MEDICATION GUIDE QSYMIA (Kyoo sim ee uh) (phentermine and topiramate extended-release) Capsules CIV

Transcription

1 MEDICATION GUIDE QSYMIA (Ky sim ee uh) (phentermine and tpiramate extended-release) Capsules CIV Read this Medicatin Guide befre yu start taking Qsymia and each time yu get a refill. There may be new infrmatin. This infrmatin des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r treatment. If yu have any questins abut Qsymia, talk t yur healthcare prvider r pharmacist. What is the mst imprtant infrmatin I shuld knw abut Qsymia? (Fr ther side effects, als see What are the pssible side effects f Qsymia? ) Qsymia can cause serius side effects, including: Birth defects (cleft lip/cleft palate). If yu take Qsymia during pregnancy, yur baby has a higher risk fr birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even befre yu knw yu are pregnant. Wmen wh are pregnant must nt take Qsymia. Wmen wh can becme pregnant shuld: 1. Have a negative pregnancy test befre taking Qsymia and every mnth while taking Qsymia. 2. Use effective birth cntrl (cntraceptin) cnsistently while taking Qsymia. Talk t yur healthcare prvider abut hw t prevent pregnancy. If yu becme pregnant while taking Qsymia, stp taking Qsymia immediately, and tell yur healthcare prvider right away. Healthcare prviders and patients shuld reprt all cases f pregnancy t: FDA MedWatch at FDA-1088, and The Qsymia Pregnancy Surveillance Prgram at Increases in heart rate. Qsymia can increase yur heart rate at rest. Yur healthcare prvider shuld check yur heart rate while yu take Qsymia. Tell yur healthcare prvider if yu experience, while at rest, a racing r punding feeling in yur chest lasting several minutes when taking Qsymia. Suicidal thughts r actins. Tpiramate, an ingredient in Qsymia, may cause yu t have suicidal thughts r actins.

2 Call yur healthcare prvider right away if yu have any f these symptms, especially if they are new, wrse, r wrry yu: thughts abut suicide r dying attempts t cmmit suicide new r wrse depressin new r wrse anxiety feeling agitated r restless panic attacks truble sleeping (insmnia) new r wrse irritability acting aggressive, being angry, r vilent acting n dangerus impulses an extreme increase in activity and talking (mania) ther unusual changes in behavir r md Serius eye prblems which include: any sudden decrease in visin, with r withut eye pain and redness, a blckage f fluid in the eye causing increased pressure in the eye (secndary angle clsure glaucma). These prblems can lead t permanent visin lss if nt treated. Tell yur healthcare prvider right away if yu have any new eye symptms. What is Qsymia? Qsymia is a prescriptin medicine that cntains phentermine and tpiramate extended-release that may help sme bese adults r sme verweight adults wh als have weight-related medical prblems lse weight and keep the weight ff. Qsymia shuld be used with a reduced calrie diet and increased physical activity. It is nt knwn if Qsymia changes yur risk f heart prblems r strke r f death due t heart prblems r strke. It is nt knwn if Qsymia is safe and effective when taken with ther prescriptin, ver-the-cunter, r herbal weight lss prducts. It is nt knwn if Qsymia is safe and effective in children under 18 years ld. Qsymia is a federally cntrlled substance (CIV) because it cntains phentermine and can be abused r lead t drug dependence. Keep Qsymia in a safe place, t prtect it frm theft. Never give yur Qsymia t anyne else, because it may cause death r harm them. Selling r giving away this medicine is against the law.

