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PACKAGE LEAFLET: Take special care with Cefalexin: INFORMATION FOR Acute generalised exanthematous (AGEP) THE USER has been reported with the use of cefalexin. AGEP appears at the initiation of treatment Cefalexin as a red, scaly widespread rash with bumps Capsules 250mg under the skin and blisters accompanied by Cefalexin fever. The most common location: mainly Capsules 500mg localised on the skin folds, trunk, and upper cefalexin extremities. The highest risk of occurence of this serious skin reaction is within the first week of treatment. If you develop a Read all of this leaflet carefully before serious skin rash or another of these skin you start taking this medicine because it symptoms, stop taking cefalexin and contact contains important information for you. your doctor or seek medical attention - Keep this leaflet. You may need to read immediately. it again. Other medicines and Cefalexin Capsules - If you have any further questions, ask Tell your doctor or pharmacist if you are your doctor or pharmacist. taking, have recently taken or might take - This medicine has been prescribed for any other medicines, including medicines you only. Do not pass it on to others. It obtained without a prescription. may harm them, even if their signs of This is especially important of the following, illness are the same as yours as they may interact with your Cefalexin: - If you get any side effects, talk to your • Any other antibiotics (e.g. gentamicin, doctor or pharmacist. This includes any tobramycin, cefuroxime) possible side effects not listed in this • Potent diuretics e.g. furosemide (water leaflet. See section 4. tablets used to treat high blood pressure What is in this leaflet: or water retention) 1. What Cefalexin Capsules are and what • Probenecid (a treatment for gout) they are used for • Metformin (a treatment for diabetes) 2. What you need to know before you take • Drugs used to treat leukaemia. Cefalexin Capsules It may be still be all right for you to be given 3. How to take Cefalexin Capsules Cefalexin Capsules and your doctor will be 4. Possible side effects able to decide what is suitable for you. 5. How to store Cefalexin Capsules 6. Contents of the pack and other Pregnancy and breast-feeding If you are pregnant or breast-feeding, think information you may be pregnant or are planning to 1. WHAT CEFALEXIN CAPSULES ARE have a baby, ask your doctor or pharmacist AND WHAT THEY ARE USED FOR for advice before taking this medicine. Driving and using machines Cefalexin Capsules contain cefalexin as Cefalexin Capsules should not affect your the active ingredient, which belongs to a ability to drive or use machines. class of antibiotics called ‘cephalosporins’. Cefalexin Capsules are used to treat Cefalexin Capsule contains Lactose following infections caused by bacteria that If you have been told by your doctor that can be killed by cefalexin: you have an intolerance to some sugars, • Respiratory tract (lung and airways) e.g. contact your doctor before taking this tonsillitis, pharyngitis and bronchitis medicinal product • Middle ear infections (otitis media) • Skin and soft tissue (e.g. muscle) 3. HOW TO TAKE CEFALEXIN infections CAPSULES • Bone and joint infections Always take this medicine exactly as your • Infections of the reproductive organs doctor or pharmacist has told you. Check and urinary tract (e.g. cystitis), including with your doctor or pharmacist if you are not acute inflammation of the prostate gland sure. (prostatitis) These capsules may be taken before, • Dental infections. during or after your meals. 2. WHAT YOU NEED TO KNOW Dosage BEFORE YOU TAKE CEFALEXIN Adults and the elderly CAPSULES The recommended total daily dose is 1-4 g orally, in divided doses. Do not take Cefalexin Capsules: • Most infections can be treated by • If you are allergic to cefalexin, other 500 mg every 8 hours. For skin and cephalosporins (similar antibiotics) soft tissue infections, sore throat or any of the other ingredients of this (streptococcal pharyngitis), and mild, medicine (listed in Section 6). An allergic uncomplicated urinary tract infections, reaction may include rash, itching, the usual dose is 250 mg every 6 hours, difficulty breathing or swelling of the or 500 mg every 12 hours. face, lips, throat or tongue. • For more severe infections, larger doses Tell your doctor before taking Cefalexin: may be needed. A reduced dose is • If you have ever developed a severe needed for patients with severe kidney skin rash or skin peeling, blistering and/ disorders. or mouth sores after taking cefalexin or Use in children other antibacterials. The usual total daily dose for children is Warnings and precautions 25-50 mg/kg (body weight) in divided doses. Talk to your doctor or pharmacist before • For skin and soft tissue infections, taking Cefalexin Capsules if you: streptococcal pharyngitis, and mild, • Have had allergic reaction to cefalexin, uncomplicated urinary tract infections, cephalosporins, penicillins or other drugs the total daily dose