NovoRapid NovoLet 100 U/ml solution for injection in pre-filledpen

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 NovoLet is dropped, damaged or crushed 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 Always use a new needle for each injection to prevent contamination.

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 childres 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 concentration 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. Make sure you get the NovoRapid NovoLet that your doctor and nurse have told you to use and 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.

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 hypo may 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.

How to handle NovoRapid NovoLet

NovoRapid NovoLet is a pre-filled disposable pen containing insulin aspart.

Read carefully the NovoRapid NovoLet instruction for use included in this package leaflet. You must use the pen as described in the Instructions for Use

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 NovoLet label and carton, after EXP. The expiry date refers to the last day of that month.
NovoRapid NovoLet 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 NovoLet 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 cap on your NovoLet 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 pre-filled pen contains 300 U insulin aspart in 3 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 5 and 10 pre-filled pens of 3 ml. Not all packs may be marketed.

Marketing authorisation holder and manufacturer:

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

Now turn over for information on how to use your NovoLet.

This leaflet was last approved in

NOVORAPID solution for injection in a pre-filled pen. NovoLet. INSTRUCTIONS FOR USE

Please read the following instructions carefully before using your NovoRapid NovoLet.

NovoRapidNovoLet is a simple, compact pre-filled pen. You can dial doses from 2 to 78 units in increments of 2 units. NovoRapidNovoLet is designed to be used with NovoFine needles.
As a precautionary measure, always carry a spare insulin delivery device in case your NovoLet is lost or damaged.

NovoLetNovoFine needle Big outer needle cap Protective tab Pen cap Inner needle cap Cap scale Needle Rubber membrane Insulin level indicatorInsulin cartridge Dosage indicator Colour coding Push button scale Push button

Getting started

Check the label to be sure that your NovoRapidNovoLet contains the correct type of insulin. Take off the cap.

• Disinfect the rubber membrane with a medicinal swab
• Always use a new needle for each injection to prevent contamination
• Remove the protective tab from a NovoFine needle
• Screw the needle straight and tightly onto NovoRapid NovoLet (picture A)
• Pull off the big outer needle cap and the inner needle cap. Do not discard the big outer needle cap.

A

Priming to expel air

Prior to each injection small amounts of air may collect in the needle and cartridge during normal use. To avoid injection of air and ensure proper dosing:

• Hold NovoRapid NovoLet with the needle pointing upwards
• Tap the cartridge gently with your finger a few times. Any air bubbles will collect at the top of the cartridge
• Keeping the needle upwards, turn the cartridge for one click in the direction of the arrow (picture B)
• Still with the needle upwards, press the push-button fully down (picture C)
• A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If a drop of insulin still does not appear, the device is defective and must not be used.

B C

Setting the dose

• Put the cap back on the pen, with 0 next to the dosage indicator (picture D)
• Check that the push-button is fully down. If it is not, turn the cap until the push-button is fully depressed
• Hold your NovoRapid NovoLet horizontally. Now you?re ready to set the dose you need
• Turn the cap in the direction of the arrow (picture E) to set the right dose. You?ll feel the cap clicking, and the push-button will rise up
• Do not put your hand over the push-button when you set the dose. If the push-button cannot rise freely, some of your insulin will be pushed out of the needle
• The scale on the cap shows 0, 2, 4, 6, 8, 10, 12, 14, 16 and 18 units. For every click you feel when you turn the cap, you set 2 units more. The push-button also rises as you turn the cap
• The scale under the push-button shows 20, 40 and 60 units. Every time you fully turn the cap, you set 20 units.

D

Dosage examples

To set 8 units:

Turn the cap until 8 is opposite the dosage indicator; four clicks.
To select 26 units:
Turn the cap round 1 full turn, so 0 is opposite the dosage indicator again. You?ve now set 20 units. Keep turning the cap until 6 is opposite the dosage indicator. On the push-button scale you?ll see a 20-line.
Add the 6 from the dosage indicator to the 20 on the push-button scale. There, you?ve set 26 units (picture F).

F

To check a dose you set

• Note the figure on the cap next to the dosage indicator
• Note the highest figure you can see on the push-button scale
• Add the two together to show the dose you set
• If you have set a wrong dose,simply turn the cap forwards or backwards until you set the right number of units.

The maximum dose is 78 units

• Do not try to set a dose higher than 78 units. Otherwise, insulin will leak out of the needle and the dose will be incorrect
• If you have, by mistake, tried to set a dose over 78 units, follow these steps:
• Turn the cap back as far as you can. Turn it till the push-button is fully down and you can feel resistance.
• Then take the cap off and put it back on again, lining up the 0 next to the dosage indicator. Now set the dose again.
• Remember that 78 units is the maximum dose.
• After the dose is set, remove the cap to inject the insulin. Go straight on to Injecting the insulin.

Injecting the insulin

• Insert the needle into your skin. Use the injection technique advised by your doctor
• Deliver the dose by pressing the push-button all the way in. Be careful only to push the push-button when injecting
• Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin. The needle must remain under the skin for at least 6 seconds. This will ensure that the full dose has been delivered.

Subsequent injections

• Always check that the push-button is completely down. If not, turn the cap until the push-button is fully depressed, then proceed as described in Getting started
• You may hear a clicking sound when you press the push-button. Do not use this to set or check your dose; it may not be accurate
• You can not set a dose higher than the number of units left in the cartridge
• You can use the insulin level indicator to estimate how much is left. But you can not use it to set or select your dose.

Removing the needle

• Replace the big outer needle cap and unscrew the needle
• Dispose of it carefully.

Use a new needle for each injection.
Remove and discard the needle after each injection and store NovoRapid NovoLet without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
Health care professionals, relatives and other carers must follow general precautionary measures for removal and disposal of needles to eliminate the risk of unintended needle penetration.
Close your NovoRapidNovoLet fully with 0 next to the dosage indicator.
Dispose of your used NovoRapidNovoLet carefully without the needle attached.

Maintenance

Your NovoRapidNovoLet is designed to work accurately and safely. It must be handled with care. You can clean the exterior of your NovoRapidNovoLet by wiping it with a medicinal swab. Do not soak it, wash or lubricate it as this may damage the mechanism.
Do not refill NovoRapidNovoLet.