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LEVOFLOXACIN 250 MG FILM-COATED TABLETS

Active substance(s): LEVOFLOXACIN HEMIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Levofloxacin 250 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 Levofloxacin Tablets are and what they are used for
2. What you need to know before you take Levofloxacin
Tablets
3. How to take Levofloxacin Tablets
4. Possible side effects
5. How to store Levofloxacin Tablets
6. Contents of the pack and other information

1

disopyramide, sotalol, dofetilide, ibutilide and amiodarone),
for depression (tricyclic antidepressants such as amitriptyline
and imipramine), for psychiatric disorders (antipsychotics),
and for bacterial infections (ʻmacrolideʼ 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 Tablets. If you
have kidney problems, your doctor may want to give you a
lower dose.

What Levofloxacin Tablets are and what
they are used for

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

Do not take Levofloxacin Tablets at the same time as the
following medicines. This is because it can affect the way
Levofloxacin 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.

Levofloxacin Tablets 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 ʻsoft tissueʼ.

Urine tests for opiates
Urine tests may show ʻfalse-positiveʼ results for strong
painkillers called ʻopiatesʼ in people taking Levofloxacin Tablets.
If your doctor has prescribed a urine test, tell your doctor you
are taking Levofloxacin Tablets.

In some special situations, Levofloxacin 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 Tablets

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

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.
• You have ever had epilepsy.
• You have ever had a problem with your tendons such as
tendonitis that was related to treatment with a ʻquinolone
antibiotic'. A tendon is the cord that joins your muscle to your
skeleton.
• You are a child or a growing teenager.
• You are pregnant, might become pregnant or think you may
be pregnant.
• You are breast-feeding.

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.

Levofloxacin Tablets contain lactose.
This medicine contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

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 Tablets.

3

Warnings and precautions
Talk to your doctor or pharmacist before taking
Levofloxacin Tablets if:
• You are 60 years of age or older.
• You are using corticosteroids, sometimes called steroids (see
section “Other medicines and Levofloxacin Tablets”).
• 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 ʻglucose-6-phosphate
dehydrogenase deficiencyʼ. 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 ʻbradycardiaʼ),
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 ʻTaking other medicinesʼ).
• 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 Tablets.

How to take Levofloxacin Tablets

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
• 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.

The tablet can be divided into equal doses.

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 Tablets. Take your dose of these medicines 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.

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

Adults and older people
Sinuses infection

Lungs infection, in people
with long-term breathing
problems
Pneumonia

• Two tablets of Levofloxacin
250 mg, once each day
• Or, one tablet of Levofloxacin
500 mg, once each day

• Two tablets of Levofloxacin
250 mg, once or twice each
day
• Or, one tablet of Levofloxacin
500 mg, once or twice each
day

Continued on the next page >>

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• Two tablets of Levofloxacin
250 mg, once each day
• Or, one tablet of Levofloxacin
500 mg, once each day

Date prepared:
17/03/2015

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
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Fonts:
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Infection of urinary tract,
including your kidneys or
bladder
Prostate gland infection
Infection of skin and
underneath the skin,
including muscles

(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.

• One or two tablets of
Levofloxacin 250 mg, each
day
• Or, ½ or one tablet of
Levofloxacin 500 mg, each
day

• Two tablets of Levofloxacin
250 mg, once each day
• Or, one tablet of Levofloxacin
500 mg, once each day
• Two tablets of Levofloxacin
250 mg, once or twice each
day
• Or, one tablet of Levofloxacin
500 mg, once or twice each
day

Not known side effects (frequency cannot be estimated
from the available data):
• 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 ʻprolongation of QT intervalʼ, 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).

Adults and older people with kidney problems
Your doctor may need to give you a lower dose.

Use in children and adolescents:
Levofloxacin Tablets must not be given to children or
teenagers.

If you take more Levofloxacin 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 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 take a double
dose to make up for a forgotten dose.

If you stop taking Levofloxacin Tablets
Do not stop taking Levofloxacin 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

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 (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.

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 Tablets and see a doctor or go to
a hospital straight away if you notice the following side
effect:

5

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 Tablets and see a doctor straight
away if you notice any of the following serious side effects you may need urgent medical treatment:

How to store Levofloxacin Tablets

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

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

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).

This medicinal product does not require any special storage
conditions.

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

Very rare (may affect up to 1 in 10,000 people)
• Burning, tingling, pain or numbness. These may be signs of
something called ʻneuropathyʼ.

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.

Contents of the pack and other information

What Levofloxacin Tablets contains
• The active substance is levofloxacin. Each tablet contains
250 mg of levofloxacin (as hemihydrate).
• The other ingredients are:
Tablet core:
Lactose monohydrate
Povidone K30
Sodium starch glycolate (type A)
Talc
Silica, colloidal anhydrous
Croscarmellose sodium
Glycerol dibehenate

If your eyesight becomes impaired or if you have any other eye
disturbances whilst taking Levofloxacin 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:

Tablet coating:
Hypromellose
Hydroxypropylcellulose
Macrogol 6000
Titanium dioxide (E171)
Iron oxide, yellow (E172)
Iron oxide, red (E172)
Talc

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.

What Levofloxacin Tablets looks like and contents of the
pack
Tablets are orange-pink, octagonal, biconvex and have a
score-line on both sides.

PVC/TE/PVDC//Al blisters containing 1, 3, 4, 5, 7, 10, 14, 20,
28, 30, 50, 60, 90 film-coated tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturers:
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana, Slovenia Or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany Or
Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany

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

This leaflet was last revised in 03/2015.

Artwork Proof Box
Ref: R001 - Renewal - National Phase
Proof no.
007.0

Date prepared:
17/03/2015

Colours:
Black
Black 20%
Dimensions: 165 x 420 mm

Font size:
7pt
Fonts:
Helvetica

SZ00000LT000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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