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BACITAL 500 MG FILM-COATED TABLETS

Active substance(s): LEVOFLOXACIN HEMIHYDRATE

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Package leaflet: Information for the user
Bacital 250 mg film-coated tablets
Bacital 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 Bacital is and what it is used for
2. What you need to know before you take Bacital
3. How to take Bacital
4. Possible side effects
5. How to store Bacital
6. Contents of the pack and other information
1. What Bacital tablets are and what they are used
for
What this medicine is
The name of your medicine is Bacital. Bacital 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..
Bacital 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, Bacital 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 Bacital
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 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 Bacital.
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 Bacital")
• if you have ever had a fit (seizure)
• if you have had damage to your brain due to a stroke or
other brain injury
• if you have kidney problems
• 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 “Taking other medicines”).
• 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 Bacital.
Other medicines and Bacital
Tell your doctor or pharmacist if you are taking other
medicines or have recently taken or might take any other
medicines This is because Bacital can affect the way some
other medicines work. Also some medicines can affect the
way Bacital 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 Bacital:
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
Bacital.
• probenecid - used for gout and cimetidine - used for
ulcers and heartburn. Special care should be taken when
taking either of these medicines with Bacital. 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 Bacital tablets.
Do not take Bacital tablets at the same time as the
following medicines. This is because it can affect
the way Bacital 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 Bacital. If your
doctor has prescribed a urine test, tell your doctor you
are taking Bacital.
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 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.
Bacital tablets contains sunset yellow (E110)
This medicinal product contains the colouring agent
sunset yellow (E110), which may cause allergic reactions.
3. How to take Bacital 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 Bacital
film-coated tablets. Take your dose of these medicines at
least 2 hours before or after Bacital film-coated tablets.
How much to take
• Your doctor will decide on how many Bacital 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 Bacital 250 mg, once each day.
• Or, one tablet of Bacital 500mg, once each day
Lungs infection, in people with long term breathing problems.
• Two tablets of Bacital 250 mg, once each day
• Or, one tablet Bacital 500 mg, once each day
Pneumonia
• Two tablets of Bacital 250 mg , once or twice each day
• Or, one tablet of Bacital 500mg, once or twice each day.
Infection of urinary tract, including your kidneys
or bladder.
• One or two tablets of Bacital 250 mg , each day
• Or, ½ or one tablet of Bacital 500 mg ,each day
Prostate gland infection
• Two tablets of Bacital 250 mg, once each day.
• Or, one tablet of Bacital 500mg, once each day.
Infection of the skin and underneath the
skin,including muscles
• Two tablets of Bacital 250 mg , once or twice each day
• Or, one tablet Bacital 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 adolescent
This medicine must not be given to children or teenagers.
If you take more Bacital 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 Bacital 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 Bacital tablets
Do not stop taking Bacital 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 Bacital 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 Bacital 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 Bacital, 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 Bacital 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.
This medicinal product does not require any special
temperature storage conditions.
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 Bacital contains
Bacital tablets are available in two strengths: 250 mg and
500 mg. The active substance is levofloxacin.
Each film-coated tablet contains 256.23 mg of levofloxacin hemihydrate equivalent to 250 mg of levofloxacin
Each film-coated tablet contains 512.46 mg of levofloxacin hemihydrate equivalent to 500 mg of levofloxacin
The other ingredients are:
Tablet core: Microcrystalline cellulose, hydroxypropylcellulose, crospovidone, magnesium stearate.
Film coating: Hypromellose, indigo carmine ( E132),
sunset yellow ( E110), iron oxide red (E172), macrogol
4000, titanium dioxide (E171). Additionally the 500 mg
tablets contain iron oxide yellow.
What Bacital looks like and contents of the pack
Bacital 250 mg film-coated tablets are pink, oblong,
biconvex tablets with a scoreline. The tablet can be
divided into equal halves.
Bacital 500 mg film-coated tablets are orange, oblong,
biconvex, tablets with a scoreline. The tablet can be
divided into equal halves.
Bacital 250 mg film-coated tablets are packed in blister
strips, and are available in pack sizes of 1, 3, 5, 7 and 10
tablets.
Bacital 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
6 Dervenakion str. 153 51 Pallini
Attiki, Greece
Manufacturer
Pharmathen S.A
6 Dervenakion str. 153 51 Pallini
Attiki, Greece
&
Pharmathen International S.A
Industrial Park Sapes, Block No 5, 69300
Rodopi, Greece
This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom
Bacital
Ireland

Refaz

Germany

Levofloxacin SIGA 250-500mg
Filmtabletten

Italy

Levofloxacina Doc

For any information about this medicinal product, please
contact the Marketing Authorisation Holder, details
provided above.
This leaflet was last revised in 09/2013

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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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