PYLERA

Posology Each dose of Pylera includes 3 identical hard capsules. Each dose should be taken 4 times a day, 3 capsules after breakfast, 3 capsules after lunch, 3 capsules after the evening meal and 3 capsules at bedtime (preferably after a snack) for a total of 12 capsules per day over a period of 10 days.

One omeprazole 20 mg capsule/tablet should be taken twice a day, at the same time as the morning meal and evening meal doses of Pylera for the full 10 days of therapy. Table 1 Daily dosing schedule for Pylera Time of dose Number of capsules of Pylera Number of capsules/tablets of omeprazole After breakfast 3 1 After lunch 3 0 After evening meal 3 1 At bedtime (preferably after a snack) 3 0 Missed doses can be made up by extending the normal dosing schedule beyond 10 days until all the medicinal product has been consumed.

Patients should not take two doses at one time. If more than 4 consecutive doses (1 day) are missed, the prescribing physician should be contacted. 4). The safety and effectiveness of Pylera in hepatic or renal impaired patients has not been evaluated.

Older people Experience in older people is limited. In general, the greater prevalence of decreased hepatic, renal, or cardiac function, as well as the presence of concomitant diseases and multiple concomitant medicinal therapies should be considered when prescribing Pylera for this patient population.

3) and not recommended in children 12 to 18 years of age. Method of administration For oral use. The capsules should not be opened but swallowed whole. 8). Patients should not lay down immediately after Pylera and omeprazole intake.

a. Summary of the safety profile The adverse reactions reported with Pylera in combination with omeprazole during controlled clinical trials were consistent with the known safety profile of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride when given as separate products.

The most commonly reported adverse reactions (very common) during treatment with Pylera are, in decreasing order of frequency: abnormal faeces, diarrhoea, nausea, and dysgeusia (including metallic taste). Severe cutaneous adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome; potentially fatal) have been reported with the use of Pylera and the individual components, metronidazole and tetracycline.

The occurrence of severe cutaneous adverse reactions require immediate discontinuation of Pylera. 4). b. Tabulated list of adverse reactions Adverse reactions are presented from pooled data of three phase III controlled clinical trials (540 patients exposed to Pylera) and post-marketing experience (including spontaneous, regulatory and literature reports).

Adverse reactions are ranked under headings of frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 0 c. Description of selected adverse reactions Black stools and tongue discolouration may occur with bismuth compounds, due to conversion to bismuth sulfide in the gastrointestinal tract; stomatitis has been attributed to bismuth salts but has also been reported with the use of metronidazole.

Like other antimicrobial agents, tetracycline may lead to development of superinfections. Candidiasis (oral and vaginal) is probably due to tetracycline. Dizziness, dysgeusia, headache and chromaturia (darkening of the urine) are most likely attributable to metronidazole.

There have been rare reports of encephalopathy associated with excessive doses of various bismuth- containing products with prolonged treatment, reversible with discontinuation of therapy. c). Post marketing cases of encephalopathy associated with the use of Pylera have been received.

Peripheral neuropathy has been reported in patients given metronidazole, usually for long periods. However, cases of peripheral neuropathy have also been reported with Pylera. If abnormal neurologic signs appear, prompt discontinuation of Pylera is required.

8). Oral candidiasis, vulvovaginitis, and pruritus ani, mainly due to overgrowth with Candida albicans, may occur during therapy with tetracycline and may require treatment with an antifungal agent. There may be associated overgrowth of resistant coliform organisms, such as Pseudomonas spp.

, causing diarrhoea. More serious, enterocolitis due to superinfection with resistant staphylococci and pseudomembranous colitis due to Clostridium difficile have occasionally been reported with the use of tetracycline. 8). Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.

Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs. Treatment should be discontinued at the first evidence of skin erythema. 8). Metronidazole should be used with caution in patients with evidence, or history, of blood dyscrasia.

8) with prolonged use of metronidazole. The dose of oral anticoagulants such as warfarin may require reduction during the treatment with Pylera (metronidazole may prolong prothrombin time). Prothrombin times should be monitored. 5). Omeprazole may delay the elimination of warfarin, a reduction of the warfarin dose may be necessary.

5). 5). Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracycline. The usual clinical manifestations are headache and blurred vision. 5 for interaction with retinoids). Myasthenic syndrome has been reported rarely with tetracycline.

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