Levofloxacin Almus 500 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Levofloxacino Almus 500 mg film-coated tablets EFG

Please read all of this leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.

Leaflet contents:

What Levofloxacino Almus is and what it is used for
What you need to know before taking Levofloxacino Almus
How to take Levofloxacino Almus
Possible side effects
How to store Levofloxacino Almus
Contents of the pack and other information

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

Levofloxacin belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone, a type of antibacterial (antibiotic) with bactericidal activity.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Levofloxacino Almus can be used to treat infections of:

Sinuses (sinus infection)
Lungs, in people with long-term respiratory problems or pneumonia
Urinary tract, including kidneys or bladder
Prostate, when the infection is persistent
Skin and beneath the skin, including muscles. Sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino Almus may be used to reduce the risk of developing or worsening a lung infection called anthrax following exposure to the anthrax-causing bacterium.

2. What you need to know before taking Levofloxacino Almus

Do not take Levofloxacino Almus

If you are allergic to levofloxacin, any other quinolone, such as moxifloxacin, ciprofloxacin or ofloxacin, or to any of the other ingredients of this medicine (listed in section 6).

Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of your lips, face, throat or tongue.

If you have or have had epilepsy
If you have or have ever had tendon problems, such as tendinitis related to taking medicines from the quinolone family. A tendon is the tissue that connects muscle to bone.
If you are a child or adolescent who is still growing
If you are pregnant, could be pregnant or think you may be pregnant
If you are breastfeeding

Do not use this medicine if any of the above apply to you. If in doubt, consult your doctor, nurse or pharmacist before using this medicine.

Warnings and precautions

Before taking this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Almus, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor or pharmacist before taking this medicine:

If you are 60 years of age or older
If you are taking corticosteroids, sometimes called steroids (see section "Taking Levofloxacino Almus with other medicines")
If you have ever had a seizure (convulsion)
If you have had brain damage due to head injury, stroke or other brain injury
If you have kidney problems
If you have a condition known as "glucose-6-phosphate dehydrogenase deficiency". You are more likely to experience serious blood problems when taking this medicine.
If you have ever had mental health problems
If you have ever had heart problems: you should be cautious 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 imbalances in blood electrolyte levels (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "bradycardia"), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal changes in the ECG (see section "Taking Levofloxacino Almus with other medicines").
If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
If you are diabetic
If you have ever had liver problems
If you have myasthenia gravis
If you have been diagnosed with enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
If you have previously experienced aortic dissection (a tear in the wall of the aorta).
If you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).
If you have ever developed a severe skin rash, peeling skin, blisters and/or mouth sores after taking levofloxacin.

During treatment with this medicine

If you experience sudden, severe pain in your abdomen, chest or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department.

Your risk may be increased if you are receiving treatment with systemic corticosteroids.

If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or the onset of palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you begin to experience sudden involuntary jerks, muscle spasms or contractions – consult a doctor immediately, as these could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and initiate appropriate therapy.
If you experience fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and 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 discontinue treatment.

In rare cases, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping treatment with Levofloxacino Almus. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacino Almus, contact your doctor and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking Levofloxacino Almus and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, disabling, long-lasting and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacino Almus, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling or potentially irreversible. These include tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell or hearing, depression, memory impairment, severe fatigue and serious sleep disorders.

If you experience any of these adverse effects after taking Levofloxacino Almus, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Inform your doctor, nurse or pharmacist before using Levofloxacino Almus if you are unsure whether any of the above conditions apply to you.

Serious skin reactions

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

SJS/TEN may initially appear on the trunk as reddish, 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 rash on the face, followed by a more widespread rash, elevated body temperature, increased liver enzymes 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.

Taking Levofloxacino Almus with other medicines

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Levofloxacino Almus may interact with the way other medicines work, and vice versa.

