Oxytetracycline 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxytetracycline dihydrate

Available from:

Crescent Pharma Ltd

ATC code:

J01AA06

INN (International Name):

Oxytetracycline dihydrate

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010300; GTIN: 5017123054136

Patient Information leaflet

PATIENT INFORMATION LEAFLET
OXYTETRACYCLINE TABLETS BP 250 MG
This medicine will be called Oxytetracycline Tablets in this leaflet.
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 Oxytetracycline Tablets are and what they are used for
2.
What you need to know before you take Oxytetracycline Tablets
3.
How to take Oxytetracycline Tablets
4.
Possible side effects
5.
How to store Oxytetracycline Tablets
6.
Contents of the pack and other information
1.
WHAT OXYTETRACYCLINE TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets contain the active ingredient, oxytetracycline.
Oxytetracycline belongs to a group of
medicines called broad spectrum antibiotics. This means that it is
active against a large number of
bacteria which cause infections.
Oxytetracycline Tablets are used to treat a wide range of infections
caused by bacteria. They are
also used for preventing and treating chronic bronchitis, urinary
tract (bladder and kidney)
infections,
pneumonia,
brucellosis,
pertussis
and
venereal
diseases
such
as
syphilis
and
gonorrhoea.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXYTETRACYCLINE TABLETS
DO NOT TAKE OXYTETRACYCLINE TABLETS:
Some people MUST NOT take these tablets. Do not take these tablets if:

You know you are allergic to Oxytetracycline (or any other medicine
belonging to the
tetracycline group of drugs) or you are allergic to any of the other
ingredients of this
medicine (listed in section 6)

You have kidney problems

You suffer from (SLE) systemic lupus erythematosus (an a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxytetracycline 250 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Oxytetracycline 250.0 mg (as dihydrate).
Excipients with known effect:
Each tablet contains lactose 13.44mg, sucrose 180mg and tartrazine
(E102)
approximately 0.24mg.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated tablet.
Plain
round
biconvex
, yellow, sugar coated tablets.
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: _Ro