Levofloxacin Galenica Senese: detailed information

Package leaflet: Information for the user

LEVOFLOXACIN GALENICA SENESE 5 mg/ml infusion solution

levofloxacin
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What Levofloxacin Galenica Senese is and what it is used for.
2. What you need to know before using Levofloxacin Galenica Senese.
3. How to use Levofloxacin Galenica Senese.
4. Possible side effects.
5. How to store Levofloxacin Galenica Senese.
6. Contents of the pack and other information.

1. What Levofloxacina Galenica Senese infusion solution is and what it is used for.

The name of this medicine is Levofloxacina Galenica Senese.
Levofloxacina Galenica Senese contains a medicine called levofloxacin. This medicine
belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic.
This medicine works by killing the bacteria responsible for infections in the body.
Levofloxacina Galenica Senese may be used to treat the following infections:

of the lungs, in patients with pneumonia
of the urinary tract, including kidneys and bladder
of the prostate, where a persistent infection may develop
of the skin and subcutaneous tissue, including muscles. These are sometimes referred to as "soft tissues".

2. What you should know before using Levofloxacin Galenica Senese infusion solution

Do not use this medicine and inform your doctor if:

You are allergic (hypersensitive) to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin, or ofloxacin, or to any of the excipients of Levofloxacin Galenica Senese infusion solution (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, and tongue.
You have had epilepsy.
You have previously experienced tendon-related problems, such as tendinitis, associated with treatment with a quinolone antibiotic. Tendons are fibrous structures that connect muscles to the skeleton.
You are a child or adolescent during the growth period (up to 18 years of age).
You are pregnant, could become pregnant, or think you may be pregnant.
You are breastfeeding.

Do not take this medicine if any of the above applies to you. If you have any
doubts, consult your doctor, nurse, or pharmacist before taking Levofloxacin
Galenica Senese.
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Levofloxacin Galenica Senese, if you have previously experienced any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Consult your doctor, nurse, or pharmacist before taking this medicine if:
you are 60 years of age or older
you are taking corticosteroids, sometimes called steroids (see “Other medicines and
Levofloxacin Galenica Senese”)
you have undergone organ transplantation
you have had seizures
you have suffered brain damage due to stroke or other brain injury, as this may
increase the risk of convulsions
you have kidney problems
you have a condition known as “glucose-6-phosphate dehydrogenase deficiency (G6PD)” or a family member has this condition. Administration of this
medicine increases the likelihood of developing blood-related problems.

you have a history of psychiatric illness. You may develop suicidal thoughts or self-harm
you have heart problems – particular 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 ECG, an electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), if you have a very slow heart rate (called “bradycardia”), if you have a weak heart (heart failure), 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 on the ECG (see section “Other medicines and Levofloxacin Galenica Senese”)
you have blood pressure problems
you have diabetes – you may need to carefully monitor your blood sugar levels
you have myasthenia gravis
you have nerve problems (peripheral neuropathy)
you experience severe, persistent, and/or bloody diarrhoea during or after treatment, as this may be a sign of a serious intestinal inflammation (pseudomembranous colitis) that may occur after antibiotic treatment
you are exposed to strong sunlight or artificial ultraviolet (UV) rays (e.g. sunlamps, tanning beds), as you may be prone to sunburn-like reactions due to increased photosensitivity. Avoid direct sunlight. Make sure to use high-protection sunscreen creams, wear a hat and clothing covering arms and legs, and avoid sunbeds
you have or have had liver problems
your vision deteriorates or your eyes are otherwise affected in any way, consult an ophthalmologist immediately
you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
you have previously experienced episodes of aortic dissection (a tear in the aortic wall)
you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular conditions such as Takayasu arteritis, giant cell arteritis, Behçet's syndrome, high blood pressure, or known atherosclerosis)

Consult your doctor, nurse, or pharmacist while taking fluoroquinolones if:

you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.

