Levox SPIMACO

Transcription

1 08-15 SPIMACO 250 mg tablets 500 mg tablets 750 mg tablets levofloxacin tablets contain a medicine called levofloxacin, used in adults 18 years or older. This belongs to a group of medicines called antibiotics. Levofloxacin is a quinolone antibiotic. It works by killing the bacteria that cause infections in your body. tablets can be used to treat infections of the: Nasal sinuses. Lungs, in people with long-term breathing problems or pneumonia. Urinary tract, including your kidneys or bladder. Prostate gland, where you have a long lasting infection. Skin and underneath the skin, including muscles. This is sometimes called soft tissue. Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including, do not kill viruses. You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or any of the other ingredients of tablets (listed in Section 6 below). Signs of an allergic reaction include rash, swallowing or breathing problems, and swelling of your lips, face, throat or tongue. You have ever had epilepsy. You have ever had a problem with your tendons such as tendonitis that was related to treatment with a quinolone antibiotic. You are a child or a growing teenager. You are pregnant, might become pregnant or think you may be pregnant. You are breast-feeding. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking tablets. Due to possible side effects, is not recommended for pediatric and adolescent patients -less than 18- except for the prevention of anthrax for those who are 6 months and older and have breathed the anthrax bacteria germ. - Tendons are the tough cords of tissue that connect muscles to bones. Pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take quinolone antibiotics, including. The risk of getting tendon problems is higher if you: Are over 60 years of age. Are taking steroids (corticosteroids). Have had a kidney, heart or lung transplant. Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take quinolones who do not have the above risk factors. Other reasons for tendon ruptures can include: - Physical activity or exercise. - Kidney failure. - Tendon problems in the past, such as in people with rheumatoid arthritis (RA). Call your doctor right away at the first sign of tendon pain, swelling or inflammation. Stop taking until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Get medical help right away if you get any of the following signs or symptoms of a tendon rupture: - Hear or feel a snap or pop in a tendon area. - Bruising right after an injury in a tendon area. - Unable to move the affected area or bear weight.. Are 60 years of age or older. SPIMACO- - p.1/5

2 SPIMACO- - p.2/5 Are using corticosteroids. Have ever had a fit (seizure). Have tendon problems. Have low blood potassium (hypokalemia). Have had damage to your brain due to a stroke or other brain injury. Have kidney problems. Have something known as glucose 6 phosphate dehydrogenase deficiency. Have ever had mental health problems. Have ever had heart problems. Are diabetic. Have bone and joint problems such as rheumatoid arthritis (RA) or other history of joint problems. Have nerve problems. Have or anyone in your family has an irregular heartbeat, especially a condition called QT prolongation. Have ever had liver problems. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking tablets. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Do not start a new medicine without first consulting a doctor or pharmacist. This includes medicines you buy without prescription, including herbal medicines. This is because tablets can affect the way some other medicines work. In addition, some medicines can affect the way tablets work. In particular, tell your doctor if you are taking any of the following medicines. This is because it can increase the chance of you getting side effects, when taken with tablets: - used for inflammation. You may be more likely to have inflammation and/or breakage of your tendons. - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot. - used for breathing problems. You are more likely to have a fit (seizure) if taken with tablets. - used for pain and inflammation such as aspirin, ibuprofen, fenbufen, ketoprofen and indomethacin. You are more likely to have a fit (seizure) if taken with tablets. - used after organ transplants. You may be more likely to get the side effects of Ciclosporin. This includes medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine and amiodarone). - such as amitriptyline and imipramine. - such as erythromycin, azithromycin and Clarithromycin. - (used for gout). - used for ulcers and heartburn. Special care should be taken when taking either of these medicines with. If you have kidney problems, your doctor may want to give you a lower dose. Iron tablets (for anemia), multivitamin, or other product that has magnesium, aluminum, iron or zinc. Magnesium or aluminum-containing antacids (for acid or heartburn). Sulcralfate (for stomach ulcers). Didanosine antiviral drug for HIV. This is because it can affect the way tablets work. Urine tests may show false-positive results for strong painkillers called opiates in people taking ( levofloxacin) tablets. If your doctor is due to take a urine test, tell him you are taking tablets. Do not take this medicine if: You are pregnant, might become pregnant or think you may be pregnant. You are breast-feeding or planning to breast-feed. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. You may get side effects after taking this medicine, including feeling dizzy, sleepy, a spinning feeling (vertigo) or changes to your eyesight. Some of these side effects can affect you being able to concentrate and your reaction speed. If this happens, do not

