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Logo ASPEN LEVOFLOXACIN 250 mg
ASPEN LEVOFLOXACIN 500 mg

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ASPEN LEVOFLOXACIN 250 mg
(film coated tablets)
ASPEN LEVOFLOXACIN 500 mg
(film coated tablets)

COMPOSITION:
Each 250 mg film coated tablet contains Levofloxacin Hemihydrate equivalent to 250 mg
Levofloxacin
Each 500 mg film coated tablet contains Levofloxacin Hemihydrate equivalent to 500 mg Levofloxacin

PHARMACOLOGICAL CLASSIFICATION:
A.20.1.1 Broad and Medium Spectrum Antibiotics.

PHARMACOLOGICAL ACTION:
Levofloxacin is a broad spectrum bactericidal agent from the chemical group fluoroquinolone.
Levofloxacin is the pure (-)-(S)-enantiomer of ofloxacin.
Levofloxacin’s bactericidal action results from interference with the enzymes topoisomerase IV and DNA gyrase, which are needed for the DNA replication, transcription, repair and recombination.
Levofloxacin is bactericidal in-vitro. Cross-resistance exists between levofloxacin and other fluoroquinolones in-vitro. Generally there is no cross-resistance between levofloxacin and other classes of antibacterial agents, due to the mechanism of action of levofloxacin. The antibacterial spectrum of levofloxacin covers many Gram-positive and Gram-negative bacteria.
In vitro sensitivity does not imply in vivo efficacy.
Gram-negative organisms: Acinetobacter calcoaceticus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis and Pseudomonas aeruginosa.
Gram-positive organisms: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes and Streptococcus faecalis.
Other organisms: Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae.

Pharmacokinetics:
Absorption:
After oral administration levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being obtained within one hour. Food has little effect on the absorption of levofloxacin and the tablets may be taken during or between meals.
The absolute bioavailability is approximately 100%.
Distribution, Metabolism and Excretion:
Levofloxacin is approximately 30-40% bound to serum protein. Steady-state is achieved within three days.
Levofloxacin is metabolised to a small degree to inactive metabolites being desmethyllevofloxacin and levofloxacin-N-oxide. The elimination half-life of levofloxacin is six to eight hours after oral and intravenous administration.
Levofloxacin is excreted largely unchanged, primarily via the kidney.
Distribution in tissues and fluids:
Levofloxacin penetrates well into lung tissue, bone tissue, bronchial mucosa, epithelial lining fluid and blister fluid.

INDICATIONS:
ASPEN LEVOFLOXACIN can be used in adults, in the treatment of the following bacterial infections:
Acute exacerbations of chronic bronchitis: caused by H. influenzae, K. pneumoniae, S. aureus, M. catarrhalis, E. coli, H. parainfluenzae or S. pneumoniae.
Pneumonia (community acquired): caused by H. influenzae, S. pneumoniae, S. aureus, M. catarrhalis, H. parainfluenzae, K. pneumoniae, E. coli, Mycoplasma pneumoniae, Chlamydia pneumoniae or Legionella pneumophila.
Sinusitis: caused by H. influenzae, S. pneumoniae, S. aureus, M. catarrhalis or H. parainfluenzae.
Urinary tract infections (complicated) and acute pyelonephritis: caused by E. coil, K. pneumoniae, S. faecalis, P. mirabilis, Enterobacter cloacae and P. aeruginosa.
Uncomplicated urinary tract infections in women: caused by E. coli, K. pneumoniae.
Skin and soft tissue infections (uncomplicated): caused by S. aureus, S. pyogenes, Acinetobacter calcoaceticus, E. cloacae, P. mirabilis, P. aeruginosa, E. coli, K. pneumoniae or S. faecalis.
Skin and soft tissue infections (complicated): caused by S. aureus, S. pyogenes, P. mirabilis, E. coli, K. pneumoniae, S. faecalis, E. cloacae, K. oxytoca.
Intra-abdominal infections: caused by E. coli and anaerobic micro-organisms.

CONTRA-INDICATIONS:
The use of ASPEN LEVOFLOXACIN is contra-indicated in:
Previous hypersensitivity reactions to levofloxacin, other quinolones, or any other ingredient.
Epilepsy.
Patients with a history of tendon disorders associated with fluoroquinolone administration.
Children or adolescents (under 18 years of age).
During pregnancy and lactation.

