Package leaflet: Information for

the user
ALLGRAM 500 mg film-coated tablets
Levofloxacin
“Equivalent 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 further 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 yours, because it may be harmful.
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ALLGRAM is and what it is used for

ALLGRAM contains the active substance called levofloxacin, an antibiotic belonging to the group of quinolone antibacterial agents, known as fluoroquinolones.
This medicine works by killing the bacteria responsible for infections in the body.
ALLGRAM may be used to treat the following infections:

of the sinuses
of the lungs, in patients with chronic respiratory conditions or 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."

In certain special situations, ALLGRAM tablets may be used to reduce the risk 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

ALLGRAM
Do not take ALLGRAM:

if you are allergic to levofloxacin, 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 (angioedema)
if you suffer or have suffered from epilepsy
if you have had tendon problems, such as tendinitis (inflammation of tendons), 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, suspect you may be pregnant, or are planning a pregnancy
if you are breastfeeding

Do not take this medicine if any of the above applies to you. If you have
any doubts, consult your doctor or pharmacist before taking ALLGRAM.
Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
ALLGRAM, 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 or pharmacist before taking ALLGRAM:

if you are 60 years old or older
if you are taking corticosteroids, sometimes called steroids (see "Other medicines and ALLGRAM")
if you have undergone transplantation
if you have had epileptic seizures
if you have suffered brain damage due to stroke or other brain injuries
if you have kidney problems
if you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Administration of this medicine increases the likelihood of developing serious blood-related problems
if you have suffered from mental health problems
if you have had heart problems: you should exercise caution when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the electrical tracing of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called “bradycardia”), have a weak heart (heart failure), have had a heart attack (myocardial infarction), are female or elderly, or are taking other medicines that can alter the electrocardiogram (see section “Other medicines and ALLGRAM”).
if you have diabetes
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 been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation);
if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).
if you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin.

If you have any doubts whether any of the above may apply to you, consult your
doctor or pharmacist before taking ALLGRAM.
While taking this medicine:

If you experience sudden abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat)
If you begin to experience sudden involuntary jerks, fasciculations or muscle contractions – consult a doctor immediately as these may be signs of myoclonus. Your doctor may need to stop treatment with levofloxacin and start appropriate therapy.
If you experience nausea, general malaise, severe or persistent stomach pain or worsening of stomach pain, or vomiting, contact your doctor immediately as these may be signs of inflammation of the pancreas (acute pancreatitis).
In case of fatigue, paleness of the skin, bruising, uncontrolled bleeding, fever, sore throat and severe worsening of your general condition, or if you feel your resistance to infections has decreased – consult a doctor immediately as these may be signs of blood disorders. Your doctor must

monitor your blood with a complete blood count. If the blood count is abnormal, your
doctor may need to stop treatment.
Rarely, joint pain and swelling, and inflammation or rupture of tendons 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 ALLGRAM.
At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with ALLGRAM, consult your doctor and rest the affected area. Avoid any unnecessary movement, 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. In such cases, stop treatment with ALLGRAM and inform your doctor immediately to prevent permanent nerve damage.
Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including ALLGRAM, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, numbness or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking ALLGRAM, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
Severe skin reactions
Severe skin reactions have been reported with levofloxacin use, 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 and 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 potentially 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 other skin symptoms, stop taking levofloxacin and contact your doctor or seek immediate medical assistance.
Children and adolescents
Children or adolescents in the growth phase must not take ALLGRAM.
Other medicines and ALLGRAM
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because ALLGRAM may affect the action of other medicines. Likewise, some medicines may affect the action of ALLGRAM.
In particular, inform your doctor if you are taking any of the following
medicines. This is because concomitant administration of ALLGRAM may
increase the likelihood of side effects:

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or rupture is higher.
warfarin – used to thin the blood. The risk of bleeding is higher. Your doctor may ask you to have regular blood tests to monitor blood clotting.
theophylline – used for respiratory problems. The risk of seizures is higher if you take theophylline in combination with ALLGRAM.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures when taken in combination with ALLGRAM is higher.
Cyclosporine, a medicine used to prevent rejection after organ transplantation. The risk of experiencing typical side effects of cyclosporine is higher.
Medicines known for their effects on heart rhythm. These include medicines used to treat abnormal heart rhythm (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, sotalol, dofetilide, ibutilide and amiodarone), for depression (tricyclic antidepressants such as amitriptyline and imipramine), for psychiatric disorders (antipsychotics), and for bacterial infections (“macrolide” antibiotics such as erythromycin, azithromycin and clarithromycin).
Probenecid, a medicine used to treat gout (accumulation of uric acid in the small joints of hands and feet),
Cimetidine, a medicine used to treat ulcers and heartburn. Special caution is required when using any of these
medicines in combination with ALLGRAM. If you have kidney problems, your doctor
may prescribe a lower dose.
Do not take ALLGRAM concomitantly with the following medicines. This is because the
mechanism of action of ALLGRAM tablets may be affected:
iron salts in tablet form (for anemia), 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 tablet form, zinc supplements, antacids, didanosine or sucralfate”.

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

you are pregnant, may become pregnant, or think you are pregnant
you are breastfeeding or think you may breastfeed

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and use of 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 concentration and reaction speed. If this occurs, do not drive or perform activities requiring high attention.
ALLGRAM contains monohydrate lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
ALLGRAM contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e.
essentially "sodium-free".

3. How to take ALLGRAM

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.

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 your skin to direct sunlight during treatment with this medicine and for two days after finishing the 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 high protection factor
always wear a hat and clothing covering arms and legs
avoid sunlamps and 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 ALLGRAM. Take the prescribed dose of these medicines at least 2 hours before or after taking ALLGRAM.

