Each capsule contains Main ingredient: 250 mg hydrochlorate tetracycline.
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, impetigo).
Significant hypersensitivity towards tetracycline or other components of this drug.
As occurs with other antibiotics, 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 Childhood
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 anti-bacterial activities.
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 antibiotics but has also been observed following brief but repeated treatments.
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 renal insufficiency.
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 derivatives.
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 chemist.
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