3 Wh shuld nt take Qsymia? D nt take Qsymia if yu: are pregnant, planning t becme pregnant, r becme pregnant during Qsymia treatment. have glaucma have thyrid prblems (hyperthyridism) are taking certain medicines called mnamine xidase inhibitrs (MAOIs) r have taken MAOIs in the past 14 days. are allergic t tpiramate, sympathmimetic amines such as phentermine, r any f the ingredients in Qsymia. See the end f this Medicatin Guide fr a cmplete list f ingredients in Qsymia. What shuld I tell my healthcare prvider befre taking Qsymia? Tell yur healthcare prvider if yu: are pregnant r planning t becme pregnant have had a heart attack r strke have r have had an abnrmal heart rhythm have r have had depressin, md prblems, r suicidal thughts r behavir have eye prblems, especially glaucma have a histry f metablic acidsis (t much acid in the bld) r a cnditin that puts yu at higher risk fr metablic acidsis such as chrnic diarrhea, surgery, a diet high in fat and lw in carbhydrates (ketgenic diet), weak, brittle, r sft bnes (stemalacia, steprsis, stepenia), r decreased bne density have kidney prblems, have kidney stnes, r are getting kidney dialysis have liver prblems have seizures r cnvulsins (epilepsy) are breastfeeding. It is nt knwn if Qsymia passes int yur breast milk. Yu and yur healthcare prvider shuld decide if yu will take Qsymia r breastfeed. Yu shuld nt d bth. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and nn-prescriptin medicines, vitamins, and herbal supplements. Qsymia taken with ther medicines may affect hw each medicine wrks and may cause side effects. Especially tell yur healthcare prvider if yu take: Birth cntrl pills. Tell yur healthcare prvider if yur menstrual bleeding changes while yu are taking birth cntrl pills and Qsymia.

4 Water pills (diuretics) such as hydrchlrthiazide (HCTZ) Any medicines that impair r decrease yur thinking, cncentratin, r muscle crdinatin Carbnic anhydrase inhibitrs [such as ZONEGRAN (znisamide), DIAMOX (acetazlamide) r NEPTAZANE (methazlamide)] Seizure medicines such as Valpric acid (DEPAKENE r DEPAKOTE ) Ask yur healthcare prvider r pharmacist fr a list f these medicines, if yu are nt sure. Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist each time yu get a new medicine. D nt start a new medicine withut talking t yur healthcare prvider. Hw shuld I take Qsymia? Yur healthcare prvider shuld start yu n a diet and exercise prgram when yu start taking Qsymia. Stay n this prgram while yu are taking Qsymia. D nt change yur dse withut talking t yur healthcare prvider. Qsymia can be taken with r withut fd. If yu miss a dse f Qsymia, wait until the next mrning t take yur usual dse f Qsymia. D nt duble yur dse. T start treatment with Qsymia Take ne Qsymia 3.75 mg/23 mg capsule (Figure A) nce each mrning fr the first 14 days After taking Qsymia 3.75 mg/23 mg capsule fr 14 days, then take ne Qsymia 7.5 mg/46 mg capsule (Figure B) nce each mrning After taking Qsymia fr 12 weeks Yur healthcare prvider shuld either (1) tell yu t stp taking Qsymia r (2) increase yur dse f Qsymia if yu d nt lse a certain amunt f weight within the first 12 weeks f treatment at the recmmended dse. If yur healthcare prvider increases the dse f Qsymia Take ne Qsymia mg/69 mg capsule (Figure C) nce each mrning fr 14 days After taking 14 days f Qsymia mg/69 mg capsule, then take ne Qsymia 15 mg/92 mg capsule (Figure D) nce each mrning Stpping Qsymia treatment Yur healthcare prvider shuld tell yu t stp taking Qsymia if yu have nt lst a certain amunt f weight after an additinal 12 weeks f treatment n the higher dse.

