importance in patients treated for diabetes. Very rare: fever, allergic inflammation of small
tance in patients with myasthenia gravis (a
blood vessels or allergic lung reactions.
attacks of porphyria in patients with porphyria
rare disease of the nervous system). ACTIVE SUBSTANCE AND EXCIPIENTS MARKETING AUTHORIZATION HOLDER
(a very rare metabolic disease). This might
Isolated cases: muscle reactions with muscle
Tell your doctor or pharmacist if you ex- (What do the tablets contain?) AND MANUFACTURER perience any of these side-effects or any other unexpected effect. As with all medi- Nervous system 250 mg film-coated Each tablet of Tavanic 250mg contains (Who markets Tavanic)
250 mg levofloxacin (equivalent to 256.23 mg
The marketing authorization for Tavanic in the
cines, to prevent serious reactions contact Uncommon: headache, dizziness, drowsi-
Uncommon: increase or decrease in the
a doctor immediately when you experi-
UK is held by Hoechst Marion Roussel Ltd,
Broadwater Park, Denham, Uxbridge, Middle-
ence a severe side-effect or a side-effect Rare: feeling like tingling, e.g. in the hands
Rare: decrease in the number of blood plate-
with sudden onset or fast progression.
(paraesthesia), trembling, “fits” (convulsions)
lets leading to a tendency to bruise and bleed
500 mg levofloxacin (equivalent to 512.46 mg
The marketing authorization for Tavanic in Ire-
HOW TO STORE THIS MEDICINE? Very rare: severe decrease in the number of
500 mg film-coated levofloxacin hemihydrate) as active sub- land is held by Hoechst Marion Roussel Ire- Very rare:vision and hearing disorders, distur-
land Ltd, Cookstown, Tallaght, Dublin 24 Ire-
No special precautions are required but it is
bances of taste and smell, numbness. Disor-
white blood cells (agranulocytosis) leading to
best to keep Tavanic tablets in the original
The tablets also contain the following excipi-
ders of movement, including walking difficul-
symptoms such as recurrence or persistence
ents (other ingredients): crospovidone, hy-
of fever, sore throat and feeling more ill again.
promellose, microcrystalline cellulose and
Keep the pack in a safe place, where Isolated cases: decrease in red blood cells
sodium stearyl fumarate. The film-coating
Psychiatric disorders children cannot reach or see it. Tablets
contains hypromellose, titanium dioxide (E
Rare: anxiety, depression, psychotic reac-
can harm them.
crease in the number of all types of blood cells.
171) talc, macrogol, yellow ferric oxide (E 172)
THERAPEUTIC INDICATIONS (Why have Tavanic tablets been pre- Very rare: hallucinations, psychotic reactions
Liver, kidney REMEMBER this medicine is forYOU. Only PHARMACEUTICAL FORM AND CON- scribed?)
with risk of suicidal thoughts or actions. Common: increase in blood levels of liver en-
a doctor can prescribe it for you. Never
Tavanic is used to treat infections due to bac-
give it to other people. It may harm them, (What do the tablets look like?)
teria against which the medicine is active. Cardiovascular system Uncommon: blood test abnormalities due to
even if they have the same symptoms as
250 mg tablets are pale yellowish-white to
Some infections which the tablets can be used
Rare: abnormally rapid beating of the heart,
you.
reddish white, oblong (approximately 13 mm
to treat are: infections of the sinuses, chest in-
Very rare: inflammation of the liver; distur-
fections in patients with long standing breath-
Do not use the tablets after the expiry date
Very rare : circulatory collapse (anaphylactic
Patient Information Leaflet
long and 6 mm wide), with a score line.
bances of kidney function and occasional kid-
shown on the packaging. If the tablets go out
500 mg tablets are pale yellowish-white to
ing difficulties, pneumonia, urinary tract infec-
ney failure which may be due to allergic kidney
of date, take them to your pharmacist so that
Please read this leaflet carefully before you
reddish white, oblong (approximately 16 mm
tions, skin infections and infection of the pros-
Isolated cases:heart disorders, possibly lead-
start to take your medicine.
long and 8 mm wide), with a score line.
