Avelon 400 mg Film-Coated Tablets

AVELON is used for the treatment of a bacterial infection of the sinuses, airways, lungs (where the infection was contracted outside a hospital), 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.

Do not take AVELON

• If you are hypersensitive (allergic) to moxifloxacin, any other quinolone antibiotic, or any of the other ingredients of AVELON (listed in section 6).
• If you have 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 have severe liver disease, e.g. liver cirrhosis.
• If you are pregnant or breastfeeding your baby (see section Pregnancy and breastfeeding).
• If you were born with or have any condition with abnormal heart rhythm whether related to QT time prolongation or not (seen on ECG, electrical recording of the heart).
• If you have a 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 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 damaged mitral and/or aortic heart valve which cannot close properly.
• If you have myasthenia gravis (abnormal muscle fatigue leading to weakness and, in serious cases, paralysis).
• If you or your child are younger than 18 years.
• If you have moderate to severe impairment of your kidney function and are treated with ACE inhibitors/angiotensin-receptor blockers. Ask your doctor if you are not sure.

Do not share medicines prescribed for you with any other person. Always take AVELON exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. AVELON tablets are for oral use. The usual dose is 400 mg (one tablet) once daily. The duration of treatment will be determined by your doctor and the severity of your condition. You should swallow the tablets whole with a glass of water. They can be taken independent of food intake. Do not double the dose. Do not change the dose prescribed by your doctor. If you have the impression that the effect of AVELON is too strong or too weak, tell your doctor or pharmacist.

If you take more AVELON than you should

If you are concerned that you may have taken too much AVELON, contact your doctor immediately. If you take more than the prescribed dose, get medical help immediately as it can cause heart rhythm problems. If possible, take your tablets or the box with you to show the doctor. In the event of overdosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison centre.

If you forget to take AVELON

If you forget to take your tablet and it is:

• 8 hours until your next scheduled dose, take your missed tablet right away. Then take your next dose at your regular time.
• Less than 8 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular scheduled time.

Do not take more AVELON next time; simply continue the treatment as prescribed. (Do not take double doses to make up for a forgotten dose).

If you stop taking AVELON

It is important that you finish the course of treatment even if you begin to feel better. If the treatment with AVELON is stopped too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse, or the bacteria may become resistant to the medicine. You should always consult your doctor before deciding to interrupt the course of treatment or stop taking AVELON altogether.

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

• angioedema (rapid swelling of the skin and mucous membranes of the face, lips, tongue, or throat with difficulty to breathe);
• Anaphylactic reaction/shock which is a severe sudden allergic reaction and is rapid in onset. Symptoms of anaphylactic reaction include dizziness feeling dizzy, sick or faint or experiencing dizziness when standing up), tightness in the chest, loss of consciousness, difficulty in breathing, swelling of the face, lips, tongue, or throat and airways (breathing tubes), blueness of the skin, low blood pressure, heart failure, and can result in death;
• Sudden severe pain in your chest, abdomen (tummy) or back;
• severe dizziness, fainting, fast or pounding heartbeats;
• sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your muscles, ligaments or joints;
• diarrhoea that is watery or bloody;
• confusion, hallucinations, depression, unusual thoughts or behaviour;
• seizure (convulsions);
• pale or yellowed skin, dark coloured urine, fever, weakness;
• urinating less than usual or not at all;
• easy bruising or bleeding;
• numbness, tingling, or unusual pain anywhere in your body;
• the first sign of any skin rash, no matter how mild; or
• 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.