In particular, inform your doctor if you are taking any of the following medicines. This is because they may increase the likelihood of experiencing side effects when taken with Levofloxacino Almus:

Corticosteroids, sometimes called steroids: used for inflammation. You may be more likely to develop 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 that your blood is clotting properly.
Theophylline – used for respiratory problems. You may be more likely to have a seizure (convulsion) when taken with Levofloxacino Almus.
Non-steroidal anti-inflammatory drugs (NSAIDs) – for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen and indomethacin. You may be more likely to have a seizure (convulsion) when taken with Levofloxacino Almus.
Cyclosporine – used after organ transplants. You may be more likely to experience side effects from 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 amitriptiline 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 care should be taken when these medicines are taken with Levofloxacino Almus. If you have kidney problems, your doctor may wish to prescribe a lower dose.

Do not take Levofloxacino Almus at the same time as the following medicines. This is because they may affect the way Levofloxacino Almus works:

Iron salts (for anemia), zinc supplements, magnesium, antacids containing aluminium (for acid or heartburn), didanosine or sucralfate (for stomach ulcers). See section 3: “If you are taking iron salts, zinc supplements, antacids, didanosine or sucralfate.”

Opioid testing in urine

Urine tests may give "false positive" results for strong painkillers known as "opioids" in people taking Levofloxacino Almus. If your doctor has prescribed a urine test, inform them that you are taking Levofloxacino Almus.

Tuberculosis testing

This medicine may give "false negative" results in certain laboratory tests used to detect the bacterium that causes tuberculosis.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take this medicine:

If you are pregnant, could be pregnant or think you may be pregnant.

If you are breastfeeding or plan to breastfeed.

Driving and using machines

Due to the possibility of certain adverse effects such as dizziness, drowsiness, balance disturbances (vertigo) or visual disturbances, some of these effects may affect your ability to concentrate or reduce your reaction speed. If this occurs, do not drive or perform any work requiring a high level of attention.

Levofloxacino Almus contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially "sodium-free".

3. How to take Levofloxacino Almus

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How to take 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

Protect your skin from sunlight

Do not expose yourself directly to sunlight or UV radiation while taking this medicine and for 2 days after stopping it. This is because your skin may become much more sensitive to sunlight, which could cause burns, tingling, or severe blisters if you do not take the following precautions:

Make sure you use sunscreen cream with a high sun protection factor.
Always wear a hat and clothing covering your arms and legs
Avoid ultraviolet (UVA) lamps

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

Do not take these medicines at the same time as Levofloxacino Almus. Take your dose of these medicines at least 2 hours before or after taking Levofloxacino Almus

What dose should you take

Your doctor will decide how many Levofloxacino Almus tablets 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 your treatment will depend on the severity of your infection
If you feel that the effect of this medicine is too weak or too strong, do not change the dose on your own—ask your doctor

Adults and elderly patients

Sinusitis (infection in the paranasal sinuses)

1 tablet once daily

Lung infection in people with long-term respiratory problems

1 tablet once daily

Pneumonia

1 tablet once or twice daily

Urinary tract infection, including kidneys or bladder

Half or one tablet per day

Prostate infection

1 tablet once daily

Skin and underlying tissue infection, including muscles

1 tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may prescribe you a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

If you take more Levofloxacino Almus than you should

Symptoms of overdose with levofloxacin may include dizziness, confusion, tremors, altered consciousness, seizures (convulsions), and heart disturbances that could possibly lead to abnormal heart rhythm, as well as nausea or heartburn. Your doctor will apply standard measures to eliminate the unabsorbed drug. Treatment will be based on your symptoms. ECG monitoring should be performed. Levofloxacin is not eliminated from the body by dialysis. There is no specific antidote.

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 Almus

If you forget to take your dose at the scheduled time, take it as soon as possible, then continue with your usual dosing schedule. Do not take a double dose to make up for missed doses.

If you stop taking Levofloxacino Almus

Do not stop taking Levofloxacino Almus just because you feel better. It is important that you complete the treatment prescribed specifically for you by your doctor. If you stop taking the tablets too early, the infection may recur, your condition may worsen, or bacteria may become resistant to the medicine.

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

4. Possible adverse effects

Like all medicines, Levofloxacin Almus may cause adverse effects, although not everyone will experience them.

