Levofloxacin Krka

Package leaflet: Information for the patient

Levofloxacina Krka 250 mg film-coated tablets, 500 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levofloxacina Krka is and what it is used for

The name of the medicine is Levofloxacina Krka tablets. Levofloxacina Krka tablets contain an
active substance called levofloxacin, which belongs to the group of antibiotics. Levofloxacin is
a 'quinolone' antibiotic that works by killing bacteria causing infections in the body.
Levofloxacina Krka tablets can be used to treat the following infections:

• Sinus infections
• Lung infections, in people with chronic respiratory problems or pneumonia
• Urinary tract infections, including kidneys or bladder
• Prostate gland infections, in case of persistent infection
• Skin and subcutaneous infections, including muscles. These are sometimes referred to as 'soft tissues'

In certain specific cases, Levofloxacina Krka tablets may be used to reduce the likelihood
of developing a lung disease called anthrax or to prevent worsening of the disease after
exposure to bacteria that cause pulmonary anthrax.

2. What you need to know before taking Levofloxacina Krka

Do not take Levofloxacina Krka and inform your doctor:

• 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).
• Symptoms of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If you have had seizures
• If you have had tendon problems such as tendonitis associated with treatment with a quinolone antibiotic. A tendon is the cord that connects a muscle to the skeleton.
• If you are a child or adolescent during the growth period
• If you are pregnant, think you might be pregnant, or are planning to become pregnant
• If you are breastfeeding. Do not take this medicine if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking Levofloxacina Krka.

Warnings and precautions
Talk to your doctor or pharmacist before taking Levofloxacina Krka if:

• You are 60 years old or older
• You are taking corticosteroids, sometimes called steroids (see section "Other medicines and Levofloxacina Krka")
• You have had previous seizures (convulsions)
• You have had brain damage due to stroke or other brain injuries
• You have kidney problems
• You have 'glucose-6-phosphate dehydrogenase deficiency'. You may be at higher risk of serious blood problems if you take this medicine
• You have had mental health problems
• You have heart problems: you need to take this type of medicine with particular caution if you were born with or have a family history of QT interval prolongation (detected by ECG, the electrical trace 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 previous heart attacks (myocardial infarction), are a woman or an elderly person, or are taking other medicines that cause abnormal changes in the ECG (see section "Other medicines and Levofloxacina Krka").
• You are diabetic
• You have had liver problems
• You suffer from myasthenia gravis.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Levofloxacina Krka.

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

Other medicines and Levofloxacina Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, because Levofloxacina Krka may alter the effect of other medicines. In turn, some medicines may affect the action of Levofloxacina Krka.

In particular, inform your doctor if you are taking any of the following medicines, as
concomitant use with Levofloxacina Krka may increase the risk of side effects:

• Corticosteroids, sometimes called steroids – used for inflammation. Tendon inflammation and/or tendon rupture may occur more frequently.
• Warfarin – used to thin the blood. Bleeding may occur more frequently. Your doctor may consider it necessary to regularly prescribe blood tests to monitor proper blood clotting.
• Theophylline – used for respiratory problems. Seizures (convulsions) may occur more frequently if taken together with Levofloxacina Krka.
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain and inflammation, such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. Seizures (convulsions) may occur more frequently if taken together with Levofloxacina Krka.
• Cyclosporine – used after organ transplantation. Side effects of cyclosporine may occur more frequently.
• Medicines known to affect heart rhythm. These include medicines used for heart rhythm disorders (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 for gout – and cimetidine – used for ulcers and heartburn. Particular caution is required when taking these medicines together with Levofloxacina Krka. If you have kidney problems, your doctor may prescribe a reduced dose.

Do not take Levofloxacina Krka tablets together with the following medicines. This is because
the effect of Levofloxacina Krka tablets may be altered:

• 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 already taking iron salts in tablets, zinc supplements, antacids, didanosine or sucralfate".

Urine tests for opiates
Urine tests performed on people taking Levofloxacina Krka may give 'false-positive' results for strong painkillers called 'opiates'. If your doctor has prescribed urine tests, inform them that you are taking Levofloxacina Krka.

Tuberculosis testing
This medicine may cause 'false-negative' results in certain laboratory tests for the bacterium that causes tuberculosis.