may be divided and in the past administered every 12 hours. • Develop severe or prolonged diarrhoea For most infections the following schedule is during or after taking cefalexin suggested: • Have a severe kidney disorder (you may Children under 5 years: 125 mg every 8 need reduced dose) hours. • have ever developed a severe skin rash Children 5 years and over: 250 mg every or skin peeling, blistering and/or mouth 8 hours. sores after taking cefalexin or other In severe infections, the dose may be antibacterials doubled. In the treatment of middle ear Tell your doctor if you are having blood and infections, a total daily dose of 75 to urine Cefalexin may interfere with these 100 mg/kg in 4 doses is required. tests. P15XXXXX Black Version: 04 Date & Time: 13.09.2021 & 11.40 AM Supersede Item Code: N08418 If you have any further • Discharge from the vagina caused by questions on the use of thrush this product, ask your • Nervousness doctor or pharmacist. • Sleep disturbances • Arthritis and joint disorder If you take more • Hypertonia (increased tightness of Cefalexin Capsules than muscle tone) you should Contact your doctor or Frequency not known: nearest hospital casualty A red, scaly widespread rash with bumps department immediately under the skin and blisters accompanied for advice if you or a by fever at the initiation of treatment (acute child have swallowed generalised exanthematous pustulosis). too many capsules. Take Stop using cefalexin if you develop these this leaflet, the pack or symptoms and contact your doctor or seek any capsules with you, medical attention immediately. See also if you can. Symptoms of section 2. overdose include nausea, vomiting, stomach upset, Reporting of side effects If you get any side effects, talk to your appearance of blood in doctor, pharmacist or nurse. This includes the urine. any possible side effects not listed in this If you forget to take Cefalexin Capsules leaflet. You can also report side effects If you miss a dose, take it as soon as you directly via the Yellow Card Scheme at: remember. If it is almost time to take the www.mhra.gov.uk/yellowcard or search for next dose, skip the missed dose and carry MHRA Yellow Card in the Google Play or on as before. Do not take a double dose to Apple App Store. make up for a forgotten dose. By reporting side effects you can help If you have any further questions on the provide more information on the safety of use of this medicine, ask your doctor or this medicine. pharmacist. 5. HOW TO STORE CEFALEXIN 4. POSSIBLE SIDE EFFECTS CAPSULES Like all medicines, Cefalexin Capsules can Keep this medicine out of the sight and cause side effects, although not everyone reach of children. gets them. Do not store above 25°C. Tell your doctor immediately if you get any sudden wheeziness, difficulty in Store Cefalexin Capsules in their original breathing, swelling of the eyelids, face or package and keep containers tightly closed. lips, rash or itching (especially affecting your Do not use the capsules after the expiry whole body). ‘EXP’ date which is printed on the carton Serious side effects (the expiry date refers to the last day of the The following side effects are serious. You month stated). should stop taking this medicine and contact Medicines should not be disposed of via your doctor immediately if you experience wastewater or household waste. Ask your them: pharmacist how to dispose of medicines no • Serious peeling or blistering of the longer required. These measures will help to skin protect the environment. • Severe diarrhoea • A red, scaly widespread rash with 6. CONTENTS OF THE PACK AND bumps under the skin and blisters OTHER INFORMATION accompanied by fever at the initiation of treatment (acute generalised What Cefalexin Capsules contain exanthematous pustulosis). Stop The active ingredient is cefalexin, 250mg or using cefalexin if you develop these 500mg. symptoms and contact your doctor or The other ingredients are lactose, seek medical attention immediately. magnesium stearate. The capsule shell See also section 2. contains black iron oxide (E172), titanium The following side effects have been dioxide (E171), erythrosin (E127), quinoline reported yellow (E104) and gelatin. • Diarrhoea What Cefalexin Capsules look like and • Feeling sick (nausea) contents of the pack • Vomiting Cefalexin Capsules are grey/orange capsule • Indigestion containing white powder and printed with • Stomach pains ‘CHX 250’ (250mg) or ‘CHX 500’ (500mg). • Measles-like rash, (alone) They are available in blisters pack of 7, • Itching 14, 20, 21, 28, 30, 50, 56, 60, 100, or 500 • Red wheals on the skin (urticaria) capsules (alone) (not all pack sizes may be marketed). • Rash with wide spread joint pain and/ Marketing Authorisation Holder or stiffness, swollen lymph glands, fever Marketing Authorisation Holder: and, possibly, cloudy urine Milpharm Limited • Changes in blood counts, which may Ares, Odyssey Business Park, show up as bruising or a very tired West End Road, feeling.
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