Patient Information Leaflet

Alvand 250 mg film-coated tablets, 500 mg film-coated tablets

Equivalent medicine
Please read 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 give it to other people, even if they have the same symptoms as you, because it may be harmful. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Alvand is and what it is used for

Levofloxacin is an antibiotic used to treat infections caused by bacteria. It belongs to a group of medicines called fluoroquinolones. Levofloxacin is used to treat various infections including infections of:

skin and the underlying layers, including muscles (also known as soft tissues)
chest and lungs (respiratory tract) in people with long-term respiratory problems such as bronchitis or pneumonia
sinusitis
prostate gland, in case of persistent infection
bladder and kidneys (urinary tract).

2. What you should know before taking Alvand

Do not take ALVAND:

if you are allergic to levofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6)
if you have had an allergic reaction to other antibiotics such as ciprofloxacin or norfloxacin
if you suffer from seizures (epilepsy)
if you have previously experienced tendon inflammation and swelling (tendinitis)
if you are pregnant or could become pregnant
if you are breastfeeding
if you are under 18 years of age.

Do not use this medicine if any of these conditions apply to you. If you are unsure, speak with your
doctor or pharmacist before taking ALVAND.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alvand if:

you have developed a severe skin reaction or skin peeling, blisters and/or mouth ulcers after taking any medicine containing levofloxacin;
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 been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Alvand, if in
the past you have experienced any serious adverse reaction during treatment with a quinolone or
fluoroquinolone. In such a case, inform your doctor as soon as possible.
Take special care with Alvand if:

you are 60 years old or older
you are taking corticosteroids, sometimes called steroids (see "Other medicines and Alvand")
you have had seizures
you have suffered brain damage due to stroke or other brain injury
you have kidney problems
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.
you have experienced mental health problems
you have had heart problems: you should be cautious when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on electrocardiogram, the heart's electrical tracing), 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 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 Alvand”).
you have diabetes
you have had liver problems
you have myasthenia gravis.

While taking Alvand
Rarely, joint pain and swelling, and tendon inflammation or rupture may occur.
The risk is higher if you are elderly (over 60 years of age), 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 Alvand.
At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee),
discontinue treatment with Alvand, consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture could 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,
discontinue treatment with Alvand and inform your doctor immediately to prevent permanent nerve damage.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of
aortic aneurysm or dissection, seek emergency medical attention immediately. The risk may be
higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a 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 could be signs of myoclonus. Your doctor may need to discontinue treatment with levofloxacin and start appropriate therapy.
If you experience 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 could be signs of blood disorders. Your doctor should monitor your blood with a complete blood count. If blood tests are abnormal, your doctor may need to discontinue treatment.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Alvand, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, 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 Alvand, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Severe skin reactions
Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with levofloxacin use.

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 eruptions 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 with 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.
If you have any doubts that any of the above may apply to you, consult your doctor or pharmacist before taking Alvand.
Other medicines and Alvand
You must inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because Alvand may affect how other medicines work.
Some medicines may also affect how Alvand works.
In particular, inform your doctor if you are taking any of the following medicines. This
is because taking Alvand together with other medicines may increase the likelihood
that you experience 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 together with Alvand.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen, and indomethacin. The risk of seizures is higher when taken together with Alvand.
cyclosporine – used in organ transplantation. The risk of experiencing typical cyclosporine side effects is higher.
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), 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 – used to treat gout, and cimetidine – used for ulcers and heartburn. Particular caution is required if taking either of these medicines together with Alvand.
Your doctor may prescribe a lower dose if you have kidney problems.

Do not take Alvand tablets together with the following medicines. This is because the
mechanism of action of Alvand tablets may be affected:

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

Urine testing for opioids
In patients taking Alvand, 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 Alvand.
Tuberculosis testing
This medicine may cause "false-negative" results in certain laboratory tests that detect bacteria causing tuberculosis.
Pregnancy and breastfeeding
Do not take Alvand if you are pregnant, trying to become pregnant, breastfeeding, or planning to breastfeed. If you become pregnant while taking Alvand, stop taking the tablets and contact your doctor immediately.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
No studies have been conducted on the ability to drive or use machinery. Alvand may cause drowsiness, dizziness, or vision problems. Do not drive or operate machinery until you know how this medicine affects you.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially "sodium-free".

