Document: Levofloxacin Bluefish film-coated tablet ENG PL change

• Levofloxacin Bluefish film-coated tablet PL
• Levofloxacin Bluefish film-coated tablet ENG PL

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Package Leaflet: Information for the User

Levofloxacin Bluefish 250 mg film-coated tablets

Levofloxacin Bluefish 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

Levofloxacin Bluefish tablets contain 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.

Levofloxacin Bluefish 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’.

Do not take Levofloxacin Bluefish

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

• You have ever had epilepsy

• 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

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 Levofloxacin Bluefish.

Warnings and precautions

Talk to your doctor or pharmacist before taking Levofloxacin Bluefish

• You are 60 years of age or older

• You are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin Bluefish”)

• You have ever had a fit (seizure)

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

• You have kidney problems

• 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

• You have ever had mental health problems

• 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 Levofloxacin Bluefish”).

• You are diabetic

• You have ever had liver problems

• 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 Levofloxacin Bluefish.

Other medicines and Levofloxacin Bluefish

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

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

• 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.

• Theophylline - used for breathing problems. You are more likely to have a fit (seizure) if taken with Levofloxacin Bluefish

• 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 Levofloxacin Bluefish

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

• 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)

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

Do not take Levofloxacin Bluefish tablets at the same time as the following medicines. This is because it can affect the way Levofloxacin Bluefish 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 Levofloxacin Bluefish. If your doctor has prescribed a urine test, tell your doctor you are taking Levofloxacin Bluefish.

Tuberculosis tests

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

Levofloxacin Bluefish with food and drink

The tablets may be taken with or without food.

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 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.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

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:

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

How much to take

Your doctor will decide on how many Levofloxacin Bluefish 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 Levofloxacin Bluefish 250 mg, once each day

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

Lungs infection, in people with long-term breathing problems

• Two tablets of Levofloxacin Bluefish 250 mg, once each day

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

Pneumonia

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

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

Infection of urinary tract, including your kidneys or bladder

• One or two tablets of Levofloxacin Bluefish 250 mg, each day

• Or, 1/2 or one tablet of Levofloxacin Bluefish 500 mg, each day

Prostate gland infection

• Two tablets of Levofloxacin Bluefish 250 mg, once each day

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

Infection of skin and underneath the skin, including muscles

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

• Or, one tablet of Levofloxacin Bluefish 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 Levofloxacin Bluefish 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 Levofloxacin Bluefish

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

If you stop taking Levofloxacin Bluefish

Do not stop taking Levofloxacin Bluefish 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 pharmacist.

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 Levofloxacin Bluefish 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)

Stop taking Levofloxacin Bluefish 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)

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 Levofloxacin Bluefish, 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)

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

Reporting of side effectsIf you get effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Levofloxacin Bluefish after the expiry date which is stated on the carton and blister strip after EXP. The expiry date refers to the last day of that month.

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

What Levofloxacin Bluefish contains

The active ingredient is levofloxacin.

Levofloxacin Bluefish 250mg tablets contain levofloxacin hemihydrate equivalent to levofloxacin 250mg.

Levofloxacin Bluefish 500mg tablets contain levofloxacin hemihydrate equivalent to levofloxacin 500mg.

The other ingredients are:

• Tablet core: povidone, crospovidone type B, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica.

• Film coating: hypromellose, talc, titanium dioxide (E171), macrogol, red iron oxide (E172) and yellow iron oxide (E172).

What Levofloxacin Bluefish look like and the contents of the pack

Two strengths of Levofloxacin Bluefish are available: 250 mg and 500 mg

The 250 mg tablets are Pink coloured, capsule shaped, biconvex, film coated tablet with break line on both sides. Debossed ‘L’ and ‘F’ either side of the break line on one face.

The 500 mg tablets are Pink coloured, capsule shaped, biconvex, film coated tablet with break line on both sides. Debossed ‘L’ and ‘V’ either side of the break line on one face.

The tablet can be divided into equal halves.

Levofloxacin Bluefish 250mg tablets are packed in PVC/Aluminium blisters & PVC/PVdC/Aluminium blisters of 3, 5, 7 & 10 tablets. Not all pack sizes may be marketed.

Levofloxacin Bluefish 500mg tablets are packed in PVC/Aluminium blisters & PVC/PVdC/Aluminium blisters of 5, 7, 10, 14 & 50 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bluefish Pharmaceuticals AB

Torsgatan 11

111 23 Stockholm

Sweden

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

This leaflet was last revised in 2015-09-23

Advice/medical education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.

When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.

1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.

2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.

3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.

4. You should not give antibiotics that were prescribed for you to other people.

5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.