Tetracycline Tablets 250Mg Reporting of Side Effects Pack Size 28 If You Get Any Side Effects, Talk to Your Doctor, Pharmacist Or Nurse
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Additional side effects in children What Tetracycline tablets look like and Not known (frequency cannot be estimated from the contents of the pack available data): Tetracycline tablets are orange, circular, biconvex, • bulging fontanelles in infant (raised pressure in the film coated tablets, impressed “C” on one face and the skull) identifying letters “TE” on the reverse. which come in Package leaflet: Information for the patient • thinning or low amount of tooth enamel one strength. Each tablet contains 250mg of the active ingredient. Tetracycline tablets 250mg Reporting of side effects Pack size 28 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in Marketing Authorisation Holder and manufacturer this leaflet. You can also report side effects directly via the Accord, Barnstaple, EX32 8NS, UK Read all of this leaflet carefully before you • sexually transmitted diseases such as chlamydia, Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or start taking this medicine because it contains gonorrhoea or syphilis search for MHRA Yellow Card in the Google Play or Apple This leaflet was last revised in November 2020. important information for you. • skin infections such as acne App Store. • Keep this leaflet. You may need to read it again. • infections of the eye such as conjunctivitis • If you have any further questions, ask your • rickettsial infections such as Q fever or tick fever By reporting side effects you can help provide more doctor or pharmacist. (severe headache, rash, high fever) information on the safety of this medicine. • This medicine has been prescribed for you only. • other infections including brucellosis (headache, Do not pass it on to others. It may harm them, sickness, fever, swollen lymph nodes), psittacosis 5 How to store Tetracycline tablets even if their signs of illness are the same as (headache, nose bleeds, shivering, fever), plague yours. (painful swelling of the lymph nodes), cholera Keep this medicine out of the sight and reach of children. • If you get any side effects, talk to your doctor (severe sickness and diarrhoea) Do not store above 25°C and keep in the original package. If in a or pharmacist. This includes any possible side • tetracycline may also be used to treat leptospirosis polypropylene container keep the container tightly closed. effects not listed in this leaflet. See section 4. (fever, causing jaundice or meningitis), gas-gangrene Do not use this medicine after the expiry date stated on the and tetanus (lock jaw). label/carton/bottle. The expiry date refers to the last day of that What is in this leaflet month. 1 What Tetracycline tablets are and what 2 What you need to know before you take Do not throw away any medicines via wastewater or household they are used for Tetracycline tablets waste. Ask your pharmacist how to throw away medicines 2 What you need to know before you take you no longer use. These measures will help protect the Tetracycline tablets Do not take Tetracycline tablets if you: environment. 3 How to take Tetracycline tablets • are allergic to tetracycline, other similar 4 Possible side effects antibiotics (such as minocycline or doxycycline) 6 Contents of the pack and other information 5 How to store Tetracycline tablets or any other ingredients of this medicine (listed in 6 Contents of the pack and other section 6) What Tetracycline tablets contain information • have had kidney or liver problems for a long time • The active substance is Tetracycline hydrochloride. or severe kidney disease have systemic lupus erythematosus (SLE), a • The other ingredients in the tablet are sodium lauryl 1 What Tetracycline tablets are and what • sulfate hydroxypropylcellulose (E463), colloidal silicon they are used for condition characterised by a rash (especially on dioxide, croscarmellose sodium, magnesium stearate. the face), hair loss, fever, malaise and joint pain • The tablet coating contains Tetracycline is a broad-spectrum antibiotic, which is a • are giving it to a child under 12 years old. methylhydroxypropylcellulose (E464), propylene glycol, substance with an anti-bacterial action. It may be used purified talc (E553), sunset yellow FCF aluminium lake to treat a wide range of infections caused by bacteria, Warnings and precautions (E110), titanium dioxide (E171), erythrosine (E127). these include: Talk to your doctor or pharmacist before taking Tetracycline tablets if you: • respiratory tract infections such as pneumonia, bronchitis or whooping cough • suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing • urinary tract infections and slurred speech Continued top of next column 50995421 BBBA9695 Continued top of next column Continued over page 350x210 Leaflet Reel Fed Profile Landscape (BST) page 4 page 1 Tetracycline 250 mg 28 Tablets PIL (Reel Fed) - UK Tetracycline BP Tablets approved for print/date 250mg x 28 (UK) Item number: BBBA9695 Colours Non Printing Colours 1. Black 1. Profile JDE No.: Originator: R.Paul Dimensions: 350x210 50995421 2. 