Insulatard FlexPen 100 IU/ml suspension for injection in apre-filled pen

Insulatard is human insulin to treat diabetes. Insulatard is a long-acting insulin. This means that it will start to lower your blood sugar about 1½ hours after you take it, and the effect will last for approximately 24 hours. Insulatard is often given in combination with fast-acting insulin products.

Do not use Insulatard

If you are allergic hypersensitive to this insulin product, metacresol or any of the other ingredients see 7 Further information. Look out for the signs of allergy in 5 Possible side effects If you feel a hypo coming on a hypo is short for a hypoglycaemic reaction and is a symptom of low blood sugar. See 4 What to do in an emergency for more about hypos.

Take special care with Insulatard

If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are drinking alcohol watch for signs of a hypo and never drink alcohol on an empty stomach If you are exercising more than usual or if you want to change your usual diet If you are ill carry on taking your insulin If you are going abroad travelling over time zones may affect your insulin needs and the timing of your injections.

Using other medicines

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment. Talk to your doctor or pharmacist if you take or have recently taken any other medicines, even those not prescribed. Your need for insulin may change if you also take: oral antidiabetic products; monoamine oxidase inhibitors (MAOI); beta-blockers; ACE-inhibitors; acetylsalicylic acid; anabolic steroids; sulphonamides; oral contraceptives; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide or lanreotide.

Pioglitazone (oral antidiabetic medicine used for the treatment of type 2 diabetes mellitus) Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Pregnancy and breast-feeding

If you are pregnant, planning a pregnancy or breast-feeding: please contact your doctor for advice.

Driving and using machines

Ifyou drive or use tools or machines: watch out for signs of a hypo. Your ability to concentrate or to react will be less during a hypo. Never drive or use machinery if you feel a hypo coming on. Discuss with your doctor whether you can drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Talk about your insulin needs 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.
It is recommended that you measure your blood glucose regularly.

Injecting insulin

See overleaf for detailed instructions.

Before using Insulatard

Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination.

Do not use Insulatard

In insulin infusion pumps If FlexPen is dropped, damaged or crushed there is a risk of leakage of insulin If it hasnt been stored correctly or been frozen see 6 How to store Insulatard If its not uniformly white and cloudy when its resuspended.

Insulatard is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein or muscle. Always vary the sites you inject, to avoid lumps (see 5 Possible side effects). The best place to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist.

Like all medicines, Insulatard can cause side effects, although not everybody gets them. Insulatard may cause hypoglycaemia (low blood sugar). See the advice in 4 What to do in an emergency.

Side effects reported uncommonly (in less than 1 patient in 100)

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.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These reactions 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 the 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; feel like fainting. You may have a very rare serious allergic reaction to Insulatard or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Insulatard.

Diabetic retinopathy (eye background changes). If you have diabetic retinopathy and your blood glucose levels improve very fast, the retinopathy may get worse. Ask your doctor about this.

Swollen joints. When you start taking insulin, water retention may cause swelling around your ankles and other joints. This soon disappears.

Side effects reported very rarely (in less than 1 patient in 10,000)

Vision problems. When you first start your insulin treatment, it may disturb your vision, but the reaction usually disappears.

Painful neuropathy (nerve related pain). If your blood glucose levels improve very fast it may cause a burning, tingling or electric pain. This is called acute painful neuropathy and it usually disappears. If it does not disappear, see your doctor.

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 Insulatard after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

The FlexPen that is not being used is to be stored in a refrigerator (2°C - 8°C).
Do not store them in or too near the freezer section or cooling element.
Do not freeze.
The FlexPen that isbeing used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing the FlexPen from the refrigerator it is recommended to let it reach room temperature before resuspending the insulin as instructed for the first time use. See 3 How to use

Insulatard. You can carry it with you and keep it at room temperature (not above 30°C) for up to 6 weeks.
Always keep the pen cap on your FlexPen when you?re not using it in order to protect it from light. Insulatard must be protected from excessive heat and sunlight.

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

What Insulatard contains

The active substance is insulin human made by recombinant biotechnology. Insulatard is an isophane insulin suspension NPH. 1 ml contains 100 IU of insulin human. 1 pre-filled pen contains 3 ml equivalent to 300 IU

The other ingredients are zinc chloride, glycerol, metacresol, phenol, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, protamine sulphate and water for injections.

What Insulatard looks like and contents of the pack

The suspension for injection comes as a cloudy, white, aqueous suspension.
It is supplied in packs of 1, 5 or 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 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 yourFlexPen.

This leaflet was last approved in

Introduction

Please read the following instructions carefully before using your Insulatard 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 and tested to be used with NovoFine and 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.

Insulatard FlexPen Pen capCartridge PointerRubber membrane 12 units Glass ball Residualscale Doseselector Push-buttonNeedle example Needle Big outer needle cap Innerneedle cap Protectiveta

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 Insulatard FlexPen

Check the label to make sure that your FlexPen contains the correct type of insulin. Before your first injection with a new FlexPen you must resuspend the insulin:

A

Let the insulin reach room temperature before you use it.
This makes it easier to resuspend.

Pull off the pen cap.

A

B

Move the pen up and down twenty times between position 1 and 2 as shown, so the glass ball moves from one end of the cartridge to the other. Repeat until the liquid appears uniformly white and cloudy.

For every following injectionmove the pen up and down between position 1 and 2 at least ten times until the liquid appears uniformly white and cloudy.

After you have resuspended the insulin, complete all the following steps of injection without delay.

B

• Always check there are at least 12 units of insulin left in the cartridge to allow resuspension. If there are less than 12 units left, use a new FlexPen.

Attaching a needle

Disinfect the rubber membrane with a medicinal swab.

C

Remove the protective tab from a new disposable needle.

Screw the needle straight and tightly onto your FlexPen.

C

D

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

D

E

Pull off the inner needle cap and dispose of it.

E

• 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:

F

Turn the dose selector to select 2 units.

F

2 units-
selected

G

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.

G

H

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.

H

Selecting your dose

Check that the dose selector is set at 0.

I

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.

I

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.

J

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.

J

K

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.

K

L

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 pen cap back on.

L

• 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.

WHAT TO DO IN AN EMERGENCY

If you get a hypo

A hypo means your blood sugar level is too low.
Thewarning 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 get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest.
Don?t take any insulin if you feel a hypo coming on.
Carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
Tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must: turn you on your side and seek medical advice straight away. They must not give you any food or drink as it could choke you.
- If 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.

Using glucagon

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. Seek medical advice after an injection of glucagon; you need to find the reason for your hypo to avoid getting more.

Causes of a hypo

You get a hypo if your blood sugar gets too low. This might happen:

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

If your blood sugar gets too high

Your blood sugar may get too high (this is called hyperglycaemia).
Thewarning 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 and test your urine for ketones if you can. Then seek medical advice straight away.
These may be signs of a very serious condition called diabetic ketoacidosis. If you don?t treat it, this could lead to diabetic coma and death.

Causes of hyperglycaemia

• Having forgotten to take your insulin
• Repeatedly taking less insulin than you need
• An infection or a fever
• Eating more than usual
• Less exercise than usual.