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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

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