LEVOFLOXACINA 500 mg Tabletki Powlekane

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1. Levofloxacina TecniGen Italia 500 mg film-coated tablets
   1. What is Levofloxacina TecniGen Italia and what is it used for
   2. What you need to know before taking Levofloxacina TecniGen Italia
   3. How to take Levofloxacina TecniGen Italia
   4. Possible side effects
   5. How to store Levofloxacina TecniGen Italia
   6. Contents of the pack and other information
2. Levofloxacina TecniGen Italia 500 mg is available in packs containing blisters of 5

Levofloxacina TecniGen Italia 500 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What Levofloxacina TecniGen Italia is and what it is used for.
• 2. What you need to know before you take Levofloxacina TecniGen Italia.
• 3. How to take Levofloxacina TecniGen Italia.
• 4. Possible side effects.
• 5. How to store Levofloxacina TecniGen Italia.
• 6. Contents of the pack and other information.

1. What is Levofloxacina TecniGen Italia and what is it used for

Levofloxacina TecniGen Italia tablets contains the active substance called levofloxacin.
This medicine belongs to a group of medicines called antibiotics. Levofloxacin is a
“quinolone” antibiotic. This medicine works by killing the bacteria responsible for infections
in the body.

Levofloxacina TecniGen Italia tablets can be used for the treatment of
infections:

• of the sinuses
• of the lungs, in patients suffering from chronic respiratory problems 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 called “soft tissues”.

In some special situations, Levofloxacina TecniGen Italia tablets can be used to
reduce the likelihood of contracting a lung disease called anthrax or the worsening
of the disease after exposure to the bacterium that causes anthrax.

2. What you need to know before taking Levofloxacina TecniGen Italia

Do not take Levofloxacina TecniGen Italia:

• if you are allergic to levofloxacin, to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other components of this medicine (listed in section 6).

The signs of an allergic reaction include: skin rash, problems with swallowing or
breathing, swelling of the lips, face, throat or tongue.

• if you have had epilepsy
• if you have had problems affecting your tendons, 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 growth
• if you are pregnant, may become pregnant or think you may be pregnant
• if you are breastfeeding

Do not take this medicine if any of the above applies to you. If you have any
doubts, ask your doctor, nurse or pharmacist before taking Levofloxacina
TecniGen Italia.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levofloxacina TecniGen Italiaif:

• you are 60 years old or older and are taking corticosteroids, sometimes called steroids (see “Other medicines and Levofloxacina TecniGen Italia”)
• you have had seizures
• you have suffered brain damage following a stroke or other brain damage
• you have kidney problems
• you suffer from a condition known as “glucose-6-phosphate dehydrogenase deficiency”. Taking this medicine makes it more likely to develop serious blood problems
• you have suffered from mental health problems
• 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 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/aged or are taking other medicines that can alter the electrocardiogram (see section “Other medicines and Levofloxacina TecniGen Italia”)
• you have diabetes
• you have had liver problems
• you have myasthenia gravis

If you have any doubt that any of the above may apply to you, ask your doctor or
pharmacist before taking Levofloxacina TecniGen Italia.

Other medicines and Levofloxacina TecniGenItalia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Levofloxacina TecniGen Italia can affect the mechanism
of action of other medicines. Also, some medicines can affect the mechanism of action of
Levofloxacina TecniGen Italia.

In particular, tell your doctor if you are taking any of the following medicines.
This is because taking them at the same time as Levofloxacina TecniGen Italiacan
increase the possibility that you experience unwanted effects.

• corticosteroids, sometimes called steroids - used for the treatment of inflammation. You are more likely to develop inflammation and/or rupture of the tendons.
• warfarin - used to thin the blood. You are more likely to experience bleeding. Your doctor may ask you to have regular blood tests to check your blood clotting.
• theophylline - used for breathing problems. You are more likely to have a seizure (fit) if you take theophylline in combination with Levofloxacina TecniGen Italia.
• non-steroidal anti-inflammatory drugs (NSAIDs) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indometacin. You are more likely to have a seizure (fit) if taken in combination with Levofloxacina TecniGen Italia.
• cyclosporine - used for organ transplants. You are more likely to experience the unwanted effects typical of cyclosporine.
• medicines known for their effects on the heartbeat. These include medicines used to treat irregular heartbeat (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 care should be taken when using any of these medicines in combination with Levofloxacina TecniGen Italia. If you have kidney problems, your doctor may prescribe you a lower dose.

