pdf 915 IC Lansoloc 15-30 Capsules Enclo.ai

915 IC Lansoloc 15-30 Capsules Enclo.ai   Author:avadhootm | Size:53.11 K | View:172 | Page:1

915 ICSKEDULERINGSTATUS: S4EIENDOMSNAAM (EN DOSEERVORM):LANSOLOC 15 (Kapsules)LANSOLOC 30 (Kapsules)SAMESTELLING:Elke LANSOLOC 15 kapsule bevat lansoprasool 15 mg. Elke LANSOLOC 30 kapsule bevat lansoprasool 30 mg. FARMAKOLOGIESE KLASSIFIKASIE:A. 11.4.3 Middels wat op die gastro-intestinale kana...  
915 ICSKEDULERINGSTATUS: S4EIENDOMSNAAM (EN DOSEERVORM):LANSOLOC 15 (Kapsules)LANSOLOC 30 (Kapsules)SAMESTELLING:Elke LANSOLOC 15 kapsule bevat lansoprasool 15 mg. Elke LANSOLOC 30 kapsule bevat lansoprasool 30 mg. FARMAKOLOGIESE KLASSIFIKASIE:A. 11.4.3 Middels wat op die gastro-intestinale kanaal inwerk.FARMAKOLOGIESE WERKING:Lansoprasool is ‘n inhibeerder van gastriese H+,K+-ATPase (protonpomp). Lansoprasool inhibeer gastriese suursekresie op ‘n dosisverwante basis onafhanklik van die oorsprong van stimulasie. Gastriese sekretoriese funksies herstel geleidelik na onttrekking van die middel. Lansoprasool het geen effek op histamien, gastrien of cholinerge reseptore nie.Farmakokinetika:Na orale toediening, word lansoprasool goed geabsorbeer met ‘n uiteindelike biobeskikbaarheid van ongeveer 78 %. Die biobeskikbaarheid word verminder wanneer lansoprasool saam met voedsel geneem word. Piek serumkonsentrasies word bereik ongeveer 1-2 uur na inname.Lansoprasool is hoogs proteïengebonde (97 %).Lansoprasool word ekstensief gemetaboliseer via die hepatiese sitochroom P450 sisteem na die onaktiewe, gesulfeerde metaboliete, sulfoon, sulfied en 5-hidroksilansoprasool. Die halflewe van lansoprasool is 1,4 tot 1,5 uur.Die hoofroete van eliminasie is via die gal met 15-30 % van lansoprasool wat uitgeskei word deur die niere as die gehidroksileerde metaboliet.INDIKASIES: LANSOLOC 30 word aangedui vir die korttermyn behandeling van gastriese en duodenale ulsera en refluksesofagitis. LANSOLOC 15 word aangedui vir: - Die korttermyn behandeling van geringe funksionele dispepsie.- Die voorkoming van relaps van gastro-esofageale refluks. LANSOLOC word aangedui vir Helicobacter pylori-positiewe duodenale ulsera saam met gepaste antibiotika as deel van ‘n uitwissingsprogram.KONTRA-INDIKASIES: Hipersensitiwiteit vir lansoprasool of vir enige van die ander bestanddele. Swangerskap en laktasie. Lewerinkorting.WAARSKUWINGS:Die veiligheid en effektiwiteit in kinders is nog nie vasgestel nie.Behandeling met LANSOLOC kan die simptome van maligne ulsera verlig en sodoende die diagnose vertraag. Die moontlikheid van maligniteit van ‘n gastriese ulkus of ‘n maligniteit van die esofagus behoort dus uitgesluit te word voordat behandeling met LANSOLOC begin word.Hierdie middel kan lei tot lomerigheid en verswakte konsentrasie wat vererger kan word deur die gelyktydige inname van alkohol of ander sentrale senustelsel onderdrukkers. Pasiënte behoort ingelig te word, veral met die aanvang van behandeling, teen die bestuur van voertuie of hantering van masjinerie of die aanpak van potensieel gevaarlike take waar verlies van konsentrasie kan lei tot ongelukke.INTERAKSIES: Aangesien LANSOLOC ‘n swak induseerder van die sitochroom 450 sisteem is, bestaan die moontlikheid vir interaksies met middels wat gemetaboliseer word deur hierdie sisteem. Monitering van pasiënte wat gelyktydige warfarin ontvang word aanbeveel, aangesien ‘n geringe vermindering in die konsentrasie van warfarin kan voorkom.SWANGERSKAP EN LAKTASIE:Voldoende en goed gekontroleerde studies in mense is nog nie gedoen nie.Dit is nie bekend of lansoprasool in borsmelk uitgeskei word nie. Tog word lansoprasool of sy metaboliete in die melk van rotte versprei. Aangesien dit aangetoon is dat lansoprasool tumorigeniese effekte kan veroorsaak in diere, behoort daar besluit te word of borsvoeding gestaak moet word of die medikasie