Levofloxacin Tarbis 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Levofloxacino Tarbis 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 must not be given 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Levofloxacino Tarbis tablets are and what they are used for
2. What you need to know before taking Levofloxacino Tarbis tablets
3. How to take Levofloxacino Tarbis tablets
4. Possible side effects
5. How to store Levofloxacino Tarbis tablets
6. Contents of the pack and other information

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

The name of this medicine is Levofloxacino Tarbis 500 mg film-coated tablets. Levofloxacino Tarbis tablets contain 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 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 that you 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 your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Levofloxacino Tarbis tablets can be used to treat infections in:

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

In certain special situations, Levofloxacino Tarbis tablets may be used to reduce the risk 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 Levofloxacin Tarbis 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 from or have previously 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 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 Levofloxacin Tarbis.

Warnings and precautions

Before starting this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Levofloxacin Tarbis, 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 Tarbis 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 salt levels (especially low potassium or magnesium levels), have a slow heart rate (called “bradycardia”), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are a woman or an elderly person, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Taking Levofloxacin Tarbis 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 an episode of aortic dissection (tearing of the aortic wall)

• You have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an 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 been diagnosed with heart valve insufficiency (heart valve regurgitation)

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

During treatment with this medicine

• If you experience sudden and severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. The risk may be increased 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 (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

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

Rarely, joint pain and swelling, and tendon inflammation or 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 treatment with Levofloxacin Tarbis. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Levofloxacin Tarbis, 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 Levofloxacin Tarbis 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 Levofloxacin Tarbis, 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 disorders.

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

Taking Levofloxacin Tarbis 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 Tarbis may affect how other medicines work. In addition, some medicines may affect how Levofloxacin Tarbis 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 Tarbis:

• 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 that your blood clots properly
• Theophylline – used for respiratory problems. You may have an increased risk of seizures (epileptic fits) when taken with Levofloxacin Tarbis
• 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 (epileptic fits) when taken with Levofloxacin Tarbis
• Cyclosporine – used after organ transplants. You may have an increased risk of cyclosporine-related adverse effects
• 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 (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 Tarbis. If you have kidney problems, your doctor may consider giving you a lower dose.

Do not take Levofloxacin Tarbis tablets at the same time as the following medicines, as they may affect the action of Levofloxacin Tarbis 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.

Opiate urine testing

Urine tests may show “false positive” results for strong painkillers known as “opioids” in patients taking Levofloxacin Tarbis. Inform your doctor that you are taking Levofloxacin Tarbis 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 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 tablets

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 it is cloudy) while you are 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:

• Make 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 Tarbis. You must take these medicines at least two hours before or two hours after taking Levofloxacino Tarbis tablets.

What dose should you take?

• Your doctor will decide how much Levofloxacino Tarbis 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 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

• one 500 mg Levofloxacino Tarbis tablet once daily

Lung infection in patients with long-term respiratory problems

• one 500 mg Levofloxacino Tarbis tablet once daily

Pneumonia

• one 500 mg Levofloxacino Tarbis tablet once or twice daily

Urinary tract infection, including kidneys or bladder

• half or one 500 mg Levofloxacino Tarbis tablet daily

Prostate infection

• one 500 mg Levofloxacino Tarbis tablet once daily

Skin and soft tissue infection, including muscles

• one 500 mg Levofloxacino Tarbis 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 must not be given to children or adolescents.

If you take more Levofloxacino Tarbis 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. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. Possible effects include epileptic seizures (convulsions), confusion, dizziness, decreased consciousness, tremors, heart disturbances that may cause irregular heartbeat, as well as nausea or stomach burning.

If you forget to take Levofloxacino Tarbis 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 Tarbis tablets

Do not stop your treatment with Levofloxacino Tarbis 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, this medicine can cause adverse effects, although not everyone will experience them. Usually, these effects are mild to moderate and tend to disappear in a short time.

Stop treatment with Levofloxacino Tarbis 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 the lips, face, throat, or tongue

Stop treatment with Levofloxacino Tarbis 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 frequently affected
• Seizures (convulsions)

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”

Other:

• Severe skin rashes which may include blisters or peeling around the lips, eyes, mouth, nose, and genitals
• Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching, or painful abdomen (tenderness). These may be signs of liver problems, which may include fulminant liver failure

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

Frequent (may affect up to 1 in 10 people)

• Sleep disturbances

• Headache, dizziness

• Nausea, vomiting, and diarrhoea

• Increased levels of certain liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people)

• Changes in the number of other bacteria or fungi, fungal infection caused by a fungus called Candida, which may require treatment
• Changes in the number of white blood cells in your blood test results (leucopenia, eosinophilia)
• Stress (anxiety), confusion, nervousness, drowsiness, tremors, dizziness (vertigo)
• Difficulty breathing (dyspnoea)
• Changes in taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), or constipation
• Itching and skin rash, intense pruritus or hives (urticaria), excessive sweating (hyperhidrosis)
• Joint pain or muscle pain
• Abnormal blood test results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• Generalised weakness

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

• Appearance of bruises and easy bleeding due to reduced number of blood platelets (thrombocytopenia)
• Decreased number of white blood cells in blood (neutropenia)
• Exaggerated immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycaemia). This is important for diabetic patients
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in 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)
• Ear disorders (tinnitus) or vision disorders (blurred vision)
• Abnormally fast heartbeat (tachycardia) or decreased blood pressure (hypotension)
• Muscle weakness. This is important in people 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 kidney reaction known as interstitial nephritis
• Fever

Other adverse effects include:

• Decreased red blood cells in blood (anaemia): this may cause the skin to become pale or yellowish due to damage to red blood cells; decreased number of all types of blood cells (pancytopenia)

• Fever, sore throat, and persistent general malaise. This may be due to a decreased number of 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)

• Movement and gait disorders (dyskinesia, extrapyramidal disorders)

• Temporary loss of consciousness or posture (syncope)

• Temporary loss of vision

• Hearing problems or hearing loss

• Abnormally fast heartbeat, irregular heartbeat that may be life-threatening including cardiac arrest, disturbances in heart rhythm (known as “prolongation of the QT interval”, 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 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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levofloxacino Tarbis tablets

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 Levofloxacino Tarbis tablets in the 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 unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levofloxacin Tarbis tablets

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

The other components (excipients) are:

• Core: Crospovidone, hypromellose, microcrystalline cellulose, and sodium stearyl fumarate.
• Coating: Hypromellose, talc, titanium dioxide (E171), macrogol 8000, red iron oxide (E172), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Levofloxacin Tarbis are film-coated tablets for oral use. The tablets are pink, capsule-shaped, and scored on both sides.

They are available in packs containing 7 and 14 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Via Carlos III, 94

08028 Barcelona, Spain

Manufacturer

Farmaprojects, S.A.

C/ Santa Eulalia, 240 – 242

08902 L’Hospitalet de Llobregat (Barcelona), Spain

or

Pharmaceutical Works Polpharma, S.A.:

Production Department in Nowa Deba

1 Szypowskiego Str.

39-460 Nowa Deba, Poland

or

Pharmaceutical Works Polpharma, S.A.:

Pelplinska 19,

83-200 Starogard Gdanski, Poland

This leaflet does not contain all the information about your medicine. If you have any questions or are unsure about anything, consult your doctor or pharmacist.

Date of the most recent revision of this leaflet: December 2020

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