ALVAND 250 mg Film-Coated Tablets

Зміст інструкції

1. Alvand 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Alvand and what is it used for
   2. What you need to know before taking Alvand
   3. How to take Alvand
   4. Possible side effects
   5. How to store Alvand
   6. Package Contents and Other Information

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

Generic medicine

because it contains important information for you.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous. 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 Alvand is and what it is used for
• 2. What you need to know before you take Alvand
• 3. How to take Alvand
• 4. Possible side effects
• 5. How to store Alvand 6 Contents of the pack and other information

1. What is Alvand and what is it 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 that
include infections of:

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

2. What you need to 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 suffered from inflammation and swelling of the tendons (tendinitis)
• if you are pregnant or may 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 not sure, talk to 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 ulcers in the mouth after taking any medicine containing levofloxacin;
• you have been diagnosed with an enlargement 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 wall of the aorta).
• you have been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation);
• you have a family history of aneurysm or dissection of the aorta or congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, or 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, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [an inflammation of the heart]).

Before taking this medicine
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including Alvand, if in
the past you have had any serious adverse reaction during treatment with a quinolone or
fluoroquinolone. In this case, inform your doctor as soon as possible.

Take particular care with Alvand if:

• you are 60 years of age or older
• you are taking corticosteroids, sometimes called steroids (see “Other medicines and Alvand”)
• you have had seizures
• you have suffered brain damage following a stroke or other brain damage
• you have kidney problems
• you suffer from a disease known as “glucose-6-phosphate dehydrogenase deficiency”. Taking this medicine makes the development of serious blood problems more likely.
• you have suffered from mental health problems
• you have had heart problems: you should be careful when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on an electrocardiogram, the electrical trace of the heart), have an imbalance of salts 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 a woman 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.

During the taking of Alvand
Rarely, pain and swelling in the joints and inflammation or rupture of the tendons can occur.
The risk is greater if you are elderly (over 60 years of age), if you have received an organ transplant, if
you have kidney problems or if you are being treated with corticosteroids. Inflammation and rupture of the tendons can
occur within the first 48 hours of treatment and up to several months after stopping therapy with
Alvand. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Alvand, consult your doctor and keep the
painful part at rest. 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, especially in the feet and legs or hands and arms, can occur. In this case,
stop treatment with Alvand and inform your doctor immediately, to avoid permanent nerve damage.
If you experience severe and sudden abdominal, chest or back pain, which may be a symptom of
aneurysm and dissection of the aorta, go to the emergency room immediately. The risk may be
greater if you are taking systemic corticosteroid drugs.
Immediately inform your doctor if you notice a rapid onset of shortness of breath, especially in
a lying position, or swelling of the ankles, feet or abdomen, or new episodes of
palpitations (feeling of rapid or irregular heartbeat).

Serious, prolonged, disabling and non-improving adverse effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Alvand, have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling or that
may not improve. These include pain in the tendons, muscles and joints of arms and
legs, difficulty walking, abnormal sensations such as tingling, tingling, itching, numbness or
burning (paresthesia), disorders of the sense organs such as altered vision, taste, smell and
hearing, depression, impaired memory, severe fatigue and severe sleep disorders.
If you experience any of these adverse effects after taking Alvand, contact
your doctor immediately before continuing treatment. The doctor will decide with you whether to
continue treatment and will also consider the use of an antibiotic from another class.

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

• SJS and TEN may initially appear on the body as reddish spots or circular patches often with blisters in the center. Ulcers of the mouth, throat, nose, genitals and eyes (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 peeling of the skin and life-threatening or fatal complications.
• DRESS initially presents as flu-like symptoms and a skin rash on the face, then an extensive skin rash with fever, increased levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes.

If you develop a severe skin rash or another of these skin symptoms, stop taking
levofloxacin and contact your doctor or seek medical attention immediately.
If you have any doubts as to whether the above may in any way apply to you, consult your doctor or
pharmacist before taking Alvand.

Other medicines and Alvand
You must tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Alvand can affect the mechanism of action of other medicines.
Also, some medicines can affect the mechanism of action of Alvand.

