NovoMix Suspension

1 ml of the suspension contains 100 U of soluble insulin aspart (rapid acting insulin) /protaminated-crystallised insulin (intermediate acting insulin) aspart in the ratio 30/70. NovoMix ® 30 is used for the treatment of insulin requiring patients with diabetes mellitus.

Do not use NovoMix ® 30:

• If you are allergic to insulin aspart or any of the other ingredients in NovoMix ® 30
• If your blood sugar is too low (hypoglycaemia)
• In insulin infusion pumps
• Into the vein or blood vessel

Warnings and precautions

Take special care with NovoMix ® 30:

• If you have diseases of your kidneys or liver, or with your adrenal, pituitary or thyroid glands
• If you are ill: carry on using your NovoMix ® 30 and consult your doctor
• Pioglitazone (class of oral antidiabetic medicines 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 are treated with pioglitazone in combination with insulin may develop 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).

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoMix ® 30). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medicine dose.

Children and adolescent

Novomix ® 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred.

Other medicines and NovoMix ® 30

Always tell your health care provider if you are taking any medicine. (This includes complementary or traditional medicines.)

Some medicines affect the way your 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 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 mentioned below that may affect your blood sugar level.

If you take any of the below medicines your blood sugar level may fall (hypoglycaemia):

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (used to treat depression)
• Beta-blockers (used to treat high blood pressure) such as propranolol
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure) and ARBs (Angiotensin Receptor Blockers)
• Aspirin (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections)

If you take any of the below medicines 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 (used to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine, or salbutamol, terbutaline used to treat asthma)
• Growth hormone (medicines for stimulation of skeletal and somatic growth and pronounced influence on the body’s metabolic processes)
• Danazol (medicines acting on ovulation) may both 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 a hypoglycaemia.

Octreotide (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.

NovoMix ® 30 with food and drink and alcohol

If you are drinking alcohol your need for insulin may change as your blood sugar level may either rise or fall.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby or breastfeeding please contact your doctor, pharmacist or other health care provider for advice before using NovoMix ® 30. There is limited clinical experience with insulin aspart in pregnancy. Breastfeeding whilst taking insulin does not put your baby at risk, however your insulin dosage may need to be monitored more frequently. Therefore it is important to consult your doctor immediately to discuss your insulin needs in order to control your diabetes and thereby avoid high blood sugar (hyperglycaemia) and low blood sugar (hypoglycaemia) as these conditions could harm you and your baby.

Driving and using machines

Your ability to concentrate and react may be reduced if you have low blood sugar (hypoglycaemia). Please keep this possible problem in mind in all situations where you might put yourself and other people at risk (e.g. when driving a car or operating machinery). You must contact your doctor about the advisability of driving if you have frequent episodes of low blood sugar (hypoglycaemia) or have reduced or absent awareness of warning signs of low blood sugar (hypoglycaemia).

NovoMix ® 30 contains sodium

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

Do not share medicines prescribed for you with any other person.

Dose and when to administer your insulin

You should always use NovoMix ® 30 exactly as your doctor or pharmacist has instructed you. You should check with your doctor or pharmacist if you are unsure.

You should administer NovoMix ® 30 immediately before a meal. When necessary, NovoMix ® 30 may be given immediately after meal. Dosage of NovoMix ® 30 is individualised and determined on the basis of your doctor’s advice in accordance with your needs.

Use in children and adolescent

Novomix ® 30 can be used in adolescents and children aged 10 years and above when premixed insulin is preferred. Limited clinical data exists for children aged 6 to 9 years.

Use in special patient groups

Renal or hepatic impairment may reduce the patient’s insulin requirements.

How and where to inject

Check the label to make sure it is the right type of insulin. The injection can be administered subcutaneously by injection in the abdominal wall, the thigh or the deltoid region, or the gluteal region. Injection sites should be rotated within the same region. When injected subcutaneously into the abdominal wall, the onset of action will occur within 10 - 20 minutes of injection. The maximum effect is reached between 1 and 4 hours after the injection. The duration of action is up to 24 hours. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

Always vary the sites you inject within the same region to avoid or reduce the risk of developing lumps or skin pitting.

Do not use NovoMix ® 30 in insulin infusion pumps. Never administer NovoMix ® 30 intravenously.

Do not use NovoMix 30 ®:

• If it has not been stored correctly or if it has been frozen
• If the re-suspended insulin does not appear uniformly white and cloudy
• If after re-suspension clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge

If you use more NovoMix ® 30 than you should

Low blood sugar (hypoglycaemia) may develop over sequential stages:

Low blood sugar (hypoglycaemia) can be treated by oral administration of glucose or sugary products; it is therefore recommended that you always carry products containing sugar.

