Levofloxacin DermoGen 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Dermogen 250 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Levofloxacino Dermogen is and what it is used for
2. What you need to know before taking Levofloxacino Dermogen
3. How to take Levofloxacino Dermogen
4. Possible adverse effects
5. How to store Levofloxacino Dermogen
6. Contents of the pack and other information

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

This medicine contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is a quinolone-type antibiotic that works by killing the bacteria causing infections in your body.

Levofloxacino 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 beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Dermogen can be used to reduce the chance of developing or worsening a lung infection called anthrax after exposure to the bacteria that cause anthrax.

2. What you need to know before taking Levofloxacino Dermogen

Do not take Levofloxacino Dermogen

• If you are allergic to levofloxacin or to any of the other components of this medicine (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 experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues connecting your muscles to your bones.
• If you are a child or adolescent undergoing growth.
• If you are pregnant, could become pregnant, or think you might be pregnant.
• If you are breastfeeding.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Levofloxacino Dermogen if:

• • You are 60 years of age or older
• You are taking corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacino Dermogen”)
• You have ever had a seizure (epileptic fit)
• You have suffered brain damage due to stroke or other brain injury
• You have kidney problems
• You have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be prone to serious blood problems while taking this medicine
• You have ever had mental health problems
• You have ever had heart problems: caution is needed when using this type of medicine if you were born with, or have a family history of, prolonged QT interval (seen on electrocardiogram [ECG], a graphical representation of the heart's electrical activity), have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and Levofloxacino Dermogen”)
• You have diabetes
• You have ever had liver problems
• You have myasthenia gravis
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
• You have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• You have previously experienced an episode of aortic dissection (tear in the wall of the aorta)
• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular 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, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection))
• You have ever developed a severe skin rash, skin peeling, blisters, and/or mouth sores after taking levofloxacin

While taking Levofloxacino Dermogen

• If you experience sudden, severe pain in your abdomen or back, which could be symptoms of aortic dissection or aneurysm, seek immediate emergency medical attention. The risk may be increased if you are receiving treatment with systemic corticosteroids.

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

• If you begin to experience sudden, involuntary jerking, muscle spasms, or muscle contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.

• If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat, a significant worsening of your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these could be signs of blood disorders. Your doctor should monitor your blood with blood counts. If blood counts are abnormal, your doctor may need to stop treatment.

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

Severe skin reactions

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

• SJS/TEN may initially appear on the trunk as red, target-like spots or circular lesions, often with blisters in the center. Ulcers may also develop in the mouth, throat, nose, genitals, and eyes (red, swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
• DRESS initially presents with flu-like symptoms and a facial rash, followed by a more widespread rash, elevated body temperature, increased liver enzymes seen in blood tests, elevated levels of a type of white blood cell (eosinophilia), and enlarged 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 medicines and Levofloxacino Dermogen

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

In particular, inform your doctor if you are taking any of the following medicines, as they may increase the risk of adverse 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 have an increased risk of bleeding. Your doctor may need periodic blood tests to check your blood’s clotting ability.
• Theophylline – used for respiratory problems. You may have an increased risk of seizures when taking it with Tavanic.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may have an increased risk of seizures when taking them with this medicine.
• Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects of cyclosporine.
• Medicines known to affect heart rhythm. This includes medicines 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). Special caution is required when taking these medicines with this medicine. If you have kidney problems, your doctor may want to prescribe a lower dose.

Do not take Levofloxacino Dermogen at the same time as the following medicines, as they may interfere with its effectiveness:

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

Opiate testing in urine

Urine tests may show “false positive” results for strong painkillers known as “opiates” in patients taking this medicine. Inform your doctor that you are taking this medicine if you are prescribed a urine test.

Tuberculosis testing

This medicine may cause a “false negative” result in certain laboratory tests used to detect the bacterium causing tuberculosis.

Taking Levofloxacino Dermogen with food, drinks, and alcohol

Levofloxacin may be taken with or without food.

Pregnancy, breastfeeding, and fertility

Do not take this medicine if:

• You are pregnant, could become pregnant, or think you might be pregnant.
• You are breastfeeding or plan to breastfeed.

Driving and using machines

Some adverse effects such as dizziness, drowsiness, loss of balance (vertigo), or visual disturbances may occur. Some of these side effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any activity requiring a high level of alertness.

3. How to take Levofloxacino Dermogen

Follow exactly the dosing instructions for levofloxacin as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

Method of administration

Take this medicine by mouth.

Swallow the tablets whole with some water.

The tablets may be taken during or between meals.

Protect your skin from sunlight

Do not expose your skin directly to sunlight (even when cloudy) while taking this medicine 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:

• Be sure to use sunscreen creams with a high protection factor.
• Always wear a hat and clothing covering your arms and legs.
• Avoid ultraviolet (UVA) lamps.

