cream

This information is a summary only. It does not contain all information about this medicine. If you would like more information about the medicine you are taking, check with your doctor or other health care provider. No rights can be derived from the information provided in this medicine leaflet.

SILVER SULFADIAZINE Cream How to use it SILVER SULFADIAZINE should be applied by means of a sterile spatula or by hand, What SILVER SULFADIAZINE is used for covered with a sterile glove, in a layer approximately 3-5 mm thick. One SILVER SULFADIAZINE is a topical antibacterial cream with an active ingredient application at least every 24 hours is normally sufficient but the number of times which belongs to the group of medicines called sulfonamides. a day to apply the cream will depend on your own individual needs. Where SILVER SULFADIAZINE is used to prevent infection in severe . Other types of necessary reapply SILVER SULFADIAZINE to any area where it has been removed wounds, such as pressure sores and leg ulcers, may also benefit from the during activity. application of SILVER SULFADIAZINE cream. • It is soothing when applied and has proven activity against a broad range of It is important to apply SILVER SULFADIAZINE exactly as your doctor or pharmacist organisms including both Gram-positive and Gram-negative bacteria and some has told you. If you use it less often than you should, it may not work as well and viruses and fungi. your skin problem may not improve. Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects. Before you use SILVER SULFADIAZINE Apply SILVER SULFADIAZINE at about the same time every day. When you must not use it Do not use SILVER SULFADIAZINE if: How long to use it you have an to: Treatment is continued until healing is progressing satisfactorily or the site is • SILVER SULFADIAZINE or any medicine within the group or any of ready for skin grafting. the ingredients in SILVER SULFADIAZINE listed at the end of this leaflet. Your doctor or pharmacist will tell you how long to keep applying SILVER Ask your doctor or pharmacist if you are not sure. SULFADIAZINE cream. Do not use SILVER SULFADIAZINE for longer than your doctor tells you. Do not give SILVER SULFADIAZINE to premature infants or newborn infants in the If you use SILVER SULFADIAZINE for longer than your doctor or pharmacist tells first months of life. Sulfonamides may cause a life-threatening condition known you, the chance of side effects may increase. as “kernicterus” (jaundice of the brain) in babies during the first months of life by If you are not sure how long to use SILVER SULFADIAZINE, talk to your doctor. interfering with normal metabolism. If you swallow it Tampering and expiry date warnings: Immediately tell your doctor. Do not use SILVER SULFADIAZINE if the tube or jar has been opened or shows signs of tampering before your first application. While you are using SILVER SULFADIAZINE Do not use SILVER SULFADIAZINE if the expiry date (EXP) printed on the tube or Things you must do jar has passed. Tell all doctors and pharmacists who are treating you that you are using SILVER If you use this medicine after the expiry date has passed, it may not work SULFADIAZINE. If you feel that SILVER SULFADIAZINE is not helping your effectively. condition, tell your doctor (or pharmacist). Tell your doctor if, for any reason, you have not used SILVER SULFADIAZINE exactly as prescribed. Otherwise, your Before you start to use it doctor may think that it was not effective and change your treatment Tell your doctor if: unnecessarily. If you become pregnant while using SILVER SULFADIAZINE, tell 1. you have any to any other medicines or any other substances, such as your doctor. foods, preservatives or dyes. 2. you are pregnant or intend to become pregnant. SILVER SULFADIAZINE should Things you must not do not be used during the last month of . Your doctor will discuss the risks Do not use SILVER SULFADIAZINE in or near the eyes. and benefits of using SILVER SULFADIAZINE when pregnant. Do not give SILVER SULFADIAZINE to anyone else, even if they have similar 3. you are breast-feeding or intend to breast-feed Sulfonamides are excreted in problems to yours. the milk in small amounts and should be used with caution in breast-feeding mothers. Things to be careful of Your doctor will discuss the risks and benefits of using SILVER SULFADIAZINE Do not use large amounts of SILVER SULFADIAZINE for a long time. when breastfeeding. If you use large amounts for a long time, the chance of absorption through the Do not apply SILVER SULFADIAZINE to the breasts before breast feeding. skin and the chance of side effects increases. 4. you know you are glucose-6- phosphate deficient Ask your doctor or pharmacist if you are concerned about the length of time you 5. you have or have had any other medical conditions, including: have been using SILVER SULFADIAZINE. • Low white blood cell count: A fall in white blood cell count has been demonstrated very occasionally, but it is not thought to be associated with the Side effects treatment. Nevertheless, regular blood counts are advisable if you are on long- Tell your doctor or pharmacist if you do not feel well while you are using SILVER term treatment. SULFADIAZINE. • Problems with your liver and / or kidney. SILVER SULFADIAZINE should be used SILVER SULFADIAZINE helps most people with skin problems but it may have with caution in patients with poor liver or kidney function. Reaction to the cream unwanted side effects in a few people. can sometimes cause worsening in these areas but the incidence is lower than All medicines can have side effects. Sometimes they are serious, most of the time with other sulfonamides. they are not. You may need medical treatment if you get some of the side effects. If you have not told your doctor about any of the above, tell them before you use Ask your doctor or pharmacist to answer any questions you may have. any SILVER SULFADIAZINE. Tell your doctor if you notice any of the following and they worry you: Using other medicines • Nausea, vomiting and diarrhoea Tell your doctor or pharmacist if you are using other creams, ointments or lotions • Skin , increasing pain, burning or itching. or taking any medicine. This includes any that you buy without a prescription These side effects are usually mild. from a pharmacy, supermarket or health food shop. Tell your doctor immediately if you notice any of the following: How to use SILVER SULFADIAZINE • Red, raised bumps on the face and scalp (lupus erythematosus) How much to use • Problems with urine volume or colour (Renal or hepatic toxicity) One jar or tube of SILVER SULFADIAZINE should be reserved for one person. If you • Heart pain (myocarditis), are using jars, discard any remaining cream 24 hours after opening the jar. If you • Severe abdominal pain (pancreatitis) are using tubes, discard the product 7 days after opening. • Inflammation of the blood vessels causing nodular swellings along length of Follow all directions given to you by your doctor and pharmacist carefully. vessel (vasculitis, including polyarteritis nodosa). These directions may differ from the information contained in this leaflet. • Allergy-type reactions such as blistering or angry red rash. If you do not understand the instructions, ask your doctor or pharmacist for help. • Skin discolouration.

Lagaay International BV Van Helmontstraat 99 3029 AA Rotterdam, The Netherlands Tel: +31 - 10 4123871

These are serious side effects. You may need urgent medical attention. Serious side effects are rare. Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. Ask your doctor or pharmacist if you don’t understand anything in this list. Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using SILVER SULFADIAZINE Storage Keep SILVER SULFADIAZINE in a cool dry place away from light where the temperature stays below 25°C. Refrigeration is not normally needed but in temperatures in excess of 30°C some form of cooling is desirable. Do not store SILVER SULFADIAZINE or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Keep SILVER SULFADIAZINE where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal If your doctor tells you to stop using SILVER SULFADIAZINE or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Lagaay International BV Van Helmontstraat 99 3029 AA Rotterdam, The Netherlands Tel: +31 - 10 4123871