Xivelam

Package Leaflet: Information for the Patient

Xyvelam, 250 mg, Film-Coated Tablets

Xyvelam, 500 mg, Film-Coated Tablets

Levofloxacin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Xyvelam and what is it used for
• 2. Important information before taking Xyvelam
• 3. How to take Xyvelam
• 4. Possible side effects
• 5. How to store Xyvelam
• 6. Contents of the pack and other information

1. What is Xyvelam and what is it used for

The name of this medicine is Xyvelam. Xyvelam contains the active substance levofloxacin, which belongs to a group of medicines called antibiotics. Levofloxacin is a "quinolone" antibiotic. It works by killing bacteria that cause infections.

Xyvelam can be used to treat certain infections

• sinus infections
• lung infections in patients with long-term breathing problems or pneumonia
• urinary tract infections, including kidney or bladder infections
• prostate infections, in cases of chronic inflammation
• skin and soft tissue infections, including muscle infections; sometimes referred to as "soft tissue" infections

In some exceptional cases, Xyvelam can be used to treat or prevent a lung disease called anthrax, which can develop after contact with anthrax bacteria.

2. Important information before taking Xyvelam

When not to take Xyvelam

• if you are allergic to levofloxacin, any other quinolone antibiotic, such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if you have ever had seizures
• if you have ever had tendon problems (such as tendonitis) related to treatment with quinolone antibiotics. A tendon is a cord of fibrous tissue that connects muscles to bones.
• if the medicine has been prescribed for a child or adolescent during growth
• if you are pregnant, may become pregnant, or suspect you are pregnant
• if you are breastfeeding

Do not take this medicine if any of the above statements apply to you. If in doubt, consult your doctor or pharmacist before taking Xyvelam.

Warnings and precautions

Before taking Xyvelam, discuss with your doctor or pharmacist if:

• you are 60 years old or older
• you are taking corticosteroids, sometimes called steroids (see "Xyvelam and other medicines")
• you have had a transplant
• you have ever had seizures (epileptic fits)
• you have had brain damage due to stroke or other injury
• you have kidney problems
• you have a condition called "glucose-6-phosphate dehydrogenase deficiency"; you may be more prone to developing serious blood disorders while taking this medicine
• you have ever had mental health problems
• you have ever had heart problems: caution should be exercised when taking this medicine if you have been born with or have a family history of prolonged QT interval (visible on an ECG, i.e., an electrical activity test of the heart), you have electrolyte disturbances in the blood (especially low potassium or magnesium levels in the blood), you have a slow heart rate (bradycardia), your heart function is impaired (heart failure), you have had a heart attack (myocardial infarction) in the past, you are a woman or an elderly person, or you are taking other medicines that cause abnormal changes in the ECG (see "Xyvelam and other medicines")
• you have diabetes
• you have ever had liver problems
• you have myasthenia gravis
• you have nerve damage (peripheral neuropathy)
• you have been diagnosed with a large blood vessel enlargement (aortic or large peripheral artery aneurysm)
• you have had an aortic dissection (tear in the aortic wall) in the past
• you have been diagnosed with heart valve problems
• there have been cases of aortic aneurysm or dissection, or congenital heart valve disease, or other risk factors or conditions in your family (e.g., Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease] or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or rheumatoid arthritis [joint disease], or endocarditis [heart infection])
• you have ever experienced a severe skin rash or skin peeling after taking levofloxacin

If you are unsure whether any of the above statements apply to you, consult your doctor or pharmacist before taking Xyvelam.

Severe skin reactions

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

• SJS or TEN may initially appear as reddish, target-like or circular patches, often with blisters in the center on the torso. They can also cause mouth ulcers, throat, nose, genital, and eye ulcers (red and swollen eyes). These severe skin rashes are often preceded by fever and/or flu-like symptoms. These rashes can lead to widespread skin peeling, which can be life-threatening or cause death.
• In DRESS syndrome, flu-like symptoms and a rash on the face initially occur, followed by a widespread rash with high fever, elevated liver enzymes, and an increased white blood cell count (eosinophilia), as well as swollen lymph nodes.

If a severe rash or any of these skin symptoms occur, stop taking levofloxacin and consult your doctor or seek immediate medical attention. Do not take antibacterial medicines containing fluoroquinolones or quinolones, including levofloxacin, if you have experienced any severe side effects while taking a quinolone or fluoroquinolone in the past. In such cases, inform your doctor as soon as possible.

