Read all of this leaflet carefully before you start using your insulin.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor, diabetes nurse or pharmacist. This medicine is prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

This side of the leaflet:

• 1. What Insulatard® is
• 2. Before you use Insulatard®
• 3. Using Insulatard®
• 4. In an emergency
• 5. Possible side ef fects
• 6. How to store Insulatard®

Do not use Insulatard

• If you feel a hypo coming on (a hypo is short for a hypoglycaemic reaction and is symptoms of low blood sugar). See 4 What to do in an emergency for more about hypos
• If you have ever had an allergic reaction to this insulin product, metacresol or any of the other ingredients (see box, below left). Look out for the signs of allergy in 5 Possible side effects.

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
• 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
• If you are pregnant, or planning a pregnancy: you must be especially careful to control your blood sugar; too much or too little could harm your health and the baby's
• If you are breast-feeding: there's no risk to the baby, but you may need to adjust your insulin and your diet
• If you 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 should drive or use machines at all, if you have a lot of hypos or if you find it hard to recognise hypos.

Other medicines and Insulatard

Many medicines affect the way glucose works in your body and they may influence your insulin dose. Listed below are the most important medicines which may affect your insulin treatment. Talk to your doctor if you take or change any other medicines, even those not prescribed.

Your need for insulin may change if you also take: oral hypoglycaemic agents; monoamine oxidase inhibitors (MAOI); certain beta-blockers; ACE-inhibitors; acetylsalicylic acid; thiazides; glucocorticoids; thyroid hormone therapy; beta-sympathomimetics; growth hormone; danazol; octreotide and lanreotide.

Injecting insulin

See overleaf for detailed instructions.

Before using Insulatard

• Make sure it is the right type of insulin.

Do not use Insulatard

• If it hasn't been stored correctly or been frozen (see 6 How to store Insulatard)
• If it's not uniformly white and cloudy when it's mixed.

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 is the front of your thighs. If convenient, the front of your waist (abdomen), your buttocks or the front of your upper arms may be used.

You should always measure your blood glucose regularly.

If you get a hypo

A hypo means your blood sugar level is too low.

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 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 people that if you pass out (become unconscious), they should: turn you on your side and get medical help straight away. They should not give you any food or drink. 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. 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.

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).

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 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 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.

Side effects reported rarely

(less than 1 in a 1,000)

Low or high blood sugar. Taking too much or too little Insulatard may cause respectively hypo or hyperglycaemia.

Side effects reported very rarely

(less than 1 in 10,000)

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

Changes at the injection site. If you inject yourself too often in the same site, lumps may develop underneath. Prevent this by choosing different injection sites each time within the same area.

Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually go away after a few weeks of taking your insulin. If they do not go away, see your doctor.

Seek medical advice straight away:

• 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.

You may have a very rare serious allergic reaction to Insulatard or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use Insulatard.

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

If you notice any side effects, also those not mentioned in this leaflet, please inform your doctor or pharmacist.

Introduction

Insulatard InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit. Insulatard InnoLet is designed to be used with NovoFine® S needles of 8 mm or shorter in length. Look for an S on the needle box.

The S stands for short cap.

1A Suspending the insulin

Before every injection:

• Check there are at least 12 units of insulin left in the cartridge to allow even mixing. If there are less than 12 units left, use a new Insulatard InnoLet
• Move the pen slowly up and down between positions A and B and back so that the glass ball moves from one end of the cartridge to the other. Repeat this movement before the first use at least 20 times and for every injection at least 10 times. The movement should always be repeated, until the liquid appears uniformly white and cloudy
• After mixing complete all the following stages of injection without delay.

1B Attaching the needle

• Disinfect the rubber membrane with surgical spirit
• Remove the protective tab from a NovoFine S short cap needle
• Screw the needle straight and tightly onto Insulatard InnoLet
• Pull off the big outer needle cap and the inner needle cap. You may want to store the big outer needle cap in the compartment.

1C Priming to get rid of 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:

• Dial 2 units by turning the dose selector clockwise
• Hold Insulatard InnoLet with the needle upwards and tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge
• Keeping the needle upwards, press the push-button and the dose selector returns to zero
• A drop of insulin should appear at the needle tip. If not, 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.