LEVOFLOXACIN DERMOGEN 250 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Levofloxacin Dermogen 250 mg film-coated tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Levofloxacin Dermogen and what is it used for
2. What you need to know before taking Levofloxacin Dermogen
3. How to take Levofloxacin Dermogen
4. Possible side effects
5. Storage of Levofloxacin Dermogen
6. Contents of the pack and further information

1. What is Levofloxacin Dermogen and what is it used for

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

Levofloxacin Dermogen can be used to treat infections in:

• the paranasal 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 subcutaneous tissue, including muscles. This is sometimes referred to as "soft tissue"

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

2. What you need to know before taking Levofloxacin Dermogen

Do not take Levofloxacino Dermogen

• If you are allergic to levofloxacin or any of the other components of this medication (listed in section 6).
• If the 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 tendon problems, such as tendinitis, related to the use of quinolone-type medications. The tendon is the tissue that connects your muscle to your skeleton.
• If you are a child or adolescent in the growth phase.
• If you are pregnant, may become pregnant, or think you may be pregnant.
• If you are breastfeeding or plan to breastfeed.

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:

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

While taking Levofloxacino Dermogen

• If you feel a sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. 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 your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), inform your doctor immediately.

• If you start experiencing sudden, involuntary jerks, muscle spasms, or muscle contractions, consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to interrupt treatment with levofloxacin and initiate appropriate treatment.

• If you experience fatigue, pale skin, bruising, 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 could 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 treatment.

Tell your doctor or pharmacist before taking this medication if you are not sure if 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 levofloxacin.

• SJS/TEN may initially appear on the trunk as reddish targets or circular patches, often with blisters in the center. They may also appear as ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). 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 is initially manifested 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 swollen lymph nodes.

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

Other medications and Levofloxacino Dermogen

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

In particular, inform your doctor if you are taking any of the following medications, as they may increase the risk of side effects when taken with Levofloxacino Dermogen:

• Corticosteroids, sometimes called steroids, used for inflammation. You may be more likely to experience tendon inflammation and/or rupture.
• Warfarin, used to thin the blood. You may be more likely to experience bleeding. Your doctor may need to perform periodic blood tests to check if your blood is clotting properly.
• Theophylline, used for respiratory problems. You may be more likely to experience a seizure (convulsions) if taken with Tavanic.
• Non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to experience a seizure (convulsions) when taken with this medication.
• Cyclosporine, used after organ transplants. You may be more likely to experience the adverse effects of cyclosporine.
• Medications known to affect heart rhythm. This includes medications used for irregular 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). Caution should be exercised 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 acid reflux), 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 "opiates" in patients taking this medication. Inform your doctor that you are taking this medication if you have been prescribed a urine test.

Tuberculosis Test

This medication may cause a "false negative" result in some laboratory tests used to detect the bacteria that causes tuberculosis.

Taking Levofloxacino Dermogen with Food, Drinks, and Alcohol

Levofloxacin 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 breastfeed.

Driving and Using Machines

Some side effects, such as dizziness, drowsiness, balance disturbance (vertigo), or visual disturbances, may occur. Some of these side effects may affect your ability to concentrate or reduce your reaction time. If this happens, do not drive or operate any machinery that requires a high level of attention.

3. How to Take Levofloxacino Dermogen

Follow your doctor's instructions for taking levofloxacin exactly. If in doubt, consult your doctor or pharmacist again.

Method of Administration

Take this medication by mouth.

Swallow the tablets whole with a little water.

The tablets can be taken during or between meals.

Protect Your Skin from the Sun

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, sting, or even blister if you do not take the following precautions:

• Make sure to use high-factor sunscreens.
• Always wear a hat and clothing that covers your arms and legs.
• Avoid UVA lamps.

If You Are Already Taking Iron, Zinc Supplements, Antacids, Didanosine, or Sucralfate

• Do not take these medications at the same time as levofloxacin. 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 what dose of 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.

Lung 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 per 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 the doctor knows what you have taken. The effects that may occur are: seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that can cause irregular heartbeats, as well as nausea or heartburn.

