Product Information

Simvastatin tablet

What is this medicine?

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.

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

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

• frequently drink alcoholic beverages
• kidney disease
• liver disease
• muscle aches or weakness
• other medical condition
• an unusual or allergic reaction to simvastatin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. You can take this medicine with or without food. Take your doses at regular intervals. Do not take your medicine more often than directed.

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

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

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

• medicines for fungal infections like itraconazole, ketoconazole
• nefazodone
• other medicines for high cholesterol
• red yeast rice
• some antibiotics like clarithromycin, erythromycin, telithromycin
• some medicines for HIV infection like amprenavir, indinavir, ritonavir

This medicine may also interact with the following medications:

• alcohol
• amiodarone
• cyclosporine
• danazol
• diltiazem
• grapefruit juice
• fluconazole
• verapamil
• voriconazole
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check-ups. You may need regular tests to make sure your liver is working properly.

Tell you 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.

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 use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.

If you are going to have surgery tell your health care professional that you are taking this drug.

Some drugs may increase the risk of side effects from simvastatin. If you are given certain antibiotics or antifungals, your doctor or health care professional may stop simvastatin for a short time. Check with your doctor or pharmacist for advice.

What side effects may I notice from 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
• dark urine
• fever
• joint pain
• muscle cramps, pain
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• trouble passing urine or change in the amount of urine
• unusually weak or tired
• 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
• heartburn
• stomach gas, pain, upset

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 30 degrees C (86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.