Protaphane NovoLet 100 IU/ml suspension for injection in apre-filled pen

Protaphane is human insulin to treat diabetesProtaphane 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. Protaphane is often given in combination with fast-acting insulin products.

Do not use Protaphane

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 Protaphane

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

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 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 diabetes 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 Protaphane

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 Protaphane

In insulin infusion pumps If NovoLet 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 Protaphane If its not uniformly white and cloudy when its resuspended.

Protaphane 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, Protaphane can cause side effects, although not everybody gets them. Protaphane 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 diabetes 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 Protaphane or one of its ingredients (called a systemic allergic reaction). See also warning in 2 Before you use Protaphane.

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, diabetes nurse or pharmacist.

Keep out of the reach and sight of children.

Do not use Protaphane 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 NovoLet 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 NovoLet that isbeing used, about to be used or carried as a spare is not to be kept in a refrigerator. After removing the NovoLet 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

Protaphane. 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 NovoLet when you?re not using it in order to protect it from light. Protaphane must be protected from excessive heat and sunlight.

Protaphane 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 Protaphane contains

The active substance is insulin human made by recombinant biotechnology. Protaphane 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 Protaphane looks like and contents of the pack

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

This leaflet was last approved in

Information on how to use Protaphane NovoLet

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

Introduction

Protaphane NovoLet is a simple, compact pre-filled pen. You can dial doses from 2 to 78 units in increments of 2 units. Protaphane NovoLet 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 indicator Insulin cartridge Glass ball Dosage indicator Colour coding Push button scale Push button

Getting started

Check the label to make sure that your Protaphane NovoLet contains the correct type of insulin. Take off the pen cap.
Resuspending is easier when the insulin has reached room temperature.

Before every injection:

• Check there are at least 12 units of insulin left in the cartridge to allow even resuspending. If there are less than 12 units left, use a new Protaphane NovoLet
• Move the pen up and down between positions a and b and back(picture A) so that the glass ball moves from one end of the cartridge to the other, at least 20 times. Repeat this movement at least 10 times before each injection. The movement must always be repeated, until the liquid appears uniformly white and cloudy
• After resuspending, complete all of the following stages of injection without delay
• 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 Protaphane NovoLet (picture B)
• Pull off the big outer needle cap and the inner needle cap. Do not discard the big outer needle cap.

A Ba b

Priming to expel air

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

• Hold Protaphane 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 C)
• Still with the needle upwards, press the push-button fully down (picture D)
• A drop of insulin must 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.

C D

Setting the dose

• Put the cap back on the pen, with 0 next to the dosage indicator(picture E)
• Check that the push-button is fully down. If it isn?t, turn the cap until the push-button is fully depressed
• Hold your Protaphane NovoLet horizontally. Now you?re ready to set the dose you need
• Turn the cap in the direction of the arrow (picture F) to set the right dose. You?ll feel the cap clicking, and the push-button will rise up
• Don?t 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-buttonshows 20, 40 and 60 units. Every time you fully turn the cap, you set 20 units.

E

Dosage examplesTo 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 G).

G

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

• Don?t 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 fully down. Be careful only to push the push-button when injecting
• Keep the push-button fully depressed after the injectionuntil 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. Don?t use this to set or check your dose; it may not be accurate
• You can?t 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?t 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 the needle after each injection and store NovoLet without a 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 Protaphane NovoLet fully with 0 next to the dosage indicator.
Dispose of your used Protaphane NovoLet carefully without the needle attached.

Maintenance

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

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.