Levofloxacin Almus: detailed information

Package leaflet: Information for the user

Levofloxacina Almus 250 mg film-coated tablets, 500 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking 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 pass it on to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levofloxacina Almus is and what it is used for

What this medicine is
The name of this medicine is Levofloxacina Almus. Levofloxacina Almus contains the active
substance called levofloxacin. This belongs to a group of medicines known as antibiotics.
Levofloxacin is a “quinolone” antibiotic. This medicine works by killing the bacteria
responsible for infections in the body.
Levofloxacina Almus may be used to treat infections of:

Paranasal sinuses
Lungs, in patients with chronic respiratory problems or with pneumonia
Urinary tract, including kidneys and bladder
Prostate in case of chronic infections
Skin and underlying layers, including muscles. These are sometimes referred to as “soft tissues”.

In certain special situations, Levofloxacina Almus may be used to reduce the likelihood
of developing a lung disease called anthrax or to prevent worsening of the disease after
exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacina Almus

Do not take Levofloxacina Almus and inform your doctor:

if you are allergic to levofloxacin or to any other quinolone antibiotic 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:

rash, difficulty swallowing or breathing, swelling of the lips, face,
throat or tongue

if you have had epilepsy.
if you have previously experienced tendon problems such as tendinitis related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to the skeleton.
if you are a child or adolescent during the growth period
if you are pregnant, could become pregnant, or think you may be pregnant
if you are breastfeeding
Do not take this medicine if any of the above apply to you. If you have any doubts, consult your doctor or pharmacist before taking Levofloxacina Almus.

Warnings and precautions
Consult your doctor or pharmacist before taking Levofloxacina Almus:

if you are 60 years old or older
if you are taking corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacina Almus")
if you have suffered brain damage due to stroke or other brain injury
if you have kidney problems
if you have had epileptic seizures
if you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood disorders
if you have suffered from mental health problems
if 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), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on the ECG (see section "Other medicines and Levofloxacina Almus")
if you are diabetic
if you have had liver problems
if you have myasthenia gravis
if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
if 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 suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure, or known atherosclerosis)
if you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin. If you experience sudden pain in your abdomen, chest, or back, go immediately to the emergency room. If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Levofloxacina Almus.

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

SJS and TEN may initially appear on the body as reddish spots or circular patches, often with central blisters. Mouth, throat, nose, genital, and eye ulcers (red, swollen eyes) may also occur. These severe skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread skin peeling and life-threatening or fatal complications.
DRESS initially presents as flu-like symptoms and a skin rash on the face, followed by widespread skin rash with fever, elevated liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

If you develop a severe skin rash or any of these skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical attention.

Other medicines and Levofloxacina Almus
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Levofloxacina Almus may affect the way other medicines work. Likewise, some medicines may affect the action of Levofloxacina Almus.

In particular, inform your doctor if you are taking any of the following medicines.
This is because taking Levofloxacina Almus together with other medicines may increase the risk of experiencing side effects:

warfarin – used to thin the blood. Your risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
medicines known to affect heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide, and amiodarone), depression (tricyclic antidepressants such as amitriptyline and imipramine), psychiatric disorders (antipsychotics), and bacterial infections (macrolide antibiotics such as erythromycin, azithromycin, and clarithromycin).
theophylline – used for respiratory problems. Your risk of having a seizure (epileptic fit) is higher if you take theophylline together with Levofloxacina Almus.
probenecid, used to treat gout, and cimetidine, used for ulcers and heartburn. Particular caution is required when using either of these medicines together with Levofloxacina Almus. If you have kidney problems, your doctor may prescribe a lower dose.
cyclosporine, used in organ transplants. Your risk of experiencing typical cyclosporine side effects is higher.
corticosteroids, sometimes called steroids – used to treat inflammation. Your risk of developing inflammation and/or tendon rupture is increased.
non-steroidal anti-inflammatory drugs (NSAIDs), used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. Your risk of having a seizure (epileptic fit) is higher when these are taken together with Levofloxacina Almus.

Do not take Levofloxacina Almus at the same time as the following medicines. This is because
the effectiveness of Levofloxacina Almus may be affected:

iron salts in tablets (for anaemia), zinc supplements, antacids containing magnesium or aluminium (for acidity or heartburn), didanosine, or sucralfate (for gastric ulcers). See section 3 "If you are taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate".

Urine test for opioids
In patients taking Levofloxacina Almus, urine tests may give "false-positive" results for strong painkillers called "opioids". If your doctor considers it necessary to perform urine tests, inform them that you are taking Levofloxacina Almus.

Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests that detect the 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 think you may breastfeed

Driving and using machines
Some side effects may occur after taking this medicine, including dizziness, drowsiness, subjective sensation of movement (vertigo), or visual disturbances. Some of these side effects may impair your ability to concentrate and your reaction speed. If this occurs, do not drive or perform activities requiring high attention.

Levofloxacina Almus contains sunset yellow (E110)
This medicine contains the colouring agent sunset yellow (E110), which may cause allergic reactions.

3. How to take Levofloxacina Almus

Take this medicine exactly as prescribed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
How to take this medicine

Take this medicine by mouth
Swallow the tablets whole with water
The tablets may be taken with or without food

Protect your skin from sunlight
Do not expose yourself to direct sunlight during treatment with this medicine and for 2 days after stopping treatment. 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 (tanning beds)
If you are already taking iron tablets, zinc supplements, antacids, didanosine, or sucralfate: Do not take these medicines at the same time as Levofloxacina Almus. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacina Almus.