In particular, tell your doctor if you are taking any of the following medicines. This
because the administration of Alvand in combination with other medicines may increase the
possibility that you experience adverse effects:

• corticosteroids, sometimes called steroids - used for the treatment of inflammation. The possibility that you develop inflammation and/or rupture of the tendons is greater.
• warfarin - used to thin the blood. The possibility that you experience bleeding is greater. Your doctor may ask you to have regular blood tests to check your blood clotting.
• theophylline - used for breathing problems. The possibility that you experience a seizure (fit) is greater if you take theophylline in combination with Alvand.
• non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. The possibility that you experience a seizure (fit) if taken in combination with Alvand is greater.
• cyclosporine - used for organ transplants. The possibility that you experience the typical adverse effects of cyclosporine is greater.
• medicines known for their effects on the heartbeat. 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 stomach ulcers and heartburn. Particular caution should be exercised if taking one of these drugs and Alvand.
• The doctor may prescribe you a lower dosage if you suffer from kidney problems. Do not take Alvand tablets in conjunction with the following medicines. This is because themechanism of action of Alvand tablets may be affected:
• iron tablets (for anemia), zinc supplements, antacids containing magnesium or aluminum (for acidity or heartburn), didanosine or sucralfate (for stomach ulcers). See section 3 below “If you are already taking iron 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 deems it necessary to have urine tests performed, inform them that you are taking Alvand.

Tuberculosis testing
This medicine may cause “false-negative” results in some laboratory tests that look for the bacteria
that cause tuberculosis.

Pregnancy and breastfeeding
Do not takeAlvand if you are pregnant, trying to become pregnant or if you are breastfeeding or plan to do so. If you become
pregnant during treatment with Alvand stop takingthe tablets and contact immediatelyyour
doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Studies have not been performed on the ability to drive or use machines. Alvand may cause
drowsiness, dizziness or cause vision problems. Do not drive or use machines until you know how
you are affected by this medicine.
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 following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.

Adults:the dose depends on the infection. The usual dose is 250 mg or 500 mg once a day. Sometimes the doctor may increase the dose up to 500 mg twice a day.
The doctor will prescribe a course of therapy. Usually you should take Alvand for a period of 7 to 14
days, for some infections you must take the film-coated tablets for up to 28 days.

You musttake all the film-coated tablets that have been prescribed to you.

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 takethis medicine if you are under 18 years of age.

If you take more Alvand than you should
Confusion and dizziness may occur, you may have convulsions or seizures, your heartbeat
may be accelerated and you may faint. If you have taken more Alvand than you should, contact the Emergency Room
together with the box and the remaining tablets.

If you forget to take Alvand
If you have forgotten to take a dose, take it as soon as possible unless it is almost time
for the next dose.

Do not takea double dose to make up for the forgotten one.

If you stop taking Alvand
The doctor will tell you how long you should take these film-coated tablets.

Do not stopsuddenly taking this medicine without talking to your doctor.
If you have doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alvand can cause side effects, although not everyone gets them.
The following side effects may occur during treatment with Alvand.

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

• you have an allergic reaction. The signs can include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.

Stop taking Avand and see your doctor immediately if you notice any of the
following serious side effects – you may need urgent medical attention:
Rare(may affect up to 1 in 1,000 people)

• watery diarrhoea with possible 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 can, in some cases, rupture. The Achilles tendon is most often affected.
• convulsions.
• Widespread rash, fever, increased 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 insufficient 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 be indicative of a disease 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 as circular patches often with blisters in the centre, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes and may be preceded by fever and flu-like symptoms. See also section 2.

Others:

• loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These can be signs of liver problems which can include fatal liver failure (liver failure that can cause death).

If your vision is impaired or you experience any other visual disturbances while taking
Alvand, consult an ophthalmologist immediately.