5 D nt stp taking Qsymia withut talking t yur healthcare prvider. Stpping Qsymia suddenly can cause serius prblems, such as seizures. Yur healthcare prvider will tell yu hw t stp taking Qsymia slwly. If yu take t much Qsymia, call yur healthcare prvider r g t the nearest emergency rm right away. What shuld I avid while taking Qsymia? D nt get pregnant while taking Qsymia. See What is the mst imprtant infrmatin I shuld knw abut Qsymia. D nt drink alchl while taking Qsymia. Qsymia and alchl can affect each ther causing side effects such as sleepiness r dizziness. D nt drive a car r perate heavy machinery, r d ther dangerus activities until yu knw hw Qsymia affects yu. Qsymia can slw yur thinking and mtr skills, and may affect visin. What are the pssible side effects f Qsymia? See What is the mst imprtant infrmatin I shuld knw abut Qsymia? at the beginning f this Medicatin Guide Md changes and truble sleeping. Qsymia may cause depressin r md prblems, and truble sleeping. Tell yur healthcare prvider if symptms ccur. Cncentratin, memry, and speech difficulties. Qsymia may affect hw yu think and cause cnfusin, prblems with cncentratin, attentin, memry, r speech. Tell yur healthcare prvider if symptms ccur. Increases f acid in bldstream (metablic acidsis). If left untreated, metablic acidsis can cause brittle r sft bnes (steprsis, stemalacia, stepenia), kidney stnes, can slw the rate f grwth in children, and may pssibly harm yur baby if yu are pregnant. Metablic acidsis can happen with r withut symptms. Smetimes peple with metablic acidsis will: feel tired nt feel hungry (lss f appetite) feel changes in heartbeat

6 have truble thinking clearly Yur healthcare prvider shuld d a bld test t measure the level f acid in yur bld befre and during yur treatment with Qsymia. Lw bld sugar (hypglycemia) in peple with type 2 diabetes mellitus wh als take medicines used t treat type 2 diabetes mellitus. Weight lss can cause lw bld sugar in peple with type 2 diabetes mellitus wh als take medicines used t treat type 2 diabetes mellitus (such as insulin r sulfnylureas). Yu shuld check yur bld sugar befre yu start taking Qsymia and while yu take Qsymia. Pssible seizures if yu stp taking Qsymia t fast. Seizures may happen in peple wh may r may nt have had seizures in the past if yu stp Qsymia t fast. Yur healthcare prvider will tell yu hw t stp taking Qsymia slwly. Kidney stnes. Drinking plenty f fluids when taking Qsymia t help decrease yur chances f getting kidney stnes. If yu get severe side r back pain, and/r bld in yur urine, call yur healthcare prvider Decreased sweating and increased bdy temperature (fever). Peple shuld be watched fr signs f decreased sweating and fever, especially in ht temperatures. Sme peple may need t be hspitalized fr this cnditin. Cmmn side effects f Qsymia include: numbness r tingling in the hands, arms, feet, r face (paraesthesia) dizziness change in the way fds taste r lss f taste (dysgeusia) truble sleeping (insmnia) cnstipatin dry muth Tell yur healthcare prvider if yu have any side effect that bthers yu r des nt g away. These are nt all f the pssible side effects f Qsymia. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t VIVUS at r FDA at FDA Hw shuld I stre Qsymia? Stre Qsymia at rm temperature between 59 F t 77 F (15 C t 25 C). Keep Qsymia and all medicines ut f the reach f children. General Infrmatin abut Qsymia Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use Qsymia fr a cnditin fr which it was nt

7 prescribed. D nt give Qsymia t ther peple, even if they have the same symptms yu have. It may harm them. This Medicatin Guide summarizes imprtant infrmatin abut Qsymia. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur pharmacist r healthcare prvider fr infrmatin abut Qsymia that is written fr healthcare prfessinals. Fr mre infrmatin, g t r call What are the ingredients in Qsymia? Active Ingredient: phentermine hydrchlride and tpiramate extended-release Inactive Ingredients: methylcellulse, sucrse, starch, micrcrystalline cellulse, ethylcellulse, pvidne, gelatin, talc, titanium dixide, FD&C Blue #1, FD&C Red #3, FD&C Yellw #5 and #6, and pharmaceutical black and white inks. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Cpyright VIVUS, Inc. All rights reserved. VIVUS, Inc 351 East Evelyn Avenue Muntain View, CA USA US Patent Numbers: 7,056,890; 7,553,818; 7,659,256; 7,674,776; 8,580,298; and 8,580,299 Qsymia is a registered trademark f VIVUS, Inc. ME Issued: 10/2014