How much medicine to take

Your doctor will decide how many Levofloxacina tablets you should take
The dose depends on the type of infection you have and where in the body the infection is located
The duration of treatment depends on the severity of the infection
If you think the effect of the medicine is too weak or too strong, do not change the dose on your own; consult your doctor.

Adults and elderly:

Sinus infections

Two tablets of Levofloxacina Almus 250 mg once daily
Or, one tablet of Levofloxacina Almus 500 mg once daily

Lung infections in patients with chronic respiratory problems

Two tablets of Levofloxacina Almus 250 mg once daily
Or, one tablet of Levofloxacina Almus 500 mg once daily

Pneumonia

Two tablets of Levofloxacina Almus 250 mg once or twice daily
Or, one tablet of Levofloxacina Almus 500 mg once or twice daily

Urinary tract infections, including kidneys or bladder

One or two tablets of Levofloxacina Almus 250 mg once daily
Or, half or one tablet of Levofloxacina Almus 500 mg once daily

Prostate infections

Two tablets of Levofloxacina Almus 250 mg once daily
Or, one tablet of Levofloxacina Almus 500 mg once daily

Skin and subcutaneous tissue infections, including muscles

Two tablets of Levofloxacina Almus 250 mg once or twice daily
Or, one tablet of Levofloxacina Almus 500 mg once or twice daily

Adults and elderly with kidney problems
Your doctor may decide to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacina Almus than you should
If you accidentally take more tablets than prescribed, inform your doctor immediately or seek medical advice. Take the medicine pack with you. This will help the doctor understand what you have taken. The following side effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremors, and heart problems – which may lead to irregular heartbeat and feelings of discomfort (nausea) or stomach burning.

If you forget to take Levofloxacina Almus
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.

If you stop taking Levofloxacina Almus
Do not stop taking Levofloxacina Almus just because you feel better. It is important that you complete the full course of 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 develop resistance to the medicine.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Usually, these effects are mild or moderate in severity and often disappear after a short time.

Stop taking Levofloxacina Almus and go immediately to the doctor or hospital if you notice the following side effect:
Very rare (may affect up to 1 in 10,000 people)

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

Stop taking Levofloxacina Almus and go immediately to the doctor if you notice any of the following 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
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
seizures
severe skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These may appear on the body as reddish spots or circular patches, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.
widespread rash, fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). See also section 2.
Syndrome associated with inadequate water excretion and low sodium levels (SIADH).

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

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

Other:

loss of appetite, yellowing of the skin and eyes, dark urine, itching or abdominal pain. These may be signs of liver problems, which may include fatal liver failure (liver failure that can lead to death).

If your vision becomes blurred or if you experience any eye discomfort while taking Levofloxacina Almus, 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 levels of 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 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, dizziness
shortness of breath (dyspnoea)
altered taste, loss of appetite, stomach upset or indigestion (dyspepsia), stomach area 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 tendency to bleed 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 real (hallucinations, paranoia), changes in thinking and second thoughts (psychotic reactions), possibly leading to suicidal ideation or suicide attempts
feeling depressed, mental problems, feeling restless (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 nervous system disorder)
changes in kidney function and occasional kidney failure, which may be caused by an allergic reaction affecting the kidneys called interstitial nephritis
fever
clearly defined erythematous patches, with or without blistering, developing within a few hours of levofloxacin administration and healing with residual redness; usually reappear at the same skin or mucosal site after subsequent exposure to levofloxacin.

Other side effects include:

decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and reduced number of all types of blood cells (pancytopenia)
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)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision
worsening or loss of hearing
abnormally fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (called "QT interval prolongation" seen on electrocardiogram, electrical activity of the heart)
breathing difficulties 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)
inflammation of blood vessels supplying the whole 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 limb pain
attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)

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:
https://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 Levofloxacin Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Keep the blister in the box to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levofloxacina Almus contains
Levofloxacina Almus tablets are available in two strengths: 250 mg and 500 mg. The active
substance is levofloxacin.
Each tablet of Levofloxacina Almus 250 mg contains levofloxacin hemihydrate equivalent to
250 mg of levofloxacin.
Each tablet of Levofloxacina Almus 500 mg contains levofloxacin hemihydrate equivalent to
500 mg of levofloxacin.
The other components are:
Tablet core: Microcrystalline cellulose, hydroxypropylcellulose, crospovidone,
magnesium stearate.
Film coating: Hypromellose, indigo carmine - aluminium lake (E132), sunset yellow -
aluminium lake (E110), iron oxide red (E172), macrogol 4000, titanium dioxide (E171).
Additionally, the 500 mg tablets contain yellow iron oxide.
Description of the appearance of Levofloxacina Almus and pack contents
Levofloxacina Almus 250 mg film-coated tablets are pink, oblong, biconvex tablets with a
scored line. The tablets can be divided into two equal parts.
Levofloxacina Almus 500 mg film-coated tablets are orange, oblong, biconvex tablets with a
scored line. The tablets can be divided into two equal parts.
Levofloxacina Almus 250 mg film-coated tablets are packaged in blisters and available in pack sizes of 1, 5, 7 and 10 tablets.
Levofloxacina Almus 500 mg film-coated tablets are packaged in blisters and available in pack sizes of 1, 5, 7 and 10 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa, Italy
Manufacturer:
Pharmathen S.A.
6 Dervenekion str.,
153 5 Pallini, Attiki
Greece
e-mail: [email protected]
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Levofloxacina Almus