6. If you use the cream on your face be Reporting of side effects careful to avoid your eyes. If you get any side effects, talk to your 7. Always wash your hands after using the doctor, pharmacist or nurse. This includes cream, unless you are using the cream any possible side effects not listed in this PACKAGE LEAFLET: INFORMATION FOR THE USER to treat your hands. leaflet. You can also report side effects If you accidentally get any cream in your directly via the Yellow Card Scheme at: Fusidic Acid 20 mg/g cream eye, wash it out with cold water straight www.mhra.gov.uk/yellowcard. Fusidic Acid away. Then rinse your eye with eye wash By reporting side effects you can help if possible. Your eye may sting. If you start provide more information on the safety to have any problems with your sight or of this medicine. Read all of this leaflet carefully before planning to have a baby, ask your your eye is sore, contact your doctor you start using this medicine because it doctor or pharmacist for advice before immediately. contains important information for you. using this medicine. 5. How to store Fusidic Acid Cream • Keep this leaflet. You may need to Duration of treatment Keep this medicine out of the sight and read it again. Pregnancy: The duration of the treatment will be reach of children. • If you have any further questions, ask There is not enough evidence to say that decided by your doctor. Treatment is it is safe to use Fusidic acid cream during usually 1 to 2 weeks, although it may be Do not use this medicine after the expiry your doctor, pharmacist or nurse. date which is stated on the carton or the • This medicine has been prescribed for pregnancy. longer. This depends on the type of infection and the result of the treatment. tube after “EXP”. The expiry date refers to you only. Do not pass it on to others. It You need to discuss your specific the last day of that month. may harm them, even if their signs of circumstances with your doctor to weigh Take special care if you use the cream illness are the same as yours. up the overall risks and benefits of using for a long time or in large amounts, Do not store above 25°C. • If you get any side effects, talk to your this medicine. You and your doctor can because then there is a higher chance Discard the tube after 4 weeks of first doctor, pharmacist or nurse. This make a decision about whether you are of getting side effects. Therefore, always opening the tube even if there is still includes any possible side effects not going to use this medicine during follow the advice of your doctor. some cream left in it. listed in this leaflet. See section 4. pregnancy. If you use more Fusidic acid cream than Do not throw away any medicines via What is in this leaflet You should only use this medicine during you should wastewater or household waste. Ask your 1. What Fusidic acid cream is and what it pregnancy if your doctor thinks that you If you apply too much or accidentally pharmacist how to throw away is used for need it. swallow Fusidic acid cream, it is unlikely medicines you no longer use. These to cause any harm. However, if you measures will help protect the 2. What you need to know before you Breast-feeding: use Fusidic acid cream notice any effect or are worried, contact environment. Using Fusidic acid cream topically and your doctor or pharmacist. You should 3. How to use Fusidic acid cream breast-feeding is unlikely to harm your 4. Possible side effects contact the doctor if Fusidic acid cream baby. Fusidic acid cream may be used is accidentally swallowed by an infant. 5. How to store Fusidic acid cream during breast-feeding but you should 6. Contents of the pack and other 6. Contents of the pack and other avoid applying it on your breast. If you forget to use Fusidic acid cream information information What Fusidic acid cream contains You should only breast-feed your baby If you forget to use the cream, apply the usual amount of Fusidic acid cream as • The active substance is fusidic acid. while using this medicine on the advice Each gram of cream contains 20 mg of your doctor. soon as you remember. Do not apply a 1. What Fusidic Acid Cream is and double dose to make up for a forgotten fusidic acid. what it is used for Fertility: dose. • The other ingredients are The active ingredient of Fusidic acid There is not enough evidence to say that butylhydroxyanisole (E320), cetyl cream is fusidic acid. This is an antibiotic Fusidic acid cream affects fertility. If you stop using Fusidic acid cream alcohol, glycerol (E422), liquid paraffin, (this means that it kills bacteria that However, using Fusidic acid cream is Always use Fusidic acid cream for potassium sorbate (E202), polysorbate cause infections). unlikely to affect fertility in women of duration directed by your doctor. Speak 60 (E435), white soft paraffin, child bearing potential. to your doctor if unsure. If you stop using hydrochloric acid for pH adjustment, Fusidic acid cream should be used on Fusidic acid cream prematurely, it is purified water. Some of these the skin. The cream