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TETRACYCLINE CAPSULES 250MG

Active substance(s): TETRACYCLINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Encomycin Capsules 250 mg
Tetracycline Capsules 250 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetracycline Hydrochloride BP 250 mg

3

PHARMACEUTICAL FORM
Capsule

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of infections due to sensitive organisms and particularly
those affecting the respiratory tract, gastro-intestinal tract and genito-urinary
tract, and infections of the skin and soft tissues.
Prophylactically before or after dental and/or surgical procedures.

4.2

Posology and method of administration
Capsules should be swallowed whole with a glass of water one hour before or
two hours after a meal.
Adults:

1 g per day in four divided doses of 250 mg or two divided doses of 500 mg
each. Higher doses may be required to control acute episodes.
Acute gonococcal urethritis 500 mg three times daily for one or two days.
Female patients require more prolonged therapy.
Acne: 500mg twice daily. If no improvement is seen after the first three

months another oral antibiotic should be used.
Children:

Not recommended for children under 12 years of age.
Usual dose for children of 12 years and above: 25 mg/kg/day in 4 divided
doses. Children weighing more than 40 kgs should be given the
recommended adult dose.

Elderly:

Economycin should be used with caution in the treatment of elderly patients
where accumulation is a possibility.

Therapy for most infections should be continued for 24-48 hours after the
patient has become asymptomatic or afebrile.

4.3

Contraindications
Known hypersensitivity to tetracyclines. Renal impairment. Children under
12 years of age. Use during pregnancy or lactation.

4.4

Special warnings and precautions for use
In renal impairment small doses of the drug may lead to systemic
accumulation with possible hepatic toxicity. Under these circumstances lower
doses are indicated and tetracycline serum level determinations are advisable.
Likewise in patients with hepatic dysfunction or when they are taking other
potentially hepatotoxic drugs.
Tetracycline should not be administered to children because a yellow-brown
discolouration of the teeth may occur. Enamel hypoplasia has been reported.
Photosensitivity reactions can sometimes occur. Susceptible patients should
avoid direct exposure to natural or artificial sunlight and discontinue therapy at
the first sign of skin discomfort.
Weak neuromuscular blockade may occur in patients suffering from
Myasthenia Gravis.
Exacerbation of SLE (systemic lupus erythematosus) may occur.
In common with all antibiotics overgrowth of non-susceptible or resistant
organisms may occur. Both cross-sensitisation in patients and cross-resistance
between tetracyclines may develop.
Increased intra-cranial pressure, with bulging of the fontanelles has
occasionally occurred in infants. This condition rapidly disappears when the
drug is withdrawn.

4.5

Interaction with other medicinal products and other forms of interaction
Patients receiving concurrent anti-coagulant therapy should have the doses of
those drugs reduced because tetracycline depresses plasma prothrombin
activity. The anaesthetic methoxyflurane increases the risk of kidney failure.
Atovaquone plasma concentration is reduced by tetracycline.
Tetracyclines bind to di-/tri-valent cations. Absorption from the
gastrointestinal tract is impaired by the concomitant administration of iron,
calcium, aluminium, magnesium, bismuth and zinc salts (interactions with
specified salts, antacids, Bismuth containing ulcer-healing drugs, quinapril,
which may contain a magnesium carbonate excipient).
Food, milk and milk products impair absorption of tetracyclines.
The concomitant use of tetracycline may reduce the efficacy of oral
contraceptives and the concomitant use of retinoids may increase the risk of
benign intracranial hypertension. It is advisable to avoid giving tetracyclines
in conjunction with penicillin.
Diuretics may aggravate nephrotoxicity by volume depletion.

4.6

Pregnancy and lactation
Tetracycline should only be used during pregnancy if absolutely essential.

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
Nausea, vomiting, diarrhoea and on rare occasions dysphagia have been
reported.
Skin reactions have occasionally occurred. The most common reaction is
photosensitivity. Erythematous, and macro-papular rashes, pruritis, bullous
dermatoses, and exfoliative dermatitis and skin discolouration have also been
reported.

A few cases of pancreatitis have been reported. Oesophagitis and oesophageal
ulceration have been reported, usually when taken before bed or with
inadequate fluids.
Hypersensitivity reactions include rash, exfoliative dermatitis, urticara,
angioedema, anaphylaxis, pericarditis and exacerabation of sytemic lupus
erythematosus.
Tetracycline should not be administered to children because a yellowingbrown discolouration of the teeth may occur. Teeth discolouration has
occurred in adults, but is usually only obvious after repeated doses. Enamel
hypoplasia has also been reported.
Increased intra-cranial pressure with bulging of the fontanelles has
occasionally occurred in infants but rapidly disappears when the drug is
withdrawn. Benign intracranial hypertension in juveniles and adults have been
reported indicated by headache and visual disturbances including blurring of
vision, scotomata and diplopia. Permanent visual loss has been reported.
Overgrowth of resistant organisms may cause candidiasis, pseudomembranous
colitis (Clostridium difficile overgrowth), glossitis, stomatitis, vaginitis and
staphylococcal entero-colitis.
On rare occasions transient increases in liver function tests, hepatitis, jaundice
and hepatic failure have been reported.
Haemolytic anaemia, thromocytopenia, neutropenia, agranulocytosis, aplastic
anaemia and eosinophilia have been reported on rare occasions.

4.9

Overdose
Gastric lavage plus oral administration of milk or antacids.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Broad spectrum antibiotic to sensitive organisms.

5.2

Pharmacokinetic properties
Absorption of tetracycline occurs largely in the stomach and small intestine.
Serum concentration is achieved in 2-4 hours. The half-life of tetracycline is
8.5 hours and its volume of distribution 1.3 l/kg. The drug is 35%-50% bound
to plasma proteins.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Maize starch
Sodium starch glycollate
Silicon dioxide
Magnesium stearate
Gelatin
Titanium dioxide
Tartrazine (E102)
Amaranth (E123)

6.2

Incompatibilities
None known.

6.3

Shelf life
36 months.

6.4

Special precautions for storage

Store below 25°C in a dry place in well closed containers.
Keep out of reach of children.

6.5

Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene container
with polypropylene or polythene lids and polyurethane/polythene inserts.
Pack sizes: 100 and 500.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0110

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
09/08/1990

10

DATE OF REVISION OF THE TEXT
27/02/2009

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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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