NovoMix 30 Penfill 100 U/ml, suspension for injection in cartridge.

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.

In this leaflet:

1. What NovoMix® 30 is and what it is used for
2. Before you use NovoMix® 30
3. How to use NovoMix® 30
4. Possible side effects
5. How to store NovoMix® 30
6. Further information

Do not use NovoMix® 30

• If you are allergic (hypersensitive) to insulin aspart, or any of the other ingredients in NovoMix® 30 (see section 6, Further information).
• If you suspect hypoglycaemia (low blood sugar) is starting (see Other effects from diabetes in section 4).
• In insulin infusion pumps.
• If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
• If it has not been stored correctly or if it has been frozen (see section 5, How to store NovoMix® 30).
• If the resuspended insulin does not appear uniformly white and cloudy.
• If after resuspension, clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge.

If any of these applies, do not use NovoMix® 30. Talk with your doctor, nurse or pharmacist for advice.

Before using NovoMix® 30

• Check the label to make sure it is the right type of insulin.
• Always check the cartridge, including the rubber plunger (stopper) at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the Penfill®. This could be a result of leakage of insulin. If you suspect the cartridge to be damaged, take it back to your supplier. See your pen manual for further instructions.
• Always use a new needle for each injection to prevent contamination.
• Needles and NovoMix® 30 Penfill® must not be shared.

Take special care with NovoMix® 30

Some conditions and activities can affect your need for insulin.

These include:

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• If you exercise 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 your injections. Consult your doctor if you are planning such travelling.

Using other medicines

Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines affect the way blood sugar works in your body and this may influence your insulin dose. Listed below are the most common medicines which may affect your insulin treatment.

Your blood sugar level may fall (hypoglycaemia) if you take:

• 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).

Your blood sugar level may rise (hyperglycaemia) if you take:

• 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 (used 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, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes) Some patients with long-standing type 2 diabetes 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).

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Drinking alcohol and taking NovoMix® 30

• If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast–feeding

• If you are pregnant or planning a pregnancy please contact your doctor for advice. There is limited clinical experience with insulin aspart in pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important, for the health of your baby.
• There are no restrictions on treatment with NovoMix® 30 during breast–feeding.

Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast–feeding.

Driving and using machines

• Please ask your doctor whether you can drive a car or operate a machine:
  • If you have frequent hypoglycaemia.
  • If you find it hard to recognise hypoglycaemia.

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.

Important information about some of the ingredients in NovoMix® 30

NovoMix® 30 contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoMix® 30 is essentially ‘sodium-free’.

Dose and when to take your insulin

Always use your insulin as prescribed by your doctor and follow the doctors advice carefully.

NovoMix® 30 is generally taken immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoMix® 30 can be given soon after a meal. See How and where to inject, below for information.

When NovoMix® 30 is used in combination with tablets for diabetes, the dose should be adjusted.

Do not change your insulin unless your doctor tells you to. 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.

Use in children

NovoMix® 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred. Limited clinical data exists for children aged 6-9 years. Only use NovoMix® 30 in children below 10 years, if your doctor has specifically told you to.

No clinical studies with NovoMix® 30 have been carried out in children under the age of 6 years.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoMix® 30 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly).

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). The best places to give yourself an injection are: the front of your waist (abdomen); your buttocks; the front of your thighs or upper arms. The insulin will work more quickly if you inject around the waist. You should always measure your blood sugar regularly.

• Do not refill the cartridge.
• NovoMix® 30 Penfill® cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine® or NovoTwist® needles.
• If you are treated with NovoMix® 30 Penfill® and another insulin Penfill® cartridge, you should use two insulin delivery systems, one for each type of insulin.
• As a precautionary measure, always carry a spare Penfill® cartridge in case your Penfill® cartridge is lost or damaged.

Resuspension of NovoMix® 30

Always check if there is enough insulin left (at least 12 units) in the cartridge to allow even resuspension. If there is not enough insulin left, use a new one. See your pen manual for further instructions.

