Package leaflet: Information for the user

Prixoter 250 mg film - coated tablets Prixoter 500 mg film - coated tablets

Levofloxacin

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 further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Prixoter is and what it is used for

2.    What you need to know before you take Prixoter

3.    How to take Prixoter

4.    Possible side effects

5.    How to store Prixoter

6.    Contents of the pack and other information

1.    What Prixoter tablets are and what they are used for

What this medicine is

The name of your medicine is Prixoter. Prixoter contains a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a 'quinolone' antibiotic. It works by killing the bacteria that cause infections in your body.

Prixoter can be used to treat infections of the:

-    Sinuses

-    Lungs, in people with long-term breathing problems or pneumonia

-    Urinary tract, including your kidneys or bladder

-    Prostate gland, where you have a long lasting infection

-    Skin and underneath the skin, including muscles. This is sometimes called 'soft tissue'.

In some special situations, Prixoter may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax.

2.    What you need to know before you take Prixoter tablets

Do not take this medicine and tell your doctor

•    if you are allergic to Levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

•    if you have ever had epilepsy.

•    if you have ever had a problem with your tendons such as tendonitis that was related to treatment with a 'quinolone antibiotic'. A tendon is the cord that joins your muscle to your skeleton

•    if you are a child or a growing teenager

•    if you are pregnant, might become pregnant or think you may be pregnant

•    if you are breast - feeding.

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Prixoter.

Warnings and precautions

Talk to your doctor or pharmacist before taking

your medicine if:

•    if you are 60 years of age or older

•    if you are using corticosteroids, sometimes called steroids (see section "Other medicines and Prixoter")

•    if you have had damage to your brain due to a stroke or other brain injury

•    if you have kidney problems

•    if you have ever had a fit (seizure)

•    if you have something known as glucose-6-phosphate dehydrogenase deficiency. You are more likely to have serious problems with your blood when taking this medicine

•    if you have ever had mental health problems.

•    if you have ever had heart problems: caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section "Other medicines and Prixoter").

•    if you are diabetic

•    if you have ever had liver problems.

•    if you have myasthenia gravis

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Prixoter.

Other medicines and Prixoter

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This is because Prixoter can affect the way some other medicines work. Also some medicines can affect the way Prixoter work.

In particular tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with Prixoter:

•    Warfarin - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.

•    Medicines known to affect the way your heart beats.

This includes medicines used for 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)

•    theophylline - used for breathing problems You are more likely to have a fit (seizure) if taken with Prixoter

•    probenecid - used for gout and cimetidine - used for ulcers and heartburn Special care should be taken when taking either of these medicines with Prixoter. If you have kidney problems, your doctor may want to give you a lower dose.

•    ciclosporin used after organ transplants. You may be more likely to get the side effects of ciclosporin

•    corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to have inflammation and/or rupture of your tendons.

•    non-steroidal anti-inflammatory drugs (NSAIDS) - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with Prixoter tablets.

Do not take Prixoter tablets at the same time as the following medicines. This is because it can affect the way Prixoter tablets work:

•    Iron tablets (for anemia), zinc supplements, magnesium or aluminum-containing antacids (for acid or heartburn), didanosine, or sucralfate (for stomach ulcers). See section 3 "If you are already taking iron tablets, zinc supplements, antacids, didanosine or sucralfate" below.

Urine tests for opiates

Urine tests may show 'false-positive' results for strong painkillers called 'opiates' in people taking Prixoter. If your doctor has prescribed a urine test, tell your doctor you are taking Prixoter.

Tuberculosis tests

This medicine may cause "false negative" results for some tests used in laboratory to search for the bacteria causing tuberculosis.

Pregnancy and breast-feeding

Do not take this medicine if:

•    You are pregnant, might become pregnant or think you may be pregnant

•    You are breast-feeding or planning to breast-feed

Driving and using machines

You may get side - effects after taking this medicine, including like feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not drive or carry out any work that requires a high level of attention.

