Levofloxacin 500 Mg Film-Coated Tablets
8
5
24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVOFLOXACIN 250MG FILM-COATED TABLETS LEVOFLOXACIN500MG 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.
What is in this leaflet:
1. What Levofloxacin Film-coated Tablets are and what they are used for
2. What you need to know before you take Levofloxacin Film-coated Tablets
3. How to take Levofloxacin Film-coated Tablets
4. Possible side- effects
5. How to store Levofloxacin Film-coated Tablets
6. Contents of the pack and other information
1. What Levofloxacin Film-coated Tablets are and what are they used for
The name of your medicine is Levofloxacin 250mg or 500mg Film-coated Tablets and will be referred to as Levofloxacin Film- coated Tablets throughout this leaflet. Levofloxacin Film-coated Tablets contain the active ingredient levofloxacin. Levofloxacin is a quinolone antibiotic. It works by killing the bacteria that cause infection in your body.
Levofloxacin Film-coated Tablets can be used in adults including elderly to treat infections of the:
• Sinuses
• Lungs, in people with long-term breathing problems or pneumonia
• Urinary tract, including your bladder or kidneys
• Skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’
• Prostate gland, where you have a long lasting infection
In some special situations, Levofloxacin film-coated tablets 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 Levofloxacin Film-coated Tablets Do not take Levofloxacin Film-coated Tablets and tell your doctor if:
• you are allergic to Levofloxacin, or any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of the levofloxacin tablets (listed in Section 6). 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 tendon problems (e.g. tendonitis) related to treatment with a ‘quinolone antibiotic’. A tendon is the cord that joins your muscle to your skeleton
• you are pregnant, might become pregnant or think you may be pregnant
• you are breast-feeding
• you are a child or growing teenager
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin Film-coated tablets.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Levofloxacin Film-coated Tablets if:
• you are 60 years of age or older
• you are using corticosteroids, sometimes called steroids (see Section “Other medicines and Levofloxacin Fim-coated Tablets”)
• you have ever had a fit (seizure)
• you have had damage to your brain due to 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 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 ECQ 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 film-coated tablets”).
• you have ever had mental health problems
• you are diabetic
• you have ever had liver problems
• you have myasthenia gravis
Do not stay out in strong sunlight or use a sun lamp or solarium whilst you are taking these tablets.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Levofloxacin Film-coated Tablets.
Other medicines and Levofloxacin Film-coated Tablets
Tell your doctor or pharmacist, if you are taking, have recently taken or might take any other medicines. This is because levofloxacin film-coated tablets can affect the way some other medicines work. Also some medicines can affect the way levofloxacin film-coated tablets work.
The following medicines can increase the chance of you getting side effects, when taken with Levofloxacin Film-coated Tablets
• Corticosteroids, sometimes called steroids - used for inflammation. You may be more likely to have inflammation and/or breakage 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.
• 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 fit (seizure) if taken with Levofloxacin.
• Ciclosporin - used after organ transplants. You may be more likely to get the side effects of Ciclosporin
• Probenecid - used for gout, and cimetidine- used for ulcers and heartburn. Special care should be taken when taking either of these medicines with Levofloxacin. If you have kidney problems, your doctor may want to give you a lower dose.
• 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)
Do not take Levofloxacin Film-coated Tablets at the same time as the following medicines. This is because it can affect the way Levofloxacin Film-coated Tablets work:
• Iron tablets (for anaemia), 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 Film-coated Tablets. If your doctor is due to take a urine test, tell them you are taking Levofloxacin Film-coated Tablets.
Tuberculosis tests
This medicine may cause “false negative” results for some tests used in laboratory to search for the bacteria causing tuberculosis.
Levofloxacin Film-coated Tablets with food and drink
Levofloxacin Film-coated Tablets can be taken with or without food.
Pregnancy, Breast-feeding and Fertility
Do not take this medicine if you are pregnant, think that you may be pregnant or intend to become pregnant whilst taking these tablets or are breast-feeding or are 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.