Pregnancy and breastfeeding
Do not take this medicine if:

• you are pregnant, think you might be pregnant, or are planning to become pregnant
• you are breastfeeding or intend to 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 using machines
After taking this medicine, you may experience side effects such as dizziness, drowsiness, vertigo (spinning sensation) or vision problems. Some of these side effects may affect your ability to concentrate and your reaction speed. In such cases, do not drive or perform tasks requiring high attention.

Levofloxacina Krka contains Sunset Yellow FCF (E110)
It may cause allergic reactions.

3. How to take Levofloxacina Krka

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

• Take this medicine by mouth
• Swallow the tablets whole with a glass of water
• The tablets may be taken during meals or at any time between main meals
• The tablets may be divided into equal doses

Protecting your skin from sunlight
Avoid exposure to direct sunlight during treatment with this medicine and for
2 days after stopping treatment. Your skin will become more sensitive to
sunlight and may suffer burns, sunburn, or severe blistering if you do not take the
following precautions:

• Be sure to use high-protection sunscreen creams
• Always wear a hat and clothing covering arms and legs
• Avoid sunbeds

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

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

How much to take

• Your doctor will determine how many Levofloxacina Krka tablets you should take
• The dose will depend on the type of infection and its location in your body
• The duration of treatment will depend on the severity of the infection
• If you feel the effect of the medicine is too weak or too strong, do not change the dose yourself; consult your doctor

Adults and elderly
Sinus infection

• Two 250 mg Levofloxacina Krka tablets once daily
• Or, one 500 mg Levofloxacina Krka tablet once daily

Lung infection in people with chronic respiratory problems

• Two 250 mg Levofloxacina Krka tablets once daily
• Or, one 500 mg Levofloxacina Krka tablet once daily

Pneumonia

• Two 250 mg Levofloxacina Krka tablets once or twice daily
• Or, one 500 mg Levofloxacina Krka tablet once or twice daily

Urinary tract infection, including kidneys or bladder

• One or two 250 mg Levofloxacina Krka tablets once daily
• Or, half or one 500 mg Levofloxacina Krka tablet once daily

Prostate gland infection

• Two 250 mg Levofloxacina Krka tablets once daily
• Or, one 500 mg Levofloxacina Krka tablet once daily

Skin and subcutaneous infection, including muscles

• Two 250 mg Levofloxacina Krka tablets once or twice daily
• Or, one 500 mg Levofloxacina Krka tablet once or twice daily

Adults and elderly with kidney problems
Your doctor may prescribe you a reduced dose.
Use in children and adolescents
This medicine must not be given to children or adolescents.
If you take more Levofloxacina Krka than you should
If you accidentally take more tablets than you should, inform your doctor or seek
immediate medical advice. Take the medicine pack with you so the doctor
can see what you have taken. The following side effects may occur: seizures
(convulsions), confusion, dizziness, reduced level of consciousness, tremors, and heart problems –
up to irregular heartbeat, feeling unwell (nausea), or heartburn.
If you forget to take Levofloxacina Krka
If you forget to take a dose, take it as soon as possible unless it is almost time for the
next dose. Do not take a double dose to make up for the missed dose.
If you stop taking Levofloxacina Krka
Do not stop taking Levofloxacina Krka 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 recur, your condition may
worsen, or the bacteria may become resistant 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 everyone gets them.
These side effects are usually mild or moderate and often disappear after a short time.
Stop taking Levofloxacin Krka and contact a doctor or go
immediately to a hospital if you notice the following side effects:
Very rare (may affect up to 1 in 10,000 people)

• Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Stop taking Levofloxacin Krka and contact a doctor immediately 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, which may contain blood, possibly accompanied by stomach cramps and high fever. These symptoms could indicate a serious bowel problem
• Pain and inflammation of tendons or ligaments, which could lead to their rupture. The Achilles tendon is most commonly affected
• Seizures (convulsions)

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

• Burning, tingling, pain or numbness. These symptoms could be signs of a condition called 'neuropathy'.