While taking Xyvelam

• if you experience sudden severe abdominal, back, or chest pain, which may be a sign of an aortic aneurysm or dissection, seek emergency medical attention immediately. The risk of these changes may be higher if you are being treated with systemic corticosteroids.
• if you experience sudden shortness of breath, especially when lying down or noticing swelling of the ankles, feet, or abdomen, or an irregular heartbeat (palpitations), consult your doctor immediately
• if you experience sudden, involuntary muscle jerks, muscle tremors, or muscle cramps, seek medical attention immediately, as these may be symptoms of myoclonus. Your doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• if you experience nausea, general malaise, discomfort, or persistent or worsening abdominal pain, or vomiting, seek medical attention immediately, as these may be symptoms of pancreatitis (acute pancreatitis)
• if you experience fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration in health or a feeling of reduced resistance to infection, seek medical attention immediately, as these may be symptoms of blood disorders. Your doctor should monitor your blood count through a blood morphology test. If abnormalities are found in the blood morphology test, your doctor may decide to discontinue treatment.

Rarely, pain and swelling of the joints and tendons, as well as tendon inflammation or rupture, may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after discontinuing Xyvelam. If you experience the first symptoms of pain or tendon inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), discontinue Xyvelam, consult your doctor, and rest the affected area. Avoid excessive strain, as it may increase the risk of tendon rupture.

Rarely, patients may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, or weakness, especially in the feet and legs, as well as hands and arms. In such cases, discontinue Xyvelam and inform your doctor immediately to prevent the development of potentially irreversible disease.

Long-term, disabling, and potentially irreversible severe side effects

Fluoroquinolone and quinolone antibacterial medicines, including Xyvelam, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon pain, muscle pain, and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell, as well as hearing disturbances, depression, memory impairment, severe fatigue, and severe sleep disturbances.

If you experience any of these side effects after taking Xyvelam, consult your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, also considering antibiotics from another group.

If in doubt whether any of the above situations apply to you, consult your doctor or pharmacist before taking Xyvelam.

Xyvelam and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. This is because Xyvelam may affect the way other medicines work. Other medicines may also affect the way Xyvelam works.

In particular, inform your doctor if you are taking any of the following medicines, as their concurrent use with Xyvelam may increase the risk of side effects:

• corticosteroids, sometimes called steroids, used in inflammatory conditions. You may be more prone to developing tendonitis or tendon rupture.
• warfarin, used to thin the blood. You may be more prone to bleeding. Your doctor may order regular blood tests to check your blood clotting.
• theophylline, used in breathing problems. You may be more prone to seizures (epileptic fits) if you take Xyvelam.
• non-steroidal anti-inflammatory medicines (NSAIDs), used to treat pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, indomethacin. You may be more prone to seizures (epileptic fits) if you take Xyvelam.
• cyclosporine, used after organ transplantation. You may be more prone to cyclosporine side effects.
• medicines that affect heart rhythm. This includes anti-arrhythmic medicines (such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), tricyclic antidepressants (such as amitriptyline and imipramine), antipsychotic medicines, and antibacterial medicines (macrolide antibiotics, such as erythromycin, azithromycin, and clarithromycin).
• probenecid, used to treat gout. Your doctor may recommend a lower dose if you have kidney problems.
• cimetidine, used to treat stomach ulcers and heartburn. Your doctor may recommend a lower dose if you have kidney problems.

If any of the above statements apply to you, inform your doctor.

Do not take Xyvelam at the same time as the following medicines, as they may affect its action:

• iron tablets (used for anemia), zinc supplements, antacids containing magnesium or aluminum (used for heartburn or acid reflux), didanosine, or sucralfate (used for stomach ulcers) (see "If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate")

Opioid tests in urine

The results of tests to detect strong painkillers called opioids in urine may be falsely positive in patients taking Xyvelam. If your doctor has ordered a urine test, inform your doctor that you are taking Xyvelam.

Tuberculosis tests

This medicine may cause false-negative results in some laboratory tests used to detect tuberculosis bacteria.

Pregnancy and breastfeeding

Do not take this medicine if you:

• are pregnant, may become pregnant, or suspect you are pregnant
• are breastfeeding or plan to breastfeed

Driving and using machines

After taking this medicine, you may experience side effects, including dizziness, drowsiness, vertigo, or vision disturbances. Some of these side effects may impair your ability to concentrate and react. In such cases, do not drive vehicles or perform any work that requires attention.

Xyvelam contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking Xyvelam.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Xyvelam

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How to take the medicine

• Take the medicine orally.
• Swallow the tablet whole with water.
• Tablets can be taken with or without food.

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

• do not take these medicines at the same time as Xyvelam. Take the prescribed dose at least 2 hours before or 2 hours after taking Xyvelam tablets.

Recommended dose

• Your doctor will decide how many Xyvelam tablets you should take.
• The dose depends on the type and location of the infection.
• The duration of treatment depends on the severity of the infection.
• If you feel that the effect of the medicine is too weak or too strong, do not change the dose yourself, but consult your doctor.

