Package leaflet: Information for the patient Cloxacillin Villerton Nordic A/S 1 g powder for solution for injection/infusion Cloxacillin Villerton Nordic A/S 2 g powder for solution for injection/infusion cloxacillin Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or pharmacist. - 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Cloxacillin Villerton Nordic A/S is and what it is used for 2. What you need to know before you use Cloxacillin Villerton Nordic A/S 3. How to use Cloxacillin Villerton Nordic A/S 4. Possible side effects 5. How to store Cloxacillin Villerton Nordic A/S 6. Contents of the pack and other information 1. What Cloxacillin Villerton Nordic A/S is and what it is used for Cloxacillin Villerton Nordic A/S contains the active substance cloxacillin, which is an antibiotic acting against bacterial infections. It prevents the bacteria to form normal cell wall. Without a cell wall the bacteria die quickly. Cloxacillin is used to treat infections caused by certain bacteria, particularly staphylococci, which creates an enzyme called beta-lactamase. This enzyme has the ability to break down penicillin. Cloxacillin is different respect to standard penicillin since it is not degraded by beta-lactamase. Cloxacillin Villerton Nordic A/S is used to treat infections of skin and soft tissue, heart inflammation, abscesses, inflammation of bone marrow and blood poisoning. 2. What you need to know before you use Cloxacillin Villerton Nordic A/S Do not use Cloxacillin Villerton Nordic A/S: - if you are allergic to cloxacillin, other penicillins or to cephalosporins. - if you are allergic to cephalosporins (another group of antibacterial medicines). Warnings and precautions Talk your doctor or pharmacist before using Cloxacillin Villerton Nordic A/S - if you have impaired kidney function. - if you have/get diarrhoea. Other medicines and Cloxacillin Villerton Nordic A/S Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. It is especially important for the doctor to know if you are taking any of the following: - methotrexate (a medicine used in treatment of cancer or rheumatism) - contraceptive pill 1 - probenecid (a medicine against gout) - warfarin (a blood-thinning medicine) Pregnancy, breast-feeding and fertility 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 taking this medicine. Pregnancy No known risks related to use of Cloxacillin Villerton Nordic A/S during pregnancy. Breast-feeding Cloxacillin is excreted in human milk, but at therapeutic doses the risk of an effect on the infant is considered to be unlikely. Driving and using machines Cloxacillin Villerton Nordic A/S is not considered to influence on the ability to drive and use machines. Each person must assess their ability to drive a car or perform hazardous work. Drugs can affect your ability to drive or perform hazardous work. Read the information in this leaflet carefully. If necessary, talk to your doctor or pharmacist. Cloxacillin Villerton Nordic A/S contains sodium The maximum recommended daily dose of this medicinal product contains 600 mg sodium (found in table salt). This is equivalent to 30% of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need Cloxacillin Villerton Nordic A/S on a daily basis for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet. 3. How to use Cloxacillin Villerton Nordic A/S Your doctor will decide the dose according to your needs. Cloxacillin Villerton Nordic A/S is a powder for solution to be dissolved in sterile water. The solution is injected intravenously or intramuscularly or administered by intravenous infusion. If you use more Cloxacillin Villerton Nordic A/S than you should As this medicine is given by a doctor or other healthcare professional, it is very unlikely that you will be given too much Cloxacillin Villerton Nordic A/S. However, if you have any concerns you should let your doctor, nurse or pharmacist know immediately. Symptoms of an overdose include nausea, vomiting, diarrhoea, reduced level of consciousness and cramps. If you have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if you get any of the following serious side effects: - Severe allergic reaction (anaphylactic reaction). This kind of side effect may be life-threatening. One or several of the following symptoms may occur: erythema, itchy hives-like eczema (urticaria), breathing difficulties and vertigo (rare, may affect up to 1 in 1,000 users). 2 - In rare cases, Cloxacillin Villerton Nordic A/S may affect white blood cells so that the immune response weakens. If you get an infection with symptoms like fever combined with a severely worsened general condition or fever combined with local signs of infection, for example, pain in the neck/throat/mouth, or difficulties in passing urine, you should see a doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be excluded by blood tests. In this case, it is important that you inform the doctor about your medication. Other possible side effects: Common side effects (may affect up to 1 in 10 users): - inflammation of a blood vessel (thrombophlebitis) - nausea, diarrhoea - skin rash Uncommon (may affect up to 1 in 100 users): - increased number of white blood cells - hives (urticaria) Rare (may affect up to 1 in 1,000 users): - acute infection of the colon (pseudomembranous colitis) - decreased number of white blood cells - lack of blood platelets, resulting in a tendency to bleed (thrombocytopenia) - effect on the liver - effect on kidneys A fungal infection of the oral cavity and the female organs may occur. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Cloxacillin Villerton Nordic A/S Keep this medicine out of the sight and reach of children. Do not store above 25 °C. Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Cloxacillin Villerton Nordic A/S contains - The active substance is cloxacillin. Each vial contains 1 g or 2 g of cloxacillin (as cloxacillin sodium). - This medicine contains no excipients. What Cloxacillin Villerton Nordic A/S looks like and contents of the pack The medicine is a white or almost white crystalline powder. 3 Pack sizes: 10 vials of 1 g powder 10 vials of 2 g powder Marketing Authorisation Holder and Manufacturer <[To be completed nationally]> {Name and address} <{tel}> <{fax}> <{e-mail}> <This medicinal product is authorised in the Member States of the EEA under the following names: {Name of the Member State}{Name of the medicinal product} {Name of the Member State}{Name of the medicinal product}> This leaflet was last revised in <{MM/YYYY}> <--------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE AND HANDLING: Intramuscular injection: Dilute 500 mg in 2 ml water for injections and 2 g in 4 ml water for injections. Intravenous injection: Dilute 500 mg in 10 ml water for injections, 1 g in 20 ml water for injection and 2 g in 40 ml water for injections. Intermittent infusion: Dilute 2 g in a 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection, or 100 ml water for injections. Reconstitution of the powder or preparation of solution for infusion must be performed under aseptic conditions. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. SHELF LIFE OF THE RECONSTITUTED SOLUTION: Chemical and physical stability is documented for 12 hours at 25 °C and 24 hours at 2 - 8 °C. From a microbiological point of view the medicinal product should be administered immediately. If reconstituted solution is not administered immediately, the storage time and storage conditions prior to use is the responsibility of the administrator and should normally not exceed 12 hours at 25 °C or 24 hours at 2 - 8 °C, if reconstitution does not take place under controlled and validated aseptic conditions. 4 .