Prixoter tablets contains sunset yellow (E110)

This medicinal product contains the colouring agent sunset yellow (E110), which may cause allergic reactions.

3. How to take Prixoter tablets

Always take this medicine exactly as your doctor has told you.

Check with your doctor or your pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole with a drink of water

•    The tablets may be taken during meals or at any time between meals

Protect your skin from sunlight

Keep out of direct sunlight while taking this medicine and for 2 days after you stop taking it. This is because your skin will become much more sensitive to the sun and may burn, tingle or severely blister if you do not take the following precautions:

•Make sure you use high factor sun cream •Always wear a hat and clothes which cover your arms and legs.

•Avoid sun beds.

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

•Do not take these medicines at the same time as Levofloxacin film-coated tablets. Take your dose of these medicines at least 2 hours before or after Levofloxacin film-coated tablets.

How much to take

•    Your doctor will decide on how many Levofloxacin film-coated tablets you should take.

•    The dose will depend on the type of infection you have and where the infection is in your body.

•    The length of your treatment will depend on how serious your infection is

•    If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor.

Adults and the elderly.

Sinuses infection

•    Two tablets of Levofloxcin 250 mg, once each day.

•    Or, one tablet of Levofloxacin 500mg, once each day.

Lungs infection, in people with long term breathing problems.

•    Two tablets of Levofloxaciin 250 mg , once each day

•    Or, one tablet Levofloxacin 500 mg , once each day

Pneumonia

•    Two tablets of Levofloxacin 250 mg , once or twice each day

•    Or, one tablet of Levofloxacin 500mg , once or twice each day.

Infection of urinary tract, including your kidneys or bladder.

•    One or two tablets of Levofloxaciin 250 mg , each day

•    Or, / or one tablet of Levofloxacin 500 mg ,each day

Prostate gland infection

•    Two tablets of Levofloxcin 250 mg , once each day.

•    Or, one tablet of Levofloxacin 500mg, once each day.

Infection of the skin and underneath the skin ,including muscles

•    Two tablets of Levofloxaciin 250 mg , once or twice each day

•    Or, one tablet Levofloxacin 500 mg , once or twice each day

Adults and the elderly with kidney problems

Your doctor may need to give you a lower dose

Children and adolescents

This medicine must not be given to children or teenagers.

If you take more Prixoter tablets than you should

If you accidentally take more tablets than you should, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: convulsive fits (seizures), feeling confused, dizzy, less conscious, having tremor and heart problems - leading to uneven heart beats as well as feeling sick (nausea) or having stomach burning.

If you forget to take Prixoter tablets

If you forgot to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not double up the next dose to make up for the missed dose.

If you stop taking Prixoter tablets

Do not stop taking Prixoter just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine.

If you have any further questions on the use of this medicine, ask your doctor or your pharmacist.

4. Possible side effects

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

Stop taking Prixoter and see a doctor or go to a hospital straight away 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 may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat, or tongue

Stop taking Prixoter and see a doctor straight away 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 have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel problem

•    Pain and inflammation in your tendons or ligaments, which could lead to rupture. The Achilles tendon is affected most often

•    Fits (convulsions)

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

•    Burning, tingling, pain or numbness. These may be signs of something called 'neuropathy'

Other:

•    Severe skin rashes which may include blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals

•    Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver

If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Prixoter, consult an eye specialist immediately.

Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:

Common (may affect up to 1 in 10 people)

•    Sleeping problems

•    Headache, feeling dizzy

•    Feeling sick (nausea, vomiting) and diarrhoea

•    Increase in the level of some liver enzymes in your blood

Uncommon (may affect up to 1 in 100 people)

•    Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated

•    Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia, eosinophilia)

•    Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling (vertigo)

•    Shortness of breath (dyspnoea)

•    Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation

•    Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis)

•    Joint pain or muscle pain

•    Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems

•    General weakness

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

•    Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia)

•    Low number of white blood cells (neutropenia)

•    Exaggerated immune response (hypersensitivity)

•    Lowering of your blood sugar levels (hypoglycaemia). This is important for people that have diabetes.