onttrek moet word, inaggenome die belang van lansoprasool vir die moeder.DOSIS EN GEBRUIKSAANWYSINGS:LANSOLOC behoort verkieslik voor ‘n maaltyd geneem te word.Gastriese ulkus:30 mg een maal daagliks vir ag weke of minder.Duodenale ulkus:30 mg een maal daagliks vir vier weke of minder.LANSOLOC word aangedui vir Helicobacter pylori-positiewe ulsera saam met gepaste antibiotika, as deel van ‘n uitwissingsprogram.Esofagitis weens gastro-esofageaIe refluks:30 mg een maal daagliks vir vier weke. Afhangende van die endoskopiese resultate, mag ‘n tweede kursus van 4 weke nodig wees.Instandhoudingsterapie vir die voorkoming van gastro-esofageale refluks: 15 mg een maal per dag vir ‘n maksimum tydperk van een jaar.Funksionele dispepsie:Volwassenes: 15-30 mg een maal per dag vir 2 tot 4 weke.Bejaardes: Geen dosisaanpassing is nodig nie. 30 mg per dag is egter die maksimum daaglikse dosis.Nierinkorting: Geen dosisaanpassing is nodig in nierversaking nie. Dit is ook van toepassing op pasiënte op dialise.NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS:Newe-effekte:Hematologiese afwykings:Minder dikwels: Anemie, eosinofilie, leukopenie, neutropenie, trombositopenie.Kardiovaskulêre afwykings:Minder dikwels: Edeem.Neurologiese afwykings:Minder dikwels: Duiseligheid, hoofpyn, slapeloosheid, slaperigheid, tremor.Gastro-intestinale afwykings:Dikwels: Diarree, naarheid, braking, hardlywigheid, buikpyn.Minder dikwels: Droë mond, glossitis, smaakafwykings, ulseratiewe kolitis.Endokriene afwykings:Minder dikwels: Ginekomastie, galaktoree.Hepatobiliêre afwykings:Minder dikwels: Toename in lewerensieme.Muskuloskeletale afwykings:Minder dikwels: Astenie, artralgie, mialgie.Oogafwykings:Minder dikwels: Verswakte visie.Vel en subkutane weefselafwykings:Dikwels: Uitslag, pruritus, urtikarieë.Minder dikwels: Haarverlies.Algemene afwykings:Minder dikwels: Koors.Spesiale Voorsorgmaatreëls:Dit is belangrik om die diagnose van refluksesofagitis te bevestig met endoskopie.Effekte verwant aan inhibering van suursekresie: Tydens langtermyn behandeling, is ‘n verhoogde insidensie van gastriese kliersiste gemeld. Hierdie fisiologiese veranderinge is as gevolg van volgehoue inhibering van gastriese suursekresie.Verminderde gastriese suurinhoud verhoog gastriese tellings van bakterieë wat normaalweg teenwoordig is in die gastro-intestinale kanaal. Behandeling met LANSOLOC kan ‘n verhoogde risiko vir gastro-intestinale infeksies, soos Salmonella en Campylobacter, tot gevolg hê.In die teenwoordigheid van simptome soos betekenisvolle, onwillekeurige gewigsverlies, herhaalde braking, disfagie, hematemese of melena, of wanneer ‘n gastriese ulkus vermoed word of teenwoordig is, behoort maligniteit uitgeskakel te word, aangesien behandeling met LANSOLOC simptome kan verlig en diagnose vertraag.BEKENDE SIMPTOME VAN OORDOSERING EN BESONDERHEDE VAN DIE BEHANDELING DAARVAN: (Sien “NEWE-EFFEKTE EN SPESIALE VOORSORGMAATREËLS”).Behandeling is simptomaties en ondersteunend.IDENTIFIKASIE:LANSOLOC 15: Wit tot naaswit, enteriesbedekte korreltjies in harde gelatien kapsule omhulsels, grootte ‘3’, met blou doppie en wit romp.LANSOLOC 30: Wit tot naaswit, enteriesbedekte korreltjies in harde gelatien kapsule omhulsels, grootte ‘1’, met rooi doppie en wit romp.AANBIEDING:LANSOLOC 15: Stulpverpakte kapsules in houers van 7, 14 en 30’s.LANSOLOC 30: Stulpverpakte kapsules in houers van 14 en 30’s.BERGINGSINSTRUKSIES:Berg in ‘n koel, droë plek, benede 25°C.Beskerm teen lig.HOU BUITE DIE BEREIK VAN KINDERS.REGISTRASIENOMMERS:LANSOLOC 15: 37/11.4.3/0238LANSOLOC 30: 37/11.4.3/0155NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE SERTIFIKAAT VAN REGISTRASIE:CIPLA LIFE SCIENCES (EDMS) BPKRosen Heights, Pasitastraat,Rosenpark, Bellville 7530DATUM VAN PUBLIKASIE VAN HIERDIE VOUBILJET:Junie 2005© CIPLA LIFE SCIENCES (EDMS) BPK915 