Oxytetracycline 250 Mg Tablets
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Pharma code 194
(Main)
OXYTETRACYCLINE 250 mg TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Oxytetracycline is and what it is used for
2. Before you take Oxytetracycline
3. How to take Oxytetracycline
4. Possible side effects
5. How to store Oxytetracycline
6. Further information
OWHAT OXYTETRACYCLINE IS AND WHAT IT IS USED FOR
• Oxytetracycline is an antibiotic, and is used to treat infections caused by certain bacteria. These infections include lung and chest infections (including pneumonia), urinary tract infections, and some fevers.
©BEFORE YOU TAKE OXYTETRACYCLINE
DO NOT take Oxytetracycline if you:
• are allergic (hypersensitive) to oxytetracycline or any of the other ingredients of this medicine • are pregnant or breast-feeding • are allergic to tetracycline antibiotics • have problems with your kidneys, unless considered essential by your doctor • are a child under 12 years of age, because there is a risk of permanent tooth discolouration and a thinning effect on the tooth enamel.
Take special care with Oxytetracycline Talk to your doctor before you start to take Oxytetracycline if you:
• have myasthenia gravis (a disorder in which the muscles are weak and tire easily) • have acute porphyria (a deficiency of specific enzymes within the body, causing an increase in substances called porphyrins) • have problems with your liver, or if you are taking any drugs which may potentially harm your liver • have systemic lupus erythematosus (a disease that causes the body tissues to become inflamed and swollen), as this may be made worse by taking Oxytetracycline • are sensitive to sunlight or are exposed to ultraviolet light or direct sunlight • suffer from thrush whilst being treated with antibiotics • are suffering from syphilis.
Taking other medicines
Talk to your doctor if you are taking any of
the following:
• any antacids for indigestion containing aluminium, magnesium, calcium, zinc or iron salts, as they may interfere with the way the oxytetracycline is absorbed in your body
• ulcer healing drugs, e.g. ranitidine, bismuth citrate; sucralfate and tripotassium dicitrobismuthate
• kaolin (to treat diarrhoea)
• quinapril (to control high blood pressure)
• atovaquone (to treat and prevent infections such as malaria or pneumonia)
• other bactericidal drugs (e.g. penicillin)
• anticoagulants (to prevent blood clots) e.g. warfarin
• strontium ranelate (to treat osteoporosis)
• retinoids (to treat acne) e.g. tretinoin or acitretin
• cytotoxic drugs (to treat cancer) e.g. methotrexate
• ergot alkaloids (to treat migraines) e.g. ergotamine or methysergide
• oral contraceptives (birth control pill), as this could cause contraceptive failure. It is recommended that you use other forms of contraception such as the diaphragm or condom whilst you are taking oxytetracycline, and continue for 7 days after the course of oxytetracycline has been completed.
Tell your doctor if you are to undergo a surgical procedure requiring a general anaesthetic because methoxyflurane (a type of anaesthetic) should not be used if you are taking Oxytetracycline.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Important information about some of the ingredients of Oxytetracycline
• Patients who are intolerant to lactose should note that Oxytetracycline tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine
• Your tablets also contain Tartrazine (E102), which may cause allergic reactions.
Taking Oxytetracycline with food and drink
• Food, milk and some dairy products may interfere with the way the oxytetracycline is absorbed in your body. Therefore, you should take these tablets on an empty stomach (at least one hour before, or two hours after meals, or milk and dairy products).
Pregnancy and breast-feeding
• DO NOT take Oxytetracycline if you are pregnant, planning to become pregnant or breast-feeding
• Pregnant women should not take this medicine as it can affect the bone and tooth development in the developing baby
• Breast-feeding women should not take this medicine as it can pass into breast milk and affect the tooth formation of the baby
• Ask your doctor for advice before taking any medicine.
Driving and using machines
• Oxytetracycline is not known to affect your ability to drive or operate machinery.
^ HOW TO TAKE OXYTETRACYCLINE
Always take Oxytetracycline exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
It is important to take the tablets at regular intervals and to take the full course to prevent the infection returning, unless your doctor advises otherwise.
The tablets should be swallowed preferably with plenty of water on an empty stomach (at least one hour before, or two hours after meals).
• DO NOT take indigestion remedies or medicines containing aluminium, magnesium, calcium, zinc, or iron at the same time of day as this medicine
Top of page cut-off to middle of registration mark: 44 mm.
TEVA UK LIMITED
• 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.
^ 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)
• 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
©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.
^ 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, 168, 1000, 5000 and 20000 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:
November 2010
PL00289/0167
TFWTI 63434-V