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

• Severe skin rashes 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 abdominal pain. These could be symptoms of liver problems, including fatal liver failure

Contact an ophthalmologist immediately if you experience any weakening of vision or any other
eye disturbances during treatment with Levofloxacin Krka.
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
• Nausea, vomiting and diarrhoea
• Increase in levels of certain 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 caused by Candida, which may require treatment
• Changes in white blood cell count reported in blood test results (leucopenia, eosinophilia)
• Feeling of stress (anxiety), confusion, nervousness, drowsiness, tremor, dizziness (vertigo)
• Shortness of breath (dyspnoea)
• Changes in taste, loss of appetite, stomach ache or indigestion (dyspepsia), abdominal pain, bloating (flatulence) or constipation
• Itching and skin rash, intense itching or hives, excessive sweating (hyperhidrosis)
• Joint or muscle pain
• Blood tests may show abnormal values 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 increased bleeding tendency due to reduced platelet count in the blood (thrombocytopenia)
• Reduced number of white blood cells (neutropenia)
• Excessive immune response (hypersensitivity)
• Decreased blood sugar levels (hypoglycaemia). This is relevant for people with diabetes.
• Seeing or hearing things that are not real (hallucinations, paranoia), changes in thoughts and beliefs (psychotic reactions), with risk of suicidal thoughts or actions
• 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 relevant for people with myasthenia gravis (a rare nervous system disorder).
• Changes in kidney function and occasional kidney failure, possibly due to an allergic reaction in the kidneys called interstitial nephritis.
• Fever

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

• Decrease in red blood cells (anaemia): may cause paleness or yellowing of the skin due to damage to red blood cells; reduction in all types of blood cells (pancytopenia)
• Fever, sore throat and a persistent general feeling of illness. These could be caused by a reduced number of white blood cells (agranulocytosis).
• Lack of blood flow (similar to anaphylactic shock)
• Increased blood sugar levels (hyperglycaemia) or reduced blood sugar levels leading to coma (hypoglycaemic coma). This is relevant for people with diabetes.
• Changes in smell perception, loss of smell or taste (parosmia, anosmia, ageusia)
• Movement and walking problems (dyskinesia, extrapyramidal disorders)
• Temporary loss of consciousness or postural tone (syncope)
• Temporary loss of vision
• Hearing problems or hearing loss
• Unusually rapid heartbeat, dangerously irregular heartbeat up to cardiac arrest, changes in heartbeat rhythm (known as 'QT interval prolongation', detected on ECG, the heart's electrical activity)
• Breathing difficulties or wheezing (bronchospasm)
• Allergic lung reactions
• Pancreatitis
• Inflammation of the liver (hepatitis)
• Increased sensitivity of the skin to sunlight and ultraviolet light (photosensitivity)
• Inflammation of blood vessels supplying blood throughout the body due to an allergic reaction (vasculitis)
• Inflammation of the mucosal tissue inside the mouth (stomatitis)
• Rupture and breakdown of muscles (rhabdomyolysis)
• Inflammation and swelling of joints (arthritis)
• Pain, including back, chest and limb pain
• Attacks of porphyria in people already affected by 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 national reporting system at 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 Levofloxacin Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Krka contains

• The active substance is levofloxacin. Each film-coated tablet contains 250 mg or 500 mg of levofloxacin as levofloxacin hemihydrate.
• The other components (excipients) are microcrystalline cellulose, hydroxypropylcellulose, crospovidone (type A) and magnesium stearate in the tablet core; hypromellose, indigo carmine (E132), orange yellow S (E110), macrogol 4000, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172) (only for 500 mg) in the coating.

Description of the appearance of Levofloxacina Krka and package contents
The 250 mg film-coated tablets are pink, oblong, biconvex, with a break line, measuring 13.7 mm x 6.7 mm and 3.8 mm thick. The tablet can be divided into equal doses.
The 500 mg film-coated tablets are orange, oblong, biconvex, with a break line, measuring 19.3 mm x 7.8 mm and 5.0 mm thick. The tablet can be divided into equal doses.
The 250 mg and 500 mg film-coated tablets are available in blister packs containing 1, 5, 7, 10 or 14 tablets per box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative in Italy
Krka Farmaceutici S.r.l. – Viale Achille Papa 30 – 20149 Milano (Italy)

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
PHARMATHEN S.A., Dervenakion 6, Pallini 15351, Attikis, Greece

This medicinal product is authorized in the European Economic Area Member States under the following names: