Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levofloxacin hemihydrate
Macleods Pharma UK Ltd
J01MA12
Levofloxacin hemihydrate
250mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05011200; GTIN: 8901463112984 8901463112991
PACKAGE LEAFLET: INFORMATION FOR THE USER In chronic obstructive pulmonary disease (COPD) including bronchitis, complicated skin and soft tissue infections, acute bacterial sinusitis and in acute pyelonephritis and complicated urinary tract infections, levofloxacin tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking levofloxacin tablets. Ÿ Sinuses 1. WHAT LEVOFLOXACIN TABLETS ARE AND WHAT THEY ARE USED FOR _LEVOFLOXACIN _ _TABLETS _ _CAN _ _BE _ _USED _ _TO _ _TREAT _ _INFECTIONS OF THE:_ Ÿ Lungs, in people with long-term breathing problems or pneumonia Ÿ Urinary tract, including your kidneys or bladder Ÿ Prostate gland, where you have a long lasting infection Ÿ Skin and underneath the skin, including muscles. This is sometimes called 'soft tissue’ In some special situations, levofloxacin tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOFLOXACIN TABLETS _DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:_ - You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or 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 - You have ever had epilepsy - You have ever had a problem with your tendons such as tendonitis that was related to treatment with a 'quinolone antibiotic'. A tendon is the cord that joins your muscle to your skeleton - You are a child or a growing teenager - You are pregnant, might become pregnant or think you may be pregnant WARNINGS AND PRECAUTIONS Before taking this medicine You should n Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levofloxacin 250 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of levofloxacin as active substance corresponding to 256.23 mg of levofloxacin hemihydrate. Excipient(s) with known effect Each film-coated tablet contains 3.84 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Pink, oval, film-coated, biconvex 6 x 13mm, scored on one face with side scores. Engraved “L” on the unscored face. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levofloxacin tablets are indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1): • Acute bacterial sinusitis • Acute exacerbations of chronic bronchitis • Uncomplicated cystitis (see section 4.4) • Complicated skin and soft tissue infections For the above-mentioned infections Levofloxacin tablets should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections. • Community-acquired pneumonia • Acute pyelonephritis and complicated urinary tract infections (see section 4.4) • Chronic bacterial prostatitis • Inhalation Anthrax: post exposure prophylaxis and curative treatment (see section 4.4) Levofloxacin tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Levofloxacin tablets are administered once or twice daily. The dosage depends on the type and severity of the infection and the susceptibility of the presumed causative pathogen. _ _ Levofloxacin tablets may also be used to complete a course of therapy in patients who have shown improvement during initial trea Baca dokumen lengkapnya