Levofloxacin Pharma Combix 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacin Pharma Combix 500 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 must 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.

Leaflet contents

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

1. What Levofloxacino Pharma Combix is and what it is used for

Levofloxacino Pharma Combix contains an active substance called levofloxacin, which belongs to a group of medicines known as antibiotics. Levofloxacin is an antibiotic of the quinolone type and works by eliminating 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 your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

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.

Levofloxacin 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, levofloxacin may be used to reduce the likelihood of acquiring or worsening a lung infection called anthrax after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacin Pharma Combix

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 during growth period
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 levofloxacin.

Warnings and precautions

Before starting treatment

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Pharma Combix, 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
You are taking corticosteroids, sometimes called steroids (see section “Taking Levofloxacin Pharma Combix 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 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, 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 weak heart function (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 “Taking Levofloxacin Pharma Combix with other medicines”)
You are diabetic
You have ever had liver problems
You suffer from myasthenia gravis
You have been diagnosed with an enlargement or “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
You have previously experienced aortic dissection (tear in the wall of the aorta)
You have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
You have a family history of aortic aneurysm or aortic dissection, 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 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 previously developed a severe skin rash, skin peeling, blisters and/or mouth sores after taking levofloxacin

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

During treatment with this medicine

If you experience sudden, severe pain in your abdomen or back, which may be symptoms of aortic dissection or aneurysm, seek immediate emergency medical attention. The risk may increase if you are receiving systemic corticosteroid treatment.
If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or experience 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 may 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 marked deterioration in your general condition, or a feeling that your resistance to infections may be reduced – consult a doctor immediately, as these may 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.

Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received 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 Levofloxacin Pharma Combix. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking Levofloxacin Pharma Combix, 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, particularly in the feet and legs or hands and arms. If this occurs, stop taking Levofloxacin Pharma Combix and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, disabling, prolonged, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Pharma Combix, 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 impairment, severe fatigue and serious sleep disturbances.

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

Taking Levofloxacin Pharma Combix with other medicines

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

Corticosteroids, sometimes called steroids – used for inflammation. You may have an increased risk of tendon inflammation and/or rupture
Warfarin – used to thin the blood. You may have an increased risk of bleeding. Your doctor may require periodic blood tests to check your blood's ability to clot properly
Theophylline – used for respiratory problems. You may have an increased risk of seizures (epileptic fits) when taken with levofloxacin
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 taken with levofloxacin
Cyclosporine – used after organ transplants. You may have an increased risk of cyclosporine-related adverse effects
Medicines known to affect heart rhythm. These include 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 levofloxacin. If you have kidney problems, your doctor may consider giving you a lower dose.

Do not take levofloxacin tablets at the same time as the following medicines, as they may affect the action of levofloxacin:

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.

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 levofloxacin.

SJS/TEN may initially appear on the trunk as red, target-like spots or circular lesions, often with blisters in the center. They may also involve ulcers 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, 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 levofloxacin and contact your doctor or seek immediate medical attention.

Urine testing for opiates

Urine tests may show "false positive" results for strong painkillers known as "opiates" in patients taking levofloxacin. Inform your doctor that you are taking levofloxacin 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 bacteria causing tuberculosis.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 use of 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 Pharma Combix

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.

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 levofloxacino. You must take these medicines at least two hours before or two hours after taking levofloxacino.

What dose should you take

Your doctor will decide how much levofloxacino 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—consult your doctor.

Adults and elderly patients

Sinus infection

one 500 mg levofloxacino tablet once daily

Lung infection in people with long-term respiratory problems

one 500 mg levofloxacino tablet once daily

Pneumonia

one 500 mg levofloxacino tablet once or twice daily

Urinary tract infection, including kidneys or bladder

half or one 500 mg levofloxacino tablet daily

Prostate infection

one 500 mg levofloxacino tablet once daily

Skin and soft tissue infection, including muscles

one 500 mg levofloxacino tablet once or twice daily

Adults and elderly patients with kidney problems

Your doctor may give you a lower dose.

Children and adolescents

This medicine should not be given to children or adolescents.

If you take more Levofloxacino Pharma Combix 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 nausea or stomach discomfort.

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, stating the medicine and the amount ingested.

If you forget to take Levofloxacino Pharma Combix

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 taking Levofloxacino Pharma Combix

Do not stop your treatment with levofloxacino 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 using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Usually, these effects are mild to moderate and tend to disappear in a short time.

Stop treatment with levofloxacin 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 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 intestinal 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 disturbances in water elimination and low sodium levels (SIADH).

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

Burning, tingling, pain, or numbness. These may be signs of what is 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 the shape of targets or circular spots, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

Other:

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

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

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
Increase in 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 a fungus called Candida, which may require treatment
Changes in white blood cell count in blood tests (leucopenia, eosinophilia)
Stress (anxiety), confusion, nervousness, drowsiness, tremor, 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 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)
Decrease in the number of white blood cells in the 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, feeling restless (agitation), abnormal dreams or nightmares
Tingling sensation in hands and feet (paraesthesia)
Disorders of the ear (tinnitus) or vision (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 spots with or without blisters appearing a few hours after administration of levofloxacin and healing with post-inflammatory hyperpigmentation; usually recurring at the same skin or mucosal site after subsequent exposure to levofloxacin

Other adverse effects include:

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 that 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), darkened 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 muscle breakdown (rhabdomyolysis)
Red and swollen joints (arthritis)
Pain, including back, chest, and limb pain
Sudden, involuntary jerks, muscle spasms, or muscle contractions (myoclonus)
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 potentially be fatal, and heart valve insufficiency have been reported in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor 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 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 Pharma Combix

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

No special storage conditions are required.

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. Unused containers and medicines should be handed over to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacino Pharma Combix

The active substance is levofloxacin. Each tablet contains 500 mg of levofloxacin (as hemihydrate).
The other components are:

Tablet core: Crospovidone (E468), hypromellose (E464), microcrystalline cellulose (E460i), stearic acid and sodium fumarate.

Tablet coating: Instacoat ICG-U-10236 pink: contains hypromellose (E464), polyethylene glycol 8000 (E1521), talc (E553b), titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172).

Appearance of the product and contents of the pack

Levofloxacino Pharma Combix are pink, film-coated, capsule-shaped, biconvex tablets, scored on both sides. The tablet can be divided into equal halves.

It is available in cardboard packs with PVC/PVDC-Aluminum blisters containing 7 and 14 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

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

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