3. How to take Alvand

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults: The dose depends on the infection. The usual dose is 250 mg or 500 mg once daily. Sometimes your doctor may increase the dose up to 500 mg twice daily.
Your doctor will prescribe a course of treatment. Usually, you should take Alvand for a period of 7 to 14 days; for certain infections, you may need to take the film-coated tablets for up to 28 days.
You must take all the prescribed film-coated tablets.
Method and route of administration: Swallow the film-coated tablets whole with a glass of water. The film-coated tablets can be taken independently of meals. If you are taking medicines containing iron, antacids, or sucralfate, it is important not to take them within two hours of taking Levofloxacin.
Adults with kidney problems: Your doctor may prescribe a lower dose if you have kidney problems.
Children and adolescents: Do not take this medicine if you are under 18 years of age.
If you take more Alvand than you should
Symptoms may include confusion and dizziness, you may have seizures or epileptic fits, your heartbeat may become rapid, and you may faint. If you have taken more Alvand than you should, contact the nearest hospital emergency department or inform your doctor immediately. Take this patient information leaflet, together with the pack and any remaining tablets, with you.
If you forget to take Alvand
If you forget to take a dose, take it as soon as possible unless it is almost time for your next dose.
Never take a double dose to make up for a forgotten one.
If you stop taking Alvand
Your doctor will tell you how long you should take these film-coated tablets.
Do not stop taking this medicine suddenly without talking to your doctor first.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alvand can cause side effects, although not everyone experiences them.
The following side effects may occur during treatment with Alvand.
Stop taking Alvand and go immediately to your 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 Alvand and go immediately to your doctor 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 bowel problem.
pain and inflammation of tendons or ligaments which in some cases may rupture. The Achilles tendon is most commonly affected.
seizures.
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 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 and eye ulcers, and may be preceded by fever and flu-like symptoms. See also section 2.

Other:

loss of appetite, yellowing of the skin and eyes, dark-coloured 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 impaired or you experience other visual disturbances while taking Alvand, 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)

sleep disturbances
headache, dizziness
feeling unwell (nausea, vomiting) and diarrhoea
increased levels of liver enzymes in blood tests

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)
change in taste, loss of appetite, stomach discomfort 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)
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 behaviour (psychotic reactions) with possible development of suicidal ideation or suicide attempts
feeling depressed, mental disturbances, restlessness (agitation), abnormal 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 spots, with or without blister formation, developing within a few hours after levofloxacin administration and healing with redness remaining; usually reappears 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).
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.
change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
feeling extremely 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, eye inflammation
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat rhythm (known as "prolongation of the QT interval" 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 carrying blood 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 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 adverse drug reactions that are prolonged (lasting months or years) or permanent, 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), as well as 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 lead to death, 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 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 Alvand

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging/blister after the wording
"Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Alvand Contains
The active substance is levofloxacin.
Each Alvand 250 mg film-coated tablet contains 250 mg of levofloxacin (as levofloxacin hemihydrate).
Each Alvand 500 mg film-coated tablet contains 500 mg of levofloxacin (as levofloxacin hemihydrate).

The other ingredients are:
Tablet core: microcrystalline cellulose, corn starch, anhydrous colloidal silica, crospovidone, hypromellose, sodium stearyl fumarate.
Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow iron oxide (E172), talc.

Description of the Appearance of Alvand and Package Contents
Alvand 250 mg tablets are peach-colored, oblong, film-coated tablets, marked with "250", with a break line separating "2" from "50" on one side and "L" with a break line on the other side.
Alvand 500 mg tablets are peach-colored, oblong, film-coated tablets, marked with "500", with a break line separating "5" from "00" on one side and a break line on the other side.
The film-coated tablet can be divided into two equal parts.

Alvand 250 mg film-coated tablets are available in blister packs containing 3, 5, 7, and 10 tablets.
Alvand 500 mg film-coated tablets are available in blister packs containing 5, 7, and 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM), Italy

Manufacturer Responsible for Batch Release
Dr. Reddy's Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 – Anagni (FR), Italy