Do not take Levofloxacina TecniGen Italiatablets at the same time as the following
medicines. This is because the mechanism of action of Levofloxacina TecniGen Italia
tablets could be affected.

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

Urine tests for opioids
In patients taking Levofloxacina TecniGen Italia, urine tests may give
“false-positive” results for strong painkillers called “opioids”. If your doctor needs to
perform urine tests, tell them that you are taking Levofloxacina TecniGen Italia.

Tuberculosis tests
This medicine can cause “false-negative” results in some tests used in the laboratory to
detect the bacterium that causes tuberculosis.

Pregnancy, breastfeeding and fertility
Do not take this medicine if:

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

Driving and using machines
Some unwanted effects can occur after taking this medicine that
include dizziness, drowsiness, a subjective sensation of movement (vertigo) or visual disturbances.
Some of these unwanted effects may alter your ability to concentrate and your reaction speed. If this
happens, do not drive vehicles or operate machinery that requires a high level of
attention.

3. How to take Levofloxacina TecniGen Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.

Taking this medicine

• take this medicine by mouth
• swallow the tablets whole with some water
• the tablets can 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 the end of treatment. This is because your skin will become much more sensitive to the sun and may
burn, itch or serious lesions may occur if you do not observe the following precautions:

• make sure to use a sunscreen with a high protection factor
• always wear a hat and clothing that covers your arms and legs
• avoid sunbeds

If you are already taking iron salts in tablets, zinc supplements, antacids, didanosine or
sucralfate

• Do not take these medicines at the same time as Levofloxacina TecniGen Italia. Take the prescribed dose of these medicines at least 2 hours before or after taking Levofloxacina TecniGen Italia tablets.

How much Levofloxacina TecniGen Italia to take

• the doctor will decide how much Levofloxacina TecniGen Italia tablets you must take
• the dose will depend on the type of infection you have contracted and the location of the infection in the body
• the duration of treatment will depend on the severity of the infection
• if you feel that the effect of the medicine is too weak or too strong, do not change the dosage on your own but consult your doctor

Adults and the elderly
Infections of the sinuses

• one Levofloxacina TecniGen Italia 500 mg tablet once a day

Lung infections, in patients with chronic respiratory problems

• one Levofloxacina TecniGen Italia 500 mg tablet once a day

Pneumonia

• one Levofloxacina TecniGen Italia 500 mg tablet one or two times a day

Urinary tract infections including kidneys or bladder

• half or one Levofloxacina TecniGen Italia 500 mg tablet once a day

Prostate infections

• one Levofloxacina TecniGen Italia 500 mg tablet once a day

Skin and subcutaneous tissue infections, including muscles

• one Levofloxacina TecniGen Italia 500 mg tablet one or two times a day

Adults and the elderly with kidney problems
The doctor may deem it necessary to reduce the dosage.

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

If you take more Levofloxacina TecniGen Italia than you should
If you accidentally take more tablets than you should, inform your doctor immediately or
seek medical advice elsewhere. Bring the package of the medicine with you. This will allow the
doctor to know what you have taken. The following side effects may occur: seizures (epileptic fit), confusion, dizziness, feeling of fainting, tremor and
heart problems – which can lead to irregular heartbeat and a feeling of unwellness
(nausea) or heartburn.

If you forget to take Levofloxacina TecniGen Italia
If you forget to take a dose, take it as soon as you remember unless it is time to
take the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Levofloxacina TecniGen Italia
Do not stop taking Levofloxacina TecniGen Italia just because you feel better. It is important
that you complete the course of tablets prescribed by your doctor. If you stop taking
the tablets too soon, the infection may recur and your condition may
worsen or bacteria may develop resistance to the medicine.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Levofloxacina TecniGen Italia and go to your doctor or 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. Signs may include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking Levofloxacina TecniGen Italia and go to your doctor immediately if you notice any of the following side effects – you may need to receive urgent medical treatment:
Rare(may affect up to 1 in 1,000 people)

• watery diarrhoea with possible presence of blood accompanied possibly 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 often affected
• convulsions

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

• burning, tingling, pain or numbness. These signs may be a sign of a disease called “neuropathy”

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

• severe skin rash that may include blisters or peeling of the skin around the lips, eyes, mouth, nose and genitals
• loss of appetite, yellowing of the skin and eyes, dark urine, itching or stomach pain (abdomen). These may be signs of liver problems which can include fatal liver failure (liver failure that can cause death)

