Product Monograph ZANTAC - GlaxoSmithKline

More documents

Recommendations

Info

IMPORTANT: PLEASE READSERIOUS SIDE EFFECTS, HOW OFTEN THEYHAPPEN AND WHAT TO DO ABOUT THEMSymptom / effectVeryRareVeryRareHepatitisYellowing ofthe skin orwhites of theeyes, dark or teacoloured urine,pale colouredstools/ bowelmovements,nausea/vomiting, lossof appetite,pain, aching ortenderness onright side belowthe ribsCardiovascularSlow, fast orirregularheartbeatTalk with yourdoctor orpharmacistOnly ifsevereIn allcasesStoptakingdrug andcall yourdoctor orpharmacistThis is not a complete list of side effects. For anyunexpected effects while taking ZANTAC ® , contact yourdoctor or pharmacist.HOW TO STORE ITStore ZANTAC ® Tablets between 2°C and 30°C. Protectfrom light. Keep out of reach of children.REPORTING SUSPECTED SIDE EFFECTSYou can report any suspected adverse reactions associatedwith the use of health products to the Canada VigilanceProgram by one of the following 3 ways:--------------------------------------------------------------------------Report online at www.healthcanada.gc.ca/medeffectCall toll-free at 1-866-234-2345Complete a Canada Vigilance Reporting Form and:- Fax toll-free to 1-866-678-6789, or- Mail to: Canada Vigilance ProgramHealth CanadaPostal Locator 0701EOttawa, OntarioK1A 0K9Postage paid labels, Canada Vigilance ReportingForm and the adverse reaction reporting guidelinesare available on the MedEffect Canada Web site atwww.healthcanada.gc.ca/medeffect.NOTE: Should you require information related to themanagement of side effects, contact your health professional.The Canada Vigilance Program does not provide medical advice.MORE INFORMATIONThis document plus the full product monograph, preparedfor health professionals can be found at:http://www.gsk.ca or by contacting the sponsor,GlaxoSmithKline Inc.7333 Mississauga RoadMississauga, OntarioL5N 6L41-800-387-7374This leaflet was prepared by GlaxoSmithKline Inc.Last revised: February 18, 2014© 2014 GlaxoSmithKline Inc. All Rights Reserved® ZANTAC is a registered trade-mark of Johnson & Johnson Inc.,used under license by GlaxoSmithKline Inc.February 18, 2014Page 38 of 41
IMPORTANT: PLEASE READPART III: CONSUMER INFORMATIONPr ZANTAC ®ranitidine injectionThis leaflet is part III of a "Product Monograph" publishedwhen ZANTAC ® was approved for sale in Canada and isdesigned specifically for Consumers. This leaflet is asummary and will not tell you everything about ZANTAC ® .Contact your doctor or pharmacist if you have any questionsabout the drug.ABOUT THIS MEDICATIONWhat the medication is used for:• to heal ulcers in the stomach, or the part that it emptiesinto (the duodenum).• to prevent stomach ulcers which may be caused bymedicines called non-steroidal anti-inflammatory drugs(NSAIDs), often used to treat arthritis• to prevent ulcers from bleeding• to heal or stop problems caused by acid in the food pipe(esophagus) or too much acid in the stomach. This cancause pain or discomfort sometimes known asindigestion or heartburn• to stop acid coming up from the stomach while underanaesthetic during an operationWhat it does:ZANTAC ® belongs to a group of medicines called H 2 -receptorblockers. It works by reducing the amount of acidin your stomach.When it should not be used:Don’t take ZANTAC ® if you are allergic (hypersensitive) toranitidine or any other ingredients of ZANTAC ® (see Whatthe nonmedicinal ingredients are).What the medicinal ingredient is:ranitidine hydrochlorideWhat the nonmedicinal ingredients are:Non-medicinal ingredients include phenol (as apreservative), disodium hydrogen orthophosphate, andpotassium dihydrogen orthophosphate.What dosage forms it comes in:Each ampoule contains 50 mg ranitidine (as ranitidinehydrochloride) in 2 ml aqueous solution (25 mg/ml).WARNINGS AND PRECAUTIONSBEFORE you use ZANTAC ® talk to your doctor orpharmacist if you:• have stomach cancer• have kidney disease, your doctor may lower your dose ofZANTAC ®• have a rare condition called acute porphyria (a blooddisease)• have lung disease• are diabetic• have any problems with your immune system• have a history of heart problems• have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory (NSAID) medicines• are pregnant, planning to become pregnant, breastfeedingor planning to breastfeed• are taking any other medications including NSAIDs (seeInteractions with this Medication).INTERACTIONS WITH THIS MEDICATIONTell your doctor or pharmacist if you're taking any othermedicines, if you’ve taken any recently, or if you starttaking new ones. This includes medicines bought without aprescription. Some medicines can affect how ZANTAC ®works, or make it more likely that you’ll have side effects.ZANTAC ® can also affect how some other medicines work.Drugs that may interact with ZANTAC ® include:• procainamide or n-acetylprocainamide (used to treatheart problems)• warfarin (used to thin the blood)• triazolam (used to treat insomnia)• midazolam (a sedative that may be given just before anoperation)• ketoconazole (used to treat fungal infections)• atazanavir or delaviridine (used to treat HIV)• gefitnib (used to treat lung cancer)• Non-Steroidal Anti-Inflammatory (NSAID) medicines(used to treat pain and inflammation)PROPER USE OF THIS MEDICATIONZANTAC ® injection is not self administered by anindividual. It should be administered under the supervisionof a health professional.Usual Adult Dose:The usual dose is 50 mg every 6 to 8 hours, as a singleinjection into a muscle.Alternatively, different doses may be given to youintravenously by slow infusion or continuous infusion,depending on what condition you are being treated for.February 18, 2014Page 39 of 41
Page 1 and 2: Product MonographPr ZANTAC ®raniti
Page 3 and 4: Bioavailability of oral ranitidine
Page 5 and 6: Ranitidine injection is well tolera
Page 7 and 8: Use in Pregnancy and Nursing Mother
Page 9 and 10: 2) Competition for renal tubular se
Page 11 and 12: CardiovascularIsolated reports of t
Page 13 and 14: DOSAGE AND ADMINISTRATIONTablet Adm
Page 15 and 16: Prophylaxis of hemorrhage from stre
Page 17 and 18: PHARMACEUTICAL INFORMATIONDrug Subs
Page 19 and 20: Dilution of Parenteral ProductsIntr
Page 21 and 22: AVAILABILITY OF DOSAGE FORMSZANTAC
Page 24 and 25: In the dog up to 70% of the adminis
Page 26 and 27: TOXICOLOGYToxicology, Impairment of
Page 28: Changes in the colour or granularit
Page 31 and 32: sensitive Oral Solution microtitre
Page 33 and 34: 12. Ehsanullah RSB, Page MC, Tildes
Page 35 and 36: 33. Scarpignato C, Bertaccini G, Zi
Page 37: IMPORTANT: PLEASE READPROPER USE OF
Page 41: IMPORTANT: PLEASE READSERIOUS SIDE

Product Monograph ZANTAC - GlaxoSmithKline

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?