Optisulin ® 3,64 mg/100 Iu Solution

OPTISULIN contains insulin glargine. This is a modified insulin, very similar to human insulin. OPTISULIN is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and older. 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.

Do not use OPTISULIN:

• if you are hypersensitive (allergic) to insulin glargine or any of the other ingredients of OPTISULIN (listed in section 6)
• if your child is younger than 2 years.

Warnings and precautions:

Take special care with OPTISULIN: Please follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor. If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia under section 4. There is limited experience with the use of OPTISULIN in patients whose liver or kidneys do not function well. Accidental mix-ups between OPTISULIN and other insulins, particularly short-acting insulins, have been reported. To avoid medicine errors between OPTISULIN and other insulins, you should always check the insulin label before each injection. 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 very well if you inject into a lumpy area (see section 3). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust the dose of your insulin or your other antidiabetic medicine.

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, syringes, etc.
• correct storage of your insulin while travelling
• timing of meals and administration while travelling
• the possible effects of changing to different time zones
• possible new health risks in the countries to be visited.

Illnesses and injuries:

If you are ill or have a major injury, then your blood sugar may increase (hyperglycaemia). If you are not eating enough your blood sugar may become too low (hypoglycaemia). In such situations, the management of your diabetes may require a change in your dose of OPTISULIN. Consult your doctor.

Children and adolescents:

Do not give OPTISULIN to children under the age of 2 years because the safety and efficacy have not been established.

Other medicines and OPTISULIN:

Always tell your health care provider if you are taking any other medicine (This includes complementary or traditional medicines). Some medicines cause the blood sugar level to fall, some cause it to rise, others may have both effects, depending on the situation. In each case it may be necessary to adjust your OPTISULIN dosage to avoid too low or too high blood sugar levels. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take.

Do not share medicines prescribed for you with any other person. Always use OPTISULIN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Based on your lifestyle and the results of blood sugar (glucose) tests, your doctor will:

• determine how much OPTISULIN you will need per day
• tell you when to check your blood sugar level, and whether you need to carry out urine tests
• tell you when you may need to inject a higher or lower dose of OPTISULIN
• show you in which skin area to inject OPTISULIN.

OPTISULIN is injected under the skin (subcutaneously). Do NOT inject OPTISULIN in a vein, since this will change its action and may cause hypoglycaemia. With each injection, change the puncture site within the particular area of skin that you are using. This will reduce the risk of skin shrinking or thickening or lumps at the site. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Allow the solution to reach room temperature before using OPTISULIN. Your doctor will tell you how long your treatment with OPTISULIN will last. Do not stop treatment early. If you have the impression that the effect of OPTISULIN is too strong or too weak, tell your doctor or pharmacist.

How to handle the vials/cartridges:

Look at the vial/cartridge before you use it. Only use it if the solution is clear, colourless and waterlike, and has no visible particles in it. OPTISULIN is a solution and does not require shaking or mixing before use. Do not mix OPTISULIN with any other insulins or medicines. Do not dilute it. Mixing or diluting may change the action of OPTISULIN. Before insertion of the cartridge into the non-disposable pen, the cartridge must be kept at room temperature for 1 to 2 hours and the instructions for using the pen must be followed carefully. Empty cartridges must not be refilled. If the pen malfunctions, the solution may be drawn from the cartridge into a syringe (suitable for an insulin with 100 units/mL) and injected.

Mistakes in dosage:

Please discuss in advance with your doctor what you should do if you inject too much OPTISULIN, if you miss a dose or if you inject too low a dose.

If you use more OPTISULIN than you should: You may develop hypoglycaemia (your blood sugar level may become too low). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, refer to the section on side effects. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to use OPTISULIN: If you have missed a dose of OPTISULIN or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. Refer to the section on side effects for further information on hyperglycaemia. Do not inject a double dose to make up for forgotten individual doses.

If you stop using OPTISULIN: Do not stop treatment with OPTISULIN before consulting your doctor.

OPTISULIN can have side effects. Not all side effects reported for OPTISULIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using OPTISULIN, please consult your health care provider for advice.

If any of the following happens, stop using OPTISULIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe allergic reactions to insulins, including OPTISULIN, might occur. Such reactions to OPTISULIN or to the excipients can cause large-scale skin reactions, severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure and circulatory breakdown and may become life-threatening. These are all very serious side effects. If you have them, you may have had a serious reaction to OPTISULIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Too low blood sugar levels (hypoglycaemia): If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions. Please refer to the end of this section for important further information about hypoglycaemia and its treatment.
• OPTISULIN treatment can cause the body to produce antibodies to insulin (substances that act against insulin). Rarely, this may require a change to your insulin dosage.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Skin and allergic reactions: If you inject OPTISULIN too often at the same skin site, fatty tissue under the skin at this site may shrink or thicken (called lipodystrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (localised cutaneous amyloidosis). OPTISULIN that you inject into a lumpy area may not work very well. Changing the site with each injection may help to prevent such skin changes. You may also experience reactions at the injection site (e.g. reddening, unusually intense pain on injection, itching, hives, swelling or inflammation). They can also spread around the injection site. Most minor reactions to OPTISULIN usually resolve in a few days to a few weeks.

Less frequent side effects:

• OPTISULIN treatment may also cause temporary build-up of water in the body, with swelling in the calves and ankles.
• Eye reactions: A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Hyperglycaemia and hypoglycaemia

If your blood sugar is too high (hyperglycaemia): Your blood sugar level may be too high if, for example:

• you have not injected your insulin or not injected enough, or if it has become less effective, e.g. through incorrect storage
• you are doing less physical exercise, you are under stress (emotional distress, excitement), or if you have an injury, operation, feverish illness or certain other diseases
• you are taking or have taken certain other medicines.

Thirst, increased need to pass water, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heartbeat, and glucose and ketone bodies in the urine may be signs of too high blood sugar.

• Store all medicines out of reach of children.

• The expiry date is printed on the carton and on the label of the vial/cartridge/disposable pen.

• Do not use OPTISULIN after the expiry date.

Unopened/not in use:

• Store at 2 °C to 8 °C (in a refrigerator).

• Keep the vial/cartridge/disposable pen in the original carton in order to protect from light.

• Do not allow it to freeze. Discard if frozen.

• Do not put OPTISULIN next to the freezer compartment of your refrigerator or next to a freezer pack.

Opened/in use cartridges, vials and disposable pens:

• Once in use, you can keep the vial/cartridge/disposable pen at or below 30 °C for up to 4 weeks in the outer carton for the vial and in the pen for the cartridge.

• Do not use it after this time.

• Opened cartridges and vials, whether or not refrigerated, must be discarded after 4 weeks from the first use.

• Unrefrigerated cartridges and vials, whether in use or not, must be discarded after 4 weeks.

• The non-disposable pen containing the cartridge, or the pen in use must not be stored in the refrigerator.

• The unused portion of the cartridge or vial must be discarded.

• It is helpful to note on the label the date of the first withdrawal from the vial.

• Always use a new vial/cartridge/disposable pen if you notice that your blood sugar control is unexpectedly getting worse. This is because the OPTISULIN may have lost some of its effectiveness.

• If you think you may have a problem with OPTISULIN, have it checked by your doctor or pharmacist.

• Only use OPTISULIN if the solution is clear, colourless and water-like and has no visible particles in it.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).