ReliOn/Novolin 70/30

Insulin is a hormone that lowers glucose (sugar) levels in the blood. Insulin isophane is an intermediate-acting insulin. Insulin regular is a short-acting insulin. This combination insulin begins to work within 10 to 20 minutes after injection, peaks in 2 hours, and continues to work for up to 24 hours.

ReliOn/Novolin 70/30 is a combination medicine used to help control blood sugar in adults with diabetes mellitus.

ReliOn/Novolin 70/30 may also be used for purposes not mentioned in this medication guide.

You should not use ReliOn/Novolin 70/30 if you are experiencing low blood sugar.

Never share an injection pen or syringe with anyone else, even if the needle has been replaced.

You should not use this medicine if you are allergic to insulin, 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:

• congestive heart failure or other heart problems;
• 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 you are 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 at the injection site, an itchy skin rash all over your body, difficulty breathing, chest tightness, feeling faint, or swelling in your tongue or throat.

ReliOn/Novolin 70/30 can cause serious side effects. Contact your doctor immediately 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 ReliOn/Novolin 70/30 may include:

• low blood sugar;
• weight gain, swelling in your hands or feet;
• 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 occur. Contact 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.

Insulin is injected under the skin. A healthcare provider can teach you how to properly use the medication by yourself.

Do not give ReliOn/Novolin 70/30 with an insulin pump.

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

This insulin should look cloudy after mixing. Do not use the mixture if it looks clear or has particles in it. Call your pharmacist for new medicine.

Your care provider will show you where on your body to inject ReliOn/Novolin 70/30. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

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

After using ReliOn/Novolin 70/30, you should eat a meal within 30 to 45 minutes.

If you use an injection pen, use only the injection pen that comes with this insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

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.

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.

Insulin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) ReliOn/Novolin 70/30:

• Refrigerate and use until expiration date; or
• Store at room temperature and use within the number of days specified in the Instructions for Use provided with your medicine.

Storing opened (in use) ReliOn/Novolin 70/30:

• Store the vial in a refrigerator or at room temperature.
• Store the injection pen at room temperature (do not refrigerate). Do not store the injection pen with a needle attached.
• In-use insulin is stable for only a certain number of days. Throw away any medicine not used within that time. Follow all storage directions provided with your medicine.

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.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

Since this medicine is taken with a meal, you might not have a strict dosing schedule. Whenever you take this insulin, make sure to eat a meal within 45 minutes. Do not use extra medicine to compensate for a missed dose.

Get your prescription refilled before you completely run out of medicine.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An insulin overdose can lead to severe low blood sugar (hypoglycemia). Symptoms can include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizures (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Do not drive or operate machinery until you know how ReliOn/Novolin 70/30 affects you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

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

This insulin may not be as effective if you are using other medicines at the same time. This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can also reduce the warning signs of hypoglycemia, making it harder to recognize when your blood sugar is low. Not all possible interactions are mentioned here. Inform your doctor about all medicines you begin or stop using.