TETRACYCLINE TABLETS 250MG

Active substance: TETRACYCLINE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

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

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Tetracycline Hydrochloride BP 279.70 m
Also contains colourant E110. For full list of excipients see 6.1.

3

PHARMACEUTICAL FORM
Film-coated tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
ECONOMYCIN is indicated in the treatment of infections due to sensitive
organisms and particularly those affecting the respiratory tract, gastrointestinal 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
Tablets should be swallowed whole with a glass of water one hour before or
two hours after a meal.
Adults:
The usual dose - 1 g per day in 4 divided doses of 250 mg or 2 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 kg should be given the recommended
adult dose.
Elderly:
Economycin should be used with caution in the treatment of elderly patients
where accumulation is a possibilty.
Therapy for most infections should be continued for 24-48 hours after the
patient has become asymptomatic or afebrile.
ECONOMYCJN is taken by mouth

4.3

Contraindications
Tetracycline is contraindicated in:



Renal impairment, as tetracyclines may exacerbate renal failure



Acute porphyria



4.4

Known hypersensitivity to tetracycline antibiotics or to any of the other
excipients in Economycin Tablets.

Use during pregnancy or lactation and in children under 12 years of age and - as
deposition of tetracyclines in growing bone and teeth (by binding to calcium)
causes staining and occasionally dental hypoplasia.

Special warnings and precautions for use
The use of tetracycline in general should be avoided in renal impairment; small doses
of the drug may lead to systemic accumulation with possible hepatic toxicity. Under
these conditions lower doses are indicated and Tetracycline serum level
determinations are advisable.
Likewise Tetracycline should be used with caution in patients with hepatic
dysfunction or those taking other potentially hepatotoxic drugs. For patients with
hepatic impairment the maximum recommended daily dose is 1 g.
Antacids and aluminium, calcium, iron, magnesium and zinc salts interfere with the
absorption of tetracycline. Milk also reduces the absorption of tetracycline.

Tetracycline should not be administered to children because a yellow-brown
discolouration of the teeth may occur. Enamel hypoplasia has also 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 (increased muscle weakness) 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.
Economycin tablets contain the colourant Sunset yellow E 110, which can cause
allergic-type reactions including asthma. Allergy is more common in those people
who are allergic to aspirin.

4.5

Interaction with other medicinal products and other forms of interaction
Patients receiving concurrent anti-coagulant therapy (e.g. with coumarins or
phenindone) should have the doses of those drugs reduced because tetracycline
depresses plasma prothrombin activity.
There is a possible increased risk of benign intracranial hypertension when
tetracyclines are given with retinoids and concomitant use should be avoided.
The anaesthetic methoxyflurane increases the risk of kidney failure.
Diuretics may aggravate nephrotoxicity by volume depletion.
Food, milk, and milk products impair absorption of tetracyclines.
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. This includes interactions with Antacids, Bismuth
containing ulcer-healing drugs (e.g. tripotassium dicitratobismuthate), sucralfate and
quinapril (which may contain a magnesium carbonate excipient). Dosages should be
maximally separated.
The absorption of tetracyclines is also reduced by strontium ranelate, colestipol,
colesytramine and possibly by kaolin.
Atovaquone plasma concentration is reduced by tetracycline.
The concomitant use of tetracycline may reduce the efficacy of oral contraceptives.
It is advisable to avoid giving tetracyclines in conjunction with penicillin.
There is an increased risk of ergotism when tetracyclines are given with ergotamine
and methysergide

4.6

Pregnancy and lactation
Tetracyclines should only be used during pregnancy or lactation if absolutely
essential.
Animal studies show effects on skeletal development in the first trimester.
Permanent dental discolouration is a risk associated with the use of oral tetracycline
during the second and third trimesters.
Avoid use whilst breast-feeding, (although absorption and therefore discoloration of
teeth in infant may be prevented by chelation with calcium in milk).

4.7

Effects on ability to drive and use machines
Not applicable

4.8

Undesirable effects
The following undesired events, listed by body system, have been reported with
tetracyclines:
Infections and Infestations
Overgrowth of resistant organisms may cause candidiasis, pseudomembranous colitis
(Clostridium difficile overgrowth), glossitis, stomatitis, vaginitis and staphylococcal
enterocolitis.
Blood and the lymphatic system disorders
Rare: Blood disorders (Haemolytic anaemia, thrombocytopenia, neutropenia,
agranulocytosis, aplastic anaemia and eosinophilia)
Immune system disorders
Rare: hypersensitivity reactions including Anaphylaxis
Nervous system disorders
Rare: Headache, visual disturbances (including blurring of vision, scotomata and
diplopia) Permanent visual loss has been reported.
These symptoms may indicate benign intracranial hypertension in juveniles and
adults (in which case discontinue treatment). Increased intra-cranial pressure with
bulging fontanelles has been reported in infants but rapidly disappears when the drug
is withdrawn.
Eye disorders:
(See under nervous system disorders)
Cardiac disorders
Rare: Pericarditis

Gastrointestinal disorders
Nausea, vomiting, diarrhoea, dysphagia, oesophagitis and oesophageal ulceration
(usually when taken before bed or with inadequate fluids),
Occasionally antibiotic associated colitis.
Tetracycline should not be administered to children because a yellow-brown
discolouration of the teeth may occur. Teeth discolouration has occurred in adults,
but it is usually only obvious after repeated doses.
Rare: pancreatitis
Hepato-biliary disorders
Rare: Hepatotoxicity, hepatitis, jaundice and hepatic failure
Skin and subcutaneous tissue disorders
Rare: Photosensitivity, Erythematous, and macropapular rash, skin discoloration,
pruritis, bullous dermatoses, hypersensitivity reactions including rash, exfoliative
dermatitis, exacerbation of systemic lupus erythematosus, Stevens-Johnson
syndrome, urticaria, angioedema,
Congenital, Familial and Genetic Disorders
Enamel hypoplasia has been reported.
Renal and Urinary Disorders
Acute renal failure
Investigations
Rare: transient increases in liver function tests

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
Povidone
Microcrystalline cellulose
Sodium starch glycollate
Magnesium stearate
Industrial methylated spirit
Opaspray K-1-2410 E110
Hydroxypropylmethylcellulose
Ethylcellulose
Diethylphthalate

6.2

Incompatibilities
None known.

6.3

Shelf life
24 months.

6.4

Special precautions for storage
Store below 25ºC in a dry place in well closed containers.

6.5

Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers
with polypropylene or polythene lids and polyurethane/polythene inserts.
Pack sizes: 100, 500 & 1000.

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 33414/00111

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

10

DATE OF REVISION OF THE TEXT
02/10/2009

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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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