Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
cefalexin
Aspen Pharmacare Australia Pty Ltd
cefalexin
Registered
IALEX ® _cephalexin monohydrate_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ialex. It does not contain all the available information. It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ialex against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IALEX IS USED FOR Ialex contains cephalexin monohydrate as the active ingredient. It is used to treat infections caused by bacteria in different parts of the body, including infections of the: • respiratory tract (throat, tonsils, chest and lungs) • nose (sinusitis) • ears (otitis media) • skin and soft tissue • kidneys and bladder (genitourinary tract). This medicine belongs to a group of medicines called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. There is no evidence that it is addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE IALEX IF YOU HAVE AN ALLERGIC REACTION TO: • any medicine containing cephalexin monohydrate • other cephalosporins • any of the ingredients listed at the end of this leaflet. DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SERIOUS ALLERGIC REACTION TO PENICILLIN. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or i Přečtěte si celý dokument
IALEX –Product Information Page 1 of 8 PRODUCT INFORMATION IALEX ® Cephalexin (as cephalexin monohydrate) NAME OF THE DRUG IALEX (cephalexin monohydrate) is a semisynthetic cephalosporin antibiotic for oral administration. It is 7-(D- -amino- -phenyl-acetamido)-3-methyl-3-cephem-4-carboxylic acid, monohydrate. Cephalexin monohydrate has the following structural formula. DESCRIPTION The nucleus of cephalexin is related to that of other cephalosporin antibiotics. The compound is a zwitterion; i.e. the molecule contains both a basic and an acidic group. The isoelectric point of cephalexin in water is approximately 4.5 to 5. The crystalline form of cephalexin which is available is a monohydrate. It is a white crystalline solid having a bitter taste. Solubility in water is low at room temperature; 1or 2 mg/mL may be dissolved readily, but higher concentrations are obtained with increasing difficulty. The cephalosporins differ from penicillins in the structure of the bicyclic ring system. Cephalexin has a D-phenylglycyl group as substituent at the 7-amino position and an unsubstituted methyl group at the 3-position. IALEX is available in hard gelatin capsules and powder for oral liquid in bottles and sachets*. IALEX capsules contain the active cephalexin monohydrate equivalent to 250 mg or 500 mg of cephalexin. They also contain the excipients avicel RC 591, dimethicone 350 and magnesium stearate. The capsule shell consists of patent blue V, quinoline yellow, titanium dioxide, gelatin and colorcon S-1-8144 black ink. IALEX powder for oral liquid in bottles contains the active cephalexin monohydrate equivalent to 125 mg or 250 mg of cephalexin per 5 mL upon reconstitution. They also contain sodium lauryl sulphate, allura red AC, methylcellulose, dimethicone 350, xanthan gum, starch pregelatinised- maize, tuttifrutti 51880 TP0551 and sucrose. IALEX powder for oral liquid in sachets* contains the active cephalexin monohydrate equivalent to 125 mg or 250 mg of cephalexin per 5 mL upon reconstitution. They also c Přečtěte si celý dokument