How much medicine to take

your doctor will decide how much ALLGRAM you should take
the dose will depend on the type of infection you have and where in the body the infection is located
the duration of treatment will depend 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 yourself but consult your doctor

Adults and elderly patients
Sinus infections

the recommended dose is two tablets of ALLGRAM 250 mg once daily
or, one tablet of ALLGRAM 500 mg once daily

Lung infections in patients with chronic respiratory problems

the recommended dose is two tablets of ALLGRAM 250 mg once daily
or, one tablet of ALLGRAM 500 mg once daily

Pneumonia

the recommended dose is two tablets of ALLGRAM 250 mg one or two times daily
or, one tablet of ALLGRAM 500 mg one or two times daily

Urinary tract infections, including kidneys or bladder

the recommended dose is one or two tablets of ALLGRAM 250 mg once daily
or, half or one tablet of ALLGRAM 500 mg once daily

Prostate infections

the recommended dose is two tablets of ALLGRAM 250 mg once daily
or, one tablet of ALLGRAM 500 mg once daily

Skin and subcutaneous tissue infections, including muscles

the recommended dose is two tablets of ALLGRAM 250 mg one or two times daily
or, one tablet of ALLGRAM 500 mg one or two times daily

Adults and elderly patients with kidney problems
Your doctor may decide it is necessary to reduce the dose.

Children and adolescents
This medicine must not be given to children or adolescents.

Protect your skin from sunlight
Do not expose your skin to direct sunlight during treatment with this medicine and for 2 days after finishing the treatment. This is because your skin will become much more sensitive to sunlight and may burn, itch, or develop severe blisters if you do not follow these precautions:

make sure to use a sunscreen with high protection factor
always wear a hat and clothing covering arms and legs
avoid sunlamps and tanning beds

If you take more ALLGRAM than you should
If you accidentally take more tablets than you should, inform your doctor immediately or seek medical advice. Take the medicine pack with you. This will allow the doctor to see what you have taken. The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling faint, and heart problems, which may lead to irregular heartbeat, feeling unwell (nausea), or stomach burning.

If you forget to take ALLGRAM
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 the missed dose.

If you stop taking ALLGRAM
Do not stop taking ALLGRAM tablets just because you feel better. It is important that you complete the full course of tablets prescribed by your doctor. If you stop treatment too early, the infection may return, your condition may worsen, or the bacteria may develop resistance to the medicine.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking ALLGRAM 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 ALLGRAM 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 bowel problem
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected.
Seizures
Seeing or hearing things that are not there (hallucinations, paranoia)
Feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares
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)
Decrease in blood sugar levels (hypoglycaemia) or decrease in blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes.

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

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

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

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.
Loss of appetite, yellowing of the skin and eyes, dark-coloured urine, itching or stomach pain (abdominal pain). These may be signs of liver problems, which may include life-threatening liver failure (liver failure that can lead to death).
Changes in thoughts and beliefs (psychotic reactions) with risk of suicidal thoughts or suicide attempts.
Nausea, general feeling of illness, stomach discomfort or pain, or vomiting. These could be signs of inflammation of the pancreas (acute pancreatitis). See section 2.

If your vision becomes blurred or if you experience any eye discomfort while taking ALLGRAM, 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)

trouble 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 the number of white blood cells shown in blood test results (leucopenia, eosinophilia)
feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
shortness of breath (dyspnoea)
change in taste, loss of appetite, 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 tendency to bleed due to reduced platelet count in the blood (thrombocytopenia)
low white blood cell count (neutropenia)
exaggerated immune response (hypersensitivity)
decrease in blood sugar levels (hypoglycaemia). This is important for people with diabetes
seeing or hearing things that are not there (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions) with possible development of suicidal ideation or suicide attempts
feeling depressed, mental disturbances, feeling restless (agitation), unusual dreams or nightmares
tingling sensation in hands and feet (paraesthesia)
hearing problems (tinnitus) or vision problems (blurred vision)
unusually 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; these usually recur at the same skin or mucosal site after subsequent exposure to levofloxacin.

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

decrease in red blood cells (anaemia). This may lead to paleness or yellowish skin colour due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia)
The 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 decrease in the number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increase in blood sugar levels (hyperglycaemia) or decrease in blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
Feeling very excited, euphoric, agitated or enthusiastic (mania)
difficulty in moving and walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (called "prolongation of the QT interval" 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), 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 limb pain
sudden involuntary jerks, fasciculations or muscle contractions (myoclonus)
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)

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, tickling, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation), and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects via:
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 ALLGRAM

Keep this medicine out of the sight and reach of children.
.
This medicine does not require any special storage conditions; however, it is better to store ALLGRAM tablets in the original blister pack and outer carton to protect the medicine from moisture.
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 that month.
Do not dispose of medicines 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 ALLGRAM contains

The active substance is levofloxacin. Each ALLGRAM tablet contains 500 mg of levofloxacin.
The other components are:
for the tablet core: powdered cellulose, microcrystalline cellulose, pregelatinized starch, povidone, corn starch, crospovidone and sodium stearyl fumarate.
for the coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172), red iron oxide (E172) and black iron oxide (E172).

Description of the appearance of ALLGRAM and package contents
ALLGRAM tablets are film-coated tablets for oral use. The tablets are oblong-shaped with a break line and are pink in colour.
The tablet can be divided into two equal parts.
Tablets are available in packs containing 5, 7 or 10 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Euro-Pharma S.r.l.
Via Garzigliana 8 – 10127 Turin
Manufacturer
Pharmaceutical Industry NOVA ARGENTIA S.r.l.
Via Pascoli, 1 – Gorgonzola (MI)

Allgram