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

If You Forget to Take Levofloxacino Dermogen

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 forgotten doses.

If You Interrupt 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 come back, your condition may worsen, or the bacteria may become resistant to the medication.

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

4. Possible Adverse Effects

Like all medicines, levofloxacino can cause adverse effects, although not all people suffer from them. They are usually mild to moderate and tend to disappear in a short time.

Interrupt treatment with Levofloxacino Dermogen and contact a doctor or go to a hospital quickly if you notice the following adverse effects:

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

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

Interrupt treatment with Levofloxacino Dermogen and contact a doctor immediately if you notice the following serious adverse 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 could be signs of a serious intestinal problem
• Pain and inflammation in the tendons or ligaments, which could lead to rupture. The Achilles tendon is the most frequently affected
• Seizures (convulsions)
• Widespread 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 alterations in water elimination 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 rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear on the trunk as red, target-like patches or circular spots, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by flu-like symptoms. See also section 2.

• Lack of appetite, yellowing of skin and eyes, dark urine, itching, or painful stomach (abdomen). These may be signs of liver problems, which can include fulminant liver failure

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

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

Frequent(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, infection by a fungus called Candida, which may require treatment
• Changes in the number of white blood cells in blood test results (leukopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, feeling of dizziness (vertigo)
• Difficulty breathing (dyspnea)
• Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, feeling of bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint or muscle pain
• Abnormal blood test results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• Generalized weakness

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

• Appearance of bruises and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decrease in blood sugar levels (hypoglycemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Feeling of tingling in hands and feet (paresthesia)
• Ear disorders (tinnitus) or vision problems (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disease)
• Changes in kidney function and occasional kidney failure, which may be a consequence of an allergic reaction in the kidney called interstitial nephritis
• Fever
• Clearly defined erythematous patches with or without blisters that develop a few hours after administration of levofloxacino and heal with residual post-inflammatory hyperpigmentation; usually, it recurs in the same skin or mucous membrane site after subsequent exposure to levofloxacino.

Frequency Not Known (cannot be estimated from available data):

• Decrease in red blood cells in the blood (anemia): this can cause the skin to become pale or yellowish due to damage to red blood cells; 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 persistent general malaise. This may be due to a decrease in the number of white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic shock)
• Increased blood sugar levels (hyperglycemia) or decreased blood sugar levels that can lead to coma (hypoglycemic coma). This is important in diabetic patients
• Changes in smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Feeling very excited, euphoric, agitated, or enthusiastic (mania)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision
• Hearing problems or loss of hearing
• Abnormally fast heartbeat, irregular heartbeat with life-threatening risk, including cardiac arrest, alteration of heart rhythm (called "prolongation of the QT interval", observed in the ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Pancreatitis (inflammation of the pancreas)
• Hepatitis (inflammation of the liver)
• Increased skin sensitivity to sunlight and ultraviolet light (photosensitivity), darker skin areas (hyperpigmentation)
• Vasculitis (inflammation of the blood vessels due to an allergic reaction)
• Stomatitis (inflammation of the tissue inside the mouth)
• Rhabdomyolysis (muscle breakdown and destruction)
• Arthritis (red and swollen joints)
• Pain, including back, chest, and limb pain
• Sudden, involuntary jerks, muscle spasms, or contractions (myoclonus)
• Porphyria crisis in patients with porphyria (a very rare metabolic disease)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and cardiac valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of Adverse Effects

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

5. Storage of Levofloxacino Dermogen

Keep this medication out of sight and reach of children.

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

Do not use Levofloxacino 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 thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

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6. Package Contents and Additional Information

Composition of Levofloxacino Dermogen

• The active ingredient is levofloxacino (as hemihydrate).
• One tablet contains 250 mg of levofloxacino (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), red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

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

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

Marketing Authorization Holder and Manufacturer

Dermogen Farma, S.A.

C/ Aragoneses, 15

28108 Alcobendas Madrid

Spain

Manufacturer

Medochemie Ltd

1-10 Konstantinoupoleos Str. Zakaki, Limassol

Cyprus

Date of the Last Revision of this Prospectus: September 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/)