3. How to take Levofloxacin Film-coated Tablets
Always take Levofloxacin Film-coated Tablets exactly as your doctor or pharmacist has told you. Check with your doctor or 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. Take your dose at least 2 hours before or after Levofloxacin Tablets
How much to take
• Your doctor will decide on how many Levofloxacin 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
The recommended dose is:
Adults including elderly Sinuses
• Two tablets of Levofloxacin 250 mg Film-coated Tablets, once each day
• Or, one tablet of Levofloxacin 500 mg Film-coated Tablets, once each day
Lung infections, in people with long-term breathing problems
• Two tablets of Levofloxacin 250 mg Film-coated Tablets, once each day
• Or one tablet of Levofloxacin 500 mg Film-coated Tablets, once each day
Pneumonia
• Two tablets of Levofloxacin 250 mg Film-coated Tablets, once or twice each day
• Or, one tablet of Levofloxacin 500 mg Film-coated Tablets once or twice each day
Infection of urinary tract, including your kidneys or bladder
• One or two tablets of Levofloxacin 250 mg Film-coated Tablets, each day
• Or, V tablet or one tablet of Levofloxacin 500 mg Film-coated Tablets, each day
Prostate gland infections
• Two tablets of Levofloxacin 250 mg Film-coated Tablets, once each day
• Or, one tablet of Levofloxacin 500 mg Film-coated Tablets, once each day
Levofloxacin 250/500 mg insert
SAME SIZE ARTWORK 130 x 480 mm Front
5
Infection of skin and underneath the skin, including muscles
• Two tablets of Levofloxacin 250 mg Film-coated Tablets once or twice each day
• Or one tablet of Levofloxacin 500 mg Film-coated Tablets, once or twice each day
Adults including elderly with kidney problems
Your doctor may need to give you a lower dose.
Use in children and adolescents
This medicine must not be given to children or teenagers
If you take more Levofloxacin Film-coated 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 Levofloxacin Film-coated Tablets
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 Film-coated Tablets
Do not stop taking Levofloxacin film-coated tablets 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.
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 Levofloxacin Film-coated Tablets 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 Levofloxacin Film-coated Tablets 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. The Achilles tendon is affected most often and in some cases, the tendon could break
• 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’
Not known (frequency cannot be estimated from the available data)
• 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 film-coated tablets, 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
Not known (frequency cannot be estimated from the available data)
• Lowering in red blood cells (anaemia). This can make the skin pale or yellow due to damage of the red blood cells and lowering in the number of all types of blood cells
• 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 those 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 effects
If you get any side 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 Yellow Card Scheme at 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 Levofloxacin Film-Coated _Tablets_
• Keep this medicine out of the sight and reach of children
• Do not store above 25°C. Store in the original package.
• Do not use the tablets after the expiry date stated on the carton. The expiry date refers to the last date of the month.
• Do not throw away any medicines via wastewater or 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 Levofloxacin Film-coated Tablets contain
Each film-coated tablet contains either 250mg or 500mg of the active ingredient, levofloxacin hemihydrate
The other ingredients are : Microcrystalline cellulose (Avicel PH101), Microcrystalline cellulose (Avicel PH102), Crospovidone, hypromellose, Sodium stearyl fumarate, Titanium dioxide (E 171), Purified talc, Ferric oxide red (E172), Ferric oxide yellow( E172), Polyethylene glycol - 400 (PEG 400).
What Levofloxacin film-coated tablets look like and contents of the pack
The 250 mg tablets are pink coloured, capsule shaped, biconvex film-coated tablets with a breakline on both the sides.
The 500mg tablets are pink coloured, capsule shaped, biconvex film-coated tablets with a breakline on both the sides.
The tablets are packaged in clear blister packs of 1, 5 or 10 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Name and Address:
Bristol Laboratories Limited,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom.
Tel: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Levofloxacin 250mg Film-Coated Tablets, PL 17907/0218
Levofloxacin 500mg Film-Coated Tablets, PL 17907/0219
This leaflet was last revised in July 2014 To request a copy of this leaflet in Braille, large font or audio format please contact the licence holder at the address (or telephone, fax or email) above.
V17 01-07-14 D0 *
Levofloxacin 250/500 mg insert
SAME SIZE ARTWORK
130 x 480 mm
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