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OXYTETRACYCLINE 250 MG TABLETS

Active substance(s): OXYTETRACYCLINE DIHYDRATE

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TEVA UK Ref:

231-30-63434-W LEA OXYTETRACYCLINE 250mg TAB 28 TUK

Version:

3

12 October 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

(Main)

Pharma code 194

REG0075296

• kaolin (to treat diarrhoea)
• quinapril (to control high blood pressure)
• atovaquone (to treat and prevent
infections such as malaria or pneumonia)
PACKAGE LEAFLET: INFORMATION
• other bactericidal drugs (e.g. penicillin)
FOR THE USER
• anticoagulants (to prevent blood clots)
Read all of this leaflet carefully before you
e.g. warfarin
start taking this medicine.
• strontium ranelate (to treat osteoporosis)
• Keep this leaflet. You may need to read it • retinoids (to treat acne) e.g. tretinoin or
again.
acitretin
• If you have any further questions, ask
• cytotoxic drugs (to treat cancer) e.g.
your doctor or pharmacist.
methotrexate
• This medicine has been prescribed for
• ergot alkaloids (to treat migraines) e.g.
you. Do not pass it on to others. It may
ergotamine or methysergide
harm them, even if their symptoms are
• oral contraceptives (birth control pill), as
the same as yours.
this could cause contraceptive failure. It is
• If you get any side effects, talk to your
recommended that you use other forms
doctor or pharmacist. This includes any
of contraception such as the diaphragm
possible side effects not listed in this
or condom whilst you are taking
leaflet. See section 4.
oxytetracycline, and continue for 7 days
IN THIS LEAFLET:
after the course of oxytetracycline has
1. What Oxytetracycline is and what it is
been completed.
used for
Tell your doctor if you are to undergo a
2. Before you take Oxytetracycline
surgical procedure requiring a general
3. How to take Oxytetracycline
anaesthetic because methoxyflurane (a type
4. Possible side effects
of anaesthetic) should not be used if you are
5. How to store Oxytetracycline
taking Oxytetracycline.
6. Further information
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
WHAT
OXYTETRACYCLINE
IS
AND
1
medicines, including medicines obtained
WHAT IT IS USED FOR
without a prescription.
• Oxytetracycline is an antibiotic, and is
used to treat infections caused by certain Important information about some of the
bacteria. These infections include lung and ingredients of Oxytetracycline
• Patients who are intolerant to lactose
chest infections (including pneumonia),
should note that Oxytetracycline tablets
urinary tract infections, and some fevers.
contain a small amount of lactose. If your
doctor has told you that you have an
2 BEFORE YOU TAKE
intolerance to some sugars, talk to your
OXYTETRACYCLINE
doctor before taking this medicine
DO NOT take Oxytetracycline if you:
• Your tablets also contain Tartrazine (E102),
• are allergic (hypersensitive) to
which may cause allergic reactions.
oxytetracycline or any of the other
Taking Oxytetracycline with food and drink
ingredients of this medicine
• Food, milk and some dairy products may
• are pregnant or breast-feeding
interfere with the way the oxytetracycline
• are allergic to tetracycline antibiotics
is absorbed in your body. Therefore, you
• have problems with your kidneys, unless
should take these tablets on an empty
considered essential by your doctor
stomach (at least one hour before, or two
• are a child under 12 years of age, because
hours after meals, or milk and dairy
there is a risk of permanent tooth
products).
discolouration and a thinning effect on
Pregnancy
and breast-feeding
the tooth enamel.
• DO NOT take Oxytetracycline if you are
Take special care with Oxytetracycline
pregnant, planning to become pregnant
Talk to your doctor before you start to take
or breast-feeding
Oxytetracycline if you:
• Pregnant women should not take this
• have myasthenia gravis (a disorder in
medicine as it can affect the bone and
which the muscles are weak and tire
tooth development in the developing baby
easily)
• Breast-feeding women should not take
• have acute porphyria (a deficiency of
this medicine as it can pass into breast
specific enzymes within the body,
milk and affect the tooth formation of the
causing an increase in substances called
baby
porphyrins)
• Ask your doctor for advice before taking
• have problems with your liver, or if you
any medicine.
are taking any drugs which may
Driving and using machines
potentially harm your liver
• Oxytetracycline is not known to affect
• have systemic lupus erythematosus (a
your ability to drive or operate
disease that causes the body tissues to
machinery.
become inflamed and swollen), as this
may be made worse by taking
3 HOW TO TAKE OXYTETRACYCLINE
Oxytetracycline
• are sensitive to sunlight or are exposed
Always take Oxytetracycline exactly as your
to ultraviolet light or direct sunlight
doctor has told you. You should check with
• suffer from thrush whilst being treated
your doctor or pharmacist if you are not sure.
with antibiotics
It is important to take the tablets at regular
• are suffering from syphilis.
intervals and to take the full course to
Taking other medicines
prevent the infection returning, unless your
Talk to your doctor if you are taking any of
doctor advises otherwise.
the following:
The tablets should be swallowed preferably
• any antacids for indigestion containing
aluminium, magnesium, calcium, zinc or with plenty of water on an empty stomach
(at least one hour before, or two hours after
iron salts, as they may interfere with the
meals).
way the oxytetracycline is absorbed in
• DO NOT take indigestion remedies or
your body
medicines containing aluminium,
• ulcer healing drugs, e.g. ranitidine,
magnesium, calcium, zinc, or iron at the
bismuth citrate; sucralfate and
same time of day as this medicine
tripotassium dicitrobismuthate

Version 1.8

Approved

Top of page cut-off to middle of registration mark: 44 mm.

