Levofloxacin Tarbis Farma 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacin Tarbis Farma 500 mg, film-coated tablets EFG

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

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Levofloxacino Tarbis Farma is and what it is used for

The name of this medicine is Levofloxacino Tarbis Farma. Levofloxacino Tarbis Farma contains an active substance called levofloxacin. It 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 Tarbis Farma can be used to treat infections in:

• The nasal 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 Tarbis Farma may 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 starting Levofloxacino Tarbis Farma

Before starting this medicine

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

Do not take this medicine and consult your doctor if:

• You are allergic to levofloxacino, to other antibiotics of the quinolone type such as moxifloxacino, ciprofloxacino or ofloxacino, or to any of the other components of this medicine (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of lips, face, throat or tongue.
• You suffer from or have previously had epilepsy.
• You have ever experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to the skeleton.
• You are a child or adolescent undergoing growth.
• You are pregnant, could become pregnant, or think you might be pregnant.
• 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 Levofloxacino Tarbis Farma.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if:

• You are aged 60 years or older.

• You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino Tarbis Farma with other medicines”).

• You have received an organ transplant.

• 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 what is known as “glucose-6-phosphate dehydrogenase 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 required when using this type of medicine if you were born with, or have a family history of, QT interval prolongation (seen on electrocardiogram (ECG), a graphical representation of the heart's electrical activity), if you have an imbalance in blood salt levels (especially low potassium or magnesium levels), a slow heart rate (called “bradycardia”), weak heart (heart failure), 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 “Levofloxacino Tarbis Farma and other medicines”).

• You are diabetic.

• You have ever had liver problems.

• You suffer from myasthenia gravis.

• You have been diagnosed with an enlarged blood vessel or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).

• You have previously experienced aortic dissection (tearing of the aortic wall).

• You have been diagnosed with heart valve insufficiency (heart valve regurgitation).

• 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, vascular 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, 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 levofloxacino.

Consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.

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

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 (sensation of rapid or irregular heartbeat), inform your doctor immediately.

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

Severe skin reactions

Severe 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 levofloxacino.

• SJS/TEN may initially appear on the trunk as reddish, target-like spots or circular patches, 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, fever, elevated liver enzymes in blood tests, increased 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 levofloxacino and contact your doctor or seek immediate medical attention.

Levofloxacino Tarbis Farma and other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because Levofloxacino Tarbis Farma may affect the action of other medicines. In addition, some medicines may affect the action of Levofloxacino.

In particular, inform your doctor if you are taking any of the following medicines, as they increase the likelihood of adverse effects when taken with Levofloxacino Tarbis Farma:

• 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 monitor your blood’s clotting ability.
• Theophylline – used for respiratory problems. You may have an increased risk of seizures when taken with Levofloxacino Tarbis Farma.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indometacin. You may have an increased risk of seizures when taken with Levofloxacino Tarbis Farma.
• Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects from cyclosporine.
• Medicines known to affect heart rhythm. This includes medicines used for abnormal heart rhythms (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 (antibiotics “macrolides” such as erythromycin, azithromycin, and clarithromycin).
• Probenecid (used for gout). Your doctor may want to prescribe a lower dose if you have kidney problems.
• Cimetidine, used for ulcers and heartburn. Your doctor may want to prescribe a lower dose if you have kidney problems.

Talk to your doctor if any of these apply to you.

Do not take Levofloxacino Tarbis Farma 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.

During treatment with this medicine

Rarely, joint pain and swelling, tendon inflammation, or tendon rupture 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 Levofloxacino Tarbis Farma. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacino Tarbis Farma, 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 Tarbis Farma 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 Tarbis Farma, 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, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after taking Levofloxacino Tarbis Farma, 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.

Opiate testing in urine

Urine tests may show “false positive” results for strong painkillers called “opiates” in patients taking Levofloxacino Tarbis Farma. Inform your doctor that you are taking Levofloxacino Tarbis Farma if you are prescribed a urine test.

Tuberculosis test

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

Pregnancy and breastfeeding

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 adverse 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.

3. How to take Levofloxacino Tarbis Farma

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

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with some water.
• The tablets may be taken during or between meals.

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

Do not take these medicines at the same time as Levofloxacino Tarbis Farma. You must take these medicines at least two hours before or two hours after taking Levofloxacino Tarbis Farma.