•    Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions

•    Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares

•    Tingly feeling in your hands and feet (paraesthesia)

•    Problems with your hearing (tinnitus) or eyesight (blurred vision)

•    Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension)

•    Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system).

•    Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis.

•    Fever

Other side effects include:

•    Lowering in red blood cells (anemia): this can make the skin pale or yellow due to damage of the red blood cells; lowering in the number of all types of blood cells (pancytopenia)

•    Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a lowering in the number of white blood cells (agranulocytosis).

•    Loss of circulation (anaphylactic like shock)

•    Increase of your blood sugar levels (hyperglycaemia) or lowering of your blood sugar levels leading to coma (hypoglycaemic coma). This is important for people that have diabetes.

•    Changes in the way things smell, loss of smell or taste (parosmia, anosmia, ageusia)

•    Problems moving and walking (dyskinesia, extrapyramidal disorders)

•    Temporary loss of consciousness or posture (syncope)

•    Temporary loss of vision

•    Impairment or loss of hearing

•    Abnormal fast heart rhythm, life-threatening irregular heart rhythm including cardiac arrest, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)

•    Difficulty breathing or wheezing (bronchospasm)

•    Allergic lung reactions

•    Pancreatitis

•    Inflammation of the liver (hepatitis)

•    Increased sensitivity of your skin to sun and ultraviolet light (photosensitivity)

•    Inflammation of the vessels that carry blood around your body due to an allergic reaction (vasculitis)

•    Inflammation of the tissue inside the mouth (stomatitis)

•    Muscle rupture and muscle destruction (rhabdomyolysis)

•    Joint redness and swelling (arthritis)

•    Pain, including pain in the back, chest and extremities

•    Attacks of porphyria in people who already have 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, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Prixoter tablets

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is shown on the packaging. The expiry date refers to the last day of the month.

Keep the blister in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater of household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Prixoter contains

Prixoter tablets are available in two strengths: 250 mg and 500 mg. The active substance is levofloxacin.

Each Prixoter 250 mg tablet contains levofloxacin hemihydrates equivalent to 250 mg of levofloxacin

Each Prixoter 500 mg tablet contains levofloxacin hemihydrates equivalent to 500 mg of levofloxacin

The other ingredients are:

Tablet core: Microcrystalline cellulose, hydroxypropylcellu-lose, crospovidone, magnesium stearate.

Film coating: Hypromellose, FD&C blue #2/Indigo carmine aluminum lake (E132), FD&C yellow #6/Sunset Yellow aluminum lake (E110), iron oxide red (E172), macrogol 4000, titanium dioxide (E171). Additionally the 500 mg tablets contain iron oxide yellow.

What Prixoter looks like and contents of the pack

Prixoter 250 mg film-coated tablets are pink, oblong, biconvex tablets with a scoreline. The tablet can be divided into equal halves.

Prixoter 500 mg film-coated tablets are orange, oblong, biconvex, tablets with a scoreline. The tablet can be divided into equal halves.

Prixoter 250 mg film-coated tablets are packed in blister strips, and are available in pack sizes of 1, 5, 7 and 10 tablets.

Prixoter 500 mg film-coated tablets are packed in blister strips, and are available in pack sizes of 1, 5, 7 and 10 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pharmathen S.A.

Dervenakion 6 15351 Pallini, Attiki Greece

Manufacturer

Pharmathen S.A., Dervenakion 6, 15351 Pallini, Attiki, Greece

tel.: +30 210 666 4300 fax: +30 210 666 6749 e-mail: info@pharmathen.com

This medicinal product is authorised in the Member States of the EEA under the    following names:

United Kingdom Prixoter Hungary    Prixoter

Italy    Levoxigram    250    mg    e    500    mg

compresse rivestite con film

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

This leaflet was last approved in 12/2013