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Marketed By GlaxoSmithKline Research Triangle Park NC 27709 Distributed and Marketed By Schering Corporation Kenilworth NJ 07033 Levitra is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation Rx Only 08918646 R 07 Bayer Pharmaceuticals Corporation Printed in U S A Patient Information Levitra Luh-VEE-Trah vardenafil HCl Tablets Read the Patient Information about Levitra before you start taking it and again each time you get a refill There may be new information You may also find it helpful to share this information with your partner This leaflet does not take the place of talking with your doctor You and your doctor should talk about Levitra when you start taking it and at regular checkups If you do not understand the information or have questions talk with your doctor or pharmacist WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT Levitra Levitra can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines With a sudden drop in blood pressure you could get dizzy faint or have a heart attack or stroke Do not take Levitra if you take any medicines called nitrates use recreational drugs called poppers like amyl nitrate and butyl nitrate See Who Should Not Take Levitra Tell all your healthcare providers that you take Levitra If you need emergency medical care for a heart problem it will be important for your healthcare provider to know when you last took Levitra WHAT IS Levitra Levitra is a prescription medicine taken by mouth for the treatment of erectile dysfunction ED in men ED is a condition where the penis does not harden and expand when a man is sexually excited or when he cannot keep an erection A man who has trouble getting or keeping an erection should see his doctor for help if the condition bothers him Levitra may help a man with ED get and keep an erection when he is sexually excited Levitra does not cure ED increase a man s sexual desire protect a man or his partner from sexually transmitted diseases including HIV Speak to your doctor about ways to guard against sexually transmitted diseases serve as a male form of birth control Levitra is only for men with ED Levitra is not for women or children Levitra must be used only under a doctor s care HOW DOES Levitra WORK When a man is sexually stimulated his body s normal physical response is to increase blood flow to his penis This results in an erection Levitra helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity Once a man has completed sexual activity blood flow to his penis decreases and his erection goes away WHO CAN TAKE Levitra Talk to your doctor to decide if Levitra is right for you

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not impair fertility in male and female rats administered doses up to 100 mg kg day for 28 days prior to mating in male and for 14 days prior to mating and through day 7 of gestation in females In a corresponding 1-month rat toxicity study this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg There was no effect on sperm motility or morphology after single 20 mg oral doses of vardenafil in healthy volunteers Pregnancy Nursing Mothers and Pediatric Use Levitra is not indicated for use in women newborns or children Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma Following a single oral dose of 3 mg kg of the administered dose was excreted into the milk within 24 hours It is not known if vardenafil is excreted in human breast milk Pregnancy Category B No evidence of specific potential for teratogenicity embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg kg day during organogenesis This dose is approximately 100 fold rat and 29 fold rabbit greater than the AUC values for unbound vardenafil and its major metabolite in humans given the MRHD of 20 mg In the rat pre-and postnatal development study the NOAEL no observed adverse effect level for maternal toxicity was 8 mg kg day Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg kg possibly due to vasodilatation and or secretion of the drug into milk The number of living pups born to rats exposed pre- and