Ketek

e. two 400 mg tablets once a day. In patients of 18 years and older, according to the indication, the treatment regimen will be: - Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, - Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, - Acute sinusitis: 800 mg once a day for 5 days, - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.

Medicinal product no longer authorised 3 Elderly population No dosage adjustment is required in elderly patients based on age alone. 2). Ketek is not recommended in this population. Renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment.

Ketek is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30 ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.

If telithromycin treatment is deemed necessary, these patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg dose. 2). Hepatic impairment No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, however the experience in patients with impaired hepatic function is limited.

2). Method of administration The tablets should be swallowed whole with a sufficient amount of water. The tablets may be taken with or without food. 4).

Tabulated list of adverse reactions In 2,461 patients treated by Ketek in phase III clinical trials, and during post-marketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.

This is shown in the table below. Diarrhoea, nausea and dizziness were the most commonly reported adverse reactions in phase III clinical trials. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

4). 4) Skin and subcutaneous tissue disorders Rash, urticaria, pruritus Eczema Erythema multiforme Musculoskeletal and connective tissue disorders Muscle cramps Arthralgia, myalgia Reproductive system and breast disorders Vaginal Candida infection *post-marketing experience Description of selected adverse reactions Visual disturbances (<1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate, but severe reactions have also been reported.

They typically occurred within a few hours after the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully reversible either during therapy or following the end of treatment. The onset of the visual reaction may be sudden.

7). In clinical trials the effect on QTc was small (mean of approximately 1 msec). 0% of cases, respectively. No patient in either group developed a ΔQTc >60 msec. There were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical program and no subgroups at risk were identified.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

g. 5). 8). 8). If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/or specific therapy. Myasthenia gravis Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and sometimes occurred within a few hours of the first dose.

8). Hepatobiliary disorders Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin. 8). These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin.

Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen. 2). Visual disturbances Ketek may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.

Visual disturbances included blurred vision, difficulty focusing, and diplopia. Most events were mild to moderate; however, severe cases have been reported. The onset of the visual reaction may be sudden. 8). 8). Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.

CYP3A4 inducers Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John’s wort). Medicinal product no longer authorised 5 CYP3A4 substrates Ketek is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.

Patients with concomitant treatment of pravastatin, rosuvastatin or fluvastatin should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis. 5). Resistance In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.

1. 4). Previous history of hepatitis and/or jaundice associated with the use of telithromycin. 5). 5). Concomitant administration with simvastatin, atorvastatin, and lovastatin. 5). History of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.

g. ketoconazole, fluconazole), is contraindicated. Medicinal product no longer authorised 4