is used for the local Driving and using machines possible that the skin infection returns or ingredients can cause a skin reaction, treatment of skin infections caused by This cream does not affect your ability to does not cure. see section 2 of this leaflet. bacteria that are sensitive to fusidic acid drive or operate machinery. (especially staphylococcus infections) If you have any further questions on the What Fusidic acid cream looks like and such as impetigo (a weeping, crusty and Fusidic acid cream contains use of this medicine, ask your doctor, contents of the pack swollen patch of skin), folliculitis butylhydroxyanisole, cetyl alcohol and pharmacist or nurse. Fusidic acid cream is a white to off-white (inflammation of one or more hair potassium sorbate which may cause cream, and is available in an aluminium follicles), sycosis barbae (infection of the local skin reactions (e.g. contact tube with HDPE screw cap. bearded skin), paronychia (infection of dermatitis). Butylhydroxyanisole may also 4. Possible side effects Pack sizes: 15 gram and 30 gram. the tissue surrounding a fingernail or cause irritation to the eyes and mucous Like all medicines, this medicine can Not all pack sizes may be marketed. toenail), erythrasma (infection with membranes. cause side effects, although not everybody gets them. The most Marketing Authorisation Holder brown, scaly skin patches, especially in Focus Pharmaceuticals Limited, the folds of the body). frequently reported side effects are 3. How to use Fusidic Acid Cream various skin reactions and in particular Capital House, Always use this medicine exactly as your application site reactions. The frequency 85 King William Street, London EC4N 7BL, 2. What you need to know before you doctor or pharmacist has told you. of occurrence of side effects is as follows: Check with your doctor or pharmacist if Uncommon: may affect up to 1 in 100 UK. use Fusidic Acid Cream people Do not use Fusidic acid cream if you are you are not sure. Manufacturer allergic to fusidic acid or any of the other The recommended dose is Rare: may affect up to 1 in 1,000 people Basic Pharma Manufacturing bv, Burgemeester ingredients of this medicine (listed in Your doctor will tell you how much If you have any of the following rare side section 6). Fusidic acid cream you should use. Lemmensstraat 352, 6163 JT Geleen, effects while using your medicine tell The Netherlands. Warnings and precautions Use in adults and children your doctor immediately or go to Talk to your doctor, pharmacist or nurse Usually a small amount of cream is hospital straight away: This medicinal product is authorised in before using Fusidic acid cream applied to the infected skin three or four • Severe allergic reaction which may the Member States under the following • if you use Fusidic acid cream on the times each day. If your doctor advises include a red and lumpy skin rash, names: face. The cream should not be applied you to use a sterile bandage or dressing, difficulty breathing, swelling of face, Belgium: Affusine in or near the eye because it can lead you usually can reduce the number of mouth, lips or eyelids, unexplained high Germany: Fusidinsäure Basic to a prickling feeling in the eye applications. temperature (fever and feeling faint). If Pharma 20 mg/g • if you use the cream for a long time or the swelling affects your throat and Creme A nappy on a baby may act as a makes breathing and swallowing Luxembourg: Affusine in large amounts as it may make the dressing. Follow the advice of your chance of getting any side effects difficult, go to hospital straight away. The Netherlands: Fusidinezuur Basic doctor. Pharma 20 mg/g crème higher. Also your skin may get more Uncommon sensitive to the cream. If you think that the effect of Fusidic acid Poland: Hylosept cream is too strong or too weak, ask your • Itching United Kingdom: Fusidic acid 20 mg/g Please tell your doctor if one of the doctor or pharmacist for advice. • Rash cream above warnings applies to you or has • Eczema applied to you in the past. Method of administration: • Skin sensitivity reactions (contact This leaflet was last revised in 09/2017. How to apply Fusidic acid cream dermatitis) Other medicines and Fusidic acid cream Fusidic acid cream should be applied to • Irritation at site of application LF-103298-01 Tell your doctor or pharmacist if you are the skin. Do not swallow it. (including pain, stinging, burning and taking, have recently taken or might 1. Always wash your hands before you redness of the skin). take any other medicines, including use the cream. medicines obtained without a 2. Remove the cap. Rare prescription. There is no known effect of 3. Check that the seal is not broken • Blister Fusidic acid cream with other medicines. before you use the cream for the first • Swelling of the skin time. • Hives Pregnancy, breast-feeding and fertility • Conjunctivitis. If you are pregnant or breast-feeding, 4. Push the spike in the cap through the think you may be pregnant or are seal of the tube. 5. Rub the cream gently on the skin.