Stop taking Levofloxacin Almus and consult 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 patients)

Allergic reaction. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue

Stop taking Levofloxacin Almus and see a doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

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

Watery diarrhoea, possibly with blood, possibly accompanied by stomach cramps and high fever. These may be symptoms of a serious intestinal problem
Pain and inflammation of tendons or ligaments, which could lead to rupture. The Achilles tendon is most commonly affected
Seizures (epileptic fits)
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome associated with disturbances in water excretion and low sodium levels (SIADH)

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

Burning, tingling, pain, or numbness. These may be signs of "neuropathy"

Not known (frequency cannot be estimated from available data)

Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-shaped macules or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
Loss of appetite, yellowing of the skin and eyes, dark urine, itching or painful abdomen. These may be signs of liver problems, which could include fulminant liver failure

If your vision worsens or you experience any eye disturbances while taking Levofloxacin Almus, consult an ophthalmologist immediately.

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 patients)

Sleep disturbances
Headache, dizziness
Feeling unwell (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 infections known as Candida, which may require treatment
Changes in white blood cell count in blood test results (leucopenia, eosinophilia)
Feeling stressed (anxiety), confusion, nervousness, drowsiness, tremors, sensation of spinning (vertigo)
Difficulty breathing (dyspnoea)
Changes in taste, loss of appetite, stomach discomfort or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation
Itching and skin rashes, severe itching or hives (urticaria), excessive sweating (hyperhidrosis)
Joint pain or muscle pain
Abnormal blood test values due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
Generalised weakness

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

Appearance of bruises and easy bleeding, due to a decrease in platelet count (thrombocytopenia)
Low white blood cell count (neutropenia)
Exaggerated immune response (hypersensitivity)
Decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions), with a risk of suicidal thoughts or actions
Feeling depressed, mental disturbances, feeling restless (agitation), abnormal dreams or nightmares
Tingling sensation in hands and feet (paraesthesia)
Ear disorders (tinnitus) or vision disorders (blurred vision)
Unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
Muscle weakness. This is important for people with myasthenia gravis (a rare nervous system disorder)
Changes in kidney function and occasional kidney failure, which may result from an allergic-type kidney reaction called interstitial nephritis
Fever
Clearly defined erythematous spots with or without blisters appearing within hours of levofloxacin administration and healing with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin

Frequency not known (cannot be estimated from available data)

Reduction in red blood cells (anaemia): this may cause pale or yellowish skin due to damage to red blood cells, reducing the number of all types of blood cells (pancytopenia)
Bone marrow stops producing new blood cells, leading to fatigue, reduced ability to fight infections, and uncontrolled bleeding (bone marrow failure)
Fever, sore throat, and a general feeling of malaise that does not go away. This may be due to a decrease in white blood cells (agranulocytosis)
Sudden drop in blood pressure or circulatory collapse (such as anaphylactic shock)
Increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for 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
Worsening or loss of hearing
Abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbances in heart rhythm (known as "QT interval prolongation", 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), darkened areas of skin (hyperpigmentation)
Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
Inflammation of tissue inside the mouth (stomatitis)
Muscle rupture and muscle breakdown (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest, and limb pain
Sudden involuntary jerks, muscle spasms, or muscle contractions (myoclonia)
Attacks of porphyria in people who already have porphyria (a very rare metabolic disorder)
Persistent headache, with or without blurred vision (benign intracranial hypertension)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and deterioration in hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement 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.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Almus

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Levofloxacino Almus

The active substance in Levofloxacino Almus 500 mg film-coated tablets is levofloxacin. Each tablet contains 500 mg of levofloxacin.

The other components are: Core: microcrystalline cellulose, hydroxypropylmethylcellulose, crospovidone, sodium stearyl fumarate. Coating (Opadry 03B27148 Beige): hypromellose 6 cP, titanium dioxide, polyethylene glycol 400, talc, yellow iron oxide, red iron oxide, black iron oxide.

Appearance of the medicine and contents of the container

Levofloxacino Almus is presented as film-coated tablets. The tablets are oblong, with a yellowish core and light pink coating, scored on one side.

Each pack contains 7 or 14 tablets in blister packs. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Medinfar Manufacturing, S.A.

Armando Martins Tavares Industrial Park,

Rua Outeiro da Armada, 5, Condeixa-a-Nova

3150-194 Sebal

Portugal

Date of the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/