Why am I using NovoMix® 30 FlexPen®?

The insulin aspart (rys), or “NovoMix® 30”, in NovoMix® 30 FlexPen® is a mixture of rapid- and longer-acting insulin. NovoMix® 30 FlexPen® is used to treat diabetes mellitus. Diabetes mellitus is a condition where your pancreas does not produce enough insulin to control your blood sugar (glucose) level. Extra insulin is therefore needed. There are two types of diabetes mellitus: • Type 1 diabetes • Type 2 diabetes Patients with type 1 diabetes always require insulin to control their blood sugar levels. Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets. NovoMix® 30 lowers your blood sugar level after injection. When injected under your skin, NovoMix® 30 has a faster onset of action than soluble human insulin. It takes effect within 10 to 20 minutes. The maximum effect will occur between 1-4 hours after injection and the effect may last for up to 24 hours. As with all insulins, the duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. NovoMix® 30 is a pre-mixed neutral suspension consisting of rapid-acting insulin aspart (rys) (30%) and longer-acting protamine insulin aspart (rys) (70%).

NOTE

FlexPen® is a pre-filled dial-a-dose insulin pen able to deliver from 1 to 60 units in increments of 1 unit. NovoMix® 30 FlexPen® can be used alone, or together with other medicines, for treating diabetes. NovoMix® 30 is not addictive. NovoMix® 30 FlexPen® is available only with a doctor’s prescription.

What should I know before I use NovoMix® 30 FlexPen®?

Warnings If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help. Get help from a person with good eyesight who is trained to use NovoMix® 30 FlexPen®. Do not use NovoMix® 30 if: • you are allergic to a medicine containing insulin, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine. Some of the symptoms of an allergic reaction may include: • redness, swelling, rash and itching at the injection site • rash, itching or hives on the skin • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body. • you are experiencing a low blood sugar level (a “hypo”) when the dose is due. If you have a lot of hypos discuss appropriate treatment with your doctor. • the expiry date printed on the pack has passed, or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

Pregnancy and breast-feeding

Check with your doctor if you are pregnant or intend to become pregnant. Pregnancy may make managing your diabetes more difficult. Insulin needs usually decrease during the first three months of pregnancy and increase during the last six months. Your doctor can discuss with you the risks and benefits involved. Talk to your doctor if you are breast-feeding or intend to breastfeed. There are no restrictions on treatment with NovoMix® 30 during breast-feeding.

Heart disease or stroke history

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). Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who are treated with thiazolidinediones in combination with insulin may develop heart failure.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines and NovoMix® 30 may interfere with each other. This may mean that your insulin dose has to change.

Medicines that may cause your blood sugar to fall (hypoglycaemia):

• other medicines used to treat type 2 diabetes

• monoamine oxidase inhibitors (MAOI) - used for the treatment of depression

• alpha blockers - used to treat high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate

• non-selective beta blockers -used to treat high blood pressure and certain heart conditions which may also mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia

• ACE inhibitors - used to treat high blood pressure, certain heart conditions or elevated protein/albumin in the urine • salicylates e.g. aspirin - used to relieve pain and lower fever

• anabolic steroids – used to promote growth

• sulfonamides – used to treat bacterial infections

• quinine – used to treat malaria and relieve muscle cramps

• quinidine – used to treat heart problems.

• oral contraceptives (“the pill”) - used for birth control

• thiazides - used to treat high blood pressure or fluid retention (oedema)

• thyroid hormones - used to treat malfunction of the thyroid gland • sympathomimetics such as salbutamol or terbutaline - used to treat asthma

• growth hormone – used to treat growth disorders

• danazol - used to treat endometriosis, menorrhagia, fibrocystic breast disease and hereditary angioedema • oxymetholone – used to treat certain blood disorders

• diazoxide - used to treat high blood pressure

• nicotinic acid - used to treat high cholesterol levels in the blood

• asparaginase - used to treat leukaemia and lymph gland tumours.

Medicines that may cause your blood sugar to rise or fall:

• octreotide – used to treat gastrointestinal endocrine tumours and enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels

• lanreotide – used to treat enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal hormone levels.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NovoMix® 30.

How do I use NovoMix® 30 FlexPen®?

Your doctor, diabetes education nurse or pharmacist will have given you advice on how to use your medicine. Carefully follow all the directions.

What should I know while using NovoMix® 30 FlexPen®?

Things you should do Measure your blood sugar level regularly.

1. Make sure all friends, relatives, workmates or carers know that you have diabetes. If your child has diabetes it is important to tell their teachers and carers.
2. Keep using your insulin even if you feel well. It helps to control your condition, but does not cure it. Tell your doctor if you often have hypos (low blood sugar levels).
3. Your doctor may need to adjust your insulin dose.
4. Always carry some sugary food or fruit juice with you. If you experience any of the symptoms of a hypo, immediately eat some sugary food or have a drink, e.g. lollies, biscuits or fruit juice.
5. Tell your doctor if you have trouble recognising the symptoms of hypos. Under certain conditions, the early warning signs of hypos can be different or less obvious. Your doctor may need to adjust your insulin dose.
6. Remind any doctor, dentist or pharmacist or other health professionals you visit that you have diabetes and are using insulin. Tell your doctor, diabetes education nurse or pharmacist if you are travelling.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol. Alcohol may mask the symptoms of hypos. If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.