Levofloxacin Tecnigen Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Levofloxacina TecniGen Italia 500 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Contents of this leaflet:

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

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

Levofloxacina TecniGen Italia tablets contain the active substance called levofloxacin.
This medicine belongs to a group of medicines known as antibiotics. Levofloxacin is a
"quinolone" antibiotic. This medicine works by killing bacteria responsible for causing infections
in the body.
Levofloxacina TecniGen Italia tablets can be used to treat the following infections:

of the sinuses
of the lungs, in patients with chronic respiratory disorders 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, Levofloxacina TecniGen Italia tablets may be used to reduce the risk of developing or worsening a lung disease called anthrax after exposure to the bacterium that causes anthrax.

2. What you should 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 ingredients of this medicine (listed in section 6).

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

if you have epilepsy
if you have had tendon problems, such as tendonitis, related to treatment with a "quinolone antibiotic". Tendons are fibrous structures that connect muscles to the skeleton
if you are a child or adolescent during the growth period
if you are pregnant, could become pregnant, or think you may be pregnant
if you are breastfeeding

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Levofloxacina TecniGen Italia if:

you are aged 60 years or older and are taking corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacina TecniGen Italia")
you have had seizures
you have had 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 had mental health problems
you have had heart problems: you must 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 Levofloxacina TecniGen Italia")
you have diabetes
you have had liver problems
you have myasthenia gravis

If you have any doubts whether any of the above may apply to you, consult your doctor or pharmacist before taking Levofloxacina TecniGen Italia.

Other medicines and Levofloxacina TecniGen Italia

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 how other medicines work. Likewise, some medicines can affect how Levofloxacina TecniGen Italia works.

In particular, inform your doctor if you are taking any of the following medicines.

This is because concomitant administration with Levofloxacina TecniGen Italia may increase the likelihood of you experiencing side effects.

corticosteroids, sometimes called steroids – used to treat inflammation. The risk of developing tendon inflammation and/or tendon 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 (epileptic fits) is higher if you take theophylline together with Levofloxacina TecniGen Italia.
non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. The risk of seizures (epileptic fits) is higher when taken together with Levofloxacina TecniGen Italia.
cyclosporine – used in organ transplants. The risk of experiencing typical side effects of cyclosporine 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 when using any of these medicines together with Levofloxacina TecniGen Italia. If you have kidney problems, your doctor may prescribe a lower dose.

Do not take Levofloxacina TecniGen Italia tablets concomitantly with the following medicines. This is because the mechanism of action of Levofloxacina TecniGen Italia tablets may be affected.

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

Urine testing for opiates

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

Tuberculosis testing

This medicine may cause "false-negative" results in certain laboratory tests used to detect the bacterium that causes tuberculosis.

Pregnancy, breastfeeding and fertility

Do not take this medicine if:

you are pregnant, could become pregnant, or think you may be pregnant
you are breastfeeding or think you may be breastfeeding

Driving and using machines

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

3. How to take Levofloxacina TecniGen Italia

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

take this medicine by mouth
swallow the tablets whole with water
the tablets may be taken with or without food

Protect your skin from sunlight
Avoid exposure to direct sunlight during treatment with this medicine and for 2 days after finishing 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 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