• Every time you use a new NovoMix® 30 Penfill® (before you put the cartridge into the insulin delivery system)
  • Let the insulin reach room temperature before you use it. This makes it easier to resuspend.
  • Roll the cartridge between your palms 10 times – it is important that the cartridge is kept horizontal (level with the ground) (see picture A).
  • Move the cartridge up and down between positions a and b (see picture B) 10 times so that the glass ball moves from one end of the cartridge to the other.
  • Repeat the rolling and moving procedures (see pictures A and B) until the liquid does appear uniformly white and cloudy. Do not use the pen if the resuspended insulin does not look uniformly white and cloudy.
  • Complete the other stages of injection without delay.
• For every following injection
  • Move the delivery system with the cartridge inside up and down between a and b (see picture B) at least 10 times until the liquid appears uniformly white and cloudy. Do not use the pen if the resuspended insulin does not look uniformly white and cloudy.
  • Complete the other stages of injection without delay

How to inject NovoMix® 30

• Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.
• Keep the needle under your skin for at least 6 seconds. Keep the push–button fully depressed until the needle has been withdrawn from the skin. This will ensure correct delivery and limit possible flow of blood into the needle or insulin reservoir.
• After each injection be sure to remove and discard the needle and store NovoMix® 30 without the needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing.

If you take more insulin than you should

If you take too much insulin your blood sugar gets too low, this is called hypoglycaemia. See Other effects from diabetes in section 4.

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. See Other effects from diabetes in section 4.

If you stop taking your insulin

Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See Other effects from diabetes in section 4.

Very common side effects

Affecting more than 1 in every 10 people.

Low blood sugar (hypoglycaemia): See details in Other effects from diabetes, below.

Uncommon side effects

Affecting less than 1 in every 100 people.

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, swelling and itching) at the injection site may occur. 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

• If you notice any of these, get medical advice immediately.

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): The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. 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 (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.

Rare side effects

Affecting less than 1 in every 1,000 people.

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.

Very rare side effects

Affecting less than 1 in every 10,000 people.

Serious allergic reaction to NovoMix® 30 or one of its ingredients (called a systemic allergic reaction). See also the warning in section 2, Before you use NovoMix® 30.

• If any of the side effects listed gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

Other effects from diabetes

• Low blood sugar (hypoglycaemia)

Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see Drinking alcohol and taking NovoMix® 30 in section 2).

Warning signs of low blood sugar:

The warning signs 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.

What to do if you experience low blood sugar:

• If you experience low blood sugar, eat glucose tablets or another high sugar snack (sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.

When symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.

• Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

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.

• If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death.
• If you have such a low blood sugar that you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

• High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

• Have not injected enough insulin.
• Forget to take your insulin or stop taking insulin.
• Repeatedly take less insulin than you need.
• Get an infection and/or a fever.
• Eat more than usual.
• Exercise less than usual.

Warning signs of high blood sugar:

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.

What to do if you experience high blood sugar:

• If you get any of the above 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 (build-up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

What NovoMix® 30 contains

• The active substance is insulin aspart. NovoMix® 30 is a mixture consisting of 30% soluble insulin aspart and 70% insulin aspart crystallised with protamine. 1 ml contains 100 U of insulin aspart. Each cartridge contains 300 U of insulin aspart in 3 ml suspension for injection.
• The other ingredients are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, protamine sulphate, hydrochloric acid, sodium hydroxide and water for injections.

What NovoMix® 30 looks like and contents of the pack

NovoMix® 30 comes as a white suspension. The cartridge contains a glass ball to facilitate resuspension. After resuspension the liquid shall appear uniformly white and cloudy. Do not use the insulin if it does not look uniformly white and cloudy after resuspension.

Pack sizes of 5 and 10 cartridges of 3 ml. Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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, VG or ZF

is the manufacturer

• If the second and third characters are H7 or T6

is the manufacturer.