This leaflet gives you important information
Other reactions
250 mg tablets are packed in blister strips, and
about this medicine. It is continually updated. INFORMATION NECESSARY Muscles, tendon, bones DATE OF LAST REVISION OF THIS
If you have any questions, or are not sure about
are available in pack sizes of 1, 5 & 10 tablets. TAKING TAVANIC Rare: tendon pain and inflammation (tendini-
Any antibacterial treatment that kills certain
PATIENT INFORMATION LEAFLET
anything, ask your doctor or pharmacist.
500 mg tablets are packed in blister strips, and
Contra-indications
germs may lead to a disturbance of the micro-
are available in pack sizes of 1, 5 & 10 tablets. (When you should not take Tavanic tab- Very rare: tendon rupture (e.g.: Achilles ten-
organisms (bacteria / fungi) that are normally
PHARMACOTHERAPEUTIC GROUP lets?)
don).As with other fluoroquinolones, this side-
found in humans. Consequently, the number
OTHER INFORMATION NAME OF THE PRODUCT (What type of medicine isTavanic tablets?)
Do not take the tablets if you have ever had an
effect may occur within 48 hours after starting
of other bacteria or fungi may increase, which
The information in this leaflet applies only to
Levofloxacin, the active ingredient of Tavanic
allergic reaction to levofloxacin, any other qui-
TAVANIC® 250 mg film-coated tablets tablets,isasyntheticantibacterialagentofthe nolone antibiotic or to any of the other ingredi- TAVANIC® 500 mg film-coated tablets fluoroquinolone class (antibiotic) for oral ad- ents (which are listed above under point levofloxacin
Otherwise you could have a similar reaction to
sucralfate, the efficacy of Tavanic may be re-
immediately and rest the affected limb to avoid
Most people need a dose of one or two tablets
doctor or get other medical advice. If possible,
General allergic reactions, skin reactions
tendon damage. Do not take the next dose of
take your tablets or the box with you to show
Do not take the tablets if you suffer from epi-
USE).The tablets lead to an increase in bleed-
Tavanic tablets unless your doctor tells you to
Patients with reduced kidney activity (renal in-
the doctor.The consequences of an overdose
Rare: general allergic reactions (anaphylactic
lepsy, otherwise, your risk of getting “fits” (con-
ing in patients taking Vitamin K anatagonists,
(see also under CONTRA-INDICATIONS).
sufficiency) may need lower doses than pa-
/ anaphylactoid reactions) (which may some-
such as warfarin. With other medicines the
such as confusion, dizziness, impairment of
times occur even after the first dose and which
Do not take the tablets if you have ever had
risk of getting “fits” may be increased (with
severe, persistent and/or bloody diarrhoea
The tablets may be taken during meals or at
may develop fast within minutes or hours of
tendon problems (e.g. tendinitis) related to
fenbufen or similar medicines against rheu-
during or after treatment with the tablets.This
any time between meals. Swallow the tablets
heart disorders, possibly leading to abnormal
intake) with symptoms such as wheals (urti-
treatment with an antibiotic of the fluoroqui-
matic pain and inflammation, or with theophyl-
may be a sign of a serious bowel inflammation
with a glass of water. If you take magnesium-
heart rhythm. In the event of overdose treat-
caria), cramping of the bronchi and possibly
nolone class.This is because there is a risk of
line). Probenecid and cimetidine reduce your
(pseudomembranous colitis) which can occur
or aluminium-containing antacids (medicines
ment is according to symptoms. Levofloxacin
severe breathing problems, as well as in very
getting similar problems with Tavanic, includ-
kidneys ability to get rid of your medicine, this
following treatment by antibiotics, and it may
against heartburn and stomach pain), sucral-
is not removed from the body by dialysis. No
rare cases swelling of the skin and mucous
is unlikely to have any clinical relevance.Your
fate (medicines for protecting the stomach
membranes (e.g.in the face and throat).
