Truvelog 100 units Solution

TRUVELOG is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

TRUVELOG is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with TRUVELOG helps to prevent complications from your diabetes.

TRUVELOG will start to lower your blood sugar 10-20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3-5 hours. Due to this short action TRUVELOG should normally be taken in combination with intermediate-acting or long-acting insulin preparations.

Do not use TRUVELOG

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).
• If you suspect hypoglycaemia (low blood sugar) is starting (see “Summary of serious and very common side effects” in section 4).
• If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
• If it has not been stored correctly or been frozen (see “How to store TRUVELOG” in section 5).
• If the insulin does not appear clear and colourless.

Do not take TRUVELOG and tell your doctor if any of these apply to you.

Before using TRUVELOG

• Check the label to make sure it is the right type of insulin.
• Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you suspect the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.
• Always use a new needle for each injection to prevent contamination.
• Needles and syringes must not be shared.
• TRUVELOG is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Talk to your doctor or pharmacist before taking TRUVELOG. Record the brand name (“TRUVELOG”) and Lot number (included on the outer cartons and labels of each cartridge and pre-filled pen) of the medicine you are using and provide this information when reporting any side effects.

Some conditions and activities can affect your need for insulin. Consult your doctor:

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• If you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
• If you are ill, carry on taking your insulin and consult your doctor.
• If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Other medicines and TRUVELOG

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines affect your blood sugar level and this may mean that your insulin dose has to change.

Do not share medicines prescribed for you with any other person. Always use TRUVELOG exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

Dose and when to use your insulin

TRUVELOG is generally used immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, TRUVELOG can be given soon after a meal (see “How and where to inject” below for information).

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

TRUVELOG can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

TRUVELOG is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). TRUVELOG in cartridges is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4. “Possible side effects”). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if you inject into the front of your waist (abdomen). You should always measure your blood sugar regularly.

To ensure you get the accurate dose, the TRUVELOG cartridges are to be used only with the following pens:

• JuniorSTAR which delivers doses in steps of 0,5 units.
• Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit.

Not all of these pens may be marketed in your country. Always carry a spare cartridge in case it is lost or damaged.

How to inject TRUVELOG

• Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.
• Keep the needle under your skin for at least 10 seconds. Keep the dose button held in until the needle has been released from the skin. This will ensure you get your full dose.
• Remove and discard the needle after each injection. Do not store TRUVELOG with the needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing.
• Always use a new needle for each injection. This helps stop blocked needles, contamination and infection.

If you use more insulin than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see “Summary of serious and very common side effects” in section 4).

If you forget to use your insulin

Do not take a double dose to make up for forgotten individual doses. If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see “Effects from diabetes” in section 4).

If you stop using your insulin

Use TRUVELOG on a regular basis and for as long as your doctor keeps prescribing it. Do not stop using your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis (see “Effects from diabetes” in section 4).

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

Summary of serious and very common side effects

Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see “TRUVELOG with alcohol” in section 2).

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

• If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
• When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
• If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

Serious allergic reactions

to TRUVELOG or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect up to 1 in 10 000 people.

Seek medical advice immediately:

• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

Other side effects

Uncommon (may affect up to 1 in 100 people) Signs of allergy: Local allergic reaction (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of using your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately (see also “Serious allergic reactions” above).

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Changes in the injection site (lipodystrophy): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection reduces the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

Swollen joints: When you start using insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask you doctor about this.

Rare (may affect up to 1 in 1 000 people) Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.

Store all medicines out of reach of children. Do not use this medicine after the expiry date which is stated on the carton and on each label after EXP. The expiry date refers to the last day of that month.

Before the first use store your TRUVELOG in a refrigerator (2 – 8 °C). Do not freeze. Keep the cartridge in the outer carton in order to protect from light. Keep your cartridge in use at room temperature (below 30 °C) and dispose of after 4 weeks. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using, in the fridge. The pen with the inserted cartridge should not be stored with the needle attached. Keep the pen cap on the pen to protect it from light.

Do not use TRUVELOG if it is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).