Oxytetracycline 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxytetracycline dihydrate

Available from:

Dalkeith Laboratories 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: 5039290001089

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 Tablets BP 250 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablets contains Oxytetracycline 250.0 mg (as dihydrate).
Excipients with known effect:
Lactose 13.44 mg
Sucrose 180 mg
Tartrazine (E102) approximately 0.24 mg.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Coated tablet.
Round, yellow, sugar coated tablets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of infections due to Chlamydia, Brucella, Mycoplasma,
Rickettsia,
and other sensitive organisms. May also be used for prophylaxis and
treatment of chronic bronchitis, non-gonococcal urethritis,
gonorrhoea,
syphilis, other urinary tract infections and severe acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tablets should preferably be taken on an empty stomach (1 hour
before food or 2
hours after).
Adults, the elderly and children over 12 years:
Normal dose is 250 – 500 mg every 6 hours (4 times a day). This may
be increased in
severe infections.
For acne the dose is usually 250 mg three times a day for 4 weeks, but
this may be
prolonged if necessary.
Children under 12 years of age: Not to be given.
Route of administration
For oral administration.
4.3
CONTRAINDICATIONS
Must not be given to children under 12 years.
Known hypersensitivity to the active substance or to any of the
excipients listed in
section 6.1.
Chronic renal or hepatic dysfunction.
Pregnancy or breastfeeding.
Systemic lupus erythematosus (SLE).
Patients receiving vitamin A or retinoid therapy.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Tetracycline drugs may cause permanent tooth discoloration
(yellow-grey-brown), if
administered during tooth development, in the last half of pregnancy
and in infancy up
to twelve years of age. Enamel hypoplasia has also been reported. This
adverse reaction
is more common during long-term use of the drug but has been observed
following
repeated short term courses
The anti-anabolic action of tetracyclines