Simvastatin; Sitagliptin oral tablets

What is this medicine?

SIMVASTATIN; SITAGLIPTIN (SIM va stat in; sit a GLIP tin) is a combination of 2 medicines used in certain patients with type 2 diabetes. Sitagliptin lowers blood sugar. Simvastatin is known as a HMG-CoA reductase inhibitor or "statin". It lowers the level of cholesterol and triglycerides in the blood. This drug may also reduce the risk of heart attack, stroke, or other health problems in patients with risk factors for heart or blood vessel disease. Diet and lifestyle changes are often used with this drug.

How should I use this medicine?

Take this medicine by mouth with a glass of water. It is usually taken once a day in the evening. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• dark urine

• fever

• joint pain

• light-colored stools

• loss of appetite

• loss of memory

• muscle cramps, pain

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• right or left upper belly pain

• signs and symptoms of low blood sugar such as feeling anxious, confusion, dizziness, increased hunger, unusually weak or tired, sweating, shakiness, cold, irritable, headache, blurred vision, fast heartbeat, loss of consciousness

• trouble passing urine or change in the amount of urine

• unusual stomach pain or discomfort

• vomiting

• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• diarrhea

• headache

• heartburn

• nausea

• stomach upset

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• antiviral medicines for HIV or AIDS

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• certain medicines for cholesterol like atorvastatin or rosuvastatin

• certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole, voriconazole

• conivaptan

• cyclosporine

• danazol

• gemfibrozil

• idelalisib

• mifepristone, RU-486

• nefazodone

• supplements like red yeast rice

This medicine may also interact with the following medications:

• alcohol

• certain medicines for blood pressure or heart disease like amlodipine, diltiazem, verapamil

• certain medicines for irregular heart beat like amiodarone and dronedarone

• certain medicines for diabetes, like glipizide or glyburide

• certain medicines that treat or prevent blood clots like warfarin

• colchicine

• digoxin

• grapefruit juice

• insulin

• lomitapide

• niacin

• ranolazine

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetic ketoacidosis

• high levels of triglycerides in the blood

• history of pancreatitis

• if you often drink alcohol

• kidney disease

• liver disease

• muscle aches or weakness

• thyroid disease

• an unusual or allergic reaction to simvastatin, sitagliptin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

You may need blood work done while you are taking this medicine. You may need regular tests to make sure your liver is working properly.

A test called the HbA1C (A1C) will be monitored. This is a simple blood test. It measures your blood sugar control over the last 2 to 3 months. You will receive this test every 3 to 6 months.

Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them.

Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include hard sugar candy or glucose tablets. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once.

Tell your doctor or health care professional if you have high blood sugar. You might need to change the dose of your medicine. If you are sick or exercising more than usual, you might need to change the dose of your medicine.

Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. Many nonprescription cough and cold products contain sugar or alcohol. These can affect blood sugar.

Tell your doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness. Your doctor or health care professional may tell you to stop taking this medicine if you develop muscle problems. If your muscle problems do not go away after stopping this medicine, contact your health care professional.

This drug is only part of a total heart-health program. Your doctor or a dietician can suggest a low-cholesterol and low-fat diet to help. Avoid alcohol and smoking, and keep a proper exercise schedule.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Do not breast-feed an infant while taking this medicine. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.