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

• Do not take these medicines at the same time as levofloxacin. You must take these medicines at least two hours before or two hours after taking this medicine.

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 in your body the infection is located.
• The duration of treatment will depend on the severity of your infection.
• If you think the effect of the medicine is too weak or too strong, do not change the dose yourself—ask your doctor.

Adults and elderly patients

Sinus infection

• Two tablets of Levofloxacino Dermogen 250 mg once daily.

Lung infection in people with long-term respiratory problems

• Two tablets of Levofloxacino Dermogen 250 mg once daily.

Pneumonia

• Two tablets of Levofloxacino Dermogen 250 mg once or twice daily.

Urinary tract infection, including kidneys or bladder

• One or two tablets of Levofloxacino Dermogen 250 mg daily.

Prostate infection

• Two tablets of Levofloxacino Dermogen 250 mg once or twice daily.

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Use in children and adolescents

This medicine must 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 seek immediate medical help. Take the medicine with you so the doctor knows what you have taken. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as discomfort (nausea) or stomach burning.

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

If you forget to take Levofloxacino Dermogen

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for missed doses.

If you stop treatment with Levofloxacino Dermogen

Do not stop your treatment with this medicine even if you feel better. It is important that you complete the full course prescribed by your doctor. If you stop taking it too early, the infection may return, your condition may worsen, or the bacteria may become resistant to the medicine.

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

4. Possible adverse effects

Like all medicines, levofloxacin may cause adverse effects, although not everyone will experience them. Usually, these effects are mild to moderate and tend to resolve quickly.

Stop treatment with Levofloxacin Dermogen and contact a doctor or go to a hospital immediately if you notice the following adverse effects:

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

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

Stop treatment with Levofloxacin Dermogen and contact your doctor immediately if you notice the following serious adverse effects, as you may require urgent medical treatment:

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

• Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious bowel problem
• Pain and inflammation in tendons or ligaments, which could lead to rupture. The Achilles tendon is most frequently affected
• Seizures (epileptic fits)
• Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
• Syndrome associated with 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 known as "neuropathy"

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

• Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as reddish macules in a target-like pattern or circular spots often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by flu-like symptoms. See also section 2.

• Loss of appetite, yellowing of the skin and eyes, dark urine, burning sensation or painful abdomen. These may be signs of liver problems, which may include fulminant liver failure

Seek immediate advice from an eye specialist if your vision deteriorates or you develop any other eye problems while taking this medicine.

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

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances
• Headache, dizziness
• Nausea, vomiting and diarrhoea
• 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, fungal infection caused by Candida, which may require treatment
• Changes in white blood cell count in blood tests (leucopenia, eosinophilia)
• Stress (anxiety), confusion, restlessness, drowsiness, tremors, sensation of dizziness (vertigo)
• Difficulty breathing (dyspnoea)
• Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalised weakness

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

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia)
• Decreased number of white blood cells in blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycaemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in beliefs and thoughts (psychotic reactions) with risk of suicidal thoughts or actions
• Depression, mental disorders, feeling of restlessness (agitation), abnormal dreams or nightmares
• Tingling sensation in hands and feet (paraesthesiae)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally rapid heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people with myasthenia gravis (a rare nervous system disorder)
• Changes in kidney function and, occasionally, kidney failure which may result from an allergic-type reaction in the kidney known as interstitial nephritis
• Fever
• Clearly defined erythematous patches with or without blisters that develop a few hours after administration of levofloxacin and heal with post-inflammatory hyperpigmentation; usually, they recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

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

• Decrease in red blood cells (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decrease in all types of blood cells (pancytopenia)
• Bone marrow stops producing new blood cells, which may cause fatigue, reduced ability to fight infections and uncontrolled bleeding (bone marrow failure)
• Fever, sore throat and persistent general malaise. This may be due to a decrease in white blood cells (agranulocytosis)
• Circulatory collapse (anaphylactic-type shock)
• Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels which may lead to coma (hypoglycaemic coma). This is important in people with diabetes
• 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
• Abnormally rapid heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as "prolongation of the QT interval", observed on ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Pulmonary allergic reactions
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity), darker areas of skin (hyperpigmentation)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the tissue inside the mouth (stomatitis)
• Muscle rupture and destruction of muscle (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest and limb pain
• Sudden involuntary jerks, muscle spasms or muscle contractions (myoclonus)
• Acute porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin Dermogen

Keep this medicine out of sight and reach of children.

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

Do not use Levofloxacin after the expiry date stated on the container and blister pack. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacin Dermogen

• The active substance is levofloxacin (as hemihydrate).
• One 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), red iron oxide (E-172), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

The tablets of this medicine are orange-colored, 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, Limasso
Cyprus

Date of the most recent revision of this leaflet: September 2024

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