Avelox 400 mg/250 ml solution for infusion

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Avelox is and what it is used for
2. What you need to know before you are administered Avelox
3. How to use Avelox
4. Possible side effects
5. How to store Avelox
6. Contents of the pack and other information

Do not use Avelox

• If you are allergic to the active substance moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6.).
• If you are pregnant or breast-feeding.
• If you are under 18 years of age.
• If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections Warnings and precautions ... and 4. Possible side effects).
• If you were born with or have had any condition with abnormal heart rhythm (seen on ECG, electrical recording of the heart).
• If you have salt imbalance in the blood (especially low levels of potassium or magnesium in the blood).
• If you have a very slow heart rhythm (called ‘bradycardia’).
• If you have a weak heart (heart failure).
• If you have a history of abnormal heart rhythms.
• If you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Avelox). This is because Avelox can cause changes on the ECG, that is a prolongation of the QT-interval i.e. delayed conduction of electrical signals.
• If you have a severe liver disease or liver enzymes (transaminases) that are higher than 5 times the upper normal limit.

Warnings and precautions

Talk to your doctor before Avelox is administered for the first time

• Avelox can change your heart’s ECG, especially if you are female or if you are elderly. If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before Avelox is administered (see also section Do not use Avelox and Other medicines and Avelox.
• If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before Avelox is administered.
• If you have or have ever had any mental health problems, consult your doctor before Avelox is administered..
• If you suffer from myasthenia gravis using Avelox may worsen the symptoms of your disease. If you think you are affected consult your doctor immediately.
• If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will advise whether Avelox is suitable for you.
• Avelox should be given intravenously (in the vein) only, and should not be administered into an artery.

When using Avelox

• If you experience palpitations or irregular heart beat during the period of treatment, you should inform your doctor immediately. He/she may wish to perform an ECG to measure your heart rhythm.
• The risk of heart problems may increase with increase of the dose and the speed of the perfusion into your vein.
• There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose, with symptoms that may include tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, treatment with Avelox solution for infusion has to be discontinued immediately.
• Avelox may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section 4. Possible side effects). Please contact your doctor before you continue the treatment if you suddenly start to feel unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness.
• If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4. Possible side effects) contact your doctor immediately before you continue the treatment.
• Quinolone antibiotics, including Avelox, may cause convulsions. If this happens, treatment with Avelox has to be discontinued.
• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, inform your doctor immediately prior to continuing treatment with Avelox.
• You may experience mental health problems even when taking quinolone antibiotics, including Avelox, for the first time. In very rare cases depression or mental health problems have led to suicidal thoughts and self-injurious behaviour such as suicide attempts (see section 4. Possible side effects). If you develop such reactions, treatment with Avelox has to be discontinued.
• You may develop diarrhoea whilst taking, or after taking, antibiotics including Avelox. If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop using Avelox immediately and consult your doctor. In this situation, you should not take medicines that stop or slow down bowel movement.
• Avelox may cause pain and inflammation of your tendons, even within 48 hours of starting treatment and up to several months after discontinuing Avelox therapy. The risk of inflammation and rupture of tendons is increased if you are elderly or if you are currently being treated with corticosteroids. At the first sign of any pain or inflammation you should stop using Avelox, rest the affected limb(s) and consult your doctor immediately. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture (see sections 2. Do not use Avelox… and 4. Possible side effects).
• If you are elderly with existing kidney problems take care that your fluid intake is sufficient because dehydration may increase the risk of kidney failure.
• If your eyesight becomes impaired or if you have any other eye disturbances whilst using Avelox, consult an eye specialist immediately (see sections 2. Driving and using machines and 4. Possible side effects).
• Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light. You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while using Avelox.
• There is limited experience on use of sequential intravenous/oral Avelox for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.
• The efficacy of Avelox in the treatment of severe burns, infections of deep tissue and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.

Children and adolescents

This medicine must not be administered to children and adolescents under the age of 18 because efficacy and safety have not been established for this age group (see section Do not use Avelox).

Other medicines and Avelox

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines besides Avelox..

For Avelox, be aware of the following:

• If you are using Avelox and other medicines that affect your heart there is an increased risk for altering your heart rhythm. Therefore, do not use Avelox together with the following medicines: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
• You must tell your doctor if you are taking other medicines that can lower your blood potassium levels (e.g. some diuretics, some laxatives and enemas [large doses] or corticosteroids [anti-inflammatory drugs], amphotericin B) or cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while using Avelox.
• If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for your doctor to monitor your blood clotting times.

Avelox with food and drink

The effect of Avelox is not influenced by food including dairy products.

Pregnancy, breast-feeding and fertility

Do not use Avelox if you are pregnant or breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,ask your doctor or pharmacist for advice before using this medicine.

Animal studies do not indicate that your fertility will be impaired by using this medicine.

Driving and using machines

Avelox may make you feel dizzy or light-headed, you may experience a sudden, transient loss of vision, or you might faint for a short period. If you are affected in this way do not drive or operate machinery.

Avelox contains sodium

This medicinal product contains 787mg (approximately 34mmol) sodium per dose. If you are on a controlled-salt diet, please inform your doctor immediately.

If you receive more Avelox than you should

If you are concerned that you may have received too much Avelox, contact your doctor immediately.

If you miss a dose of Avelox

If you are concerned that you may have missed a dose of Avelox, contact your doctor immediately.

If you stop using Avelox

If the treatment with this medicine is stopped too soon your infection may not be completely cured. Consult your doctor if you wish to stop the treatment with Avelox solution for infusion or Avelox tablets before the end of the course of treatment.

What Avelox contains

• The active substance is moxifloxacin. Each bottle contains 400mg moxifloxacin (as hydrochloride). 1 ml contains 1.6 mg moxifloxacin (as hydrochloride).
• The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections (see section Avelox contains sodium)

What Avelox looks like and contents of the pack

Avelox is a clear, yellow solution for infusion.

Avelox is packaged in cartons containing a 250ml glass bottle with a chlorobutyl or bromobutyl rubber stopper. Avelox is available in packs containing 1 bottle and in multipacks comprising 5 packs, each containing 1 bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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Manufacturer: