Concentrated insulin regular is used with a proper diet and exercise program to control high blood sugar in people with diabetes who require large doses of insulin (more than 200 units per day). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

This man-made insulin product is the same as human insulin. It replaces the insulin that your body would normally make. It works right away like regular insulin but its effects last longer. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication may be used alone or with other oral diabetes drugs (such as metformin).

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

This insulin product is a high-strength concentrated liquid. If you are using the vial, use the proper syringe prescribed by your doctor to make sure you are measuring the correct dose.

Inject this medication under the skin as directed by your doctor, usually 2 to 3 times daily before meals. Because this insulin is fast-acting, do not use this insulin product if you are unable to eat within 30 minutes after the injection or if you have low blood sugar. Not eating right after a dose of this insulin may lead to low blood sugar (hypoglycemia). This injection is given in the stomach area, the thigh, the buttocks, or the back of the upper arm. Do not inject into a vein or muscle because very low blood sugar may occur.

The dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar.

Before using, check this product for particles or discoloration. If either is present, do not use the insulin. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin (for example, pits/lumps or thickened skin). Do not inject into skin that is red, swollen, itchy, or damaged. To lessen bruising, do not rub the injection site after a shot. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature. Learn how to store and discard medical supplies safely.

This product should not be mixed with any other insulins.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).

Injection site reactions (such as pain, redness, swelling, or itching) or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat)

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using concentrated insulin regular, tell your doctor or pharmacist if you are allergic to it; or to other insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do anything that needs alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while using this medication because it can increase the risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding. Your insulin needs may change while breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: signs of low blood sugar such as sweating, shakiness, loss of consciousness, fast heartbeat.

Do not share this medication, needles, or syringes with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

Lab and/or medical tests (such as liver/kidney function, fasting blood glucose, hemoglobin A1c, complete blood counts) should be done while you are taking this medication. Keep all medical and lab appointments.

Keep extra supplies of insulin, syringes, and needles on hand.

It is very important to follow your insulin regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of insulin.

Store all unopened insulin products in the refrigerator. Opened concentrated insulin regular vials may be stored in the refrigerator or at room temperature. Throw away the concentrated insulin regular vials in use after 40 days, even if there is insulin left. Opened concentrated insulin regular prefilled pens can only be stored at room temperature and should not be refrigerated. Throw away the prefilled pens in use after 28 days, even if there is insulin left. Also throw away all insulin products after the expiration date on the package. Do not freeze and do not use insulin that has been frozen.

Protect insulin from light and heat. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).