ICSCHEDULING STATUS: S4 PROPRIETARY NAME (AND DOSAGE FORM):LANSOLOC 15 (Capsules)LANSOLOC 30 (Capsules)COMPOSITION:Each LANSOLOC 15 capsule contains lansoprazole 15 mg.Each LANSOLOC 30 capsule contains lansoprazole 30 mg.PHARMACOLOGICAL CLASSIFICATION:A. 11.4.3 Medicines acting on the gastrointestinal tract.PHARMACOLOGICAL ACTION:Lansoprazole is an inhibitor of the gastric H+,K+-ATPase (proton pump). Lansoprazole inhibits gastric acid secretion in a dose related manner irrespective of the source of stimulation. Gastric secretory functions recover gradually following discontinuation of the medicine. Lansoprazole has no effect on histamine, gastrin or cholinergic receptors.Pharmacokinetics:Following oral administration, lansoprazole is well absorbed with a resultant bioavailability of approximately 78 %. The bioavailability is decreased if lansoprazole is taken with food. Peak serum concentrations are achieved approximately 1-2 hours following ingestion.Lansoprazole is highly protein bound (97 %).Lansoprazole is extensively metabolised via the hepatic cytochrome P450 system to the inactive, sulfated metabolites, sulphone, sulphide and 5- hydroxylansoprazole. The half-life for lansoprazole is 1,4 to 1,5 hours.The main route of elimination is via the bile with 15-30 % of lansoprazole being excreted via the kidneys as the hydroxylated metabolite.INDICATIONS: LANSOLOC 30 is indicated for the short-term treatment of gastric and duodenal ulcers and reflux oesophagitis. LANSOLOC 15 is indicated for: - The short-term management of mild functional dyspepsia.- The prevention of relapse of gastro-oesophageal reflux. LANSOLOC is indicated for Helicobacter pylori-positive duodenal ulcers in conjunction with appropriate antibiotics as part of an eradication programme.CONTRA-INDICATIONS: Hypersensitivity to lansoprazole or to any of the other ingredients. Pregnancy and lactation. Liver impairment.WARNINGS:Safety and efficacy in children has not been established.Treatment with LANSOLOC may alleviate the symptoms of malignant ulcers and can delay diagnosis. Therefore, the possibility of malignancy of a gastric ulcer or a malignant disease of the oesophagus should be excluded prior to treatment with LANSOLOC.This medicine may lead to drowsiness and impaired concentration that may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents.INTERACTIONS: Since LANSOLOC is a weak inducer of the cytochrome P450 system, the possibility exists for interactions with drugs which are metabolised via this system. Monitoring of patients receiving concomitant warfarin is recommended, since a minor reduction in the concentration of warfarin may occur.PREGNANCY AND LACTATION:Adequate and well-controlled studies in humans have not been done.It is not known whether lansoprazole is distributed into breast milk. However, lansoprazole or its metabolites are distributed into the milk of rats. Because lansoprazole has been shown to cause tumorigenic effects in animals, a decision should be made as to whether nursing should be discontinued or the medication withdrawn, taking into account the importance of lansoprazole to the mother.DOSAGE AND DIRECTIONS FOR USE:LANSOLOC should preferably be taken before a meal.Gastric ulcer:30 mg once a day for up to eight weeks.Duodenal ulcer:30 mg once a day for up to four weeks.LANSOLOC is indicated for Helicobacter pylori-positive ulcers in conjunction with appropriate antibiotics, as part of an eradication program.Oesophagitis due to gastro-oesophageaI reflux:30 mg once a day for four weeks. Depending on the endoscopic results, a repeat course of 4 weeks may be necessary.Maintenance treatment for the prevention of gastro-oesophageal reflux: 15 mg once a day for a maximum period of one year.Functional dyspepsia:Adults: 15-30 mg once a day for 2 to 4 weeks.Elderly: No dose adjustment is