WebSite Germany: Tetracycline Tablets 250mg (Actavis UK Ltd)

Tetracycline tablets 250mg

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.

Index

1 What Tetracycline tablets are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Tetracycline tablets are and what they are used for

Tetracycline 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:

respiratory tract infections such as pneumonia, bronchitis or 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

other infections including brucellosis, psittacosis, plague, cholera

tetracycline may also be used to treat leptospirosis, gasgangrene and tetanus.

Before you take

Do not take Tetracycline tablets and tell your doctor if you:

are allergic (hypersensitive) to tetracycline, other similar antibiotics (such as minocycline or doxycycline) or any other ingredient in the tablet (see section 6)

have had kidney or liver problems for a long time or severe kidney disease

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

are giving it to a child under 12 years old.

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

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

have kidney or liver disease

are sensitive to sunlight.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription. Especially:

penicillins such as phenoxymethylpenicillin (to treat infections)

vitamin A

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

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

anticoagulants (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

medicines which can damage your liver (check with your doctor or pharmacist to see if this applies to any medicines you are taking)

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

atovaquone (to treat pneumonia)

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

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant or are breast feeding ask your doctor or pharmacist for advice before taking any medicine as tetracycline 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.

How to take

Always take Tetracycline 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, followed by a glass of water. Swallow the tablets when standing or sitting down, 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:

Tetracycline 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.

Possible side effects

Like all medicines, Tetracycline 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, pericarditis (fever, chest pain) and anaphylaxis (breathing difficulties, collapse)
- symptoms of raised pressure in the skull: headache, visual problems including blurred vision, “blind” spots, double vision.

Tell your doctor if the following side effects occur:
- Effects on the stomach and gastrointestinal tract: feeling or being sick, diarrhoea, stomach upsets, loss of appetite, discolouration of tooth enamel, inflammation of the tongue or intestines, difficulty swallowing, swelling or
  ulceration of the gullet. Pseudomembranous colitis (watery diarrhoea, fever and cramps)
- Effects on the liver: inflammation of the liver (hepatitis) or pancreas (pancreatitis), liver failure or jaundice (yellowing of the skin or whites of the eyes)
- Effects on the blood: increased levels of urea, phosphates or acid in the blood or 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
- Other effects: redness or colour change of the skin, flaky skin, sensitivity to sunlight, thrush or irritation around your bottom and genital area, inflammation of the membrane around the heart (pericarditis). If you already suffer from SLE (systemic lupus erythematosus) Tetracycline tablets may make your condition worse.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Do not store above 25°C and keep in the original package. If in a polypropylene container keep the container tightly closed.

Do not use Tetracycline tablets after the expiry date stated on the label/carton/bottle. 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 Tetracycline tablets contain

The active substance (the ingredient that makes the tablets work) is Tetracycline hydrochloride.

The other ingredients in the tablet are sodium lauryl sulphate, hydroxypropylcellulose (E463), colloidal silicon
dioxide, croscarmellose sodium, magnesium stearate.

The tablet coating contains methylhydroxypropylcellulose (E464), propylene glycol, purified talc (E553), sunset
yellow FCF aluminium lake (E110), titanium dioxide (E171), erythrosine (E127).

What Tetracycline tablets look like and contents of the pack

Tetracycline tablets are orange, circular, biconvex, film coated tablets which come in one strength. Each tablet contains 250mg of the active ingredient.

Pack sizes are 7, 10, 14, 21, 28, 30, 50, 56, 60, 84, 100, 112, 250, 500, 1000.

Not all pack sizes may be available

Marketing Authorisation Holder and manufacturer

Actavis

Barnstaple

EX32 8NS

This leaflet was last revised in October 2007.