Each capsule contains Main ingredient: 250 mg
Excipients: Magnesium stearate, cornstarch,
titanium dioxide, indigotin, gelatine.
Boxed blister of 16 250-mg capsules
Wide ranging anti-bacterial antibiotic
Infections resulting from micro-organisms that
are sensitive to tetracycline, in particular:
Bacterial pneumonia and bronchial pneumonia
Acute infections in the urogenital area and renewal of acute phase
Surgical infections (infections of soft tissue, osteomyelitis)
Acute and subacute infections of the intestinal tract, bacterial and
amoebic dysentery, dysenteric syndrome in adults and children
Acute and subacute endocarditis
Epidemic cerebrospinal meningitis and purulent meningitis in general
Problems related to ear, nose and throat (tonsillitis, otitis, sinusitis,
mastoiditis), eyes (conjunctivitis, blepharitis, trachoma), gynaecological
disorders (adnexitis, metritis, cervicitis, vulvovaginitis) and skin disorders (furuncolisis,
Significant hypersensitivity towards tetracycline
or other components of this drug.
As occurs with other anti-biotics, treatment with
tetracycline can give rise to super-infections from bacterial agents or fungi.
Bear in mind the possibility of enterocolitis as a result of resistant
staphylococci or from Clostridium difficile. In the treatment of gonococcal
infections, be aware of the risk of its concealing the symptoms of co-existing
syphilis. In such cases, it is advisable to carry out serological controls for
at least 4 months.
Given that tetracycline's can depress
prothrombinic activity, it may be necessary to adapt the dosages of
anti-coagulants that may be used during the administration of tetracycline.
Long-term treatment cycles require periodic
controls of the haematic constitution and hepatic and renal functioning.
If tetracycline's are employed in the treatment
of infections from beta haemolytic Streptococcus (Group A), treatment should
last no less than ten days.
Use During Pregnancy, Nursing and Early
This product is to be used during pregnancy,
nursing and early childhood only when absolutely necessary and always under a
doctor's direct supervision.
Taking this medicine with penicillin is
inadvisable due to the possibility of interference following the respective
Antacid preparations with aluminium, calcium,
magnesium, in addition to dairy products reduce the oral absorption of
tetracycline. Their simultaneous ingestion should thus be avoided.
In bone tissue in the process of formation,
tetracycline can cause a stable calcium complex to form, although no
particularly harmful effects have been reported in man. The use of tetracycline
during the period of tooth formation (second half of pregnancy, post-natal
period and early childhood may cause yellow-brown pigmentation to form on
permanent teeth. This has been verified above all in prolonged treatment with
these anti-biotics but has also been observed following brief but repeated
Predisposed patients may suffer photosensitive
reactions in the course of treatment. Bear in mind this possibility and
interrupt treatment as soon as any cutaneous erythema appears.
In subjects suffering from renal insufficiency
even normal doses of tetracycline can cause an accumulation in the circulation
with the chance of hepatic damage. In such cases it is necessary to adapt the
dosage to the level of renal functionality, resorting, depending on the
individual case, to controls of haematic levels (which must never exceed 15
mcg/ml) and hepatic functioning. Moreover, it must be remembered that
tetracycline's prompt an anti-anabolic action that might aggravate states of
To avoid irritating the oesophagus, take the
product with a sufficient amount of water.
Using this product may occasionally cause
super-infections in sensitive organisms.
Taking into account the possibility of resistant
germs, when one is not sure of germ sensitivity with regard to the antibiotic,
appropriate bacteriological tests are necessary.
Tetracycline should not be used as a priority
treatment in staphylococcal infections or those of the primary respiratory
tracts (pharingo-tonsillitis, etc) from beta-haemolytic Streptococcus (A).
Tetracycline's that are not in proper condition (expired) can produce polyuria,
glycosuria, aminociduria, proteinuria. Storing the product for too long in a
warm, moist atmosphere can encourage the formation of nephrotoxic tetracycline
Directions For Use
Recommended daily oral dosage varies from 15 to
25 mg/kg of body weight. In very serious cases, the dosage may be increased
according to the doctor's criterion.
In an adult of average weight, this is in
practice 4-6 250-mg capsules per day and thus one capsule every 6-4 hours. The
duration of treatment depends on the subsiding of fever and overall health
improvement. Once the phase of acute fever has passed, it is advisable to
prolong treatment, most likely with a reduced dosage, for some days in order to
avoid the possibility of relapse.
In acute staphylococcic infections and
brucellosis, it is a good idea to prolong the treatment (approximately 2 weeks).
With subacute bacterial endocarditis, the treatment should be extended to at
least 6 weeks. In each case the treatment will be stabilised by the doctor on
the basis of the patient's clinical response. Should one or more doses be
missed, consult the doctor who has prescribed it before resuming treatment, for
the correct restoration of the therapeutic pattern.
Throughout tetracycline treatment the following
side effects can be seen:
Gastroenteric symptoms: anorexia, nausea,
vomiting, diarrhoea, glossitis and other inflammations of the mucous membranes
Cutaneous symptoms: eruptions of an erythematous or maculopapular nature
Hypersensitive reactions: urticarial eruptions,
anaphylactic purpura, angioneurotic oedema
Haematological alterations: extremely rare cases
of haemolytic anaemia, neutropenia, trombocytopenia and eosinophilia
Should the patient notice any adverse effect
other than those described here, he is advised to report it to his doctor or
Final Date For Using And Storing This Medicine
Do not use the medicine if the expiry date shown
on its packaging has passed. Remember that the expiry date shown refers to the
unopened product when properly stored.
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN