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drug-medicine : avelox

 

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Medicine: avelox

Patient Information Leaflet

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, please ask your doctor or your pharmacist.
  • This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

  • 1. What Avelox 400mg Film-coated Tablets are and what they are used for
  • 2. Before you take Avelox 400mg Film-coated Tablets
  • 3. How to take Avelox 400mg Film-coated Tablets
  • 4. Possible side-effects
  • 5. Storing Avelox 400mg Film-coated Tablets

AVELOX 400MG FILM-COATED TABLETS

(moxifloxacin)

  • The active ingredient is moxifloxacin. Each dull red, film-coated tablet contains 400mg moxifloxacin as the hydrochloride. Each tablet is marked with "M400" on one side and "BAYER" on the reverse.
  • Other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, hypromellose, macrogol 4000, ferric oxide (E172) and titanium dioxide (E171).

1. What Avelox 400mg Film-coated Tablets are and what they are used for

Moxifloxacin, the active ingredient of Avelox 400mg Film-coated Tablets, belongs to a group of antibiotics called quinolones which work by killing bacteria that cause infections.

The film-coated tablets are available in packs of 5, 7 and 10 tablets but your doctor will prescribe as many tablets as you need. However, your doctor may give you a starter pack containing one tablet to start the course of your treatment.

Not all pack sizes may be marketed.

Avelox 400mg Film-coated Tablets are used for treating the following infections when due to bacteria:

  • Sudden worsening of chronic bronchitis
  • Pneumonia (except for pneumonia which starts during a stay in hospital)
  • Sinusitis

2. Before you take Avelox 400mg Film-coated Tablets

Do not take Avelox 400mg Film-coated Tablets

  • If you have previously had an allergic reaction to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients in this medicine. An allergic reaction can include wheezing, shortness of breath, rash and swelling of the face.
  • If you are pregnant, planning to become pregnant or breast-feeding.
  • If you have been told you have a weak heart, or if you have suffered from or have abnormal heart rhythms or a very slow heart rate.
  • If you have been told you have salt imbalances in the blood, especially low concentrations of potassium in the blood.
  • You should remind your doctor if you are taking medicines that affect your heart rate/rhythm (e.g. quinidine, hydroquinidine, disopyramide,) amiodarone, sotalol, dofetilide, ibutilide), medicines to treat severe mental disorders (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants (e.g. amitriptyline), some other drugs that treat infections (e.g. sparfloxacin, intravenous erythromycin, pentamidine) medicines used to treat or prevent malaria , particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil). Taking Avelox and these medicines together may cause your heartbeat to alter.
  • If you have a history of tendon disease or disorder which was related to treatment with a quinolone antibiotic.
  • If you are under the age of 18 years old or over 18 years but still growing.
  • If you have a problem in the way your liver works, Avelox may not be suitable for you.

Special care with Avelox 400mg Film-coated Tablets

Avelox may not be suitable for you, seek medical advice before starting your tablets :

  • If you suffer from epilepsy or a condition which makes you more likely to have convulsions (‘fits’)’
  • If your eyesight becomes impaired or your eyes seem to be affected by the medicine,
  • If you are currently taking any medicines that decrease your blood potassium or magnesium levels.
  • If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a hereditary condition),

 

Important things to note, when taking your tablets:

  • This medicine may occasionally cause pain and inflammation around your tendons, particularly if you are elderly or taking one of a group of medicines called steroids, such as hydrocortisone. If you experience these symptoms, seek medical advice immediately and rest the affected limb. Do not take the next dose of your medicine unless your doctor tells you to.
  • If you experience palpitations or an irregular heartbeat whilst taking your medicine, you should inform your doctor immediately; he/she may wish to perform some tests to measure your heart rhythm.
  • If you experience yellowing and possibly itching of the skin and/or yellowing of the whites of the eyes which may be accompanied by nausea, inform your doctor, who may wish to perform a blood test.
  • You may develop diarrhoea whilst taking, or after taking, antibiotics. If this becomes severe or persistent or you notice that it contains blood or mucus you should stop taking Avelox immediately and consult your doctor. Your doctor should give you some medicine to treat this condition.
  • This medicine may make your skin become more sensitive to sunlight or UV light. You should avoid exposure to strong sunlight and should not use a sun-bed or any other UV lamp while taking Avelox.
  • In some cases allergic reactions or severe allergic reactions, which can be life threatening, can occur even after the first time you take this medicine If any of the following happen, stop taking Avelox 400mg Film-coated Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
    • swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing,
    • rash, hives, itching,
    • large fluid-filled blisters, sores and ulceration.
  • If you or any member of your family have galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (a hereditary condition), you should not take these tablets.
  • If you have a problem with your kidneys, you should consult your doctor before taking this medicine.

