What is it and how is it used?
NovoMix 30 is a modern insulin (insulin analogue) with both a rapid-acting and an intermediate-acting effect, in the ratio 30/70. Modern insulins are improved versions of human insulin.
NovoMix 30 is used to treat diabetes mellitus in adults, adolescents and children aged 10 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of your blood sugar.
NovoMix 30 will start to lower your blood sugar 10-20 minutes after you take it, a maximum effect occurs between 1 and 4 hours and the effect lasts for up to 24 hours. It may be used in combination with certain oral antidiabetic medicines.
What do you have to consider before using it?
Do not use NovoMix 30
If you are allergic hypersensitive to insulin aspart, or any of the other ingredients of NovoMix 30 see 6 Further information If you suspect hypoglycaemia low blood sugar is starting see 3 How to use NovoMix 30 In insulin infusion pumps If FlexPen is dropped, damaged or crushed If it has not been stored correctly or if it has been frozen see 5 How to store NovoMix 30 If the resuspended insulin does not appear uniformly white and cloudy If clumps of material are present or if solid white particles stick to the bottom or the wall of the cartridge giving a frosted appearance.
Before using NovoMix 30
Check the label to make sure it is the right type of insulin Always use a new needle for each injection to prevent contamination Needles and NovoMix 30 FlexPen must not be shared.
Take special care with NovoMix 30
If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands If you are exercising 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
Some medicines affect the way 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, nurse 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 as mentioned below that 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 (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).
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 [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 both increase or decrease your 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.
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).
Taking NovoMix 30 with food and drink
If you are drinking 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
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, planning a pregnancy or breast-feeding 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.
Driving and using machines
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. Please ask your doctor whether you can drive a car:
– If you have frequent hypoglycaemias
– If you find it hard to recognise hypoglycaemia.
Important information about some of the ingredients of NovoMix 30
NovoMix 30 contains less than 1 mmol sodium (23 mg) pr dose, i.e. NovoMix 30 is essentially ?sodium-free?.
How is it used?
Talk about your insulin dose with your doctor and nurse. Make sure you get the colour-coded NovoMix 30 FlexPen that your doctor and nurse have told you to use and follow their advice carefully.
When NovoMix 30 is used in combination with oral antidiabetic medicines the dose should be adjusted.
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. Do not change your insulin unless your doctor tells you to. Eat a meal or snack containing carbohydrates within 10 minutes of the injection to avoid hypoglycaemia. NovoMix 30 is generally given immediately before the meal. When necessary, NovoMix 30 can be given soon after the meal.
Use in children
NovoMix 30 can be used in children and adolescents aged 10 years and above when premixed insulin is preferred. For children 6-9 years limited clinical data exists.
No clinical studies with NovoMix 30 have been carried out in children under the age of 6 years. Only use NovoMix 30 in children below 10 years, if your doctor has specifically told you to.
Use in special populations
As with all insulin medicines, in elderly patients and patients with renal or hepatic impairment, glucose monitoring should be intensified and insulin aspart dose adjusted on an individual basis.
Method of administration
NovoMix 30 is for injection under the skin (subcutaneously). Never inject your insulin directly into a vein (intravenously) or muscle (intramuscularly).
Always vary the sites you inject within the same region to avoid lumps (see 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 glucose regularly.
If you take more NovoMix 30 than you should
If you take too much insulin your blood sugar gets too low (this is called hypoglycaemia or hypo). This may also happen:
- If you eat too little or miss a meal
- If you exercise more than usual.
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 feel a hypo coming on: take a high sugar snack and then measure your blood sugar. If your blood sugar is too low: eat glucose tablets or another high sugar snack (sweets, biscuits, fruit juice), then rest.
Always carry glucose tablets, sweets, biscuits or fruit juice with you, just in case.
When symptoms of hypoglycaemia have disappeared or when blood glucose level is stabilised continue insulin treatment.
Tell relevant people you have diabetes and what may be the consequences, including the risk of passing out due to a hypo.
Tell relevant people that if you pass out (become unconscious), they must turn you on your side and get medical help straight away. They must not give you any food or drink. It could choke you.
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.
– If prolonged 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.
If you forget to take NovoMix 30
If you forget to take your insulin your blood sugar may get too high (this is called hyperglycaemia). This may also happen:
- If you repeatedly take less insulin than you need
- If you get an infection or a fever
- If you eat more than usual
- If you exercise less than usual.
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.
If you get any of these 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. If you do not treat it, this could lead to diabetic coma and eventually death.
If you stop taking NovoMix 30
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop taking your insulin without speaking to a doctor, who will tell you what needs to be done.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How to handle NovoMix 30 FlexPen
NovoMix 30 FlexPen is a pre-filled disposable pen containing a mixture of rapid-acting and intermediate-acting insulin aspart in the ratio 30/70.
Read carefully the NovoMix 30 FlexPen instructions for use included in this package leaflet. You must use the pen as described in the Instructions for Use.
What are possible side effects?
Like all medicines, NovoMix 30 can cause side effects, although not everybody gets them.
Side effects may occur with certain frequencies, which are defined as follows:
- Very common: affects more than 1 user in 10
- Common: affects 1 to 10 users in 100
- Uncommon: affects 1 to 10 users in 1,000
- Rare: affects 1 to 10 users in 10,000
- Very rare: affects less than 1 user in 10,000
- Not known: frequency cannot be estimated from the available data.
Very common side effects
Low blood sugar (hypoglycaemia).
Uncommon side effects
Signs of allergy. Reactions (pain, redness, hives, inflammation, swelling and itching) at the injection site may occur (local allergic reactions). 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.
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). 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.
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 glucose level improve very fast, the retinopathy may get worse.
Ask your doctor about this.
Rare side effects
Painful neuropathy (pain due to nerve damage). If your blood glucose level improve very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient.
Very rare side effects
Serious allergic reaction to NovoMix 30 or one of its ingredients (called a systemic allergic reaction). See also the warning in 2 Before you use NovoMix 30.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.