While taking this medicine
Rarely, joint pain and swelling, and 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 up to several months after stopping treatment with Levofloxacin Galenica Senese. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Levofloxacin Galenica Senese, consult your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. If this happens, stop treatment with Levofloxacin Galenica Senese and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including Levofloxacin Galenica Senese, have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, unusual sensations such as pricking, tingling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these adverse effects after taking Levofloxacin Galenica Senese, consult your doctor immediately before continuing treatment. Your doctor will decide with you whether to continue treatment and may consider using an antibiotic from another class.
If you have any doubts whether any of the above may apply to you, consult your doctor or
pharmacist before taking Levofloxacin Galenica Senese.
If your doctor suspects you may have an infection caused by MRSA organisms
(methicillin-resistant Staphylococcus aureus), you will be treated with a different antibiotic.
If you have any doubts whether any of the above may apply to you, consult your doctor,
nurse, or pharmacist before taking Levofloxacin Galenica Senese.
Other medicines and Levofloxacin Galenica Senese
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those without a prescription, as well as herbal remedies. This is because Levofloxacin
Galenica Senese may affect the action of other medicines. Likewise, some medicines may affect the action of Levofloxacin Galenica Senese.
In particular, inform your doctor if you are taking any of the following medicines. This is because
concomitant administration of Levofloxacin Galenica Senese may increase the likelihood of
experiencing adverse effects:

Corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is increased.
Warfarin – used to thin the blood. The risk of bleeding is increased. Your doctor may ask you to have regular blood tests to monitor blood clotting.
Theophylline – used for respiratory problems. The risk of seizures is increased if you take theophylline together with Levofloxacin Galenica Senese.
Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. The risk of seizures is increased if taken together with Levofloxacin Galenica Senese.
Cyclosporine – used in organ transplantation. The risk of experiencing typical cyclosporine adverse effects is increased.
Medicines known for their effects on heart rhythm. These include medicines that may alter heart rhythm: antiarrhythmic drugs (e.g. quinidine, hydroquinidine, amiodarone, sotalol, dofetilide, ibutilide), antidepressants (tricyclic antidepressants such as amitriptiline and imipramine), and some antibiotics belonging to the macrolide class (e.g. erythromycin, azithromycin, clarithromycin).
Probenecid – used to treat gout.
Cimetidine – used for ulcers and heartburn. If you have kidney problems, your doctor may prescribe a lower dose. Consult your doctor if any of the above applies to you.

Urine testing for opioids
In patients taking Levofloxacin Galenica Senese, urine tests may yield “false-positive” results for strong painkillers called “opioids.” If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacin Galenica Senese.
Tuberculosis testing
This medicine may cause “false-negative” results in certain laboratory tests used to detect bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not take this medicine if:

you are pregnant, could become pregnant, or think you may be pregnant
you are breastfeeding or plan to breastfeed

Consult your doctor or pharmacist before taking any medicine if you are
pregnant or breastfeeding.
Driving and using machines
Adverse effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances. Some of these adverse effects may impair concentration and reaction speed. If this occurs, do not drive or perform activities requiring high attention.
Levofloxacin Galenica Senese infusion solution contains sodium
This medicine contains 354.2 mg of sodium per 5 mg/ml – 100 ml infusion bag.
This corresponds to 17.7% of the maximum daily recommended dietary intake for an adult.

3. How to use Levofloxacina Galenica Senese

How Levofloxacina Galenica Senese is administered:

Levofloxacina Galenica Senese infusion solution is a medicine intended for hospital use only.
The medicine will be administered by a doctor or nurse through an injection into one of your veins. The injection will be given over a certain period of time (this procedure is called intravenous infusion).
The infusion time for Levofloxacina Galenica Senese infusion solution must be 60 minutes or longer.
Your heart rate and blood pressure must be monitored continuously. This is because an abnormally increased heart rate and a temporary drop in blood pressure are possible side effects that have been observed during infusion of a similar antibiotic. If your blood pressure drops significantly during the infusion, the infusion will be stopped immediately.

