Avoxa 400 mg Film-Coated Tablets

AVOXA contains moxifloxacin, which belongs to a group of medicines called antibiotics. AVOXA is used for the treatment of a bacterial infection of the sinuses, airways, lungs, skin and skin tissues, female reproductive organs and severe infections inside the belly (abdomen) where therapy with other appropriate antibiotics have failed, cannot be used or cannot be tolerated. AVOXA is only available on your doctor’s prescription. Before prescribing the medicine, your doctor may want to determine which organism has infected you.

Do not use AVOXA:

• if you are hypersensitive (allergic) to moxifloxacin, other quinolones or any of the ingredients of AVOXA (listed in section 6),
• if you have serious liver disease,
• if you have previously experienced side effects with the use of quinolone/fluoroquinolone antibiotics relating to your joints, muscles, ligaments, nerves, central nervous system (brain), epilepsy or mental health (psychiatric disorder),
• if you were born with or have any condition with abnormal rhythm whether related to QT time prolongation or not (seen on ECG, electrical recording of the heart),
• if you are taking other medicines that result in abnormal heart rate or rhythm tracing (ECG) e.g. prolongation of the “QT time”,
• if you have an enlargement or “bulge” of a large blood vessel (aortic aneurysm) or a previous episode of aortic dissection (a tear in the aortic wall) or a family history of aortic aneurysm/dissection or have other risk factors or existing predisposing conditions,
• if you have a salt imbalance (such as low potassium concentration) in the blood which is at present not corrected by treatment,
• if you have heart failure (a “weak” heart),
• if you have a very slow heart rate (bradycardia),
• if you are pregnant or may become pregnant, or if you breastfeed your baby,
• if you or your child are younger than the age of 18 years,
• if you have moderate to severe impairment of your kidney function and are treated with ACE inhibitors/angiotensin receptor blockers,
• if you have a damaged mitral and/or aortic valve which cannot close properly,
• if you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in serious cases, paralysis).

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or professional healthcare provider.

Warnings and precautions

Take special care with AVOXA -

• If you or any of your family members have a history of heart disease. AVOXA can cause changes in your heart’s ECG, particularly in female or elderly patients or patients taking certain other medicines that lower blood potassium levels.
• If you are currently taking other medicines that can reduce your blood potassium levels.
• If you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan Syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure or known atherosclerosis).
• If you are allergic to the active ingredient or any of the inactive ingredients of AVOXA. Discontinue AVOXA at the first sign of a skin rash or other signs (tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing) indicative of an allergic reaction (an anaphylactic reaction/shock due to hypersensitivity).
• If you have severe liver disease.
• AVOXA may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases). Please tell your doctor before you continue treatment if you develop signs such as rapidly feeling unwell and/or being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed.
• If you are currently suffering from, or have ever had, mental health problems, depression, suicide thoughts or suicide attempts, inform your doctor about this, before taking AVOXA.
• If you suffer from epilepsy or a condition which makes you likely to have convulsions talk to your doctor before taking AVOXA.
• If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), inform your doctor about this, before taking AVOXA, as it may worsen the symptoms of your disease.
• If you have a kidney disease that prevents you from getting adequate fluids in your body; dehydration may increase the risk of kidney failure.
• If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), tell your doctor, who will decide if AVOXA is suitable for you.
• If you have a complicated infection of the female upper genital tract (e.g. associated with an abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an intravenous treatment necessary, treatment with AVOXA tablets is not appropriate. For the treatment of mild to moderate infections of the female upper genital tract your doctor should prescribe another antibiotic in addition to AVOXA. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
• If you suffer from diabetes, especially if you are elderly and treated with oral medicines or insulin to lower your blood sugar, as your blood sugar levels will need to be monitored carefully.
• If you have moderate to severe impairment of your kidney function, or if you are elderly and are treated with ACE inhibitors/angiotensin receptor blockers to control your blood pressure as this may cause further injury to your kidneys. Your kidney function will be checked before and during treatment if you are receiving fluoroquinolone antibiotics, such as AVOXA, with ACE inhibitors/angiotensin receptor blocker to control your blood pressure.
• If you have a damaged mitral and/or aortic heart valve which cannot close properly.
• AVOXA may cause a Stevens-Johnson syndrome, which is a serious illness with skin reaction or blistering and/or peeling of the skin, eyelids, genitals and mucosal areas of your body. You should contact your doctor immediately and treatment with AVOXA must be stopped.
• If you develop diarrhoea while taking AVOXA you should stop taking AVOXA. In this situation, you should not take medicines that stop or slow down bowel movement.
• AVOXA can cause tendon (ligament) pain, inflammation (tendinitis) or tendon tearing, during treatment and up to several months after discontinuing AVOXA treatment. The Achilles tendon (the heel tendon) is most frequently affected. The risk is of inflammation and tearing of tendons is increased if you are elderly or if you are currently treated with corticosteroids. At the first sign of any pain or inflammation of the tendon, discontinue treatment; rest and refrain from exercise; and tell your doctor immediately. The recovery process of your tendons, muscles and joints may take weeks or months and full recovery to your pre-treatment status may not occur.
• Tell the doctor or laboratory staff that you are taking AVOXA if you have to provide a blood or urine sample.
• Inform your doctor if you are going for a test for Mycobacteria such as a tuberculosis (TB) test, as receiving AVOXA at the same time may interfere with the results of the test.
• Your skin may become sensitive to sunlight or UV light when taking AVOXA. Avoid prolonged exposure to sunlight or do not use tanning beds or any other UV lamp while taking AVOXA.
• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness in your limbs. If this happens, stop taking AVOXA and contact your doctor immediately. The recovery process of your nerve condition may take weeks or months and full recovery to your pre-treatment condition may not occur.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or healthcare provider about your concerns.

