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 Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm others, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Package Leaflet Contents

• 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. Package Contents and Other Information

1. What is Xyvelam and What is it Used For

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

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-causing bacteria.

2. Important Information Before Taking Xyvelam

When Not to Take Xyvelam

• if the patient is allergic to levofloxacin, any other quinolone antibiotic (such as moxifloxacin, ciprofloxacin, or ofloxacin), or any of the other ingredients of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if the patient has ever had seizures
• if the patient has 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 medication has been prescribed for a child or adolescent during growth
• if the patient is pregnant, may become pregnant, or suspects they are pregnant
• if the patient is breastfeeding

Do not take this medication if any of the above statements apply to the patient. In case of doubts, consult a doctor or pharmacist before taking Xyvelam.

Warnings and Precautions

Before taking Xyvelam, discuss the following with a doctor or pharmacist:

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

If the patient is unsure whether any of the above statements apply to them, they should consult a 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 red, target-like, or circular patches, often with blisters in the center on the torso. They may 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, initial symptoms include flu-like symptoms and a rash on the face, followed by a widespread rash with high fever, elevated liver enzymes, and elevated white blood cell count (eosinophilia), as well as swollen lymph nodes.

If a severe rash or any of these skin symptoms occur, the patient should stop taking levofloxacin and consult a doctor or seek immediate medical attention. Do not take antibacterial medications containing fluoroquinolones or quinolones, including levofloxacin, if the patient has experienced any severe adverse reaction while taking a quinolone or fluoroquinolone in the past. In such cases, inform the doctor as soon as possible.

During Xyvelam Treatment

• in case of 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 in patients treated with systemic corticosteroids.
• in case of sudden shortness of breath, especially after lying down or noticing swelling of the ankles, feet, or abdomen, or an irregular heartbeat (palpitations), consult a doctor immediately
• if the patient experiences sudden, involuntary muscle jerks, muscle twitches, or muscle cramps, they should consult a doctor immediately, as these may be symptoms of myoclonus. The doctor may decide to discontinue levofloxacin and initiate appropriate treatment.
• in case of nausea, general malaise, discomfort, or persistent or worsening abdominal pain, or vomiting, consult a doctor immediately, as these may be symptoms of pancreatitis (acute pancreatitis)
• if the patient experiences fatigue, pallor, bruising, uncontrolled bleeding, fever, sore throat, and significant deterioration of health or feeling of reduced resistance to infections, they should consult a doctor immediately, as these may be symptoms of blood disorders. The doctor should monitor the patient's blood count through a blood morphology test. If abnormalities are found in the blood morphology, the 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 patients with 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. After the first symptoms of pain or tendon inflammation appear (e.g., in the ankle, wrist, elbow, shoulder, or knee), the patient should discontinue Xyvelam, consult a doctor, and rest the affected area. The patient should avoid excessive strain, as it may increase the risk of tendon rupture.

The patient may rarely 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, the patient should discontinue Xyvelam and immediately inform their doctor to prevent the development of potentially irreversible disease.

Long-Term, Disabling, and Potentially Irreversible Severe Adverse Reactions

Fluoroquinolone and quinolone antibacterial medications, including Xyvelam, have been associated with very rare, but severe adverse reactions. Some of these reactions 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 itching), sensory disturbances (including vision, taste, and smell disorders), depression, memory impairment, severe fatigue, and severe sleep disturbances.

If any of these adverse reactions occur after taking Xyvelam, the patient should immediately consult a doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, considering alternative antibiotics from another class.

In case of doubts about whether any of the above situations apply to the patient, they should consult a doctor or pharmacist before taking Xyvelam.

Xyvelam and Other Medications

Inform the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications they plan to take. This is because Xyvelam may affect the action of other medications, and other medications may affect the action of Xyvelam.

In Particular, Inform the Doctor if the Patient is Taking Any of the Following Medications, as Their Concurrent Use with Xyvelam May Increase the Risk of Adverse Reactions:

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

If any of the above statements apply to the patient, they should inform their doctor.

Do Not Take Xyvelam at the Same Time as the Following Medications, as They May Affect Its Action:

• iron tablets (used for anemia), zinc supplements, antacids containing magnesium or aluminum (used for acid reflux or heartburn), didanosine, or sucralfate (used for stomach ulcers) (see "If the Patient is Already Taking Iron Tablets, Zinc Supplements, Antacids, Didanosine, or Sucralfate")

Opioid Tests in Urine

Test results for strong pain-relieving medications called opioids in the urine may be falsely positive in patients taking Xyvelam. If a doctor has ordered a urine test, the patient should inform the doctor that they are taking Xyvelam.

Tuberculosis Tests

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

Pregnancy and Breastfeeding

Do not take this medication if the patient:

• is pregnant, may become pregnant, or suspects they may be pregnant
• is breastfeeding or plans to breastfeed

Driving and Operating Machinery

After taking this medication, the patient may experience side effects, including dizziness, drowsiness, vertigo, or vision disturbances. Some of these side effects may impair the patient's ability to concentrate and react. In such cases, the patient should not drive vehicles or perform any work that requires attention.

Xyvelam Contains Lactose and Sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking Xyvelam. The medication contains less than 1 mmol (23 mg) of sodium per tablet, making it "sodium-free".

3. How to Take Xyvelam

Always take this medication as directed by a doctor. In case of doubts, consult a doctor or pharmacist.

Administration

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

If the Patient is Already Taking Iron Tablets, Zinc Supplements, Antacids, Didanosine, or Sucralfate

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

Recommended Dose

• The doctor will decide how many Xyvelam tablets the patient 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 the patient feels that the medication's effect is too weak or too strong, they should not change the dose themselves but consult a doctor.

Adults and Elderly Patients

Sinusitis

• two 250 mg Xyvelam tablets once a day or
• one 500 mg Xyvelam tablet once a day

Lung Infections in Patients with Long-Term Breathing Problems

• two 250 mg Xyvelam tablets once a day or
• one 500 mg Xyvelam tablet once a day

Pneumonia

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

Urinary Tract Infections, Including Kidney or Bladder Infections

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

Prostate Infections

• two 250 mg Xyvelam tablets once a day or
• one 500 mg Xyvelam tablet once a day

Skin and Soft Tissue Infections, Including Muscle Infections

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

Anthrax Inhalation Exposure

• two 250 mg Xyvelam tablets once a day or
• one 500 mg Xyvelam tablet once a day

Adults and Elderly Patients with Renal Impairment

The doctor may recommend a lower dose.

Use in Children and Adolescents

Do not use this medication in children and adolescents.

Protecting the Skin from Sunlight

During and for 2 days after taking this medication, avoid direct sunlight. This is because the patient's skin may become more sensitive to the sun, which can lead to sunburn, tingling, and large blisters on the skin if the following precautions are not taken:

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

Overdose

In case of accidental ingestion of more than the recommended number of tablets, immediately consult a doctor or seek medical attention. Bring the medication packaging to inform the doctor about the medication taken. The following symptoms may occur: seizures (epileptic fits), confusion, dizziness, disturbed consciousness, muscle tremors, and heart disturbances leading to irregular heartbeat, as well as nausea and heartburn.

Missed Dose

If a dose of Xyvelam is missed, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.

Discontinuing Xyvelam

Do not stop taking Xyvelam just because the patient feels better. It is essential to take all the tablets prescribed by the doctor. If the patient stops taking the tablets too early, the infection may return, the patient's condition may worsen, or the bacteria may become resistant to the medication.

In case of further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible Side Effects

Like all medications, Xyvelam can cause side effects, although not everyone will experience them.

Stop Taking Xyvelam and Immediately Consult a Doctor or Go to the Hospital if the Patient Experiences the Following Side Effect:

Very Rare(may occur less frequently than 1 in 10,000 patients)

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

Stop Taking Xyvelam and Immediately Consult a Doctor if the Patient Experiences Any of the Following Side Effects – Immediate Treatment May be Necessary.

