Economycin 250 Mg Film-Coated Tablets
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P. Economycin 250 mg Product: Film-coated Tablets MA Holder: Chelonla |
Printing Colours: | Black |
Non-Printing Colours: | Profile |
Genesis#! PHARMACElinCAlS Final Preparation Date For Submission: 21/10/2015 |
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PL No.: 33414/0111 |
Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000 | ||
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Pack Size: All |
Dimensions: 148 x 297 mm | ||
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Livery: Genesis |
Created By: DTawde | ||
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Manufacturer: -Market: UK Component: Leaflet |
Artwork Code: CL0111/O/PIL1-Br/G1 |
Print Proof Approval: 00/00/0000 | |
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Bar Code: - | |||
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Font Type: Bliss Regular Font Size: 8.8 pt | |||
PACKAGE LEAFLET: INFORMATION FOR THE USER
ECONOMYCIN 250 mg FILM-COATED TABLETS
TETRACYCLINE HYDROCHLORIDE
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
THIS LEAFLET CONTAINS
1. What Economycin is for
2. Before you take Economycin
3. How to take Economycin
4. Possible side effects
5. How to store Economycin
6. Further information
1. WHAT ECONOMYCIN IS FOR
The name of your medicine is Economycin and it contains the active ingredient tetracycline hydrochloride.
Economycin 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 and fungal organisms, these include:
• respiratory tract infections such as pneumonia, bronchitis or whooping cough
• urinary tract infections
• sexually transmitted diseases such as chlamydia, gonorrhoea or syphilis
• skin and soft tissue infections such as acne or rosacea
• infections of the eye such as conjunctivitis
• rickettsial infections such as Q-fever or tick fever (severe headache, rash, high fever)
• other infections such as brucellosis (headache, sickness, fever, swollen lymph nodes), psittacosis (headache, nose bleeds, shivering, fever), plague (painful swelling of lymph nodes), cholera, gas-gangrene, tetanus and leptospirosis (fever causing jaundice or meningitis).
If you are not sure why you have been prescribed these tablets then please ask your doctor.
2. BEFORE YOU TAKE ECONOMYCIN
Do not take Economycin and tell your doctor if you:
• are allergic to tetracycline, other similar antibiotics (such as minocycline or doxycycline) or any other ingredients in Economycin tablets (listed in section 6)
• have severe kidney or liver problems
• have systemic lupus erythematosus (SLE), a condition characterised by a rash (especially on the face), hair loss, fever, a feeling of general discomfort or illness and joint pain
• have porphyria (a genetic disorder of the blood)
• are pregnant, planning a pregnancy or are breast-feeding. (see 'pregnancy and breast-feeding' below)
• are taking retinoids (see also 'other medicines and economycin' below)
Do not give this medicine to children under 12 years
old.
Warnings and Precautions
Tell your doctor before you take this medicine if you:
• suffer from myasthenia gravis, a condition characterised by muscle weakness, difficulty chewing and swallowing and slurred speech
• have kidney or liver diseases
• are sensitive to sunlight or artificial light (e.g. sunbeds).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Economycin
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following are some of the drugs with which economycin tablets may interact:
• penicillins such as phenoxymethylpenicillin (to treat infections)
• vitamin A
• retinoids (to treat acne such as acitretin, isotretinoin or tretinoin) may cause serious problems such as abnormally high pressure around brain (benign intracranial hypertension) on concurrent use
• oral contraceptives (the pill). Economycin tablets may make the oral contraceptive pill less effective. You should use additional contraceptive precautions whilst taking Economycin and for 7 days after stopping
• medicines to thin the blood and stop blood clots forming (anticoagulants) such as phenindione or coumarins
• medicines to increase urine production, diuretics (water tablets such as furosemide or spironolactone)
• medicines to treat diabetes, such as insulin, gliclazide or tolbutamide
• medicines to control diarrhoea, such as kaolin-pectin or bismuth subsalicylate
• lithium (to treat bipolar disorder, depression)
• methoxyflurane (an anaesthetic), if you need an operation, tell your doctor or dentist you are taking Economycin
• atovaquone (to treat pneumonia)
• antacids or other medicines containing aluminium, calcium, iron, magnesium, bismuth or zinc salts. Do not take at the same time as Economycin tablets, as absorption of Economycin may be reduced
• sucralfate (to treat ulcers)
• quinapril (to treat high blood pressure or heart failure)
• digoxin (to treat uneven heartbeats (arrhythmia))
• colestipol or colestyramine (to treat high cholesterol)
• strontium ranelate (to treat bone disease such as osteoporosis)
• methotrexate (to treat certain cancers or skin, joint or gut diseases)
• ergotamine and methysergide (to treat migraines). Tests
During your treatment your doctor may carry out blood, kidney and liver tests.
Economycin with food and drink
Do not take Economycin tablets at the same time as food, milk or milk products, as they can make the medicine less effective.
Pregnancy and breast-feeding
Do not take Economycin tablets if you are pregnant, planning a pregnancy or are breast-feeding, unless your doctor has advised you to, as it may affect the development of your baby.
Economycin tablets can cause permanent discolouration of tooth enamel and affect bone development in children.
Driving and using machines
Economycin tablets should not affect your ability to drive or operate machinery.
Economycin tablets contain sunset yellow (E110)
Economycin tablets contain sunset yellow (E110), which may cause allergic reactions.
