NovoLog Mix 70/30 FlexPen

Insulin is a hormone that lowers blood glucose (sugar) levels. Insulin aspart is a fast-acting insulin. Insulin aspart protamine is an intermediate-acting insulin. This combination insulin begins to work within 10 to 20 minutes after injection, reaches its highest effect in 2 hours, and continues to work for up to 24 hours.

NovoLog Mix 70/30 FlexPen is a combination medicine that helps improve blood sugar control in adults with diabetes mellitus (type 1 or type 2).

NovoLog Mix 70/30 FlexPen may also be used for other purposes not mentioned in this medication guide.

Never share an injection pen or syringe with another person, even if the needle has been changed.

You should not use this medicine if you are allergic to insulin aspart, or if you are having an episode of hypoglycemia (low blood sugar).

This medicine is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• liver or kidney disease; or
• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes found in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin if you are pregnant or become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications for both the mother and the baby.

Get emergency medical help if you have signs of an insulin allergy: redness or swelling where you injected, itchy skin rash all over your body, trouble breathing, wheezing, fast heartbeat, sweating, feeling faint, or swelling in your tongue or throat.

NovoLog Mix 70/30 FlexPen may cause serious side effects. Call your doctor right away if you experience:

• fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or
• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or feeling limp.

Common side effects of NovoLog Mix 70/30 FlexPen may include:

• low potassium;
• itching, mild skin rash; or
• thickening or hollowing of the skin at the injection site.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

This medicine is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself. Do not inject this medicine into a vein or a muscle. This type of insulin must not be given with an insulin pump, or mixed with other insulins.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. This medicine should look white and cloudy. Do not use the medicine if it looks clear or has particles in it. Call your pharmacist for new medicine.

It is important to time your insulin use with meals.

• If you have type 1 diabetes: Use this medicine within 15 minutes before the start of a meal.
• If you have type 2 diabetes: Use this medicine within 15 minutes before or after the start of a meal.

If you use an injection pen, use only the injection pen that comes with this medicine. Attach a new needle before each use.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing this medicine unopened (not in use):

• Refrigerate and use until expiration date; or
• Store at room temperature, and use the vial within 28 days or use the injection pen within 14 days.

Storing this medicine opened (in use):

• Store vial in a refrigerator or at room temperature and use within 28 days.
• Store the injection pen at room temperature (do not refrigerate) and use within 14 days. Do not store the injection pen with a needle attached.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Since NovoLog Mix 70/30 FlexPen is taken with meals, you might not follow a strict dosing schedule. Whenever you use this insulin, make sure to eat a meal within 15 minutes. Do not use extra medicine to compensate for a missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much Insulin can lead to severe low blood sugar (hypoglycemia), which can be life-threatening. Symptoms of this include feeling drowsy, confused, having blurred vision, trouble speaking, muscle weakness, uncoordinated or jerky movements, having a seizure (convulsion), or losing consciousness.

Do not drive or operate machinery until you know how this medicine affects you.

Prevent medication mistakes by always checking the medicine label before injecting your insulin.

Do not drink alcohol. It can cause low blood sugar and may disrupt your diabetes treatment.

Many other medicines can change your blood sugar levels, and some can make insulin work more or less effectively. Some medications can also reduce your symptoms of low blood sugar, making it more difficult to recognize when your blood sugar is low. Inform all your health care providers about every medicine you are currently taking and any medicine you begin or stop. This includes prescription and over-the-counter medicines, vitamins, and herbal products.