Adults and elderly patients

Sinusitis

• two Xyvelam 250 mg tablets once daily or
• one Xyvelam 500 mg tablet once daily

Lung infections in patients with long-term breathing problems

• two Xyvelam 250 mg tablets once daily or
• one Xyvelam 500 mg tablet once daily

Pneumonia

• two Xyvelam 250 mg tablets once or twice daily or
• one Xyvelam 500 mg tablet once or twice daily

Urinary tract infections, including kidney or bladder infections

• one or two Xyvelam 250 mg tablets once daily or
• half or one Xyvelam 500 mg tablet once daily

Prostate infections

• two Xyvelam 250 mg tablets once daily or
• one Xyvelam 500 mg tablet once daily

Skin and soft tissue infections, including muscle infections

• two Xyvelam 250 mg tablets once or twice daily or
• one Xyvelam 500 mg tablet once or twice daily

Anthrax exposure

• two Xyvelam 250 mg tablets once daily or
• one Xyvelam 500 mg tablet once daily

Adults and elderly patients with kidney problems

Your doctor may recommend a lower dose.

Use in children and adolescents

Do not give this medicine to children and adolescents.

Sun protection

During and for 2 days after treatment with this medicine, avoid direct sunlight. This is because your skin may become more sensitive to the sun, which can cause sunburn, tingling, and blisters on the skin if you do not take the following precautions:

• use UV filters with a high protection factor
• always wear a hat and clothing that covers your arms and legs
• avoid using sunbeds

Overdose

If you accidentally take more tablets than prescribed, seek medical attention immediately. Bring the medicine packaging with you so that your doctor knows what medicine you have taken. The following symptoms may occur: seizures (epileptic fits), confusion, dizziness, disturbances of consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea and heartburn.

Missed dose

If you miss 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 a missed dose.

Stopping treatment

Do not stop taking Xyvelam just because you feel better. It is important to take all the tablets prescribed by your doctor. If you stop taking the tablets 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 taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xyvelam can cause side effects, although not everybody gets them.

Stop taking Xyvelam and consult your doctor or go to the hospital immediately if you experience the following side effect:

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

• allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Stop taking Xyvelam and consult your doctor immediately if you experience any of the following side effects – you may need urgent medical attention.

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

• watery diarrhea, which may contain blood, possibly with stomach cramps and high fever. These may be symptoms of serious intestinal problems.
• pain and inflammation of tendons or ligaments, which can lead to rupture. This most commonly affects the Achilles tendon.
• seizures (epileptic fits)
• seeing or hearing things that are not there (hallucinations, paranoia)
• feeling depressed, mentally disturbed, anxious (agitation), having strange dreams or nightmares
• widespread rash, high fever, elevated liver enzymes, abnormal blood count (eosinophilia), swollen lymph nodes, and other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• a condition related to abnormal water excretion and low sodium levels (SIADH)
• low blood sugar levels (hypoglycemia) or low blood sugar levels leading to coma (hypoglycemic coma). This is important for patients with diabetes.

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

• burning, tingling, pain, or numbness; these may be symptoms of "neuropathy"

Frequency not known(frequency cannot be estimated from the available data)

• severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish, target-like or circular patches, often with central blisters on the torso, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
• loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, liver tenderness (abdominal pain). These may be symptoms of liver dysfunction, including life-threatening liver damage.
• change in opinion and thoughts (psychotic reactions) with a risk of suicidal thoughts or attempts
• nausea, general malaise, discomfort, or abdominal pain, or vomiting. These may be symptoms of pancreatitis (acute pancreatitis). See section 2.

If your vision worsens or you experience other vision disturbances while taking Xyvelam, seek immediate medical attention from an ophthalmologist.

The administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent side effects, such as: tendonitis, tendon rupture, joint pain, muscle pain, walking difficulties, abnormal sensations, such as tingling, burning, prickling, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell, as well as hearing disturbances, depression, memory impairment, severe fatigue, and severe sleep disturbances.

In case of worsening of any of the following side effects or if they persist for more than a few days, consult your doctor.

