PRESCRIBING INFORMATION Please refer to full Summary of Product Characteristics before prescribing Periostat® 20mg Film-coated Tablets Presentation: Film-coated tablets, each containing doxycycline hyclate equivalent to 20mg doxycycline in blister packs of 56 tablets. Indications: For patients with adult periodontitis. Periostat is indicated as an adjunct to supra- gingival and sub-gingival scaling and root planing, with oral hygiene instruction, carried out by a dental practitioner or hygienist as appropriate. Dosage and Administration: Adults and elderly - administered twice daily, at least one hour before meals or before bedtime. Swallow whole with at least 100ml of fluid, in an upright position. Take for periods of 3 months. Do not administer for more than 3 consecutive three month periods. Contra-indications Infancy and childhood up to 12 years of age; hypersensitivity to any of the product excipients or to any of the tetracyclines; achlorhydria; pregnancy and lactation. Warnings & Precautions To avoid oesophageal irritation and ulceration, adequate fluids should be taken with this medication in an upright sitting or standing position. Periostat therapy may result in overgrowth of nonsusceptible microorganisms including fungi. Periodic observation of the patient is essential and treatment stopped if overgrowth of resistant organisms appears. Use with caution in patients with a history of or predisposition to oral candidosis, hepatic impairment or to those receiving potentially hepatotoxic drugs and patients with myasthenia gravis who may be at risk of worsening of the condition. Avoid excessive sunlight or artificial UV light and discontinue therapy if phototoxicty occurs. Sunscreen should be considered. Treatment should cease at the first sign of skin erythema. In the event of the development of diarrhoea during treatment, the possibility of pseudomembranous colitis should be considered and appropriate therapy instituted. In the event of a severe acute hypersensitivity reaction (eg anaphylaxis) treatment with Periostat must be stopped at once and the usual emergency measures taken. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Interactions: Absorption of doxycycline from the gastro-intestinal tract may be inhibited by bi-or tri- valent ions such as aluminium, zinc, calcium, by magnesium or iron preparations, activated charcoal, cholestyramine, bismuth chelates and sucralfate. Such medicines or foodstuffs should be taken 2 to 3 hours following ingestion of Periostat.
Didanosine and quinapril tablets may decrease the absorption of doxycycline and should therefore be taken at least 2 hours after doxycycline. Doxycycline may potentiate the hypoglycaemic effect of sulphonylurea oral antidiabetic agents. May depress plasma prothrombin activity thereby potentiating the effect of anticoagulants of the dicoumarol type. Avoid concomitant administration of doxycycline and isotretinoin, as there is the possibility of potentiation between the drugs to cause reversible pressure increase in the intracranial cavity (pseudotumour cerebri). As bacteriostatic drugs may interfere with the bacteriocidal action of penicillin and betalactam antibiotics, it is advisable that Periostat and betalactam antibiotics should not be used in combination. Rifampicin, barbiturates, carbamazepine, diphenylhydantoin, primidone, phenytoin, and chronic alcohol abuse, may accelerate the decomposition of doxycycline due to enzyme induction in the liver thereby decreasing its half-life. Sub-therapeutic doxycycline concentrations may result. Doxycycline used concurrently with cyclosporine has been reported to decrease the half-life of doxycycline. Tetracyclines and methoxyflurane used in combination have been reported to result in fatal renal toxicity. Tetracyclines used concurrently with oral contraceptives have in a few cases resulted in either breakthrough bleeding or pregnancy. Side-effects: Refer to SPC for full list The most commonly reported adverse events in Phase III clinical trials were headache and common cold. The following adverse reactions have been observed in patients receiving tetracyclines: Gastro-intestinal: anorexia, nausea, vomiting, diarrhoea, glossitis, dysphagia, enterocolitis and inflammatory lesions with monilial overgrowth in the ano-genital region, oesophagitis and esophageal ulceration. Hepatoxicity has been reported rarely. Skin: maculopapular and erythematous rashes, Stevens-Johnson syndrome, skin photosensitivity. Exfoliative dermatitis has been reported but is uncommon. Renal: an apparently dose related increase in blood urea. Blood: thrombocytopenia, neutropenia, haemolytic anaemia, eosiniphilia and porphyria. Hypersensitivity reactions: exacerbation of systemic lupus erythematosus, anaphylaxis, anaphylactoid purpura, pericarditis, urticaria and angioneurotic oedema. Musculoskeletal: Arthralgia Other: bulging fontanelles in infants and benign intracranial hypertension in adults. Treatment should cease if evidence of raised intracranial pressure develops. Brown-
black microscopic discolouration of thyroid tissue has been reported with long term use of tetracyclines. Adverse reactions typical of the tetracycline class of drugs are less likely to occur during medication with Periostat, due to the reduced dosage and the relatively low serum levels involved. Legal Category: POM Packs: PVC Aclar/aluminium foil blisters containing 14 tablets. Carton pack size 56 tablets. Basic NHS price: 56 tablets - £16.50 Marketing Authorisation number: PL 16853/0078 PA 943/12/1 Full prescribing information is available from: Alliance Pharmaceuticals Ltd Avonbridge House Bath Road Chippenham Wiltshire SN15 2BB UK Adverse Event Reporting Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Pharmacovigilance at Alliance Pharmaceuticals (tel: 01249 466966, email: )
Date of preparation/last revised: September 2008 Periostat is a registered trademarks of Alliance Pharmaceuticals Ltd, PS20 is a registered trademarks of CollaGenex International Limited under licence by Alliance Pharmaceuticals Ltd.
HEALTH AND SAFETY DATA SHEET BRUSH MATE FLUID (including VAPOUR MATE impregnated pads) General Note: Brush Mate storage systems have proved to be very safe in normal use. Only small quantities of fluid are involved and provided that sensible practices are followed it is not visualised that any problems will occur. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY PRODU
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