Land: Malta
Språk: engelsk
Kilde: Medicines Authority
CEFPODOXIME
Sanofi Malta Limited Level2, Fort Business Centre, Mriehel Bypass, Birkirkara, Malta
J01DD13
CEFPODOXIME 200 mg
FILM-COATED TABLET
CEFPODOXIME 200 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Withdrawn
2011-05-06
1 PACKAGE LEAFLET:INFORMATION FOR THE USER ORELOX 200mg film coated tablets Cefpodoxime READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects , talk to your doctor or pharmacist. This includes any possible side effectsnot listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What ORELOX Tablets 200mg are and what they are used for 2. What you need to know before you take ORELOX Tablets 200mg 3. How to take ORELOX Tablets 200mg 4. Possible side effects 5. How to store ORELOX Tablets 200mg 6. Contents of the pack and other information 1. WHAT ORELOX TABLETS ARE AND WHAT THEY ARE USED FOR ORELOX Tablets are used to inhibit the growth of bacteria causing infections in the body. It belongs to a group of antibiotics called ‘cephalosporins’. The doctor has prescribed ORELOX for one (or more) of the following types of infection: • Tonsillitis (throat inflammation), only for the 100mg tablets • Acute sinusitis (nose inflammation) • Acute exacerbations of chronic bronchitis (chronic pulmonary disease) • Pneumonia (lung inflammation). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORELOX TABLETS 200MG DO NOT TAKE ORELOX IF: - YOU ARE ALLERGIC to CEFPODOXIME or other cephalosporins or any of the other ingredients of this medicine (listed in section 6) - you had a SERIOUS and/or immediate ALLERGIC REACTION to ANTIBIOTICS such as penicillin or beta- lactams. TALK TO YOUR DOCTOR before taking this medicine if the above applies to anyone who must take it. In cases like these, your doctor will not prescribe cefpodoxime. WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking ORELOX. In particular, please inform your doctor if: • your kidneys read_full_document
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Orelox film coated tablets 200 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Orelox 200mg film coated tablet: Each tablet contains: Active ingredient: 260.90 mg of cefpodoxime proxetil (equivalent to 200 mg cefpodoxime). Excipient: 43.1mg lactose 3. PHARMACEUTICAL FORM Film-coated tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefpodoxime is indicated for the treatment in adults of the following infections caused by bacteria of established sensitivity ( see paragraphs 4.4 and 5.1 ) - UPPER RESPIRATORY TRACT INFECTIONS: Acute bacterial sinusitis Tonsillitis ( only for the 100mg tablets ) - LOWER RESPIRATORY TRACT INFECTIONS: Acute exacerbations of chronic bronchitis Bacterial pneumonia – cefpodoxime may not be the ideal option for the causative micro- organism The official guidelines for appropriate use of antibacterial agents have to be taken in consideration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. The tablets have to be taken with food for optimum absorption. Adults and adolescents with normal renal function: _UPPER RESPIRATORY TRACT INFECTIONS_: Acute bacterial sinusitis: 200mg twice daily. Tonsillitis: 100mg twice daily ( only for the 100mg tablets) Page 2 of 10 _ LOWER RESPIRATORY TRACT INFECTIONS_: Acute exacerbations of chronic bronchitis: 200mg twice daily. Bacterial pneumonia: 200mg twice daily. Elderly: It is not necessary to modify the dose in elderly patients with normal renal function. Children: Orelox paediatric is available to treat infants and children. Hepatic impairment: The dosage does not require modification in cases of hepatic impairment. Renal impairment: The dosage of Orelox does not require modification if creatinine clearance exceeds 40 ml/min. Below this value, pharmacokinetic studies indicate an increase in plasma elimination half-life and the maximum plasma concentrations, and hence the dosage should be adjusted appropriately. CREATININE CLEARANCE (_ML/MIN_ read_full_document