OXYTETRACYCLINE TABLETS BP 250MG (Oxytetracycline dihydrate)

Please read this entire leaflet carefully before you start taking this medicine. Even if you have used this medicine or a similar product before, you should read this leaflet carefully as the information may have changed.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your 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 gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What this medicine and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further 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. Before you take this medicine

Do not take Oxytetracycline tablets and tell your doctor if:

•    You are allergic (hypersensitive) to oxytetracycline, other similar antibiotics (such as minocycline or doxycycline) or to any other ingredients in the tablet (see Section 6, Further information)

•    have systemic lupus erythematosus (SLE), a condition characterised by a rash (especially on the face), hair loss, fever, malaise and joint pain

•    You have had kidney or liver problems for a long time

Do not give to a child under 12 years old.

Take special care with these tablets and tell your doctor if you:

•    have reduced kidney or liver function.

•    suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech

Taking other Medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including any medicines obtained without prescription such as herbal remedies and health supplements, as they may interact with this medicine

Oxytetracycline Tablets may interact with other medicines. You should tell your doctor if you are taking any of the following:-

•    penicillins such as amoxicillin (to treat infections)

•    vitamin A

•    retinoids such as acitretin, isotretinoin and tretinoin (to treat acne)

•    oral contraceptives (the pill). Oxytetracycline tablets may make the oral contraceptive pill less effective. You should use additional contraceptive precautions whilst taking Oxytetracycline and for 7 days after stopping

•    anticoagulants e.g. warfarin (to stop the blood clotting)

•    diuretics ('water tablets' such as furosemide)

•    kaolin-pectin and bismuth subsalicylate (to treat diarrhoea)

•    medicines to treat diabetes such as insulin, glibenclamide or gliclazide

•    methoxyflurane (an anaesthetic), if you need an operation, tell your doctor or dentist you are taking Oxytetracycline

•    medicines such as antacids or other medicines containing aluminium, calcium, iron, magnesium, bismuth or zinc salts. Do not take at the same time as Oxytetracycline tablets, as absorption of Oxytetracycline may be reduced.

Pregnancy and Breast-Feeding If you are pregnant, planning to become pregnant or are breast feeding ask your doctor or pharmacist for advice before taking any medicine as Oxytetracycline should not be taken as it could harm the baby.

Tests

•    During long term treatment blood, kidney and liver tests will be carried out.

Taking with food or milk

•    Do not take the tablets at the same time as milk or food, as they can make the medicine less effective.

•    Tablets can be taken one hour before or two hours after meals

Important information about some of the ingredients of these tablets

•    This medicine contains SUCROSE and GLUCOSE. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine

•    This medicine contains TARTRAZINE ALUMINUM LAKE (E102) which may cause allergic reactions.

SAME SIZE ARTWORK 120 x 220mm

Front

3. How to Take this medicine

•    Always take Oxytetracycline tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

•    Swallow the tablets one hour before or two hours after meals, with a glass of water. Swallow the tablets when standing or sitting down and do not take them immediately before going to bed.

•    The usual doses are for at least 10 days unless otherwise directed by your doctor:

Adults, Elderly and Children 12 years or over:

•    General infections: 1 tablet (250mg) every 6 hours, you may be given 2 tablets (500mg) initially. For severe infections your doctor may increase your dosage to 500mg (2 tablets) every 6 hours.

•    Specific infections:

Skin infections: 1-2 tablets (250-500mg) daily either as a single dose or in divided doses for three months.

Brucellosis: 2 tablets (500mg) four times a day with streptomycin.

Sexually transmitted diseases: 2 tablets (500mg) four times a day for between 7 and 30 days depending on your condition.

Children under 12 years old:

Oxytetracycline tablets are NOT recommended for use in children under 12 years of age as it can cause permanent discolouration of tooth enamel and affect bone development.

If you take more than you should If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately.

If you forget to take the tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking the tablets

Do not stop treatment early as your infection may return

if you do not finish the course of tablets.

|    4. Possible Side Effects    |

Like all medicines, Oxytetracycline tablets can cause side effects, although not everybody gets them. Stop taking the tablets immediately and seek urgent medical advice if the following occur:

•    symptoms of an allergic reaction: skin rashes which may be itchy, swelling of the face and tongue. Fever and chest pain (symptoms of inflammation of the membrane around the heart) or breathing difficulties and collapse (anaphylaxis)

•    symptoms of raised pressure in the skull: headache, visual problems including blurred vision, "blind" spots, double vision

•    sensitivity to sunlight or artificial light such as sun-bed (symptoms such as tingling, burning or redness of the skin).

Tell your doctor if the following side effects occur:

•    Feeling or being sick, diarrhoea, stomach upsets, loss of appetite, discolouration of tooth enamel, difficulty swallowing, swelling or ulceration of the gullet.

•    Pseudomembranous colitis (watery diarrhoea, fever and cramps)

•    Inflammation of the pancreas (pancreatitis, causing pain in the abdomen or back, feeling sick and fever)

•    Changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test

•    Redness or colour change of the skin, flaky skin, thrush or irritation around your bottom and genital area. If you already suffer from SLE (systemic lupus erythematosus). Oxytetracycline tablets may make your condition worse.

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

I 5. How to store this medicine |

•    Keep the medicine in a safe place where children cannot see or reach it

•    Blisters or containers: Store in a cool, dry place.

•    Do not use the tablets after the expiry date shown on the pack on the label

•    When you have stopped taking this medicine return any unused tablets to the pharmacist for safe disposal.

|    6. Further Information    |

What these tablets contain:

•    Each tablet contains Oxytetracycline dihydrate equivalent to 250mg Oxytetracycline.

•    The other ingredients are: maize starch, cellulose microcrystalline, alginic acid, povidone, stearic acid, magnesium stearate, sucrose, glucose, purified talc, tartrazine aluminum lake (E102), titanium dioxide (E171), sodium benzoate (E211), sandarac and carnauba wax.

What these tablets look like and contents of the pack:

•    The tablets are yellow coloured and sugar coated.

•    Tablets come in packs containing 10, 14, 28, 30, 56, 84, 100, 112 and 1000 tablets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder & Manufacturer

Name and address: Bristol Laboratories Limited Unit 3, Canalside,

Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom 0044 (0)1442 200922 0044 (0)1442 873717 info@bristol-labs.co.uk Oxytetracycline Tablets B.P. 250mg; PL 17907/0174 This leaflet was last revised in April 2014 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, e-mail) above.

V6 09-04-14 D0

Telephone:

Fax:

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SAME SIZE ARTWORK 120 x 220mm