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

Adults and elderly patients
Sinus infections

one tablet of Levofloxacina TecniGen Italia 500 mg once daily

Lung infections, in patients with chronic respiratory problems

one tablet of Levofloxacina TecniGen Italia 500 mg once daily

Pneumonia

one tablet of Levofloxacina TecniGen Italia 500 mg once or twice daily

Urinary tract infections, including kidneys or bladder

half or one tablet of Levofloxacina TecniGen Italia 500 mg once daily

Prostate infections

one tablet of Levofloxacina TecniGen Italia 500 mg once daily

Skin and soft tissue infections, including muscles

one tablet of Levofloxacina TecniGen Italia 500 mg once or twice daily

Adults and elderly patients with kidney problems
Your doctor may consider it necessary to reduce the dose.
Children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacina TecniGen Italia than you should
If you accidentally take more tablets than prescribed, inform your doctor immediately or seek medical advice. Bring the medicine pack with you. This will help the doctor understand what you have taken. The following adverse effects may occur: seizures (epileptic fits), confusion, dizziness, feeling faint, tremor, and heart problems – which may lead to irregular heartbeat and feelings of discomfort (nausea) or stomach burning.
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 almost time for your next dose. Do not take a double dose to make up for the forgotten 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 full course of tablets prescribed by your doctor. If you stop taking the tablets too early, the infection may return, your condition may worsen, or bacteria may develop resistance to the medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Levofloxacina TecniGen Italia and go immediately to a doctor or hospital if you notice the following side effect:

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

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

Stop taking Levofloxacina TecniGen Italia and contact your doctor immediately if you notice any of the following side effects – you may need urgent medical treatment:

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

watery diarrhoea, possibly with blood, sometimes accompanied by stomach cramps and high fever. This may be a sign of a serious intestinal problem
pain and inflammation of tendons or ligaments, which in some cases may rupture. The Achilles tendon is most commonly affected
seizures

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

burning, tingling, pain or numbness. These symptoms may be signs of a condition called “neuropathy”

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

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

If your vision becomes blurred or if you experience any eye discomfort while taking Levofloxacina TecniGen Italia, consult an ophthalmologist immediately.

Inform your doctor if any of the following side effects worsen or last for more than a few days:

Common: (may affect up to 1 in 10 people)

difficulty sleeping
headache, dizziness
feeling unwell (nausea, vomiting) and diarrhoea
increased levels of liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people)

changes in the number of other bacteria or fungi, fungal infection known as Candida, which may require treatment
changes in white blood cell count shown in blood test results (leucopenia, eosinophilia)
feeling stressed (anxiety), confusion, nervousness, drowsiness, tremor, dizziness
shortness of breath (dyspnoea)
altered taste, loss of appetite, stomach 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 there (hallucinations, paranoia), changes in thinking and reconsideration (psychotic reactions), with possible development of suicidal thoughts or suicide attempts
feeling depressed, mental problems, feeling restless (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 in the kidneys called interstitial nephritis
fever

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

decreased red blood cells (anaemia). This may lead to paleness or yellowish skin due to damage to red blood cells and a decrease in all types of blood cells (pancytopenia)
fever, sore throat and a general feeling of illness that does not go away. This may be due to a reduced number of white blood cells in the blood (agranulocytosis)
lack of blood flow (anaphylactic shock)
increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes
change in the smell of things, loss of smell or taste (parosmia, anosmia, ageusia)
difficulty moving or walking (dyskinesia, extrapyramidal disorders)
temporary loss of consciousness or posture (syncope)
temporary loss of vision
worsening or loss of hearing
unusually fast heartbeat, irregular heartbeat with life-threatening risk including cardiac arrest, changes in heartbeat (called “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)
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 rupture and destruction of muscle (rhabdomyolysis)
redness and swelling of the joints (arthritis)
pain, including back pain, chest pain and pain in the extremities
attacks of porphyria in patients who already suffer from porphyria (a very rare metabolic disorder)
persistent headache with or without blurred vision (benign intracranial hypertension)

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the website: 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 special storage conditions; however, it is advisable to store Levofloxacina TecniGen Italia tablets in their original blister pack and outer packaging in a dry place.
Do not use this medicine after the expiry date stated on the packaging 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 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 components 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 Italia and contents of the pack
Levofloxacina TecniGen Italia 500 mg film-coated tablets are oblong tablets with a yellowish core and a light pink coating, with a score line on one side.
The tablet can be divided into two equal parts.
Levofloxacina TecniGen Italia 500 mg is available in packs containing blisters of 5 tablets.
Marketing Authorization Holder and manufacturer
Marketing Authorization Holder:
Tecnigen S.r.l., via Galileo Galilei 40 – 20092 Cinisello Balsamo – Milan (MI)
Responsible manufacturers 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
This patient information leaflet does not contain all the available information about this medicine. If you need further information or have any questions, please consult your doctor or pharmacist.