Tell your doctor if any of the following side effects worsen or lasts more than a few
days:
Common(may affect up to 1 in 10 people)

• problems 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, infection with a fungus called Candida, which may require treatment
• changes in the number of white blood cells shown in some blood tests (leukopenia, eosinophilia)
• feeling stressed (anxiety), feeling confused, feeling nervous, drowsiness, tremor, dizziness
• shortness of breath (dyspnoea)
• change in the taste of things, loss of appetite, stomach upset or indigestion (dyspepsia), pain in the stomach area, feeling bloated (flatulence), constipation
• itching and rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• blood tests may show abnormal results due to liver (increased bilirubin) or kidney (increased creatinine) problems
• general weakness

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

• bruising and easy bleeding due to a decrease in the number of platelets in the blood (thrombocytopenia)
• low number of white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• decrease in blood sugar levels (hypoglycaemia). This is important for those who suffer from diabetes.
• seeing or hearing things that are not there (hallucinations, paranoia), changes in beliefs and rethinking (psychotic reactions) with the possibility of developing suicidal thoughts or acts
• feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• hearing problems (tinnitus) or vision problems (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients who suffer from myasthenia gravis (a rare disease of the nervous system).
• changes in kidney function and occasional kidney failure which can be caused by an allergic reaction to the kidneys called interstitial nephritis
• fever
• clearly defined erythematous patches, with or without blister formation that develop within a few hours of levofloxacin administration and heal leaving the reddened part; usually reappear in the same area of the skin or mucosa after subsequent exposure to levofloxacin

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

• decrease in red blood cells (anaemia). This can lead to paleness or yellowish skin due to damage to red blood cells and a decrease in the number of all types of cells in the blood (pancytopenia).
• fever, sore throat and a general feeling of being unwell 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)
• increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for those who suffer from diabetes.
• change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
• difficulty moving and walking (dyskinesia, extrapyramidal disorders)
• temporary loss of consciousness or posture (syncope)
• temporary loss of vision, inflammation of the eyes
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (called “prolongation of the QT interval” seen on the electrocardiogram, heart electrical activity)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions in the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity)
• inflammation of the blood vessels throughout the body due to an allergic reaction (vasculitis)
• inflammation of the inner tissues of the mouth (stomatitis)
• breakdown and destruction of muscles (rhabdomyolysis)
• redness and swelling of the joints (arthritis)
• pain, including back pain, chest pain and limb pain
• attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disease)
• 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
inflammation of the tendons, tendon rupture, joint pain, arm or leg pain, difficulty
walking, abnormal sensations such as tingling, prickling, itching, burning, numbness or pain
(neuropathy), depression, fatigue, sleep disorders, impaired memory and alteration
of hearing, vision, taste and smell, have been associated with the use of antibiotics of the
quinolone and fluoroquinolone type, in some cases independently of pre-existing risk factors.
Cases of dilation and weakening of the wall of the aorta or tearing of the aortic wall (aneurysms and
dissections), with possible ruptures that can cause death, as well as cases of backflow of blood from
the heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 words
“Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is levofloxacin.
Each film-coated tablet of Alvand 250 mg film-coated tablets contains 250 mg of
levofloxacin (as levofloxacin hemihydrate).
Each film-coated tablet of Alvand 500 mg film-coated tablets contains 500 mg of
levofloxacin (as levofloxacin hemihydrate).
The other ingredients are:

Tablet core: microcrystalline cellulose, corn starch, anhydrous colloidal silicon dioxide, 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, with “250” inscribed on them,
with a fracture line separating “2” from “50” on one side and “L” with a fracture line on the other side.
Alvand 500 mg tablets are peach-colored, oblong, film-coated, with “500” inscribed on them,
with a fracture line separating “5” from “00” on one side and a fracture line on the other side.
The film-coated tablet can be divided into two equal halves.
250 mg film-coated tablets are available in blister packs of 3, 5, 7 and 10
tablets.
500 mg film-coated tablets are available in blister packs of 5, 7 and 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
I.B.N. Savio S.r.l. – via del Mare, 36 – Pomezia (RM)

Manufacturer responsible for batch release:
Dr. Reddy's Laboratories (UK) Ltd. 6 Riverview Road, Beverley, East Yorkshire, HU 17 0LD United
Kingdom
Special Product’s Line S.p.A.- Via Fratta Rotonda Vado Largo, 1 – Anagni (FR)