Children and adolescents

The use of AVOXA in children and adolescents below the age of 18 years is contraindicated.

Do not share medicines prescribed for you with any other person. Always take AVOXA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

AVOXA tablets are for oral use. AVOXA should not be used in children and adolescents below the age of 18 years. The usual dose is one tablet (400 mg) once daily. All patient groups, including elderly patients (above 65 years of age), patients with kidney problems and patients with low body weight, may take the same dose. Your doctor will tell you how long your treatment with AVOXA will last; this will depend on your type of infection and the severity of the infection. Swallow your tablets whole with a glass of water. It does not matter what time of the day you take your tablets, but you should take it at more or less the same time every day. Take plenty of fluids each day. You may take the tablet with or without food. AVOXA should be taken exactly as prescribed. Do not change the dose prescribed by your doctor. Do not stop taking your tablets, even if you are feeling better, unless your doctor tells you to do so. It is important to complete the treatment; otherwise the bacteria causing your infection may become resistant to AVOXA.

If you have the impression that AVOXA is too strong or too weak, tell your doctor or pharmacist.

If you take more AVOXA than you should

If you have accidentally taken too much AVOXA, you may experience nausea, vomiting or diarrhoea or any of the side effects mentioned in section 4 “Possible side effects”. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. The doctor may want to monitor your ECG. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take AVOXA

If you forget to take a dose, take it as soon as you remember it. If it is almost time for the next dose, wait until then. Do not take a double dose to make up for forgotten individual doses.

If you stop taking AVOXA

Talk to your doctor if you want to stop taking AVOXA. If you stop taking AVOXA too soon, your infection may not be completely cured.

AVOXA can have side effects. Not all side effects reported for AVOXA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AVOXA, please consult your health care provider for advice. If any of the following happens, stop taking AVOXA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• if you have an allergic reaction (hypersensitivity) with severe itching of the skin with raised lumps; or an allergic reaction resulting in possibly life-threatening shock (difficulty breathing, drop of blood pressure, fast pulse, swelling of the face, lips, tongue, throat and airways (breathing tubes), blueness of the skin, heart failure, and can result in death);
• if you have swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing (angioedema);
• if you experience palpitations, an irregular heartbeat or fainting spells during treatment with AVOXA. Your doctor may wish to perform an ECG to look at your heart rhythm;
• at first sign of tendon inflammation or pain. Tendon rupture may occur even after discontinuation of therapy;
• sudden severe pain in your chest, abdomen (tummy) or back. These are all very serious side effects. If you have them, you may have had a serious reaction to AVOXA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your muscles, ligaments or joints;
• severe diarrhoea, containing blood and/or mucous (antibiotic-associated colitis including pseudomembranous colitis), which in some cases, may develop into complications that are life-threatening;
• confusion, hallucinations, feeling depressed (especially if this leads to thoughts of self-harm, such as suicidal ideations/thoughts, or suicide attempts);
• seizure (convulsions);
• feeling dizzy or shaky, sensation of your heart beating fast, sweating, especially if you suffer from diabetes. These may be signs of low blood sugar levels.
• jaundice (yellowing of the whites of the eyes or skin, dark urine), inflammation of the liver.
• weakness in muscles, arms or legs;
• urinating less than usual or not at all;
• transient loss of vision;
• numbness, tingling, or unusual pain anywhere in your body;
• changes to the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina), severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling, potentially life-threatening (Stevens-Johnson Syndrome, toxic epidermal necrolysis).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice the following:

• Frequent side effects
• Infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida (thrush).
• Headache, dizziness.
• Nausea or vomiting, stomach pain, diarrhoea.
• Changes in the electrical activity of the heart (ECG) in patients with less potassium in the blood.
• Increase in transaminase (liver enzymes) which may indicate a problem with your liver.

Less frequent side effects

• Anaemia (low red blood cell count), leukopenia (low white blood cell count), neutropenia (low numbers of special white blood cells – neutrophils), thrombocytopenia (decrease or increase of special cells necessary for blood clotting), thrombocythaemia (increase in platelets in the bone marrow) prolonged prothrombin time or increased INR (decreased blood clotting), agranulocytosis (decreased granulocytes, a type of white blood cell), pancytopenia (decreased red blood cells, white blood cells and platelets).
• Allergic reactions, itching, rash, skin hives, blood eosinophilia (increased eosinophils which is a specialised type of white blood cell), anaphylactic shock, swelling of the voice box (larynx) which can be life threatening.
• Retaining water in the body due to a high level of hormone (SIADH – syndrome of inappropriate antidiuretic hormone secretion).
• Increase blood lipids/fats, increase/decrease in blood sugar, increase in uric acid.
• Feeling anxious, agitated, emotional, restless, or agitated, depression, hallucination, a feeling of self-detachment (not being yourself), psychotic reactions, with thoughts of suicide.
• Tingling sensation (pins and needles) and/or numbness, changes/loss in taste sensation, confusion and disorientation, sleep problems (e.g. sleeplessness or sleepiness), shaking, sensation of dizziness (spinning or falling over), decreased/increased sense of touch or sensation, changes in smell including loss of smell, abnormal dreams, disturbed coordination, convulsions, disturbed concentration, problems with speech, partial or total loss of memory, peripheral/polyneuropathy (damage to the nerves which results in pain, numbness, tingling and muscle weakness).
• Problems with vision (including double or blurred vision), fear of light, temporary loss of vision, inflammation of the middle layer of the eye (uveitis).
• Ringing or noise in the ears, hearing impairment including deafness (usually reversible).
• Changes in the electrical activity of the heart (ECG), palpitations, irregular and fast heartbeat, severe heart rhythm problems, faster heart rate than normal, fainting, abnormal heart rhythms, irregular heartbeat (Torsade de Pointes), stopping of heart (cardiac arrest), fainting.
• Dilation of the blood vessels, causing flushing/sweating. high blood pressure, low blood pressure, vasculitis (inflammation of the blood vessels).
• Difficulty in breathing (including asthmatic conditions).
• Loss of appetite, wind and constipation, stomach upset (indigestion or heartburn), inflammation of the stomach, difficulty in swallowing, inflammation of the mouth, antibiotic-associated colitis (severe diarrhoea with blood and/or mucus).
• Disorders of the liver with increase in liver enzymes (bilirubin, LDH, gamma-glutamyl-transferase, blood alkaline phosphatase), jaundice (yellowing of the whites of the eyes or skin), hepatitis (inflammation of the liver), severe inflammation of the liver (potentially leading to life-threatening liver failure).
• Bullous skin reactions (painful blisters in the mouth/nose or at the penis/vagina), like Stevens-Johnson-Syndrome or Toxic Epidermal Necrolysis, which are potentially life-threatening, Acute generalised exanthematous pustulosis (AGEP) which is a skin eruption and presents with small white or red elevations of the skin.
• Joint pain, muscle pain, muscle stiffness, muscle weakness, muscle cramps or twitching, muscle weakness. Pain and swelling of the tendons (tendinitis), rupture of tendons, worsening of the symptoms of myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), rhabdomyolysis (breakdown of muscle tissue).
• Dehydration, kidney impairment or kidney failure due to dehydration.
• Swelling (of the hands, feet, ankles, lips, mouth or throat), feeling unwell (weakness or tiredness), aches and pains such as back, chest, pelvic pains and pains in the legs and arms, sweating.

Frequency unknown

• Guillain-Barre Syndrome (a condition where your own immune system attacks your nerves causing numbness, weakness and pain).
• Aortic aneurysm (a balloon-like bulge in the aorta) and aortic dissection (a tear in the inner layer of the large blood vessel of the heart), mitral/aortic valve regurgitation (a backflow of blood caused by the failure of the valves to close properly).
• CDAD (C.difficile-associated disease), which is a disruption of the normal balance of flora in the intestine.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your health care provider. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of AVOXA.

Store in the original packaging at or below 25 °C. Keep blisters in the carton until required for use. Protect from moisture. Do not store your medicine in the bathroom. Do not use AVOXA after the expiry date printed on the label, container or blister. Return any expired or unused medicine to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.