Frequent side effects include

• Infections caused by fungi (oral and vaginal infections/thrush caused by Candida)
• 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), prolonged prothrombin time or increased INR (decreased blood clotting)
• Allergic reactions, pruritus (itching), rash, urticaria (skin hives), blood eosinophilia (increased specialised white blood cells – eosinophils).
• increased blood lipids/fats
• Anxiety reactions, restlessness/agitation
• Headache, dizziness, par- and dysesthesia (tingling sensation (pins and needles) and/or numbness), taste disorders or loss of taste, confusion and disorientation, sleep disorders, tremor (shaking), vertigo (sensation of dizziness, spinning or falling over), somnolence (sleepiness)
• Visual disturbances including double and blurred vision
• QT prolongation in patients with hypokalaemia (delayed electrical recovery time within the heart as shown by ECG in patients with low blood potassium level), QT prolongation (delayed electrical recovery time within the heart shown by ECG), palpitations (irregular heart beat), tachycardia (fast heart beat), vasodilatation (widening of blood vessels)
• Dyspnoea (difficulty in breathing including asthma)
• Nausea, vomiting, gastrointestinal and abdominal pain, diarrhoea, decreased appetite and food intake, constipation, dyspepsia (upset stomach, indigestion and/or heartburn), flatulence (wind), gastroenteritis (inflammation of the stomach), increased amylase (a special digestive enzyme in the blood)
• Increase in transaminases (a special liver enzyme in the blood), impaired liver function, including LDH increase (a special liver enzyme in the blood), increase of bilirubin in the blood, increase of gamma-glutamyl-transferase and/or alkaline phosphatase in the blood (special liver enzymes in the blood)
• Arthralgia (joint pain), myalgia (muscle pain)
• Dehydration (caused by diarrhoea or reduced fluid intake)
• Feeling unwell (predominantly weakness or tiredness), unspecific aches and pains such as back, chest, pelvic and extremities pains, sweating

Less frequent side effects include

• Abnormal thromboplastin level (special enzyme in the blood involved in blood coagulation), changes in prothrombin level and INR (increased or abnormal blood clotting)
• Anaphylactic reaction (severe, sudden allergic reaction for example difficulty in breathing, drop of blood pressure, fast pulse), angioedema (swelling of the face, lips, tongue, throat and airway), anaphylactic shock (with may be life-threatening)
• Blood-glucose disorders (high blood sugar – hyperglycaemia or low blood sugar - hypoglycaemia), hyperuricemia (increased blood uric acid)
• Depression, hallucinations, feelings of not being yourself, psychotic reactions (potentially leading to self-harm, such as thought to kill oneself, or suicide attempts)
• Reduced skin sensation, smell disorders, abnormal dreams, disturbed coordination due to dizziness or vertigo (may lead to fall with injuries), seizures (fits), disturbed attention, impaired speech, amnesia (partial or total loss of memory), peripheral neuropathy and polyneuropathy (troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities), increased sensitivity of the skin
• Temporary loss of vision
• Ringing in the ears (tinnitus), hearing impairment including deafness (usually reversible)
• Abnormal fast heart rhythm, syncope (fainting), high blood pressure, low blood pressure, unspecified abnormal heart rhythms, Torsade de Pointes (life-threatening irregular heart beat), cardiac arrest (stopping of heart beat)
• Dysphagia (difficulty in swallowing), stomatitis (inflammation of the mouth), antibiotic-associated colitis (severe diarrhoea containing blood and/or mucus, which may be life-threatening)
• 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
• Tendinitis (pain and swelling of the tendons), increased muscle tone and cramping, muscular weakness, tendon rupture, arthritis (inflammation of joints), gait disturbance (caused by muscular, tendon or joint symptoms), worsening of the symptoms of myasthenia gravis
• Impairment or failure of the kidneys (due to dehydration)
• Oedema (swelling of the hands, feet, ankles, lips, mouth, throat)

In isolated instances, some serious adverse drug reactions may be long-lasting (> 30 days) and disabling; such as tendinitis, tendon rupture, musculoskeletal disorders, and other reactions affecting the nervous system including psychiatric disorders and disturbance of senses.

The following side effects have been observed more frequently in patients treated with intravenously followed by oral treatment: Increased gamma-glutamyl-transferase (liver enzyme in the blood), abnormal fast heart rhythm, low blood pressure, oedema (swelling of the hands, feet, ankles, lips, mouth or throat), antibiotic-associated colitis (severe diarrhoea containing blood and /or mucus), seizures (fits), hallucinations, impairment and failure of kidneys.

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 doctor or pharmacist. You can also report side effects to SAHPRA via Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. Alternatively, you can report to Bayer SafeTrack site (https://www.safetrack-public.bayer.com). By reporting side effects, you can help provide more information on the safety of AVELON.

Store all medicines out of reach of children. Store at or below 25 °C in a dry place. Do not store in bathrooms. Return unused or expired medicines to your pharmacist for safe disposal. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Do not remove from the original packaging until administered. Do not use after the expiry date stated on the label.