Common(may affect up to 1 in 10 people)

• sleep disturbances
• headache, dizziness
• nausea, vomiting, and diarrhea
• elevated activity of some liver enzymes in the blood

Uncommon(may affect up to 1 in 100 people)

• changes in the number of certain types of bacteria or fungi, fungal infections, which may require treatment
• changes in the number of white blood cells, visible in some blood tests (leukopenia, eosinophilia)
• anxiety, confusion, nervousness, drowsiness, tremors, vertigo (dizziness)
• shortness of breath (dyspnea)
• changes in taste, loss of appetite, stomach disturbances or indigestion, abdominal pain, bloating with gas or constipation
• itching and skin rash, severe itching or hives
• joint or muscle pain
• abnormal blood test results indicating liver or kidney dysfunction (elevated bilirubin or creatinine levels)
• general weakness

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

• increased tendency to bruise and bleed due to a decrease in platelet count (thrombocytopenia)
• low white blood cell count (neutropenia)
• exaggerated immune response (hypersensitivity)
• tingling sensation in hands and feet (paresthesia)
• hearing or vision problems (tinnitus or blurred vision)
• abnormal heart rhythm (tachycardia) or low blood pressure (hypotension)
• muscle weakness - this is important for patients with myasthenia gravis (a rare nervous system disease)
• changes in kidney function and sometimes kidney failure, which may be caused by an allergic reaction in the kidneys called interstitial nephritis
• fever
• sharply defined, reddish, blistering patches, which develop within hours of taking levofloxacin. They usually resolve with post-inflammatory hyperpigmentation. Upon re-administration of levofloxacin, these patches usually appear in the same location on the skin or mucous membranes.
• memory disturbances

Frequency not known(frequency cannot be estimated from the available data)

• decrease in red blood cell count (anemia): this may cause pallor or yellowing of the skin due to damage to red blood cells; decrease in all blood cell types (pancytopenia)
• cessation of new blood cell production by the bone marrow, which may cause fatigue, decreased ability to fight infections, and uncontrolled bleeding (bone marrow failure)
• fever, sore throat, and general malaise, which do not improve. This may be caused by a decrease in white blood cell count (agranulocytosis).
• circulatory collapse (anaphylactic shock-like reaction)
• high blood sugar levels (hyperglycemia) - this is important for patients with diabetes
• changes in smell, loss of smell or taste (olfactory hallucinations, anosmia, ageusia)
• feeling of extreme excitement, agitation, or euphoria (mania)
• movement and walking difficulties (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or fainting (syncope)
• temporary loss of vision or eye inflammation
• hearing or vision disturbances
• abnormal heart rhythm, life-threatening irregular heartbeat, including QT interval prolongation (visible on an ECG, i.e., an electrical activity test of the heart), heart arrest, and other heart rhythm changes
• breathing difficulties or wheezing (bronchospasm)
• allergic reactions in the lungs
• pancreatitis
• liver inflammation
• increased sensitivity of the skin to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation)
• inflammation of blood vessels due to an allergic reaction
• inflammation of the mucous membrane lining the mouth (oral mucositis)
• muscle rupture and breakdown (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back, chest, and limb pain
• sudden, involuntary muscle jerks, muscle tremors, and muscle cramps (myoclonus)
• porphyria attacks in patients with porphyria (a very rare metabolic disorder)
• persistent headache with blurred vision (benign intracranial hypertension)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the local representative of the marketing authorization holder.

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

5. How to store Xyvelam

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

There are no special storage instructions for this medicine.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Xyvelam contains

• The active substance is levofloxacin.

Xyvelam, 250 mg, film-coated tablets
Each film-coated tablet contains 250 mg of levofloxacin in the form of levofloxacin hemihydrate (256.23 mg).
Xyvelam, 500 mg, film-coated tablets
Each film-coated tablet contains 500 mg of levofloxacin in the form of levofloxacin hemihydrate (512.46 mg).

• Other ingredients are:
• tablet core: sodium stearyl fumarate, crospovidone type A, colloidal silicon dioxide, copovidone, microcrystalline cellulose silicified (98% microcrystalline cellulose and 2% colloidal silicon dioxide)
• tablet coating: Opadry II Pink 31K34554 [lactose monohydrate, hypromellose 15 cP, titanium dioxide (E 171), triacetin, iron oxide red (E 172), iron oxide yellow (E 172)]

What Xyvelam looks like and contents of the pack

Xyvelam, 250 mg, film-coated tablets
Pink, biconvex tablets, with a score line on one side and the marking "L" on the other side. The length is approximately 13 mm, and the width is 6 mm. The tablet can be divided into equal doses.
Xyvelam, 500 mg, film-coated tablets
Pink, biconvex tablets, with a score line on one side and the marking "L" on the other side. The length is approximately 16 mm, and the width is 8 mm. The tablet can be divided into equal doses.
Pack sizes
Aluminum/PVC blisters containing 5, 7, 10, or 14 film-coated tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

+pharma arzneimittel gmbh
Hafnerstraße 211
8054 Graz, Austria

Manufacturer

Actavis Ltd.
BLB015-016, Bulebel Industrial Estate
Zejtun ZTN3000, Malta