2. Origination Date: 23.11.2020 Min Body Text Size: 9pt Dimensions: 350x210 (Reel Fed) Revision Date: Supplier: Accord Barnstaple 3. 3. Component: Leaflet for Blisters Revised By: 4. 5. Pharmacode: 9863 Proof Round Technical Date sent: N/A 6. Approval Date received: Date Sent: 26/10/20 1 Technologist: T. Hull [email protected] Technically Approved Cartons and label leaflets only (labels only when specified) GTIN 13 (Belgium & Slovenia): German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 6 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.12.2019 • have kidney or liver disease Tetracycline tablets with food and drink Sexually transmitted diseases: 2 tablets (500mg) four • A decrease in or loss of vision/eyesight • are sensitive to sunlight. Do not take the tablets at the same time as milk or food, as times a day for between 7 and 30 days depending on your • Severe or prolonged diarrhoea which may have blood or they can make the medicine less effective. condition. mucus in it, during or after treatment with Tetracycline, as Children and adolescents this may be a sign of serious bowel inflammation. Tetracycline tablets should not be taken by children under Pregnancy, breastfeeding and fertility Use in children under 12 years old: • Inflammation of the pancreas causing pain and 12 years of age as it can cause permanent discolouration of If you are pregnant or breast-feeding, think you may be Tetracycline tablets should not be used in children under tenderness in the abdomen and back (pancreatitis) tooth enamel and affect bone development. pregnant or are planning to have a baby, ask your doctor 12 years of age as it can cause permanent discolouration of or pharmacist for advice before taking this medicine as tooth enamel and affect bone development. Tell your doctor if any of the following side effects occur: Other medicines and Tetracycline tablets tetracycline could harm the baby. Rare (may affect up to 1 in 1,000 people) Tell your doctor or pharmacist if you are taking, have If you take more Tetracycline tablets than you • inflammation of the liver (hepatitis), liver failure or recently taken or might take any other medicines. Especially: Tetracycline tablets contain Sunset yellow FCF should jaundice (yellowing of the skin or whites of the eyes), • penicillins such as phenoxymethylpenicillin (to treat infections) aluminium lake (E110) If you (or someone else) swallow a lot of tablets at the changes in liver function (seen in blood tests) • vitamin A Tetracycline tablets contain sunset yellow (E110) which may same time, or you think a child may have swallowed any, • increased levels of urea, phosphates or acid in the blood • retinoids such as acitretin, isotretinoin and tretinoin (to cause allergic reactions. contact your nearest hospital casualty department or or changes in the numbers and types of your blood cells. treat acne) This medicine contains less than 1 mmol sodium (23 mg) tell your doctor immediately. Symptoms of an overdose If you notice increased bruising, nosebleeds, sore throats, • oral contraceptives (‘The Pill’), (which is a type of birth per tablet, that is to say essentially ‘sodium-free’. include feeling or being sick, crystals or blood in the urine, infections, excessive tiredness, breathlessness on exertion control). Tetracycline tablets may make the oral contraceptive hypersensitivity reactions. or abnormal paleness of the skin, you should tell your pill less effective. You should use additional contraceptive Tests doctor who may want you to have a blood test precautions whilst taking Tetracycline tablets and for 7 days During long term treatment blood, kidney and liver tests will be If you forget to take Tetracycline tablets • ulcers or swelling in the throat, difficulty swallowing after stopping carried out. Do not take a double dose to make up for a forgotten dose. • kidney failure, nephritis (may cause swollen ankles or • anticoagulants (to stop the blood clotting) If you forget to take a dose, take it as soon as you remember high blood pressure) • diuretics (‘water tablets’ such as furosemide) 3 How to take Tetracycline tablets it and then take the next dose at the right time. • kaolin-pectin and bismuth subsalicylate (to treat Not known (frequency cannot be estimated from the diarrhoea) Always take this medicine