WARNINGS:
ASPEN LEVOFLOXACIN SHOULD NOT BE GIVEN TO PATIENTS UNDER 18 YEARS OF AGE.
Caution should be exercised when using ASPEN LEVOFLOXACIN in patients:
prone to seizures, such as patients with pre-existing central nervous system lesions,
being treated with fenbufen or nonsteroidal anti-inflammatory medicines or
using medicines which lower the cerebral seizure threshold, such as theophylline.
driving or operating machinery as the use of ASPEN LEVOFLOXACIN may alter the ability to drive or operate machinery
being tested for tuberculosis as ASPEN LEVOFLOXACIN inhibits the growth of Mycobacterium tuberculosis and therefore may give false-negative results in the bacteriological diagnosis of tuberculosis
exposed to ultraviolet light such as sunlight through window glass or longer wavelength ultraviolet (UVA) from sun beds, in order to prevent photosensitisation.

INTERACTIONS:
The absorption of ASPEN LEVOFLOXACIN is significantly reduced when administered with iron salts, antacids and sucralfate. It is recommended that preparations containing iron salts, sucralfate, magnesium- or aluminium-containing antacids should not be taken two hours before or after ASPEN LEVOFLOXACIN tablet administration.
ASPEN LEVOFLOXACIN is known to inhibit hepatic medicine metabolism and may interfere with the clearance of medicines, such as theophylline, fenbufen or similar non-steroidal anti-inflammatory medicines that lower the seizure threshold.

PREGNANCY AND LACTATION:
The use of ASPEN LEVOFLOXACIN during pregnancy and lactation is contra-indicated.