How much Levofloxacina Galenica Senese infusion solution is administered
If you have any doubts about why you are being given Levofloxacina Galenica Senese or if you would like more information about the amount administered, please consult your doctor, nurse, or pharmacist.

Your doctor will decide how much Levofloxacina Galenica Senese you should receive.
The dose will depend on the type of infection you have and the location of the infection in your body.
The duration of treatment will depend on the severity of the infection.

Adults and elderly patients

Pneumonia: 500 mg once or twice daily
Urinary tract, including kidneys or bladder: 250 mg once daily (the dose may be increased in case of severe infections)
Prostate: 500 mg once daily
Skin and subcutaneous tissue, including muscles: 500 mg twice daily

Adults with kidney problems
Your doctor may consider it necessary to reduce the dose.
Use in children and adolescents
This medicine must not be administered to children or adolescents.
Protect your skin from sunlight
Do not expose your skin to direct sunlight during treatment with this medicine. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe lesions if you do not follow these precautions:

Make sure to use a sunscreen with a high protection factor
Always wear a hat and clothing covering arms and legs
Avoid sunbeds

If you receive more Levofloxacina Galenica Senese than you should
It is unlikely that a doctor or nurse will administer an excessive amount of this medicine. Your doctor and nurse will monitor your progress and ensure the correct dose is given. If you have any doubts, always ask why a particular dose is being administered.
Receiving an excessive amount of Levofloxacina Galenica Senese infusion solution may cause the following effects: seizures (epileptic fits), confusion, dizziness, feeling faint, and heart problems that may lead to irregular heartbeats and feelings of discomfort (nausea).

If you miss a dose of Levofloxacina Galenica Senese
Your doctor or nurse will receive instructions on how much and when to administer the medicine. It is unlikely that this medicine will not be administered as prescribed. However, if you think you have missed a dose, inform your doctor or nurse.

If you stop treatment with Levofloxacina Galenica Senese
Your doctor or nurse will continue to administer Levofloxacina Galenica Senese infusion solution even if you start feeling better. If treatment is stopped too early, your condition may worsen or the bacteria may develop resistance to the medicine. After a few days of treatment with the infusion solution, your doctor may decide to switch the route of administration to the tablet form of this medicine to complete the treatment course.
If you have any questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, Levofloxacina Galenica Senese may cause side effects, although not
everyone experiences them. Usually, these effects are mild or moderate in severity and often
disappear after a short time.
Very rare (may affect up to 1 in 10,000 people)

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

Stop using Levofloxacina Galenica Senese infusion solution and contact a doctor or nurse immediately
if you notice any of the following serious side effects – you may need urgent medical treatment:
Rare (may affect up to 1 in 1,000 people)

watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
tendon or ligament pain and inflammation, which in some cases may lead to rupture. The Achilles tendon is most commonly affected.
seizures

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

burning, tingling, pain or numbness. These symptoms may indicate a condition called "neuropathy"

Not known (frequency cannot be estimated from the available data)

severe skin rash which may include lesions or peeling of the skin around the lips, eyes, mouth, nose and genitals
loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or abdominal pain. These may be signs of liver problems, including fatal liver failure (liver failure that may lead to death).

If your vision becomes blurred or you experience any eye discomfort while taking
Levofloxacina Galenica Senese, consult an ophthalmologist immediately.
Inform your doctor if any of the following side effects worsen or last longer than a few days:
Common: (may affect up to 1 in 10 people)

difficulty sleeping
headache, dizziness
feeling unwell (nausea, vomiting) and diarrhoea
increased liver enzyme levels in the blood
reactions at the infusion site
inflammation of a vein

Uncommon (may affect up to 1 in 100 people)

changes in the number of other bacteria or fungi, fungal infection called Candida, which may require treatment
changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, vertigo
shortness of breath (dyspnoea)
altered taste, loss of appetite (anorexia), stomach upset or indigestion (dyspepsia), stomach pain, bloating (flatulence), constipation
itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
joint pain or muscle pain
blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
generalised weakness