Rare(may occur less frequently than 1 in 1,000 patients)

• 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 do not exist (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 body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• syndrome associated with 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 occur less frequently than 1 in 10,000 patients)

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

Frequency Not Known(frequency cannot be estimated from available data)

• severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear as red, 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 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 the patient experiences worsening vision or other vision disturbances while taking Xyvelam, they should immediately consult 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 medication side effects, such as: tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations (such as tingling, burning, prickling, numbness, or itching), sensory disturbances (including vision, taste, and smell disorders), depression, memory impairment, severe fatigue, and severe sleep disturbances.

In patients taking fluoroquinolones, cases of aortic dilatation and aortic aneurysm rupture, as well as aortic valve regurgitation, have been reported. See also section 2.

Consult a Doctor if Any of the Following Side Effects Worsen or Last Longer Than a Few Days.

Common(may occur less frequently than 1 in 10 patients)

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

Uncommon(may occur less frequently than 1 in 100 patients)

• changes in the number of certain bacteria or fungi, fungal infections (e.g., Candida), which may require treatment
• changes in the number of certain types of white blood cells, visible in some blood tests (leukopenia, eosinophilia)
• anxiety, confusion, nervousness, sleepiness, tremors, feeling of spinning (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, excessive sweating
• joint or muscle pain
• abnormal blood test results due to liver (elevated bilirubin levels) or kidney (elevated creatinine levels) dysfunction
• general weakness

Rare(may occur less frequently than 1 in 1,000 patients)

• 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 (tinnitus) or vision (blurred vision) problems
• 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
• clearly defined, red, rash-like patches with blisters, developing within hours of taking levofloxacin. These patches usually resolve with post-inflammatory hyperpigmentation. Upon re-administration of levofloxacin, these patches typically recur in the same location on the skin or mucous membranes.
• memory impairment

Frequency Not Known(frequency cannot be estimated from 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, reduced 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 (anaphylactoid shock)
• 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 intense excitement, agitation, or enthusiasm (mania)
• movement and walking difficulties (dyskinesia, extrapyramidal disorders)
• transient loss of consciousness or fainting (syncope)
• transient vision loss, eye inflammation
• hearing disturbances or hearing loss
• abnormal heart rhythm, life-threatening irregular heartbeat, including QT interval prolongation (visible on an ECG, i.e., an electrocardiogram), cardiac arrest, and changes in heart rhythm (arrhythmia)
• breathing difficulties or wheezing (bronchospasm)
• lung allergic reactions
• pancreatitis
• liver inflammation
• increased skin sensitivity to sunlight and ultraviolet radiation (photosensitivity), skin discoloration (hyperpigmentation)
• blood vessel inflammation due to an allergic reaction
• inflammation of the mucous membrane lining the mouth (oral mucositis)
• muscle rupture and breakdown (rhabdomyolysis)
• joint and muscle pain (arthritis)
• pain, including back, chest, and limb pain
• sudden, involuntary muscle jerks, muscle twitches, 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 the patient experiences any side effects, including any not listed in this package leaflet, they should inform their 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.

Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Xyvelam

Store the medication out of sight and reach of children.

There are no special storage instructions for this medication.

Do not use this medication after the expiration date stated on the packaging and blister pack after "EXP".

The expiration date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents 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 silica anhydrous, copovidone, siliconized microcrystalline cellulose (98% microcrystalline cellulose and 2% colloidal silica anhydrous)
• 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 Package Contents

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.
Package sizes
Aluminum/PVC blisters containing 5, 7, 10, or 14 film-coated tablets, in a cardboard box.
Not all package 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

To obtain more detailed information about this medication, contact the local representative of the marketing authorization holder:
+pharma Polska sp. z o.o.
ul. Podgórska 34
31-536 Kraków, Poland
tel: +48 12 262 32 36
e-mail: [email protected]
Date of Last Revision of the Package Leaflet:January 2025