OXYTETRACYCLINE
250 mg TABLETS

Page 1 of 3

TEVA UK Ref:

231-30-63434-W LEA OXYTETRACYCLINE 250mg TAB 28 TUK

Version:

3

12 October 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• DO NOT take Oxytetracycline
immediately before going to bed as the
risk of certain side effects may be
increased.
The usual dose is:
• Adults, the elderly and children over 12
years of age:
250-500 mg (one or two tablets) four
times a day, depending on the severity of
the condition.
• Children under 12 years of age:
Oxytetracycline must not be used by
children under 12 years of age.
If you take more Oxytetracycline than you
should
If you (or someone else) swallow a lot of the
tablets all together, or if you think a child
has swallowed any of the tablets, contact
your nearest hospital casualty department
or your doctor immediately. Please take this
leaflet, any remaining tablets and the
container with you to the hospital or doctor
so that they know which tablets were
consumed.
If you forget to take Oxytetracycline
If you forget to take a tablet, take one as
soon as you remember, unless it is nearly
time to take the next one. DO NOT take a
double dose to make up for a forgotten dose.
If you stop taking Oxytetracycline
You should continue to take these tablets for
as long as your doctor tells you to. Even if
you start to feel better, the original infection
may still be present and may reappear if
treatment is stopped before you have taken
the full course.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Oxytetracycline can
cause side effects, although not everybody
gets them.
Stop taking the tablets and tell your doctor
immediately or go to the casualty
department at your nearest hospital if the
following happens:
• an allergic reaction causing swelling of
the lips, face or neck leading to severe
difficulty in breathing, or severe skin rash
or hives
• in adults symptoms like headache and
loss of vision, which may indicate the
possibility of increased pressure or
swelling in the brain
• severe blistering and ulceration of the
mouth, eyes, gut and genitals; these may
be due to Stevens-Johnson Syndrome,
which is a serious illness.
These are very serious but rare side effects.
You may need urgent medical attention or
hospitalisation.
The following side effects have also been
reported:
• stomach upset (feeling sick, being sick,
diarrhoea)
• abdominal pain, and severe or bloody
diarrhoea, which may be due to
inflammation of the colon or intestine
• pancreatitis (inflammation of the
pancreas) causing severe abdominal and
back pain, fever and feeling sick
• difficulty in swallowing, swollen and
painful tongue
• loss of appetite
• chest pain, breathing difficulties or fever
caused by inflammation of the tissue
around the heart (pericarditis)
• worsening of systemic lupus
erythematosus (an allergic condition
which causes joint pain, skin rashes and
fever)

REG0075296

Version 1.8

Approved

• skin irritations including itching, rash, red,
swollen and painful skin, scaling of the
skin or flaking skin
• sensitivity to sunlight
• anaemia (reduction in number of red
blood cells)
• blood disorders characterised by
abnormal bruising of the skin
• infections of the genitals or anus, such as
thrush
• rise in blood urea
• liver problems such as hepatitis
• bulging soft spot on the head has been
reported in infants
• rarely, swelling, pain and formation of
ulcers in the oesophagus (gullet) has
occurred, but in most cases this was
when the medication was taken
immediately before going to bed.
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

5 HOW TO STORE

OXYTETRACYCLINE

Keep out of the reach and sight of children.
These tablets should be stored in the
package or container supplied.
Do not use Oxytetracycline after the expiry
date that is stated on the outer packaging.
The expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6 FURTHER INFORMATION
What Oxytetracycline tablets contain:
• The active ingredient is 250 mg of
oxytetracycline
• The other ingredients are lactose
monohydrate, maize starch,
pregelatinised maize starch, sodium
starch glycolate (Type A), magnesium
stearate (E572), anhydrous colloidal silica
and sodium lauryl sulfate. The coating
contains, hypromellose (E464),
polyethylene glycol 4000, purified talc
(E553(b)), and the colours, tartrazine
(E102) and titanium dioxide (E171). The
tablets are polished with carnauba wax
(E903).
What Oxytetracycline tablets look like and
contents of the pack:
• Oxytetracycline tablets are yellow
film-coated biconvex tablets engraved
1C5 one side and plain on the reverse
• The product is available in pack sizes of 7,
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110,
112, 120, 150, 160, and 168 tablets.
• See outer packaging or the pharmacy
label for contents i.e. the number of
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder and
company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: October 2015
PL00289/0167

63434-W

Page 2 of 3

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-pil-uk-pl-00289-0167-oxytetracycline-250mg-tablets

APPROVALS
Signed by
Michael Silvester

REG0075296

Meaning of Signature
Regulatory Affairs Approval

Version 1.8

Approved

Server Date
15-Oct-2015 01:05:55 PM

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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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