DOSAGE AND DIRECTIONS FOR USE:
ASPEN LEVOFLOXACIN tablets should be swallowed whole, without crushing. ASPEN LEVOFLOXACIN may be taken on an empty stomach or with meals.
ASPEN LEVOFLOXACIN is to be taken once or twice daily in a usual dose of 250 or 500 mg. The dosage will depend on the type of pathogen and the severity of the infection. The use of ASPEN LEVOFLOXACIN should be continued for a minimum of 48 to 72 hours after commencement of therapy. The duration of therapy varies according to the course of the disease.
The following daily doses are recommended for ASPEN LEVOFLOXACIN:
Daily dosage recommended in patients with normal renal function:
Bronchitis, bacterial exacerbations: 500 mg once daily for 5-10 days.
Pneumonia, community acquired: 500 mg once or twice daily for 10-14 days. (The higher dosage should be chosen in the presence of complicating factors e.g. co-morbidity, advanced age).
Sinusitis: 500 mg once daily for 10 to 14 days.
Urinary tract infections, (complicated) and acute pyelonephritis: 250 mg once daily for 10 days.
Urinary tract infections (uncomplicated) in women: 250 mg once daily for 3 days.
Uncomplicated skin and soft tissue infections: 250 to 500 mg once daily for 7-10 days.
Complicated skin and soft tissue infections: 500 mg once daily for 10-14 days.
Intra-abdominal infections: 500 mg once daily in combination with an antibiotic with anaerobic coverage for 10-14 days.
Above infections when bacteraemia or septicaemia is present: 500 mg twice daily for 10-14 days.
Daily dosage recommended in patients with impaired renal function:
Dosage must be adjusted in patients with impaired renal function according to the degree of impairment (creatinine clearance <50 mL/min):
Patients with a creatinine clearance between 20 and 50 mL/min:
Patients meant to be taking 250 or 500 mg once daily: a normal single dose should be given initially and then reduced by half this dose once daily.
Patients meant to be taking 500 mg twice daily: the initial dose should be 500 mg and then 250 mg should be taken twelve hourly.
Patients with a creatinine clearance between 10 and 19 mL/min:
Patients to be taking 250 mg once daily: a normal single dose should be given initially and then reduced to 125 mg every 48 hours.
Patients to be taking 500 mg once daily: should be given a normal single dose initially and then this dose should be reduced to 125 mg every 24 hours.
Patients to be taking 500 mg twice daily: should be given 500 mg initially and then this dose should be reduced to 125 mg every 12 hours.
Patients with a creatinine clearance of less than 10 mL/min or in patients on haemodialysis or CAPD (Continuous Ambulatory Peritoneal Dialysis):
In patients where the prescribed dosage is 250 mg once daily: a normal single dose should be given initially and then this dose should be reduced to 125 mg every 48 hours.
Patients to be taking 500 mg once daily: should be given a normal single dose initially and then this dose should be reduced to 125 mg every 24 hours.
Patients to be taking 500 mg twice daily: should be given 500 mg initially and then this dose should be reduced to 125 mg every 24 hours.
No adjustment of dosage is required in the elderly or in patients with impaired liver function.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Very common (>1/10):
Common (> 1/100 and
= 1/10):
Uncommon (> 1/1000 and
= 1/100):
Rare (>1/10 000 and
= 1/1000):
Very rare (< 1/10 000):
Infections and infestations:
Uncommon: fungal overgrowth and proliferation of other resistant micro-organisms
Blood and lymphatic system disorders:
Uncommon: eosinophilia, leukopenia
Rare: neutropenia, thrombocytopenia
Very rare: agranulocytosis
Isolated cases: haemolytic anaemia, pancytopenia.
Immune system disorders:
Very rare: anaphylactic-like shock (medical treatment for shock is imperative).
Metabolic and nutritional disorders:
Very rare: hypoglycaemia, particularly in diabetic patients.
Psychiatric disorders:
Uncommon: insomnia
Rare: agitation, anxiety, confusion, depression, psychotic reactions
Very rare: hallucinations, psychotic reactions with self-endangering behaviour including suicide ideation or acts. In the event of such adverse reactions, ASPEN LEVOFLOXACIN must be discontinued immediately and the medical practitioner informed.
Nervous system disorders:
Uncommon: headache, dizziness/vertigo, drowsiness
Rare: paraesthesia, tremor, convulsions
Very rare: hypoaesthesia, disturbances of taste and smell, visual and auditory disturbances
Eye disorders:
Very rare: visual disturbances (see nervous system disorders)
Ear and labyrinth disorders:
Very rare: auditory disturbances (see nervous system disorders)
Vascular disorders:
Rare: hypotension
The following side effect has been reported and frequency is unknown: hypersensitivity vasculitis
Respiratory, thoracic and mediastinal disorders:
Very rare: allergic pneumonitis
Gastrointestinal disorders:
Common: nausea, diarrhoea
Uncommon: anorexia, vomiting, abdominal pain, dyspepsia
Rare: The onset of diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with ASPEN LEVOFLOXACIN may indicate the appearance of pseudomembranous colitis. Suspicion of pseudomembranous colitis requires immediate cessation of treatment with appropriate specific antibiotic therapy.
Hepato-biliary disorders:
Very rare: hepatitis.
ASPEN LEVOFLOXACIN is known to trigger attacks of porphyria in patients suffering from porphyria.
Skin and subcutaneous tissue disorders:
Uncommon: pruritus, rash
Rare: urticaria
Very rare: angio-oedema, photosensitivity reactions (skin reactions on exposure to strong sunlight and artificial UV rays)
Isolated cases: severe bullous eruptions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), erythema exsudativum multiforma
Musculoskeletal, connective tissue and bone disorders:
Rare: arthralgia, myalgia, tendon disorders including tendonitis (e.g. Achilles tendon)
Very rare: tendon rupture (e.g. Achilles tendon). This may occur within 48 hours of starting treatment and may be bilateral, muscular weakness (may be of special importance in patients with myasthenia gravis)
Isolated cases: rhabdomyolysis
Renal and urinary disorders:
Very rare: acute renal failure, interstitial nephritis
General disorders and administration site conditions:
Uncommon: asthenia
Very rare: fever
Investigations:
Common: an increase in liver enzymes (e.g. ALT/AST)
Uncommon: an increase in bilirubin, an increase in serum creatinine

SPECIAL PRECAUTIONS:
Tendonitis and tendon rupture
Tendonitis may rarely occur. It most frequently involves the Achilles tendon and may lead to tendon rupture. The risk of tendonitis and tendon rupture is increased in the elderly and in patients using corticosteroids. Close monitoring of therse patients is therefore necessary if they are prescribed ASPEN LEVOFLOXACIN. All patients should consult their physician if they experience symptoms of tendonitis. If tendonitis is suspected, treatment with ASPEN LEVOFLOXACIN must be halted immediately, and appropriate treatment (eg, immobilization) must be initiated for the affected tendon.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms that can be expected from an acute overdosage of ASPEN LEVOFLOXACIN are central nervous system symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures. The treatment of an overdosage is symptomatic and supportive.
ASPEN LEVOFLOXACIN is not effectively removed by hemodialysis or peritoneal dialysis.

