NovoRapid 100 U/ml solution for injection in vial

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

NovoRapid is used to treat diabetes mellitus in adults, children and adolescents aged 2 to 17 years. NovoRapid will start to lower your blood sugar 10-20 minutes after you take it, a maximum effect occurs between 1 and 3 hours and the effect lasts for 3-5 hours. Due to this short action NovoRapid should normally be taken in combination with intermediate-acting or long-acting insulin preparations.

Do not use NovoRapid

If you are allergic hypersensitive to insulin aspart, or any of the other ingredients of NovoRapid see 6 Further information If you suspect hypoglycaemia low blood sugar is starting see 4 Possible side effects If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If it is not in perfect condition when you get the vial, return the vial to your supplier If it has not been stored correctly or if it has been frozen see 5 How to store NovoRapid If the insulin does not appear water clear and colourless.

Before using NovoRapid

Check the label to make sure it is the right type of insulin Remove the protective cap Disinfect the rubber membrane with a medicinal swab.

Take special care with NovoRapid

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands

If you are exercising 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 the injections. Consult your doctor if you are planning such travelling.

NovoRapid can be used in children 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.

No clinical studies with NovoRapid have been performed in children under the age of 2 years. Therefore only use NovoRapid in children below this age, if your doctor have specifically told you to.

As with all insulin products, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and insulin aspart dosage adjusted on an individual basis.

Using other medicines

Some medicines affect the way glucose works in your body and this may influence your insulin dose. Listed below are the most common medicines, which may affect your insulin treatment. Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, you should tell your doctor if you are using any medicine as mentioned below that affect your blood sugar level.

If you take any of the below medicine your blood sugar level may fall (hypoglycaemia):

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure)
• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

If you take any of the below medicine your blood sugar level may rise (hyperglycaemia):

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as "cortisone" used to treat inflammation)
• Thyroid hormones (use to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced influence on the body?s metabolic processes)
• Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly) may both increase or decrease your sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.

Taking NovoRapid with food and drink

If you are drinking alcohol your need for insulin may change as your blood sugar level may either rise or fall. Carefull monitoring is recommended.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant, planning a pregnancy or breast-feeding please contact your doctor for advice. NovoRapid can be used during pregnancy. Your insulin dosage may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particulary prevention of hypoglycaemia, is important, for the health of your baby.

Driving and using machines

If your blood sugar is low or high your concentreation and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car:
- If you have frequent hypoglycaemias
- If you find it hard to recognise hypoglycaemia.

NovoRapid has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Dosage

Talk about your insulin dose with your doctor and nurse. Follow their advice carefully. This leaflet is a general guide.
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. Do not change your insulin unless your doctor tells you to.
Eat a meal or snack containing carbohydrates within 10 minutes of the injection to avoid
hypoglycaemia. When necessary, NovoRapid may be given soon after the meal, instead of before the meal.

Method of administration

NovoRapid is for injection under the skin (subcutaneously) or for continuous infusion in a pump system. NovoRapid may also be given directly into a vein (intravenously) by health care professionals under close supervision by a doctor. Never inject your insulin directly into a vein or muscle (intramuscular).
Always vary the sites you inject within the same region to avoid lumps (see 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. You should always measure your blood glucose regularly.

How to take NovoRapid

If you use only one type of insulin

1. Draw into the syringe the same amount of air as the dose of insulin you are going to inject. Inject the air into the vial.

2. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

If you have to mix two types of insulin

1. Just before use, roll the long-acting (cloudy) insulin between your hands until the liquid is uniformly white and cloudy.

2. Draw into the syringe the same amount of air as the dose of long-acting insulin. Inject the air into the vial containing long-acting insulin and pull out the needle.

3. Draw into the syringe the same amount of air as the dose of NovoRapid. Inject the air into the vial containing NovoRapid. Turn the vial and syringe upside down and draw up the prescribed dose of NovoRapid. Expel any air from the syringe and check that the dose is correct.

4. Push the needle into the vial of long-acting insulin, turn the vial and syringe upside down and draw out the dose you have been prescribed. Expel any air from the syringe and check the dose. Inject the mixture immediately.

5. Always mix NovoRapid and long-acting insulin in the same sequence.

How to inject this insulin

• Pinch your skin between two fingers, push the needle into the skin fold and inject the insulin under the skin
• Keep the needle under your skin for at least 6 seconds to make sure you have injected all theinsulin.