What dose should you take

• Your doctor will decide how much Levofloxacino Tarbis Farma 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 treatment will depend on the severity of your infection.
• If you think that 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 Tarbis Farma 250 mg once daily
• Or, one tablet of Levofloxacino Tarbis Farma 500 mg once daily

Lung infection, in people with long-term respiratory problems

• Two tablets of Levofloxacino Tarbis Farma 250 mg once daily
• Or, one tablet of Levofloxacino Tarbis Farma 500 mg once daily

Pneumonia

• Two tablets of Levofloxacino Tarbis Farma 250 mg once or twice daily
• Or, one tablet of Levofloxacino Tarbis Farma 500 mg once or twice daily

Urinary tract infection, including kidneys or bladder

• One or two tablets of Levofloxacino Tarbis Farma 250 mg once daily
• Or, half or one tablet of Levofloxacino Tarbis Farma 500 mg once daily

Prostate infection

• Two tablets of Levofloxacino Tarbis Farma 250 mg once daily
• Or, one tablet of Levofloxacino Tarbis Farma 500 mg once daily

Skin and soft tissue infection, including muscles

• Two tablets of Levofloxacino Tarbis Farma 250 mg once or twice daily
• Or, one tablet of Levofloxacino Tarbis Farma 500 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.

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 sunlight 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 (UV) lamps.

If you take more Levofloxacino Tarbis Farma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disorders that may cause irregular heartbeat, as well as discomfort (nausea) or heartburn.

If you forget to take Levofloxacino Tarbis Farma

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 forgotten doses.

If you stop treatment with Levofloxacino Tarbis Farma

Do not stop your treatment with Levofloxacino Tarbis Farma even if you feel better. It is important that you complete the full course of treatment 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, this medicine can cause adverse effects, although not everyone gets them. They are usually mild to moderate in severity and generally disappear in a short time.

Stop treatment with LevofloxacinoTarbis Farma 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 LevofloxacinoTarbis Farma 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 commonly 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”

Not known: (frequency cannot be estimated from available data)

• Loss of appetite, yellowing of skin and eyes, dark urine, tenderness or pain in abdomen. These may be signs of liver problems, including fulminant liver failure
  • Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red target-like macules or circular lesions, 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.

Seek immediate advice from an eye specialist if your vision deteriorates or you experience any other eye problems while taking Levofloxacino Tarbis Farma.

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 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, nervousness, drowsiness, tremors, dizziness (vertigo)
• Difficulty breathing (dyspnoea)
• Changes in taste, loss of appetite, stomach discomfort 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 thoughts and beliefs (psychotic reactions), with risk of suicidal thoughts or actions
• Depression, mental disorders, 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 patients with myasthenia gravis (a rare disorder of the nervous system)
• 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 demarcated erythematous lesions with or without blisters appearing a few hours after levofloxacin administration and healing with residual post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin.

Unknown (frequency cannot be estimated from available data):

• Decreased 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)
• 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 that may lead to coma (hypoglycaemic coma). This is important in people with diabetes
• Changes in sense of smell, loss of smell or taste (parosmia, anosmia, ageusia)
• Movement and gait disorders (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or posture (syncope)
• Temporary loss of vision, eye inflammation
• Hearing problems or loss
• Abnormally rapid heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, disturbance in heart rhythm (known as “QT interval prolongation”, seen on ECG, a graphical representation of the heart's electrical activity)
• Difficulty breathing or wheezing (bronchospasm)
• Allergic lung reactions
• Inflammation of the pancreas (pancreatitis)
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the mucosal tissue inside the mouth (stomatitis)
• Muscle rupture and destruction of muscle (rhabdomyolysis)
• Red and swollen joints (arthritis)
• Pain, including back, chest and limb pain
• Porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• Persistent headache with or without blurred vision (benign intracranial hypertension)

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), depression, fatigue, sleep disturbances, memory impairment, and decreased 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 side effect, speak with your doctor or pharmacist. This includes any possible side effect not mentioned in this leaflet.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacin Tarbis Farma

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

This medicine does not require special storage conditions; however, it is preferable to store Levofloxacin Tarbis Farma tablets in their original packaging in a dry place.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Tarbis Farma

Each tablet contains 500 mg of levofloxacin as the active substance, equivalent to 512.47 mg of levofloxacin hemihydrate.

The other components are:

Core: microcrystalline cellulose (PH 101), sodium croscarmellose, povidone (k-30), microcrystalline cellulose (PH 102), magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172), polysorbate 80 (E433).

Appearance of the product and contents of the pack

Orange, capsule-shaped, biconvex, film-coated tablets, scored on both sides, with the code “I” on one side and “26” on the other.

The tablets are supplied in Alu-PVC/Aclar blisters.

The 500 mg tablets are available in packs of 1, 7, 14 and 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Portugal: Levofloxacina Hetero 500 mg comprimidos revestidos por película

Germany: Levofloxacin Hetero 500 mg Filmtabletten

Date of the most recent review of this leaflet: April 2022

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