3 SPIMACO- - p.3/5 drive or carry out any work that requires a high level of attention. Always take tablets exactly as your doctor has told you. Take this medicine by mouth. Swallow the tablets whole with a drink of water. The tablets may be taken during meals or at any time between meals. Your doctor will decide on how many tablets you should take. The dose will depend on the type of infection you have and where the infection is in your body. The length of your treatment will depend on how serious your infection is. 500 mg, once each day for days. 750 mg, once each day for 5 days. 750 mg, once each day for 7-14 days. 500 mg, once each day for days. 750 mg, once each day for 5 days. 500 mg, once each day for 7 days. 750 mg, each day for 5 days. 250 mg, each day for 10 days. 250 mg, each day for 3 days. 500 mg, once each day for 28 days. 750 mg, once each day for 7-14 days. 500 mg, once each day for 7-10 days. Your doctor may need to give you a lower dose. This medicine must not be given to children or teenagers below 18 years. Children have a higher chance of getting bone, joint, or tendon problems such as pain or swelling while taking levofloxacin. The Dose: 500 mg, once each day for 60 days for adults and for children 6 months and older and their weight is more than 50 kg. has been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ. Take exactly as prescribed by your healthcare provider. Do not stop taking without talking with your healthcare provider. If you stop taking too soon, it may not prevent you from getting the anthrax disease. It is not known if it is safe to use for more than 28 days in adults and for more than 14 days in children 6 months of age and older. If you are pregnant, or plan to become pregnant while taking, you and your healthcare provider should decide whether the benefits of taking for anthrax are more important than the risks. In children 6 months and older who have breathed the anthrax bacteria germ: is used to prevent anthrax disease (inhalation anthrax). It is not known if is safe and works in children under the age of 6 months. If you accidentally take more tablets than you should, tell a doctor or get other medical advice straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: Convulsive fits (seizures), feeling confused, dizzy, less conscious and heart problems leading to uneven heart beats as well as feeling sick (nausea). If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not double-up the next dose to make up for the missed dose. Do not stop taking tablets just because you feel better. It is important that you complete the course of tablets that your doctor has prescribed for you. If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Like all medicines, can cause side effects, although not everybody gets them. These effects are normally mild or moderate and often disappear after a short time. (affects less than 1 person in 10,000): You have an allergic reaction. Even after only one dose. The signs may include a rash, swallowing or breathing problems, hives, hoarseness, rapid heart beat, faint, and swelling of your lips, face, throat, or tongue.

4 SPIMACO- - p.4/5 Burning, tingling, pain, weakness and numbness in your arms, hands, legs or feet. These may be signs of something called peripheral neuropathy. See a doctor straight away if you notice any of these side effects. (affects less than 1 person in 1000): Watery diarrhea, diarrhea that does not go away or which may have blood in it, possibly with stomach cramps and a high temperature. These could be signs of a severe bowel problem. Pain and inflammation in your tendons. The Achilles tendon is affected most often and in some cases, the tendon could break. Fits (convulsions). Severe skin rashes that may include blistering or peeling of the skin around your lips, eyes, mouth, nose and genitals. Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems. (affects less than 1 person in 10): Feeling sick (nausea) and diarrhea. Increase in the level of some liver enzymes in your blood. Headache, feeling dizzy. Insomnia. (affects less than 1 person in 100): Itching and skin rash. Loss of appetite, stomach upset or indigestion (dyspepsia), being sick (vomiting) or pain in your stomach area, feeling bloated (flatulence) or constipation. A spinning feeling (vertigo), feeling sleepy, sleeping problems or feeling nervous. General weakness. (affects less than 1 person in 1,000): Tingly feeling in your hands and feet (paraesthesia) or trembling. Feeling stressed (anxiety), depressed, mental problems, feeling restless (agitation) or feeling confused. Unusual fast beating of your heart or low blood pressure. Joint pain or muscle pain. Bruising and bleeding easily due to a lowering in the number of blood platelets. Low number of white blood cells (called neutropenia). Difficulty breathing or wheezing (bronchospasm). Severe itching or hives (called urticaria). (affects less than 1 person in 10,000): Increased sensitivity of your skin to sun and ultraviolet light. Low blood sugar levels (hypoglycemia) and high blood sugar (hyperglycemia). This is important for people that have diabetes. Problems with your hearing or eyesight or changes in the way things taste and smell. Seeing or hearing things that are not there (hallucinations), change in your opinion and thoughts (psychotic reactions) with a chance of having suicidal thoughts. Loss of circulation (anaphylactic like shock). Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system). Inflammation of the liver, changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis. Fever, sore throat and a general feeling of being unwell that does not go away. This may be due to a lowering in the number of white blood cells. Fever and allergic lung reactions. Lowering in red blood cells (anemia). This can make the skin pale or yellow due to damage of the red blood cells and lowering in the number of all types of blood cells. Exaggerated immune response (hypersensitivity). Sweating too much (hyperhidrosis). Pain, including pain in the back, chest and extremities. Problems moving and walking. Attacks of porphyria in people who already have porphyria. Inflammation of your tubes that carry blood around your body (vessels) due to an allergic reaction. If any of the side effects gets serious, or if you

5 SPIMACO- - p.5/5 notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Keep out of the reach and sight of children. Store below 30 C, Store in the original carton. Do not use after the expiry date which is stated on the carton. The active substance is levofloxacin. Each tablet of 250 mg tablets contains 250 mg of levofloxacin, each tablet of 500 mg tablets contains 500 mg of levofloxacin and each tablet of 750 mg tablets contains 750 mg of levofloxacin. Excipients for core: Hydroxypropyl methylcellulose EP, crospovidone NF, silicified microcrystalline cellulose, and magnesium stearate. Excipients for film coating: Polysorbate 80 EP, titanium dioxide EP, purified talc EP, polyethylene glycol MW 6000 EP, hydroxypropyl methylcellulose EP, iron oxide yellow. tablets are film-coated tablets for oral use. The tablets are oblong with light yellow colour. 250, 500, and 750 mg are available in pack sizes of 5 tablets. This leaflet was last approved in June 2011.