PART III: CONSUMER INFORMATION

Transcription

1 IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION Pr ZERIT Stavudine This leaflet is Part III f a three-part Prduct Mngaph published when ZERIT was apprved fr sale in Canada and is designed specifically fr Cnsumers. This leaflet is a summary and will nt tell yu everything abut ZERIT. Cntact yur dctr r pharmacist if yu have any questins abut the drug. ABOUT THIS MEDICATION What the medicatin is used fr ZERIT (Prnunced ZER it) is a prescriptin medicine used with ther medicines t treat HIV, r human immundeficiency virus in adults. HIV is the virus that causes AIDS (Acquired Immundeficiency Syndrme). D nt take ZERIT if yu: Are allergic t stavudine r any f the ingredients in ZERIT. (See What the nnmedicinal ingredients are in this leaflet). Tell yur dctr if yu think yu have had an allergic reactin t any f these ingredients. Take didansine (anther HIV medicine) (see interactin with this medicatin sectin belw). What the medicinal ingredient is: Stavudine What the nnmedicinal ingredients are: ZERIT Capsules: lactse (milk sugar), magnesium stearate, micrcrystalline cellulse, sdium starch glyclate. Capsule shell: gelatin, black irn xide (20 mg nly), printing ink, silicn dixyde, sdium lauryl sulphate, titanium dixide and yellw and red irn xides. What dsage frms it cmes in: Capsules: 15, 20, 30 and 40 mg What it des ZERIT belngs t a class f medicines called nucleside analgues. I t w r k s by reducing the HIV amunt in the bld. It als increases CD4 cells. CD4 cells are type f white bld cells which are imprtant fr fighting HIV and ther infectins. ZERIT will nt cure yur HIV infectin. At present there is n cure fr HIV infectin. Even while taking ZERIT, yu may: Cntinue t have HIV-related illnesses, including infectins caused by ther germs (micrrganisms). Cntinue t see yur dctr regularly and reprt any medical prblems that ccur. Still give HIV. D nt have any kind f sex withut prtectin. Discuss with yur healthcare prfessinal the precautins needed t avid infecting ther peple. When it shuld nt be used Page 1 f 5

2 WARNINGS AND PRECAUTIONS Serius Warnings and Precautins ZERIT can cause serius side effects, including : Buildup f acid in yur bld (lactic acidsis) that can be life-threatening. Lactic acidsis can cause death. It is a medical emergency that must be treated in the hspital. The risk f lactic acidsis may be higher if yu: have liver prblems are pregnant. There have been deaths reprted in pregnant wmen wh had lactic acidsis after taking ZERIT and didansine. are female are verweight have been treated fr a lng time with ther medicines used t treat HIV. Liver prblems: Sme peple wh have taken ZERIT have had serius liver prblems. These prblems include liver enlargement (hepatmegaly), liver failure, fat in the liver (steatsis) and death due t liver prblems. Swelling f the pancreas (pancreatitis) that may cause death. Pancreatitis may happen any time during yur treatment with ZERIT. Fr further infrmatin and symptms see SIDE EFFECTS AND WHAT TO DO ABOUT THEM. Talk t yur healthcare prfessinal befre using ZERIT if: Yu have kidney, liver prblems r histry f heavy alchl use. Yu have had prblems with yu pancreas (pancreatitis). Yu have had gallstnes. Yu have had nerves prblems that causes tingling, numbness, and pain in the hands and feet (peripheral neurpathy). Yu are pregnant r planning n becming pregnant. It is nt knwn if ZERIT can harm an unbrn baby. In additin, pregnant wmen have experienced serius side effects when taking ZERIT in cmbinatin with didansine and ther HIV medicines (see Serius Warnings and Precautins bx abve). ZERIT shuld be used during pregnancy nly after discussin with yur dctr. Yu are breastfeeding r planned t breastfeed. It is nt knwn if ZERIT can be passed t yur baby in yur breast milk and if it culd harm yur baby. In additin HIV-infected mthers shuld nt breastfeed because HIV infectin can be passed t the baby in the breast milk. D nt breastfeed while taking ZERIT. While yu are taking ZERIT: Yur healthcare prfessinal may check yur liver regularly while yu are taking ZERIT. Be careful if yu have a histry f heavy alchl use r a liver prblem. If yur kidneys are nt wrking prperly, yur healthcare prfessinal may : check yur kidneys lwer yur dsage f ZERIT. Alchl. Yu shuld avid drinking alchl while taking ZERIT. Alchl may increase yur risk f getting pain and swelling f yur pancreas (pancreatitis) r may damage yur liver. Changes in yur immune system (Immune recnstitutin inflammatry syndrme) - Yur immune system may get strnger when yu start taking HIV medicines. It may begin t fight infectins that have been in yur bdy fr a lng time r yur immune system culd react against yur wn bdy (autimmune disease). Autimmune disease may develp at any time, smetimes mnths after the start f the HIV therapy. Call yur healthcare prfessinal right away if yu start having high temperature (fever), jint r muscle pain, redness, rash, swelling r fatigue r any new symptms after starting this ZERIT. INTERACTIONS WITH THIS MEDICATION Always keep a list f all the medicines, including prescriptin and nn-prescriptin medicines, vitamins, herbals r ther health prducts and shw it t yur healthcare prfessinal when yu get a new medicine. ZERIT may affect the way ther medicines wrk, and ther medicines may affect hw ZERIT wrks. Especially tell yur healthcare prfessinal if yu are taking: Other HIV medicatins such as:

3 didansine. The fllwing serius side effects which may cause death may ccur when ZERIT is used with didansine (see Serius Warnings bx abve). liver prblems, swelling f the pancreas (pancreatitis) lactic acidsis (a cnditin where lactic acid buildup in the bld) nerve prblems (peripheral neurpathy) zidvudine (AZT) dxrubicin, used t treat cancer ribavarin, used t treat hepatitis C infectin hydrxyurea, used t treat cancer PROPER USE OF THIS MEDICATION Usual dse Yur healthcare prfessinal will tell yu hw much ZERIT t take and when t take it. D nt stp taking ZERIT r change yur dsage unless directed t d s by yur healthcare prfessinal. Yu may take ZERIT with fd r n an empty stmach. Overdse If yu take t much ZERIT, cntact a healthcare prfessinal (e.g. yur dctr), hspital emergency department r reginal pisn cntrl centre, even if there are n symptms Rash, Nausea and vmiting. Other side effects may include: Abdminal pain, Muscle pain, Difficulty sleeping, Lss f appetite, Chills r fever, Allergic reactins, Bld disrders. Missed Dse Try nt t miss a dse, but if yu d, take it as sn as pssible. If it is almst time fr the next dse, skip the missed dse and cntinue yur regular dsing schedule. D nt duble dses. SIDE EFFECTS AND WHAT TO DO ABOUT THEM ZERIT may cause side effects that must be treated right away befre they becme serius (see Serius Warnings and Precautins bx abve and Serius and side effects table belw). Always tell yur health care prfessinal abut any symptms that yu are having even symptms that may nt seem serius. The mst cmmn side effects f ZERIT are: Headache, Diarrhea,

4 SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM Symptm / effect Talk with yur dctr right away Lactic acidsis : stmach pain nausea and vmiting feeling very weak and tired unusual muscle pain shrtness f breath feeling cld, especially in yur arms and legs felling dizzy r light-headed fast r irregular heart beat weigh lss Liver prblems Yellwing f yur skin r eyes Dark urine r light-clred bwel mvements Stmach pain r stmach swelling Nausea and vmiting Lss f appetite Only if severe In all cases Stp taking drug and call yur dctr Swelling f the pancreas (pancreatitis) Severe stmach pain, swelling f yur stmach Fever Nausea, r vmiting. Nerve prblems (peripheral neurpathy): numbness, tingling, burning r pain in the feet and/r hands Children: Neurpathy can be difficult t ntice in children wh take ZERIT. Ask yur child s healthcare prfessinal fr the signs f peripheral neurpathy in children. Changes in bdy fat (Fat redistributin): Changes may include Mre fat in r arund yur: upper back and neck ( buffal hump ), breasts trunk. Lss f fat in yur legs, arms, and face This is nt a cmplete list f side effects. Fr any unexpected effects while taking ZERIT, cntact yur dctr r pharmacist

5 HOW TO STORE IT ZERIT capsules: stre at rm temperature (15 t 30 C) prtect frm excessive misture. keep the bttle tightly clsed Keep ZERIT and all ther medicines ut f the reach f children. D NOT stre ZERIT in a damp place such as a bathrm medicine cabinet r near the kitchen sink. T help prtect the envirnment, please return all unused medicatin t the pharmacist fr prper dispsal. This medicine was prescribed fr yur particular cnditin. D nt use ZERIT fr anther cnditin r give it t thers. Reprting Side Effects Yu can reprt any suspected side effects assciated with the use f health prducts t Health Canada by: Visiting the Web page n Adverse Reactin Reprting ( fr infrmatin n hw t reprt nline, by mail r by fax; r Calling tll-free at NOTE: Cntact yur health prfessinal if yu need infrmatin abut hw t manage yur side effects. The Canada Vigilance Prgram des nt prvide medical advice. MORE INFORMATION Fr mre infrmatin r fr the full Prduct Mngraph n ZERIT, cntact the spnsr, Bristl-Myers Squibb, at: This leaflet was prepared by Bristl-Myers Squibb. Last revised: Feb 13, 2018