Oxytetracycline Tablets Bp 250mg
Read all of this leaflet carefully
before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Patient Information Leaflet gj
Oxytetracycline Tablets BP 250 mg
This medicine will be called Oxytetracycline Tablets in this leaflet.
In this leaflet:
1. What Oxytetracycline Tablets are and what they are used for
2. Before you take Oxytetracycline Tablets
3. How to take Oxytetracycline Tablets
4. Possible side effects
5. How to store Oxytetracycline Tablets
6. Further 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, severe acne, urinary tract (bladder and kidney) infections and venereal diseases such as syphilis and gonorrhoea.
2. Before you 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 in this medicine (these are listed in section 6)
• You have kidney problems
• You suffer from porphyria
• You suffer from (SLE) systemic lupus erythematosus (an allergic disease which affects the skin and internal organs -symptoms include red, scaly skin and swollen joints)
• You are pregnant or breastfeeding (unless considered essential by your doctor) as oxytetracycline can affect the development of teeth in babies and cause tooth discolouration.
Oxytetracycline Tablets should not be taken by children under the age of 12 years.
You must be especially careful if:
• You have any liver problems or if you are taking any drugs which you have been told can cause liver problems
• You have the disease called myasthenia gravis (these tablets may increase muscle weakness).
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Taking other medicines
Oxytetracycline Tablets can affect some other medicines you may be taking. Make sure your doctor knows if you are taking any of the following:
• Anticoagulants to prevent blood clotting (e.g. warfarin or phenindione)
• The contraceptive pill, as your pill may not work properly and you may need to use a different method of birth control
• Other antibiotics such as penicillin
• Antacids (indigestion remedies). Allow 2 to —
3 hours between taking antacids and __
oxytetracycline __
• Preparations containing aluminium, bismuth, calcium, magnesium, zinc or iron salts (which may be included in vitamin and mineral supplements), kaolin-pectin or sodium bicarbonate
• Ulcer healing drugs (e.g. ranitidine, sucralfate and tripotassium dicitratobismuthate)
• Diuretics (to increase urine production) or any drug you have been told can cause kidney problems
• Colestipol or colestyramine (taken to lower the amount of fats in your blood)
• Medicines to treat diabetes such as insulin, glibenclamide or gliclazide
• Quinapril (to treat high blood pressure and congestive heart failure)
• Strontium ranelate (to treat postmenopausal osteoporosis)
• Ergot alkaloids such as ergotamine or methysergide (to treat or prevent migraine)
• Lithium (to treat depressive disorder)
• Digoxin (to treat heart failure)
• Halofantrine (to treat malaria)
• Theophylline (to treat asthma)
•
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor. Other special warnings
• The tablet colouring contains tartrazine (E102) which may cause allergic reactions
• If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine as it contains lactose and sucrose
• If you take these tablets with another retinoid (a synthetic derivative of vitamin A) medicine, and you start to suffer from headache or eye problems, stop taking these tablets and consult your doctor
• Take special care if you are likely to be exposed to strong sunlight or UV light (sun beds). You may experience photosensitivity reactions (e.g. skin rash or easier burning). If you do, stop taking the tablets straightaway
• If you are using a contact lens solution containing thiomersal as an ingredient, your eyes may become inflamed. If this happens contact your doctor or optician
• If you are taking this medicine for a long time your doctor may want to carry out blood tests. This is quite usual and nothing to worry about.
Driving and using machinery
Occasionally some people may find that their vision is temporarily affected. Do not drive or operate machinery if you have any problems with your eyesight.
3. How to take Oxytetracycline Tablets
The tablets should be swallowed with a full glass of water.
Some foods, milk and other dairy products can affect the absorption of this medicine. The tablets should be taken preferably on an empty stomach (either 1 hour before food or 2 hours after).
The doctor will decide what dose of tablets you
Continued, please turn over.
need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.
