NDC 0006-0543-54 unit of use bottles of 90.

Storage

Store between 5-30°C (41-86°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with simvastatin [see Contraindications (4) and Warnings and Precautions (5.1)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking ZOCOR.

17.1 Muscle PainAll patients starting therapy with ZOCOR should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing ZOCOR. Patients using the 80-mg dose should be informed that the risk of myopathy, including rhabdomyolysis, is increased with use of the 80-mg dose. The risk of myopathy, including rhabdomyolysis, occurring with use of ZOCOR is increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

17.2 Liver EnzymesIt is recommended that liver function tests be performed before the initiation of ZOCOR, and thereafter when clinically indicated. All patients treated with ZOCOR should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

17.3 PregnancyWomen of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using ZOCOR. Discuss future pregnancy plans with your patients, and discuss when to stop taking ZOCOR if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking ZOCOR and call their healthcare professional.

17.4 BreastfeedingWomen who are breastfeeding should not use ZOCOR. Patients who have a lipid disorder and are breastfeeding should be advised to discuss the options with their healthcare professional.

SPL UNCLASSIFIED SECTION

Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

By:
MERCK SHARP & DOHME LTD.
Cramlington, Northumberland, UK NE23 3JU

For patent information: www.merck.com/product/patent/home.html

Copyright © 1999-2015 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-mk0733-t-1503r065

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg Bottle Label

NDC 0006-0726-31

Zocor®
(Simvastatin) Tablets

5 mg

Each tablet contains 5 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg Bottle Label

NDC 0006-0735-31

Zocor®
(Simvastatin) Tablets

10 mg

Each tablet contains 10 mg of simvastatin.

Rx only

30 Tablets

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 20 mg Bottle Label

NDC 0006-0740-31

Zocor®
(Simvastatin) T