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

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacino SUN 500 mg film-coated tablets EFG

Levofloxacin

Read the entire 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 could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

What Levofloxacino SUN tablets are and what they are used for
What you need to know before taking Levofloxacino SUN tablets
How to take Levofloxacino SUN tablets
Possible side effects
How to store Levofloxacino SUN tablets
Contents of the pack and other information

1. What Levofloxacino SUN tablets are and what they are used for

The name of this medicine is Levofloxacino SUN tablets. Levofloxacino SUN tablets contain an active substance called levofloxacin. This belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the quinolone type. It works by killing the bacteria that cause infections in your body.

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

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

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

Levofloxacino SUN tablets can be used to treat infections in:

the sinuses
the lungs, in people with long-term respiratory problems or pneumonia
the urinary tract, including the kidneys or bladder
the prostate, when the infection is persistent
the skin and beneath the skin, including muscles. This is sometimes referred to as "soft tissues"

In certain special situations, Levofloxacino SUN film-coated tablets 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 taking Levofloxacino SUN tablets

Do not take this medicine and consult your doctor if:

You are allergic to levofloxacin, to other antibiotics of the quinolone type 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 lips, face, throat or tongue.

You suffer or have suffered from epilepsy
You have previously experienced tendon problems, such as tendinitis, related to taking quinolone-type medicines. Tendons are the tissues that connect your muscles to your skeleton
You are a child or adolescent who is still growing
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 apply to you. If in doubt, consult your doctor or pharmacist before taking Levofloxacino SUN.

Warnings and precautions

Before starting this medicine

You must not take fluoroquinolone/quinolone antibacterial medicines, including Levofloxacino SUN, 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.

Talk to your doctor or pharmacist before taking this medicine if:

You are 60 years of age or older
You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacino SUN with other medicines”)
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 a condition 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 needed when taking 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), if you have an imbalance in blood electrolyte levels (especially low potassium or magnesium levels), if you have a slow heart rate (called “bradycardia”), if you have a weak heart (heart failure), if you 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 “Taking Levofloxacino SUN with 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 (regurgitation of heart valves)
you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other predisposing risk factors or 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 or skin peeling, blisters and/or mouth sores after taking levofloxacin.

During treatment with this medicine

Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. Your risk increases if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even up to several months after stopping levofloxacin treatment. At the first sign of tendon pain or swelling (e.g., in your ankle, wrist, elbow, shoulder or knee), stop taking levofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this could increase the risk of tendon rupture.

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

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 and 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 lead to 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 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.

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

Antibacterial medicines containing fluoroquinolones/quinolones, including levofloxacin, have been associated with very rare but serious adverse effects, some of which may be 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 decreased vision, taste, smell or hearing, depression, memory impairment, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after taking levofloxacin, 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.

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 systemic corticosteroid treatment.

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

Inform your doctor or pharmacist before taking Levofloxacino SUN if you are unsure whether any of the above situations apply to you.

Taking Levofloxacino SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Levofloxacino SUN may affect how other medicines work. In addition, some medicines may affect how Levofloxacino SUN works.

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 SUN:

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 a higher risk of bleeding. Your doctor may need periodic blood tests to check your blood’s ability to clot properly
Theophylline – used for respiratory problems. You may be more likely to have a seizure (convulsion) if taken with Levofloxacino SUN
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as acetylsalicylic acid, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more likely to have a seizure (convulsion) when taken with Levofloxacino SUN
Cyclosporine – used after organ transplants. You may be more likely to experience adverse effects from cyclosporine
Medicines known to affect your 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 (macrolide antibiotics such as erythromycin, azithromycin and clarithromycin)
Probenecid (used for gout) and cimetidine (used for ulcers and heartburn). Special care is needed when taking these medicines with Levofloxacino SUN. If you have kidney problems, your doctor may want to prescribe a lower dose.

Do not take Levofloxacino SUN tablets at the same time as the following medicines, as they may interfere with the action of Levofloxacino SUN tablets:

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.

Urine opioid testing

Urine tests may show “false positive” results for strong painkillers called “opioids” in patients taking Levofloxacino SUN. Inform your doctor that you are taking Levofloxacino SUN 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 that causes 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

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

Driving and using machines

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

Important information about some ingredients of Levofloxacino SUN

This medicine may cause allergic reactions because it contains the azo dye sunset yellow FCF (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Levofloxacino SUN tablets

Follow exactly the instructions for using this medicine as given by your doctor. 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 little 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 (UV) lamps

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

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

What dose should you take?

Your doctor will decide how much Levofloxacino SUN 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 250 mg Levofloxacino tablets once daily
Or, one Levofloxacino SUN 500 mg tablet once daily

Lung infection in people with long-term breathing problems

Two 250 mg Levofloxacino tablets once daily
Or, one Levofloxacino SUN 500 mg tablet once daily

Pneumonia

Two 250 mg Levofloxacino tablets once or twice daily
Or, one Levofloxacino SUN 500 mg tablet once or twice daily

Urinary tract infection, including kidneys or bladder

One or two 250 mg Levofloxacino tablets daily
Or, half or one Levofloxacino SUN 500 mg tablet daily

Prostate infection

Two 250 mg Levofloxacino tablets once daily
Or, one Levofloxacino SUN 500 mg tablet once daily

Skin and soft tissue infections, including muscles

Two 250 mg Levofloxacino tablets once or twice daily
Or, one Levofloxacino SUN 500 mg tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may prescribe a lower dose.

