Product Description: BASAGLAR contains insulin glargine. This is a modified insulin, very similar to human insulin. BASAGLAR is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood sugar lowering action. How to use: A new needle must be attached before each use. Only use needles that are compatible for use with BASAGLAR KwikPen. A safety test must be performed before each injection. Look at the cartridge before you use the pen. Do not use BASAGLAR KwikPen if you notice particles in it. Only use BASAGLAR KwikPen if the solution is clear, colorless and waterlike. Do not shake or mix it before use. To prevent the possible transmission of disease, each pen must be used by one patient only. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin. BASAGLAR is injected under the skin. Do NOT inject BASAGLAR in a vein, since this will change its action and may cause hypoglycemia. Your doctor will show you in which area of the skin you should inject BASAGLAR. With each injection, change the puncture site within the particular area of skin that you are using. Basaglar is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis. Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with BASAGLAR KwikPen, consult your doctor, pharmacist or nurse. Empty pens must not be refilled and must be properly discarded. Do not use BASAGLAR KwikPen if it is damaged or not working properly, it has to be discarded and a new KwikPen has to be used. Caution & Warnings: Talk to your doctor, pharmacist or nurse before using BASAGLAR. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor. Skin changes at the injection site. The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work well if you inject into a lumpy area (See How to use Basaglar). Contact your doctor if you are currently injecting into a lumpy area before you start injecting into a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose. Travel Before travelling consult your doctor. You may need to talk about: the availability of your insulin in the country you are visiting, supplies of insulin etc. correct storage of your insulin while travelling, timing of meals and insulin administration while travelling, the possible effects of changing to different time zones, possible new health risks in the countries to be visited, what you should do in emergency situations when you feel unwell or become ill. Illnesses and injuries In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests): If you are ill or have a major injury then your blood sugar level may increase (hyperglycemia). If you are not eating enough your blood sugar level may become too low (hypoglycemia). In most cases you will need a doctor. Make sure that you contact a doctor early. If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin. Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose. Some patients with longstanding type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localized swelling (oedema). Ingredients: The active substance is insulin glargine. Each milliliter of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg). The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide

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