Do not take the tablets if you are pregnant or
medicine may also prolong the effect of ciclo-
wall) or medicines containing iron salts (used
Very rare: sudden drop in blood pressure or
(What to do if you forget a dose of Tavan-
breast-feeding a baby. Tavanic could harm
Patients with some abnormalities of an en-
to treat anaemia) do not take them at the same
collapse (shock). Such general allergic reac-
ic?) Other precautions
time as Tavanic.Take these medicines at least
tions may sometimes be preceded by e.g.mild
If you forget to take a dose, take it as soon as
The tablets are only intended for adults and
The risk of getting “fits” may also be increased
genase (G6-PD) (a rare heriditary disease)
2 hours before or after Tavanic. Otherwise,
you remember, unless it is nearly time for your
must not be given to children or growing teen-
if in the past you have experienced brain dam-
may be prone to destruction of red blood cells
they may reduce the absorption and efficacy
Increased sensitivity of the skin to sun and
next dose. Do not double-up on the next dose
agers. They could harm the cartilage of their
age (such as stroke or severe brain injury) and
(hemolysis) when treated with quinolone anti-
are now treated with Tavanic. (You should not
bacterial agents, and so levofloxacin should
Isolated cases: severe blistering reactions of
(How long should Tavanic tablets be Tell your doctor if you have had any problems
take the tablets if you suffer from epilepsy).
be used with caution in these patients. SIDE-EFFECTS taken?) with taking medicines in the past.
Make sure your doctor knows about your med-
Johnson syndrome), toxic epidermal necroly-
(What special precautions should be tak- (What side-effects may occur?)
ical history, so he can give you appropriate ad-
sis (Lyells' syndrome) and erythema exsudati-
en when driving a car or operating machin-
The side-effects in this section are given with
type and severity of your infection. It is impor-
WARNINGS ery?)
an estimation of the frequency with which they
tant to finish your course of tablets as pre-
PRECAUTIONS FOR USE
Do not stay out in strong sunlight for unneces-
Some side-effects like dizziness, drowsiness,
may occur. For this purpose the following
Gastro-intestinal, metabolism
scribed by your doctor. Do not stop, even if you
(What special precautions should be tak-
sarily long periods and do not use a sun-lamp
visual disturbances (see also under SIDE-EF-
begin to feel better before you have finished
en?)
or solarium while you are taking Tavanic. This
FECTS) may impair your ability to concentrate
Uncommon: loss of appetite, stomach upset
them all. If you stop the tablets too soon your
Tavanic and other medicines
and react. Do not drive, operate dangerous
Common :side-effects which may occur in 1 to
(dyspepsia), vomiting or pain in the abdominal
condition may get worse. If you feel you have
Tell your doctor about all medicines you are
sensitive to light whilst taking the tablets (sun-
machinery or have similar activities if you feel
to stop because of a side-effect, tell a doctor
taking including any that you bought without a
that your ability to concentrate and react is
Uncommon : side-effects which may occur in
Rare: bloody diarrhoea which in very rare cas-
immediately to get advice before taking the
prescription, as some of them could have an
Tavanic may in rare cases cause pain and in-
es may be indicative of enterocolitis (inflam-
interaction with Tavanic. Furthermore, do not
flammation in tendons, particularly in elderly
Rare : side-effects which may occur in less
mation of the bowel), including pseudomem-
take any new medicine without consulting your
patients or in patients taking corticosteroids
INSTRUCTIONS FOR USE (What to do if you take too muchTavanic?)
branous colitis. (see also under Special Warn-
(cortisone and similar medicines).If you expe-
(When and how to take Tavanic tablets?)
If you accidentally take one tablet too many,
Very rare : side-effects which may occur in
When taking the tablets and iron salts, mag-
rience any tendon complaints whilst or shortly
Your doctor will tell you how many tablets to
nothing is likely to happen. If you accidentally
Very rare: decrease in blood sugar to a too low
nesium- or aluminium-containing antacids or
after taking the tablets, seek medical advice
take, at what time and for how long.
take several tablets too many, contact your
Isolated cases : even more rare.
level (hypoglycaemia) which may be of special
EXERCISES FOR FIRST DAY 1. Monograph Find a monograph on purification of sewage water. The book must be found in one of Padova libraries and to be available for loan • ______________________________________________________________ • ______________________________________________________________ • ______________________________________________________________ • _________________