País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ofloxacin
Viatris UK Healthcare Ltd
J01MA01
Ofloxacin
200mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011200; GTIN: 5016695410173
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT OFLOXACIN 200 MG TABLETS OFLOXACIN 400 MG TABLETS ofloxacin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ofloxacin is and what it is used for 2. What you need to know before you take Ofloxacin 3. How to take Ofloxacin 4. Possible side effects 5. How to store Ofloxacin 6. Contents of the pack and other information 1. WHAT OFLOXACIN IS AND WHAT IT IS USED FOR Ofloxacin belongs to a group of medicines called quinolone antibiotics. Ofloxacin is an antibiotic that can be used to treat a variety of different infections. These include infections of: • the chest (respiratory system) such as pneumonia and bronchitis. • the bladder and kidneys (urinary tract). • the male and female genital organs when the infections involve the cervix (neck of the womb in women) and the lower genital organs in men. Ofloxacin can be used to treat both gonorrhoea and some other genital infections of both the male and female genital organs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OFLOXACIN DO NOT TAKE OFLOXACIN: • If you are allergic to ofloxacin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. • If you have previously had an allergic reaction to another quinolone antibiotic e.g. ciprofloxacin or norfloxacin. • If you suffer from epilepsy or are at risk of fits. • If you have a history of inflammation and Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ofloxacin 200 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of ofloxacin. Excipient with known effect: Each film-coated tablet also contains 96.00 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White biconvex capsule-shaped, film-coated tablet marked ‘OF’ breakline ‘200’on one side and ‘G’ on the reverse. The tablet can be divided into equal doses. 4.1 THERAPEUTIC INDICATIONS The following indications are restricted to adults. Ofloxacin is suitable for treatment of the following bacterial infections if these are caused by pathogens sensitive to ofloxacin (see sections 4.4 and 5.1): • Acute pyelonephritis and complicated urinary tract infections • Non-gonococcal urethritis and cervicitis • Gonococcal urethritis and cervicitis due to susceptible _Neisseria gonorrhoeae_ In the following indications, ofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections: • Acute exacerbation of chronic obstructive pulmonary disease including bronchitis • Community-acquired pneumonia • Uncomplicated cystitis • Urethritis Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning. Generally, individual doses should be given at approximately equal intervals. In individual cases it may be necessary to increase the dose to a maximum total dose of 800 mg daily, which should be given as 400 mg twice daily, at approximately equal intervals. This may be appropriate in infections due to pathogens known to have reduced or variable Llegiu el document complet