If your vision becomes blurred or if you experience any discomfort in your eyes while taking Levofloxacina TecniGen Italia, 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 with sleeping
• headache, feeling dizzy
• feeling unwell (nausea, vomiting) and diarrhoea
• increase in the levels of liver enzymes in the blood

Not common(may affect up to 1 in 100 people)

• changes in the number of other bacteria or fungi, fungal infection called Candida, which may require the start of treatment
• changes in the number of white blood cells shown in some blood tests (leukopenia, eosinophilia)
• feeling of stress (anxiety), feeling of confusion, feeling of nervousness, 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 of bloating (flatulence), constipation
• itching and skin rash, severe itching or hives, excessive sweating (hyperhidrosis)
• joint or muscle pain
• blood tests may show abnormal results due to liver problems (increased bilirubin) or kidney problems (increased creatinine)
• general weakness

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

• bruising and easy bleeding which depends on the reduction of the number of platelets in the blood (thrombocytopenia)
• low number of white blood cells (neutropenia)
• exaggerated immune response (hypersensitivity)
• lowering of blood sugar levels (hypoglycaemia). This is important for those suffering from diabetes
• seeing or hearing things that do not exist (hallucinations, paranoia), changes in opinion and rethinking (psychotic reactions) with the possibility of developing suicidal ideation or suicidal acts
• feeling of depression, mental problems, feeling of restlessness (agitation), abnormal dreams or nightmares
• feeling of tingling in the hands and feet (paresthesia)
• problems with hearing (tinnitus) or vision (blurred vision)
• unusually fast heartbeat (tachycardia) or low blood pressure (hypotension)
• muscle weakness. This is important for patients suffering from myasthenia gravis (a rare disease of the nervous system)
• alterations in kidney function and occasional kidney failure which may be caused by an allergic reaction to the kidneys called interstitial nephritis
• fever

Not known (the 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 present in the blood (pancytopenia)
• fever, sore throat and a general feeling of unwellness 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 (hypoglycemic coma). This is important for those suffering 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
• worsening or loss of hearing
• unusually fast heartbeat, irregular heartbeat with life-threatening including cardiac arrest, changes in heartbeat (called “prolongation of the QT interval” seen on the electrocardiogram, electrical activity of the heart)
• difficulty breathing or wheezing (bronchospasm)
• allergic reactions to the lungs
• pancreatitis
• inflammation of the liver (hepatitis)
• increased sensitivity of the skin to the sun or ultraviolet rays (photosensitivity)
• inflammation of the vessels carrying blood throughout the body due to an allergic reaction (vasculitis)
• inflammation of the inner tissues of the mouth (stomatitis)
• rupture 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 already suffering from porphyria (a very rare metabolic disease)
• persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Levofloxacina TecniGen Italia

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions but it is best to
store Levofloxacina TecniGen Italia tablets in the blister and in the original box and in a
dry place.
Do not use this medicine after the expiry date which is reported on the packaging and on the blister
after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Levofloxacina TecniGen Italia contains
The active substance is levofloxacin. Each Levofloxacina TecniGen Italia 500 mg
film-coated tablet contains 500 mg of levofloxacin.
The other ingredients are:

Tablet core:microcrystalline cellulose 102, hypromellose, crospovidone, sodium stearyl
fumarate.

Tablet coating:hypromellose 6 cP, titanium dioxide, macrogol 400, talc, yellow iron oxide, red iron oxide, black iron oxide.

Description of the appearance of Levofloxacina TecniGen Italiaand contents of the pack
Levofloxacina TecniGen Italia 500 mg film-coated tablets are oblong tablets, with
a yellow-yellowish core and a light pink coating, with an incision on one side.
The tablet can be divided into two equal halves.

Levofloxacina TecniGen Italia 500 mg is available in packs containing blisters of 5

tablets.

Marketing Authorisation Holder and manufacturer

AIC Holder:
Tecnigen S.r.l., via Galileo Galilei 40 – 20092 Cinisello Balsamo – Milan (MI)

Manufacturers responsible for batch release:
WEST PHARMA - Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, N.º 11
Venda Nova, 2700 Amadora
Portugal
ATLANTIC PHARMA - Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2
Abrunheira, 2710-089 Sintra
Portugal
If you require further information or have any doubts, please contact your doctor or pharmacist.