For use in an infusion pump system

NovoRapid should never be mixed with any other insulin when used in a pump.
Follow the instructions and recommendations from your doctor regarding the use of NovoRapid in a pump. Before use of NovoRapid in the pump system you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump system.

• Before inserting the needle, use soap and water to clean your hands and the skin where the needle is inserted so as to avoid any infection at the infusion site
• When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or the tubing
• Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.

What to do in case of pump system failure

You should always have alternative insulin available for injection under the skin in case of pump system failure.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low (this is called hypoglycaemia or hypo). This may also happen:

• If you eat too little or miss a meal
• If you exercise more than usual.

The warning signs of a hypomay come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If you feel a hypo coming on:take a high sugar snack and then measure your blood sugar.

If your blood sugar is too low: eat glucose tablets or another high sugar snack (sweets, biscuits, fruit juice), then rest. Always carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

When symptoms of hypoglycaemia have disappeared or when blood glucose level is stabilised continue insulin treatment.

Tell relevant people you have diabetes and what may be the consequences, including the risk of passing out due to a hypo.

Tell relevant people that if you pass out (become unconscious), they must turn you on your side and get medical help straight away. They must not give you any food or drink. It could choke you.

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 sugary snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital. Contact your doctor or an emergency ward after an injection of glucagon: you need to find the reason for your hypo to avoid getting more.
- If prolonged severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
- If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

If you forget to take your insulin

If you forget to take your insulin your blood sugar may get too high (this is called hyperglycaemia). This may also happen:

• If you repeatedly take less insulin than you need
• If you get an infection or a fever
• If you eat more than usual
• If you exercise less than usual.

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed, dry skin; dry mouth and a fruity (acetone) smell of the breath.

If you get any of these signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

These may be signs of a very serious condition called diabetic ketoacidosis. If you do not treat it, this could lead to diabetic coma and eventually death.

If you stop taking your insulin

This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop taking your insulin without speaking to a doctor, who will tell you what needs to be done.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, NovoRapid can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows:

• Very common: affects more than 1 user in 10
• Common: affects 1 to 10 users in 100
• Uncommon: affects 1 to 10 users in 1,000
• Rare: affects 1 to 10 users in 10,000
• Very rare: affects less than 1 user in 10,000
• Not known: frequency cannot be estimated from the available data.

Uncommon side effects

Signs of allergy. Reactions (pain, redness, hives, inflammation, swelling and itching) at the injection site may occur (local allergic reactions). These usually disappear after a few weeks of taking your insulin. If they do not disappear, see your doctor.
Seek medical advice immediately:
- If signs of allergy spread to other parts of your body, or
- If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heart beat; feel dizzy.

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

Changes at the injection site (lipodystrophy). If you inject yourself too often at the same site, fatty tissue under the skin at this site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to prevent such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse because 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 taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears.

Diabetic retinopathy. If you have diabetic retinopathy and your blood glucose level improve very fast, the retinopathy may get worse. Ask your doctor about this.

Common side effects

Low blood sugar (hypoglycaemia).

Rare side effects

Painful neuropathy. If your blood glucose level improve very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.

Very rare side effects

Serious allergic reaction to NovoRapid or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before using NovoRapid.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Keep out of the reach and sight of children.
Do not use NovoRapid after the expiry date which is stated on the vial label and carton, after EXP. The expiry date refers to the last day of that month.NovoRapid vial that is not being used is to be stored in the refrigerator at 2°C - 8°C, away from the cooling element. Do not freeze.
NovoRapid vial that is being used or carried as a spareis not to be kept in the refrigerator. You can carry it with you and keep it at room temperature (below 30°C) for up to 4 weeks.
Always keep the vial in the outer carton when you are not using it in order to protect it from light. NovoRapid must be protected from excessive heat and light.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What NovoRapid contains

The active substance is insulin aspart. Each ml contains 100 U of insulin aspart. Each vial contains 1,000 U insulin aspart in 10 ml solution for injection The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What NovoRapid looks like and contents of the pack

NovoRapid comes as a clear, colourless, aqueous solution.
Pack sizes of 1 and 5 vials of 10 ml or in a multipack of 5 x (1 x 10 ml) vials. Not all packs may be marketed.

Marketing authorisation holderand manufacturer:

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

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