3. HOW TO TAKE ECONOMYCIN
Always take Economycin tablets exactly as your doctor has told you.
Swallow the tablets one hour before or two hours after meals, followed by a glass of water. Take the tablets either standing up or sitting down.
Do not take Economycin immediately before going to bed.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition.
The usual doses are:
Adults, elderly and children 12 years or over: General infections: The normal dose is 250 mg to
500 mg (1 to 2 tablets) every 6 hours (4 times a day), depending on the severity of the condition. If you are elderly your doctor may prescribe you a lower dose (for example, if you suffer from kidney problems) so that the level of tetracycline in your blood stream will be appropriate for the treatment.
Specific infections:
Skin infections: 1-2 tablets (250-500 mg) daily either as a single dose or in divided doses for 3 months. Brucellosis: 2 tablets (500 mg) four times a day with streptomycin
Sexually transmitted diseases: 2 tablets (500 mg) four times a day for between 7 to 30 days depending on your condition. You will have regular follow up and laboratory tests (blood and serum).
Children under 12 years old:
Do not give this medicine to children under 12 years old, as it can cause permanent discolouration of tooth enamel and affect bone development.
If you take more Economycin 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 nearest hospital casualty department or tell your doctor immediately.
If you forget to take Economycin
Don't worry, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking Economycin
You should continue taking Economycin for as long as your doctor has told you to, even if you start to feel better. If you stop before finishing the prescribed course of treatment your infection may still be present or may reappear.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Economycin can cause side effects, although not everybody gets them.
If you get any of the following serious side effects, STOP TAKING the tablets immediately and seek urgent medical advice:
• Allergic reactions, these include skin rashes which may be itchy, swelling of the face, eye lids, lips, tongue or throat, fever, difficulty in breathing, sudden wheezing or collapse (anaphylaxis), chest pain or tightness
• Symptoms of raised pressure in the skull: headaches, dizziness, 'ringing' in the ears or visual problems including blurred vision, "blind" spots or double vision. Bulging of the skull may occur in infants. Permanent loss of vision also has been reported.
• Symptoms of a severe skin rash: this may include fever, blisters or ulcers, reddening, peeling or swelling of the skin
• Severe or prolonged diarrhoea (which may be a sign of serious bowel inflammation).
Tell your doctor if the following side effects occur: Rare (may affect up to 1 in 1,000 people)
• liver failure, hepatitis (inflammation of the liver) and jaundice
• changes in the numbers and types of your blood cells. If you notice increased bruising, nose bleeds, 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
• ulceration/irritation/swelling of the oesophagus (gullet/throat) and difficulty in swallowing, usually when taken before bed or with inadequate fluid intake.
• kidney failure, nephritis (may cause swollen ankles or high blood pressure)
Not known (frequency cannot be estimated from the available data):
• increased sensitivity to sunlight or artificial sunlight (sun-beds or sun-lamps) causing itching, stinging and burning of the skin.
You should limit your exposure to natural sunlight, and avoid exposure to artificial sunlight, where possible. Blisters, lesions or scaly skin may develop.
• over-growth of resistant organisms which may cause infection/inflammation of the mouth, tongue, intestines and vagina
• headache, stomach upsets, feeling sick (nausea), being sick (vomiting) or diarrhoea, loss of appetite, discolouration of teeth
• inflammation of oesophagus and pancreas-causing pain in the abdomen or back, feeling sick and fever (oesophagitis and pancreatitis)
• pseudomembranous colitis (watery diarrhoea, fever and cramps)
• skin rashes, which involve changes to the colour and texture of the skin (Steven Johnson syndrome and toxic epidermal necrolysis)
• worsening of the inflammatory disease Systemic Lupus Erythematosus (SLE), which causes skin rashes, fever and joint pain
• may increase muscle weakness (myasthenia gravis)
• discoloured thyroid tissue (no changes in thyroid function are known to occur)
• fatty liver (causes tiredness, discomfort in upper abdomen)
• increased levels of urea, phosphates or acid in the blood, poor kidney function
• scaling and peeling of skin (exfoliative dermatitis), red/purple colour spots on skin, joint pain and abdominal pain (anaphylactoid purpura)
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: 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 ECONOMYCIN
Keep out of the sight and reach of children.
Store below 25°C in a dry place. Store in the original package or container and keep the container tightly closed.
Do not use the tablets after the expiry date, which is stated on the package or container. The expiry date refers to the last day of that month.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Economycin film-coated tablets contain
The active substance (the ingredient that makes the tablets work) is tetracycline hydrochloride.
The other ingredients in the tablets are microcrystalline cellulose, sodium starch glycollate, povidone, magnesium stearate, hydroxypropyl methylcellulose, ethylcellulose, diethyl phthalate, sunset yellow (E110), titanium dioxide (E171) and hydroxypropyl cellulose (E463).
What Economycin film-coated tablets look like and contents of the pack
Economycin film-coated tablets are orange, biconvex film-coated tablets.
The tablets are available in containers of 100, 500 and 1000 tablets.
Not all the pack sizes may be marketed.
Marketing Authorisation Holder Chelonia Healthcare Limited,
Boumpoulinas 11,3rd Floor Nicosia, P.C. 1060 Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 10/2015
CL0111/O/PIL1-Br/G1