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

bruising and increased bleeding tendency due to reduced platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropenia)
exaggerated immune response (hypersensitivity)
decreased blood sugar levels (hypoglycaemia). This is important for people with diabetes
seeing or hearing things that are not there (hallucinations, paranoia), changes in thinking and mood (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
feeling depressed, mental disturbances, restlessness (agitation), unusual dreams or nightmares
tingling sensation in hands and feet (paraesthesia)
hearing problems (tinnitus) or vision problems (blurred vision)
abnormally fast heartbeat (tachycardia) or low blood pressure (hypotension)
muscle weakness. This is important for patients with myasthenia gravis (a rare disorder of the nervous system)
changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
fever

Not known (frequency cannot be estimated from the available data)

decreased red blood cells (anaemia). This may lead to paleness or yellowish skin discoloration due to damage to red blood cells and a reduced number of 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 a general feeling of illness that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes.
changes in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
feeling very excited, euphoric, agitated or enthusiastic (mania)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision, eye inflammation
worsening or loss of hearing
abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as "QT interval prolongation" seen on electrocardiogram, electrical activity of the heart)
difficulty breathing or wheezing (bronchospasm)
allergic reactions affecting the lungs
pancreatitis
inflammation of the liver (hepatitis)
increased sensitivity of the skin to sunlight or ultraviolet rays (photosensitivity), darker skin areas (hyperpigmentation)
inflammation of blood vessels throughout the body due to an allergic reaction (vasculitis)
inflammation of the internal tissues of the mouth (stomatitis)
muscle breakdown and destruction (rhabdomyolysis)
redness and swelling of joints (arthritis)
pain, including back, chest and extremity pain
sudden involuntary jerks, fasciculations or contractions (myoclonus)
porphyria attacks in patients who already have porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions,
such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs,
difficulty walking, abnormal sensations such as pricking, tingling, itching, burning,
numbness or pain (neuropathy), fatigue, memory and concentration impairment,
mental health effects (which may include sleep disorders, anxiety,
panic attacks, depression and suicidal thoughts), hearing, vision, taste and
smell disturbances, have been associated with the use of quinolone and fluoroquinolone-type
antibiotics, in some cases regardless of pre-existing risk factors.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly
via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Levofloxacina Galenica Senese

Keep this medicine out of the sight and reach of children.
Keep the vial in the original packaging to protect the medicine from light. Light protection is not required during administration.
After opening the infusion bag (puncture of the rubber stopper), the solution must be used immediately (within three hours) to avoid any bacterial contamination.
Do not use Levofloxacina Galenica Senese infusion solution after the expiry date stated on the carton.
Medicines must not be disposed of via wastewater or household waste. The nurse or pharmacist will dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Levofloxacina Galenica Senese contains
The active substance is levofloxacin. Levofloxacina Galenica Senese infusion solution is available in 100 ml polypropylene bags. Each 1 ml of infusion solution contains 5 mg of levofloxacin.
The excipients are: sodium chloride, sodium hydroxide, hydrochloric acid (q.s. to pH 4.8), water for injections.

Description of the appearance of Levofloxacina Galenica Senese infusion solution and package contents
Levofloxacina Galenica Senese infusion solution is available in polypropylene bags in packages containing 1, 5, 10, and 20 bags.

Levofloxacina Galenica Senese is compatible with the following infusion solutions:

sodium chloride 0.9%
dextrose 5%
dextrose 2.5% in Ringer's solution
parenteral nutrition solutions (amino acids, carbohydrates, electrolytes)

Levofloxacina Galenica Senese infusion solution must not be mixed with heparin or alkaline solutions (e.g. sodium bicarbonate).

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351 – 53014 Monteroni D’Arbia (SI)
Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351 – 53014 Monteroni D’Arbia (SI)

This package leaflet does not contain all the information about this medicine. If you need further information or have any questions, please consult your doctor or pharmacist.