
• Decreased white blood cell count in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Low blood sugar levels (hypoglycemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thought (psychotic reactions) with a risk of suicidal thoughts or actions
• Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares
• Sensation of tingling in hands and feet (paresthesias)
• Ear or vision disorders (tinnitus, blurred vision)
• Abnormally fast heartbeat (tachycardia) or low blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (rare nervous system disease)
• Changes in kidney function and, occasionally, kidney failure due to an allergic reaction in the kidneys called interstitial nephritis
• Fever
• Clearly defined red patches with or without blisters that develop a few hours after levofloxacino administration and heal with residual post-inflammatory hyperpigmentation; usually, they repeat in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

Frequency not known (cannot be estimated from available data)::

• Decreased red blood cell count in the blood (anemia): this may cause pale or yellow skin due to damage to red blood cells; decreased count of all types of blood cells (pancytopenia)
• The bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow insufficiency)
• Fever, sore throat, and persistent general discomfort. This may be due to a decrease in white blood cell count (agranulocytosis)
• Cardiac collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that may lead to coma (hypoglycemic coma). This is important in people with diabetes
• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling extremely excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Ear or hearing problems
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including heart stoppage, alteration of heart rhythm (denominated "prolongation of the QT interval", observed in the ECG, graphical representation of heart electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic pulmonary reactions
• Pancreatitis (inflammation of the pancreas)
• Heptatitis (inflammation of the liver)
• Increased skin sensitivity to the sun and ultraviolet light (photosensitivity), darker skin patches (hyperpigmentation), zones of skin darkening
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the mucous membrane inside the mouth (stomatitis)
• Muscle rupture and muscle destruction (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest, and limb pain
• Sudden, involuntary muscle contractions, muscle spasms, or muscle contractions (myoclonia)
• Porphyria crisis in patients with porphyria (rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

Cases of aortic wall enlargement and weakening or tearing (aneurysms and dissections), which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones have been reported. See also section 2.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use Levofloxacin after the expiration date shown on the packaging and blister. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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Composition of Levofloxacino Dermogen

• The active ingredient is levofloxacin (as hemihydrate).
• Each tablet contains 250 mg of levofloxacin (as hemihydrate).
• The other components (excipients) are: Tablet core: Microcrystalline cellulose, hypromellose, crospovidone, and magnesium stearate. Tablet coating: Macrogol 6000, talc, titanium dioxide (E-171), iron oxide red (E-172), and iron oxide yellow (E-172).

Appearance of the product and content of the packaging

The tablets of this medication are orange in color, round, convex, and scored on one side.

They are packaged in cardboard boxes containing aluminum/PVC blisters with 7 or 14 tablets.

Holder of the marketing authorization and responsible for manufacturing

Dermogen Farma, S.A.

C/ Aragoneses, 15

28108 Alcobendas Madrid

Spain

Responsible for manufacturing

Medochemie Ltd

1-10 Konstantinoupoleos Str. Zakaki, Limasso

Cyprus

Last review date of this leaflet: September 2024

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/)