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Pregnancy and Breast-feeding

  • You should not take Avelox 400mg Film-coated Tablets if you are pregnant, planning to become pregnant or are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

  • There is a possibility that these tablets could make you feel dizzy or light-headed or cause visual disturbances. If you are affected in this way you should not drive, or operate machinery or take part in activities where these symptoms may put you or others at risk.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines - even those not prescribed.

For this medicine be aware of the following:

  • There are several medicines which must not be taken with Avelox. These are described in the section Before you take Avelox 400mg Film-coated Tablets. Remember to tell your doctor about all the medicines which you are taking, including those which you may buy without needing a prescription.
  • If you are taking any medicine containing magnesium or aluminium such as antacids for indigestion, or any medicine containing iron or zinc, sucralfate, or didanosine, you should ask your doctor for advice, as these can reduce the action of Avelox. If these preparations are essential, your Avelox tablet should be taken 6 hours before or after taking the other medicine.
  • If you are taking any medicine containing charcoal, this may reduce the action of Avelox. In this case, you should ask your doctor for advice.
  • If you are currently taking digoxin, Avelox may cause the blood levels of digoxin to rise. It is unlikely that your current dose of digoxin will need to be changed but you should tell your doctor if you notice any changes in your heart rate or rhythm.
  • If you are currently taking glibenclamide for your diabetes, Avelox may cause the blood levels of glibenclamide to fall. It is unlikely to affect your blood sugar levels sufficiently for your doctor to have to alter your current dose of glibenclamide. Tell your doctor if you notice any changes in blood or urine sugar tests which you perform yourself.
  • If you are currently taking oral anti-coagulants, (eg. warfarin), it may be necessary for your doctor to monitor your blood clotting times.

If you are unsure about anything consult your doctor before taking your tablets.

3. How to take Avelox 400mg Film-coated Tablets

The usual dosage for adults and the elderly is one 400mg tablet by mouth once daily.

The tablets should be swallowed whole with a sufficient quantity of liquid (one glass of water) and may be taken with or without food. It is important to keep the interval between taking each tablet as close to 24 hours as possible.

The duration of treatment depends upon the type of infection but the recommended durations of use are: -

Bronchitis 5 - 10 days

Sinusitis 7 days

Pneumonia 10 days

Your doctor will tell you how long your treatment with Avelox 400mg Film-coated Tablets will last. It is important that you complete the course of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon your infection may return and the bacteria responsible for your symptoms may become resistant to moxifloxacin (the active ingredient in your tablets). This means that your tablets will no longer be able to work in treating your bacterial infection.

If you take more Avelox 400mg Film-coated Tablets than you should:

If you take more than the prescribed dose or in the event of an overdose, seek medical advice immediately and, if possible, take any remaining tablets or this leaflet with you to show the doctor what you have taken.

If you forget to take Avelox 400mg Film-coated Tablets:

Take your normal dose as soon as you remember unless it is almost time for your next dose. If it is almost time for your next dose, take that tablet and then continue your treatment with one tablet a day making sure you complete your course of treatment. Do not take a double dose to make up for your forgotten individual doses. If you are unsure about what to do, consult your doctor.

4. Possible side-effects

Like all medicines, Avelox 400mg Film-coated Tablets can cause side effects.

Allergic reactions to Avelox occur uncommonly and serious reactions (which can be life-threatening) occur rarely. If any of the following happen, stop taking Avelox 400mg Film-coated Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

  • swelling of the hands, feet, ankles, face, lips, mouth or throat which may cause difficulty in swallowing or breathing,
  • rash, hives, itching,
  • large fluid-filled blisters, sores and ulceration.

The following side effects occurred commonly (in less than 1 in 10 patients but in more than 1 per 100 patients) in clinical trials:

  • bacterial or fungal infection
  • changes in heart rhythm. These can occur more commonly if there are imbalances in the chemicals in the blood
  • feeling and/or being sick
  • stomach aches and pains
  • diarrhoea
  • abnormal results of tests which measure liver function
  • headache
  • dizziness

The following side effects occurred uncommonly (in less than 1 in 100 patients but in more than 1 per 1000 patients) in clinical trials:

  • weakness,
  • aches and pains such as back, leg and chest pains
  • sweating
  • a fast or irregular heartbeat or any change in heart rhythm
  • palpitations
  • angina
  • loss of appetite
  • constipation and wind
  • indigestion or inflammation of the stomach
  • an increase in certain chemicals, normally produced by the liver, in your bloodstream
  • other abnormal laboratory results, e.g. changes to blood chemistry or to a certain number of red and white blood cells.
  • changes in the amount of fats in the blood.
  • muscle or joint pain
  • tingling, burning sensation or numbness
  • dry skin
  • altered sense of taste
  • confusion and disorientation
  • sleep problems
  • tremor
  • sensation of spinning or falling over
  • sleepiness
  • anxiety
  • restlessness
  • difficulty in breathing or other breathing problems (seek medical advice – see Important things to note when taking your tablets- above)
  • visual disturbances.
  • dehydration

The following side effects occurred rarely (in less than 1 in 1000 patients) in clinical trials:

  • rapid abnormal heart rate (seek medical advice – see Important things to note when taking your tablets- above)
  • flushing, low blood pressure, high blood pressure, fainting
  • difficulty in swallowing (seek medical advice – see Important things to note when taking your tablets- above)
  • pseudomembranous colitis (severe diarrhoea containing blood and/or mucus), which in very rare circumstances, may develop into complications that are life threatening(seek medical advice – see Important things to note – above
  • jaundice (a yellowing of the whites of the eyes or skin - (seek medical advice – see Important things to note when taking your tablets- above) inflammation of the liver (resulting in bile accumulation)
  • increase in the time it takes for blood to clot
  • high blood sugar, an increase in certain chemicals, normally produced by the kidneys, in your bloodstream
  • inflammation of the tendons, muscle cramps (seek medical advice – see Important things to note when taking your tablets- above)
  • decreased sensitivity to touch, changes in smell or loss of smell
  • abnormal dreams
  • difficulty in co-ordinating and/or walking caused by feeling dizzy or having a sensation of spinning/falling over (in very rare cases this may lead to injuries caused by falling over)
  • seizures or convulsions
  • difficulty in concentrating, difficulty in speaking, forgetfulness, feelings of emotional instability, depression (in very rare cases this can lead to harming yourself), hallucinations
  • ringing in the ears
  • problems with your kidneys (which may progress to kidney failure in people with existing kidney problems)
  • swelling

The following side effects occurred very rarely (in less than 1 in 10,000 patients):

  • rapid abnormal heart rate or heart attack in people with severe heart conditions(seek medical advice – see Important things to note - above
  • shortening of the time it takes blood to clot
  • rupture of the tendons(seek medical advice – see Important things to note - above
  • inflammation of the joints
  • difficulty in walking caused by muscle, tendon or joint problems
  • increased sensitivity to touch
  • a feeling of not being yourself
  • Psychotic reaction (sudden onset of mental and behavioural disorder which can lead to harming yourself)
  • Stevens-Johnson Syndrome (small bubbles of fluid on the hands and feet),
  • Other possible side effects which can occur when taking quinolone antibiotics include: a temporary loss of vision, balance disorders including lack of muscle co-ordination, other changes in the blood including high sodium and calcium levels and the breakdown of blood cells, and your skin may become more sensitive to sunlight or UV light.

If you experience any of these side effects and they are severe or troublesome or do not wear off as your course of treatment goes on, consult your doctor, but do not stop taking your medicine.

IF YOU NOTICE ANY SIDE EFFECTS NOT MENTIONED IN THIS LEAFLET, PLEASE INFORM YOUR DOCTOR OR PHARMACIST.

5. Storing Avelox 400mg Film-coated Tablets

Keep Avelox 400mg Film-coated Tablets out of the reach and sight of children.

Do not store above 25°C. Keep the tablets in the original outer packaging. Do not remove tablets from the blister(s) in the pack until just before you take them. There are no special storage instructions for the one tablet pack.

Use by date: Do not use the tablets after the end of the month on the expiry date which is marked on both the outer carton and on each blister strip of tablets.

If you find that you have tablets after their expiry date, return them to your local pharmacist (chemist) who will dispose of them properly.

 

 

Medicamentweb.com, the website for Patient Information Leaflets, is dedicated to share information about pharmaceutical products with the general public, and is particularly interested in making PILs available online. Of course, this information cannot replace the advice of your GP, doctor or pharmacist. If you should be worried in any way about your health, we urge you to see a doctor.

 

 

 

 

 

 

 

 

 

 

 

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