NovoRapid FlexPen 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 FlexPen 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 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 treatthyroid 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 colour coded NovoRapid FlexPen 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 FlexPen

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

Read carefully the NovoRapid FlexPen 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 FlexPen label and carton, after EXP. The expiry date refers to the last day of that month.NovoRapid FlexPen 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 FlexPen that is being usedor carried as a spare is 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 FlexPen 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 of 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 1, 5 and 10 pre-filled pens of 3 ml. Not all packs may be marketed.

Marketing authorisation holder

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

Manufacturer

The manufacturer can be identified by the batch number printed on the slip of the carton and on the label:

If the second and third characters are W5, S6, P5, K7, R7 or ZF Novo Nordisk AS, Novo Allé, DK-2880 Bagsværd, Denmark is the manufacturer

If the second and third characters are H7 or T6 Novo Nordisk Production SAS, 45 Avenue dOrléans F-28002 Chartres, France is the manufacturer.

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

This leaflet was last approved in

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

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

Your FlexPen is a unique dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. FlexPen is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. As a precautionary measure, always carry a spare insulin delivery device in case your FlexPen is lost or damaged.

The colour of the pen in the illustrations differs from your FlexPen.

Your NovoRapid FlexPen Pen capPointerRubber membrane Cartridge Residualscale Doseselector Push-buttonNeedle example Needle Big outer needle cap Inner needle cap Protectivetab

Maintenance

Your FlexPen is designed to work accurately and safely. It must be handled with care.
If it is dropped or crushed, there is a risk of damage and leakage of insulin.

You can clean the exterior of your FlexPen by wiping it with a medicinal swab. Do not soak it, wash or lubricate it as it may damage the pen.

Do not refill your FlexPen.

Preparing your NovoRapid FlexPen

Check the label to make sure that your FlexPen contains the correct type of insulin.

A

Pull off the cap.

Disinfect the rubber membrane with a medicinal swab.

A

B

Remove the protective tab from a new disposable needle.

Screw the needle straight and tightly onto your FlexPen.

B

C

Pull off the big outer needle cap and keep it for later.

C

D

Pull off the inner needle cap and dispose of it.

D

• Always use a new needle for each injection to prevent contamination.
• Be careful not to bend or damage the needle before use.
• To reduce the risk of unexpected needle sticks, never put the inner needle cap back on when you have removed it from the needle.

Checking the insulin flow

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

E

Turn the dose selector to select 2 units.

E

2 units-
selected

F

Hold your FlexPen with the needle pointing upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge.

F

G

Keeping the needle upwards, press the push-button all the way in. The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than six times.

If a drop of insulin still does not appear, the pen is defective, and you must use a new one.

G

Selecting your dose

Check that the dose selector is set at 0.

H

Turn the dose selector to select the number of units you need to inject.

The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer. When turning the dose selector be careful not to push the push-button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

H

5 units
selected

24 units
selected

• Do not use the residual scale to measure your dose of insulin.

Making the injection

Insert the needle into your skin. Use the injection technique shown by your doctor or nurse.

I

Inject the dose by pressing the push-button all the way in until 0 lines up with the pointer. Be careful only to push the push-button when injecting.

Turning the dose selector will not inject insulin.

I

J

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 six seconds. This will ensure that the full dose has been injected.

J

K

Lead the needle into the big outer needle cap without touching the big outer needle cap. When the needle is covered, carefully push the big outer needle cap completely on and then unscrew the needle.

Dispose of it carefully and put the cap back on.

K

• Always remove the needle after each injection and store your FlexPen without the needle attached. Otherwise, the liquid may leak out which can cause inaccurate dosing.
• Caregivers should be most careful when handling used needles to avoid needle sticks.
• Dispose of the used FlexPen carefully without the needle attached.
• Do not share your FlexPen with anyone else.