Oxytetracycline 250mg tablets

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Oxytetracycline dihydrate

Disponible desde:

Bristol Laboratories Ltd

Código ATC:

J01AA06

Designación común internacional (DCI):

Oxytetracycline dihydrate

Dosis:

250mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010300; GTIN: 5060013942372

Información para el usuario

Package Leaflet: Information for the user
OXYTETRACYCLINE TABLETS BP
250MG
(Oxytetracycline dihydrate)
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
•
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What this medicine and what it is used for
2.
What you need to know before you take
this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1. What this medicine is and
what it is used for
Oxytetracycline belongs to a group of medicines
called tetracycline-antibiotics. It is also known as a
broad spectrum antibiotic and may be used to treat
a wide range of infections caused by bacteria.
These include:
•
lung infections such as pneumonia, bronchitis
whooping cough
•
urinary tract infections
•
sexually transmitted diseases such as
chlamydia, gonorrhoea or syphilis
•
skin infections such as acne
•
infections of the eye such as conjunctivitis
•
rickettsial infections such as Q fever or tick fever
(severe headache, rash, high fever)
•
other
infections
including
brucellosis
(headache, sickness, fever, swollen lymph
nodes), psittacosis (headache, nose bleeds,
shivering, fever), plague (painful swelling of
the lymph nodes), cholera (severe sickness
and diarrhoea)
•
leptospirosis (fever causing jaundice or
meningitis), gas-gangrene and tetanus (lock
jaw).
2. What you need to know before you
take this medicine
Do not take this medicine if:
•
You are allergic to the tetracycline group of
drugs or to any of the other ingredients of this
medicine (liste

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Oxytetracycline Tablets BP 250 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 269.57 mg of oxytetracycline dihydrate equivalent
to
250mg of oxytetracyline.
Excipients with known effect: Also contains sucrose, glucose and
tartrazine
aluminium lake (E102).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A yellow sugar-coated tablet with a smooth polished surface
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxytetracycline is a bacteriostatic broad-spectrum antibiotic, active
against a
wide variety of Gram-positive and Gram-negative organisms.
Infections caused by oxytetracycline-sensitive organisms include:
1)
_Respiratory tract infections_: Pneumonia, whooping cough and other
lower
respiratory tract infections due to susceptible strains of
_Streptococcus _
_pneumoniae_, _Haemophilus influenzae, Klebsiella pneumoniae_ and
other
organisms. _Mycoplasma pneumoniae_ pneumonia. Treatment of chronic
bronchitis (including the prophylaxis of acute exacerbations).
2)
_Urinary tract infections_: caused by susceptible strains of the
Klebsiella
species. Enterobacter species, _Escherichia coli, Streptococcus
faecalis_ and
other organisms.
3)
_Sexually transmitted diseases_: Infections due to _Chlamydia
trachomatis_
including uncomplicated urethral, endocervical or rectal infections.
Non-
gonococcal urethritis caused by _Ureaplasma_ _urealyticum_.
Oxytetracycline is
also indicated in chancroid, granuloma inguinale and lymphogranuloma
venereum. Oxytetracycline is an alternative drug in the treatment of
gonorrhoea and syphilis.
4)
_Skin Infections_: Acne vulgaris when antibiotic therapy is considered
necessary
and severe rosacea.
5)
_Ophthalmic infections_: Trachoma, although the infectious agent, as
judged by
immunofluorescence, is not always eliminated. Inclusion conjunctivitis
may
be treated with oral oxytetracycline alone or in combination with
topical
agents.
6)
_Rickettsial infections_: Rocky Mountai