The usual doses are as follows:
Adults, the elderly and children over 12 years:
The usual dose is 1 or 2 tablets every six hours. Do not stop taking the tablets until the course is finished, even if you feel better, as the infection may return.
For the treatment of acne, the usual dose is 1 tablet three times a day for four weeks, but longer courses may be given if considered necessary by your doctor.
Not to be given to children under 12.
If you take more tablets than you should
You should contact your doctor or pharmacist straightaway. Take your tablets or the pack with you so that the doctor will know what you have taken.
If you forget to take a dose of Oxytetracycline Tablets
If it is more than 2 hours since your dose was due, skip the missed dose and take your next one when it is due.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious Stop taking the tablets and tell your doctor immediately if you notice any of the following symptoms:
• Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin, or sudden swelling of the face, throat, lips or genitals. These are signs of a severe allergic reaction
• Chest pain, breathing difficulties or a dry cough since these might be symptoms of pericarditis (swelling of the heart membrane)
• Headache and visual disturbances, or, in infants a bulging fontanelle (soft spot), because any of these may indicate raised pressure inside the skull
• A skin reaction like sunburn caused by photosensitivity (increased sensitivity to sunlight and UV light)
• Other serious skin reactions such as swelling or peeling, or Stevens-Johnson syndrome (symptoms are fever, blisters on the skin, eyes, mouth and genitals).
Tell your doctor, pharmacist or nurse if you suffer from any of the following other effects:
Rare (may affect up to 1 in 1,000 people)
• Swelling or ulceration of the oesophagus (gullet) (particularly if the tablets are taken with insufficient water at bedtime).
Not known (frequency cannot be estimated from the available data)
• Nausea, vomiting and diarrhoea
• Dry, sore or swollen mouth, sore throat or difficulty swallowing, discoloured or swollen tongue
• Oral thrush, swelling of the vulva and vagina, itching around the anus
• Effects, such as discolouration and thinner enamel, on both first and second teeth
• Interference of bone growth in young infants or pregnant women.
• Colitis (symptoms are colicky pain, diarrhoea or constipation)
• Nail discolouration and separation of the nail from the nail bed
• Temporary effects on vision
• Kidney problems, or worsening of symptoms in patients who already have kidney problems
• Harmful effects on the liver, and inflammation of the pancreas causing severe pain in the abdomen and back
• Blood disorders including severe reduction in the number of white or red blood cells which may cause fever or chills, severe fatigue, weakness, painful ulceration in the mouth, vagina or rectum, backache, stomach ache, pale skin, unusual bruising or bleeding, and make infections more likely
• A severe form of anaemia in which vitamin B12 and folic acid is lacking
• Other allergic reactions such as skin rashes, itching and redness and asthma.
• Abnormal pigmentation of the skin and eyes.
•
(systemic lupus erythematosus)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Tablets
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package or container and keep tightly closed to protect the tablets from moisture.
Do not use the tablets after the expiry date shown on the carton or label.
If your doctor tells you to stop taking the tablets, please take any left over back to your pharmacist to be destroyed.
6. Further Information
Ingredients
Each sugar coated tablet contains 250 mg of the active ingredient, oxytetracycline (as the dihydrate). Other ingredients are lactose, pregelatinised maize starch, sodium laurilsulfate, gelatin, talc, magnesium stearate, sucrose, titanium dioxide (E171) and yellow colour containing tartrazine (E102) and dried aluminium hydroxide.
What the medicine looks like
The tablets are round, and have a yellow sugar coat. They are supplied to your pharmacist in packs of 28 tablets or in containers of 1000 tablets.
Product licence holder and manufacturer
The product licence holder is
Dalkeith Laboratories Ltd., 2 Park Street, Woburn,
Bedfordshire, MK17 9PG, UK.
Manufactured by Surepharm Services Ltd.,
Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.
Product licence number
PL 17496/0003
Date of revision: July 2015.
If you would like the leaflet in a different format, please contact the licence holder at the above address.