necessary. However, 30 mg per day is the maximum daily dose.Renal impairment: No dose adjustment is necessary in renal failure. This also applies to patients on dialysis.SIDE-EFFECTS AND SPECIAL PRECAUTIONS:Side-effects:Haematological disorders:Less frequent: Anaemia, eosinophilia, leucopenia, neutropenia, thrombocytopenia.Cardiovascular disorders:Less frequent: Oedema.Neurological disorders:Less frequent: Dizziness, headache, insomnia, somnolence, tremor.Gastrointestinal disorders:Frequent: Diarrhoea, nausea, vomiting, constipation, abdominal pain.Less frequent: Dry mouth, glossitis, taste abnormalities, ulcerative colitis.Endocrine disorders:Less frequent: Gynaecomastia, galactorrhoea.Hepatobiliary disorders:Less frequent: Elevation in hepatic enzymes.Musculoskeletal disorders:Less frequent: Asthenia, arthralgia, myalgia.Visual disorders:Less frequent: Blurred vision.Skin and subcutaneous tissue disorders:Frequent: Rash, pruritus, urticaria.Less frequent: Alopecia.General disorders:Less frequent: Fever.Special Precautions:It is important to confirm the diagnosis of reflux oesophagitis by endoscopy.Effects related to acid inhibition: During long-term treatment, gastric glandular cysts have been reported in increased frequency. These physiological changes result from pronounced inhibition of gastric acid secretion.Decreased gastric acidity increases gastric counts of bacteria normally present in the gastro-intestinal tract. Treatment with LANSOLOC may lead to an increased risk of gastro-intestinal infections such as Salmonella and Campylobacter.In the presence of symptoms such as, significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena, and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with LANSOLOC may alleviate symptoms and delay diagnosis.KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: (See “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”).Treatment is symptomatic and supportive.IDENTIFICATION:LANSOLOC 15: White to off-white, enteric coated pellets in hard gelatine capsule shells, size ‘3’, with blue cap and white body.LANSOLOC 30: White to off-white, enteric coated pellets in hard gelatine capsule shells, size ‘1’, with red cap and white body.PRESENTATION:LANSOLOC 15: Blister-packed capsules in packs of 7, 14 and 30’s.LANSOLOC 30: Blister-packed capsules in packs of 14 and 30’s.STORAGE INSTRUCTIONS:Store in a cool, dry place, below 25°C.Protect from light.KEEP OUT OF REACH OF CHILDREN.REGISTRATION NUMBERS:LANSOLOC 15: 37/11.4.3/0238LANSOLOC 30: 37/11.4.3/0155NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:CIPLA LIFE SCIENCES (PTY) LTDRosen Heights, Pasita Street,Rosen Park, Bellville 7530DATE OF PUBLICATION OF THIS PACKAGE INSERT:June 2005© CIPLA LIFE SCIENCES (PTY) LTDPACKAGING DEVELOPMENTProduct Name : Lansoloc 15-30 Caps Enclo. Item Code : 915 IC Date : 17-12-2010Software : Illustrator CS3Artist : AvadhootDesign : UnfoldedVarnish : Cordinator : SachitaFonts : -----------Colours :BLUE WOOL TEST VALUE 5-8(LIGHT FASTENING DATA)Links :Supersedes / Reference Screen : # __ Unwinding Direction : Tuck flap: __ mm Side / Collar flap overlap: yes / no 2D Code: 915ICMaterial : 54 Gsm J. K. Maplitho PaperActual Size : 130 x 290 mm Size after Folding : Print repeat length : Grain Direction : Reference / Instructions / Remark / Braille Text Embossing: Path : PC:42 \ Avadhoot \ E \ avadhoot \ Export \ Sandhya \ S.A. \ Lansoloc \ 915 IC Lansoloc 15-30 Caps Enclo.aiChecked by Artist Co-ordinator Section Head File Copied by: Pharma Code /2D CodeBarcodeArtwork Spell Check Date :K BlackGlossmeter reading (for white surface): NOT LESS THAN 80 %Spectro-Densitometer Delta-E reading (ΔE) for colour: NOT MORE THAN dE2.5
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915 IC Lansoloc 15-30 Capsules Enclo.ai

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