IDENTIFICATION:
ASPEN LEVOFLOXACIN 250 mg
: Pink, oval, film-coated, biconvex 6x13 mm, scored on one face with side scores and an engraved “L”on the unscored face. Or with a C03 embossed on one side and a deep bisect line on the other side.
ASPEN LEVOFLOXACIN 500 mg: Pink, oval, film-coated, biconvex 8x16 mm, scored on one face with side scores and an engraved “L” on the unscored face. Or with C04 embossed on one side and a deep bisect line on the other side.

PRESENTATION:
10 tablets are packed into Al-PVC blisters or 40 tablets are packed into high density polytethylene containers.
The outer container is a printed cardboard unit carton.

STORAGE INSTRUCTIONS:
Store below 25ºC in a dry place.
Protect from light. Keep the tablets in the outer container until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ASPEN LEVOFLOXACIN 250 mg: 42/20.1.1/0509
ASPEN LEVOFLOXACIN 500 mg: 42/20.1.1/0510

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THE PACKAGE INSERT:
4 December 2008



PATIENT INFORMATION LEAFLET
Read this leaflet carefully before you start taking this medicine.
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or pharmacist.
•        This medicine has been prescribed for you personally and you should not share your medicine with other people.
        It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS: S4

NAME, STRENGTH AND DOSAGE FORM:

ASPEN LEVOFLOXACIN 250 mg tablets
ASPEN LEVOFLOXACIN 500 mg tablets

WHAT THIS MEDICINE CONTAINS
Each 250 mg tablet contains Levofloxacin 250 mg as Levofloxacin hemihydrate.
Each 500 mg tablet contains Levofloxacin 500 mg as Levofloxacin hemihydrate.

WHAT THIS MEDICINE IS USED FOR
Levofloxacin is a fluoroquinolone-type antibiotic. It works by killing bacteria or preventing their growth. ASPEN LEVOFLOXACIN is used in adults to treat bacterial infections such as bronchitis, pneumonia, sinusitis, urinary tract infections, skin and soft tissue infections and infections in the abdomen.

BEFORE YOU TAKE THIS MEDICINE
Do not take ASPEN LEVOFLOXACIN:
If you are hypersensitive (allergic) to levofloxacin, to other quinolone-type antibiotics or to any of the other ingredients of ASPEN LEVOFLOXACIN.
If you have epilepsy - ASPEN LEVOFLOXACIN may increase the chance of a seizure.
If you developed a tendon disorder following the use of another fluoroquinolone-type antibiotic.
If you are pregnant or breast-feeding.
ASPEN LEVOFLOXACIN should not be used in children under the age of 18 years.

Take special care with ASPEN LEVOFLOXACIN:
If you have brain or spinal cord disease or a history of seizures - ASPEN LEVOFLOXACIN may increase the chance of a seizure.
If you are taking inflammation or pain medicine of the NSAID class or if you are taking theophylline - These medicines may increase the chance of a seizure.
If you have diabetes mellitus (sugar diabetes) - ASPEN LEVOFLOXACIN may cause changes in blood sugar levels.
If you have kidney disease - The effects of ASPEN LEVOFLOXACIN may be increased because of slower removal from the body.
If you have prophyria - ASPEN LEVOFLOXACIN may trigger an attack of porphyria.

Taking ASPEN LEVOFLOXACIN with food and drink:
ASPEN LEVOFLOXACIN may be taken with food or on an empty stomach.
Drink plenty of water while you take this medicine.

Pregnancy and breast-feeding:
ASPEN LEVOFLOXACIN should not be used during pregnancy or while breast-feeding.
If you are pregnant or breast-feeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Driving and using machinery:
ASPEN LEVOFLOXACIN may cause dizziness or drowsiness. Make sure you know how you react to this medicine before you drive or use machines that require you to be alert.

Important information about ASPEN LEVOFLOXACIN:
ASPEN LEVOFLOXACIN may make your skin more sensitive to the sun and ultraviolet light.
Stay out of the direct sun and do not use a sun bed or sunlamp while you take this medicine.
Before you have a tuberculosis test, tell the doctor that you are taking this medicine.