Low blood sugar (hypoglycaemia) whereby you become unconscious can be treated by administration of glucagon intramuscularly or subcutaneously by a trained person, or glucose can be given intravenously by a healthcare professional. After regaining consciousness, oral administration of any sugar containing products is recommended to avoid any relapse.

Hypoglycaemia may also happen:

• If you eat too little or miss a meal
• If you exercise more than usual

If you forget to use NovoMix ® 30 or missed a dose of NovoMix ® 30:

If you are Type 1 Diabetes (insulin-dependant diabetes), you may experience hyperglycaemia (i.e. blood sugar gets too high) and diabetic ketoacidosis. High blood sugar (hyperglycaemia) develops gradually over a period of hours or days and includes the following symptoms: Thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite, odour of acetone when you breathe.

If High blood sugar (hyperglycaemia) is not treated, this will eventually lead to diabetic ketoacidosis (with loss of consciousness), which is potentially dangerous and lethal. If you get any of the signs mentioned above, test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.

High blood sugar (hyperglycaemia) may also happen:

• If you repeatedly take less insulin than you need.
• If you get an infection or fever
• If you eat more than usual
• If you exercise less than usual

Do not take a double dose to make up for forgotten individual doses.

If you stop using NovoMix ® 30

If you stop taking your insulin, this could lead to severe hyperglycaemia (high blood sugar) and ketoacidosis. You must never stop using your NovoMix ® 30 even if you are ill, as you may need to have more insulin than normal. This may be especially the case if you have an infection. If you develop a kidney or liver disease, your doctor may lower your insulin dosage. Do not stop using your NovoMix ® 30 without speaking to your doctor, who will tell you what needs to be done. Your doctor will also inform about inadvisability of driving your car or operating machinery should you stop using insulin.

NovoMix ® 30 can have side effects. Not all side effects reported for NovoMix ® 30 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using NovoMix ® 30, please consult your doctor, pharmacist or other health care provider for advice.

The following side effects may occur during NovoMix ® 30 treatment:

(a) Summary of serious side effects

• Anaphylactic reactions (serious allergic reaction) It is a very rare side effect, but it can potentially be life-threatening. 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.

• Low blood sugar (hypoglycaemia) it is very frequent

It develops very frequently. Taking too much NovoMix ® 30 or not eating adequate amount of food or unusual exercise may cause low blood sugar (hypoglycaemia). Please refer to the section,” If you use more NovoMix ® 30 than you should” for treatment of low blood sugar (hypoglycaemia). If you get low blood sugar:

The warning signs of low blood sugar may come on suddenly and can include: cold sweat, cool pale skin, headache, rapid heartbeat, feeling sick, feeling very hungry, temporary changes in vision, drowsiness, unusual tiredness and weakness, nervousness or tremor, feeling confused, difficulty in concentration. If you get any of these signs, eat glucose tablets or high sugar snack (sweets, biscuits, fruit juice), then rest. Do not use NovoMix ® 30 if you feel low blood sugar 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 the side and seek medical advice straight away.

The following side effects are less frequent

• Signs of allergy: Pain, redness, swelling and itching at the injection site. These symptoms usually disappear after a few weeks of taking NovoMix ® 30. If they do not disappear please consult your doctor or pharmacist.
• Refraction disorders (vision problems): When you first start your NovoMix ® 30 treatment, it may disturb your vision, but the disturbance is usually temporary.
• Swollen joints (Oedema): When you start taking NovoMix ® 30, water retention may cause swelling around your ankles and other joints usually this soon disappears.
• Diabetic retinopathy (eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar levels improve very fast, the retinopathy may get worse. Ask your doctor about this.
• Lipodystrophy (Changes at injection site): The fatty tissue under the skin at injection site may shrink or thicken. Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. 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 injection site, tell your doctor or pharmacist. These reactions can become more severe, or they may change the absorption of your insulin, if you inject at such a site.
• The other side effects reported are: Peripheral neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain, this is called acute neuropathy and is usually transient.

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

Keep all medicines out of reach and sight of children.

Before opening: Store NovoMix ® 30 between 2 °C – 8 °C (in a refrigerator), not near the freezing compartment. Do not freeze. Protect from light.

During use or when carried as a spare: Keep NovoMix ® 30, Penfill ® (cartridge) in the outer carton in order to protect it from light. Always keep the pen cap on your FlexPen ® when you are not using it, in order to protect it from light. NovoMix ® 30 (Penfill ® /FlexPen ® ) that you are using or carrying as a spare must be kept at room temperature (at or below 30 °C) for up to 4 weeks. Do not expose NovoMix ® 30 to excessive heat or sunlight. Do not use NovoMix ® 30 after the expiry date stated on the label and carton ‘EXP’. The expiry date refers to the last day of that month. It is recommended to resuspend the insulin as instructed every time you use a new NovoMix ® 30 Penfill ® /FlexPen ®. Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).