Children and adolescents

This medicine must not be given to children or adolescents.

If you take more Levofloxacino SUN tablets 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 disorders that may cause irregular heartbeat, as well as discomfort (nausea) or heartburn.

Contact your doctor, pharmacist immediately, or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount taken.

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Levofloxacino SUN tablets

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 taking Levofloxacino SUN tablets

Do not stop your treatment with Levofloxacino SUN even if you feel better. It is important that you complete the 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, Levofloxacin SUN may cause adverse effects, although not everyone experiences them. These are usually mild to moderate in intensity and typically disappear within a short time.

Stop taking Levofloxacin SUN and contact a doctor or go to a hospital immediately if you experience the following adverse effects:

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

Stop taking Levofloxacin SUN and contact your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

Frequency not known (cannot be estimated from available data)

Watery diarrhoea that may contain blood, possibly with stomach cramps and fever. These could be signs of a serious intestinal problem.

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

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 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).
Decreased blood sugar levels (hypoglycaemia), or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for diabetic patients.
Seeing or hearing things that are not real (hallucinations, paranoia), changes in thinking and beliefs (psychotic reactions), with risk of suicidal thoughts or actions.
Depression, mental disorders, feeling restless (agitation), abnormal dreams or nightmares.

Frequency not known (cannot be estimated from available data)

Burning, tingling, pain or numbness. These may be signs of a condition called "neuropathy".
Severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the trunk as red, target-like spots or circular lesions, often with blisters in the centre, skin peeling, mouth ulcers, and sores in the throat, nose, genitals and eyes, 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, burning sensation or painful abdomen on palpation. These may be signs of liver problems, which could include fulminant liver failure.

Consult an eye specialist immediately if your vision deteriorates or you develop any other eye problems while taking Levofloxacin SUN.

Inform your doctor if any of the following adverse effects worsen or persist for more than a few days:

Frequent (may affect up to 1 in 10 people)

Sleep disturbances.
Headache, dizziness.
Discomfort (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 test results (leucopenia, eosinophilia).
Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo).
Difficulty breathing (dyspnoea).
Changes in taste, loss of appetite, stomach disorders or indigestion (dyspepsia), stomach pain, bloating (flatulence) or constipation.
Itching and skin rash, intense itching 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 the blood (neutropenia).
Exaggerated immune response (hypersensitivity).
Tingling sensation in hands and feet (paraesthesia).
Ear disorders (tinnitus) or vision problems (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 kidney reaction called 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 residual hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin.
Delirium.
Memory impairment.

Frequency not known (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 reduced number of white blood cells (agranulocytosis).
Circulatory collapse (anaphylactic-type shock).
Increased blood sugar levels (hyperglycaemia). This is important in people with diabetes.
Changes in 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.
Hearing problems or hearing loss.
Abnormally rapid heartbeat, irregular heartbeat that may be life-threatening including cardiac arrest, disturbances 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).
Pulmonary allergic 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 tissue inside the mouth (stomatitis).
Muscle rupture and destruction of muscle (rhabdomyolysis).
Red and swollen joints (arthritis).
Pain, including back, chest and limb pain.
Acute attacks of porphyria in patients with 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-lasting (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.

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 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 Levofloxacino SUN tablets

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

This medicine does not require special storage conditions, but it is preferable to store Levofloxacino SUN tablets in the original container 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 unused medicines and their containers at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino SUN tablets

The active substance is levofloxacin.

Each Levofloxacino SUN 500 mg tablet contains 500 mg of levofloxacin in the form of levofloxacin hemihydrate.

The other components are:

Core: Microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium stearate.

Coating: Hypromellose, aluminium lake of indigo carmine (E-132), aluminium lake of orange yellow S (E-110), iron oxide red (E-172), macrogol 4000, titanium dioxide (E-171) and yellow iron oxide.

Appearance of the product and contents of the container

Levofloxacino SUN are film-coated tablets for oral use. Levofloxacino SUN 500 mg film-coated tablets are oblong, biconvex, scored and orange in colour. The tablet can be divided into equal halves.

Levofloxacino SUN 500 mg film-coated tablets are packed in blisters and available in pack sizes of 1, 5, 7 and 10 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer responsible

Pharmathen, S.A.

6 Dervenakion str 153 51 Pallini

Attiki, Greece

Local Representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

IT/H/0294/01-02/DC

Spain: Levofloxacino SUN 500 mg film-coated tablets
Italy: LEVOFLOXACINA SUN

For any information about this medicinal product, please contact the Marketing Authorization Holder.

This leaflet has been last reviewed in September 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) http://www.aemps.gob.es/