Taking other medicines with ASPEN LEVOFLOXACIN:
ASPEN LEVOFLOXACIN should not be taken together with:
Antacids (magnesium- or aluminium-containing), sucralfate or iron salts - These medicines may reduce the absorption of ASPEN LEVOFLOXACIN by the body. Take ASPEN LEVOFLOXACIN either two hours before or two hours after taking these medicines.
Theophylline, inflammation or pain medicine from the NSAID class - These medicines may increase the chance of a seizure.
Warfarin (blood thinner) - The chance of bleeding is increased.
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ASPEN LEVOFLOXACIN with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

HOW TO TAKE THIS MEDICINE
Always take ASPEN LEVOFLOXACIN exactly as your doctor has instructed you. Take ASPEN LEVOFLOXACIN for the full time of treatment, even if you start to feel better within a few days.
If your symptoms do not improve within a few days or if they get worse, contact your doctor.

Dosage (adults):
The dosage of ASPEN LEVOFLOXACIN depends on the type and the severity of infection. The length of time that you take ASPEN LEVOFLOXACIN also depends on the nature of the infection. The usual dose range is 250 to 500 mg once or twice daily. The dose of ASPEN LEVOFLOXACIN may need to be reduced if you have kidney problems.
Swallow ASPEN LEVOFLOXACIN tablets whole with a full glass of water. The tablets may be broken along the score-line.
If you have the impression that the effect of ASPEN LEVOFLOXACIN is too strong or too weak, talk to your doctor or pharmacist.
Do not share medicines prescribed for you with any other person.

If you take more ASPEN LEVOFLOXACIN than you should:
Dizziness, confusion, loss of consciousness and fits can occur. In the event of overdosage, consult your doctor or pharmacist.
If neither is available, contact the nearest hospital or poison control centre.

If you forget to take ASPEN LEVOFLOXACIN:
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.
If you do miss a dose of this medicine, take it as soon as you remember. If you don’t remember until the next day, skip the missed dose and go back to your normal dosing schedule. Do not take a double dose to make up for forgotten individual doses.

Effects when treatment with ASPEN LEVOFLOXACIN is stopped:
After you stop taking this medicine, your body may need some time to adjust. During this time, contact your doctor at once if you develop severe abdominal pain or stomach cramps, diarrhoea (watery and severe and may also be bloody) or fever.

POSSIBLE SIDE-EFFECTS
Like all medicines, ASPEN LEVOFLOXACIN can have side-effects.

If any of the following minor side-effects continue, are severe or bother you, speak to your doctor or pharmacist:
Frequent:
Nausea, diarrhoea
Less frequent:
• Loss of appetite, vomiting, abdominal pain or discomfort, headache, dizziness, drowsiness, trouble in sleeping, vaginal itching or discharge.
If any of the following side-effects occur, speak to your doctor or pharmacist as soon as possible:
Less frequent or rare:
• Unusual bleeding or bruising, mood or mental changes, low blood sugar in diabetic patients, tremor, fits, numbness, tingling or painful sensations, changes in taste, smell, touch, vision or hearing, fainting, yellowing of the skin or eyes, sun sensitivity, blistering, peeling or loosening of skin, pain, swelling or inflammation in calves, shoulders or hands, joint pain, muscle pain, stiffness or weakness, problems with passing urine.
If any of the following side-effects occur, speak to your doctor immediately:
Rare:
• Skin rash, itching or redness, difficult breathing, tightness of chest, swelling of the eyelids, lips, face or tongue, severe dizziness, hallucinations, psychotic reactions, severe, persistent or bloody diarrhoea, fever.Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

STORING AND DISPOSING OF THIS MEDICINE
Store in a dry place (below 25ºC). Protect from light.
Keep the tablets in the outer container until required for use.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

PRESENTATION
10 tablets are packed into Al-PVC blisters or 40 tablets are packed into high density polyethylene containers.
The outer container is a printed cardboard unit carton.

IDENTIFICATION
ASPEN LEVOFLOXACIN 250 mg:
Pink, oval, film-coated, biconvex 6 X 13 mm, scored on one face with side scores and an engraved “L”on the unscored face,
OR with a C03 embossed on one side and a deep bisect line on the other side.

ASPEN LEVOFLOXACIN 500 mg:
Pink, oval, film-coated, biconvex 8 X 16 mm, scored on one face with side scores and an engraved “L”on the unscored face,
OR with C04 embossed on one side and a deep bisect line on the other side.

REGISTRATION NUMBER
ASPEN LEVOFLOXACIN 250 mg: 42/20.1.1/0509
ASPEN LEVOFLOXACIN 500 mg: 42/20.1.1/0510

NAME AND ADDRESS OF REGISTRATION HOLDER
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION
4 December 2008

New addition to this site: May 2010
Source: Pharmaceutical Industry

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